The LASIK industry & the FDA have conspired since LASIK’s inception to purposely withhold information vital to the public in making a truly informed LASIK decision. With Lasikdecision.com, The hope is to show you what the industry and FDA would not and did not even think of doing until LASIK casualties started speaking out, and yet, they still did NOTHING.
Video Testimonies on LASIK, Depression, and Suicide From the April 25th, 2008 Special Hearing of the FDA’s Ophthalmic Devices Panel
“The FDA’s capacity to oversee the refractive surgery industry is in my opinion no different than the doctors who have tarnished it. The FDA has been ineffective in overseeing investigational studies, ineffective in enforcing the policies mandated for the industry, and ineffective in providing thus far the protection that many of us here today should have had.” Dom Morgan (Speaker #6) – April 25th, 2008, FDA Ophthalmic Panel Meeting.
On April 25th, 2008, the FDA’s Ophthalmic Panel held an open public meeting to address ‘Quality of Life’ issues after Refractive Surgery. Among the presenters were Gerry Dorrian, whose son took his own life in 2007 as a result of his complications. David Shell help up charts depicting his distorted vision.
The ‘positive side’ was shown as well. The military spoke stating this was one of the best procedures available for those in the field. Doctors brought in patients portraying LASIK as a miracle.
The panel was made aware that refractive surgery had a complication rate of about 5%. Think about it: If 1 million people had the procedure done, then that means 50,000 (5%) were damaged. Majority rules though, so 50,000 doesn’t mean anything to the FDA. What about 5 million? That would make 250,000 people with complications! When I hear that the FDA is influenced by financial interest, you get no argument, especially since I’ve seen how they work!!!
As the FDA wants information on quality of life, I say give it to them. Anyone who’s had a complication from refractive surgery, send them your story. Let them know what your life is like now. And if you’re sending it to them, copy, paste, and send a copy to any LASIK casualty with a website because they simply cannot be trusted!
What was Presented
1) Dr. Michael Patterson urged discontinuation of LASIK. He said the LASIK procedure on his left eye ruined his vision and quality of life (QOL) and that what doctors often call a good outcome is actually poor. He said he had numerous complications and that FDA?s risk/benefit analysis did not fully evaluate the risks, including quality of vision and dry eye. He said that the LASIK procedure is unsafe, with a 5 percent failure rate. He accused LASIK surgeons of dishonesty and FDA of failing to ensure compliance. He accused the FDA of intentional negligence and noted that there were few adverse event reports, despite numerous customer complaints. He said there was bias in the LASIK QOL study, that ASCRS?s involvement was a conflict of interest, and that the connection between LASIK and suicide was known to the FDA. He said LASIK patients commit suicide at four times the normal rate. He mentioned Dr. Richard Lindstrom as a surgeon with financial COI. He asked FDA to redo the risk/benefit analysis and make the risks known; regulate LASIK centers as Ambulatory Surgical Facilitiess; utilize physicians independent of the LASIK industry in the QOL study; place a moratorium on LASIK devices; evaluate potential dry eye treatments; and stop LASIK procedures. He said that LASIK surgeons should not sit on an FDA panel evaluating LASIK, mentioning Dr. Huang by name.
2) Dean Andrew Kantis said LASIK ruined his vision and that he had spent $30,000 trying to restore his vision, finding no cure. He said that hundreds of patients had contacted him at his website, lifeafterlasik.com, expressing suicidal thoughts. He said that there had been backlash when he spoke out, including a lawsuit and harassment from his surgeon. He asked why his surgeon faces no disciplinary action despite numerous lawsuits. He said that the doctors cover for each other when giving second opinions and in regulatory bodies. He said that doctors lie about the healing period so that the statute of limitations will run out. He urged FDA to investigate flap and pupil size; mandate an updated pamphlet with all known side effects as well as the statute of limitations for malpractice; accurately define LASIK success to exclude patients with complications; review 21 CFR 803.17, which requires the reporting of adverse outcomes; and look into the emotional effect on doctors, patients,
and family. He asked the media to investigate visionsite.net. He asked for the creation of a fund to assist hurt LASIK patients.
3) Glen Hagele spoke on behalf of Barbara Berney and Dr. David Hartzok, founders of the Vision Surgery Rehab Network (VSRN), which helps patients with complications from surgery that alters the eyes? refractive status. Refractive Surgery Syndrome (RSS) is a complex and chronic visual, psychological, and physiological condition. Symptoms include dry eye, which can cause pain and
reduced vision. Vision has a substantial effect on perception. Since a person’s reality is based on perceptions, LASIK alters reality in sometimes disturbing ways. Patients are frustrated by surgeons? denial of complaints, which aggravates the psychological aspects of RSS. Loss of visual quality
reduces well-being, leading to depression and anxiety. How doctors manage LASIK problems affects stress levels and is critical to recovery. Patients whose rehab efforts fail to restore normal vision suffer a higher degree of RSS. The discrepancy between the surgeons? procedural view of success and the patients’ perceptional view of success must be resolved, and QOL investigations must be
impartial and include behavioral and perceptional specialists.
4) Gerard Dorrian spoke on his son, Colin. Colin had LASIK surgery in law school after becoming intolerant to contact lenses due to dry eyes. He was warned that the size of his pupils could affect the procedure but that there was less than one percent of a chance that his experience would be worse than contacts. After treatment, he experienced large starbursts, triple overlapping images, and ghosting off white objects. His eyes were too dry to tolerate contact lenses. He lost contrast sensitivity. He said everything looked ugly and confusing, and he fell into a deep depression. Six and a half years after the surgery, he killed himself.
5) Glenn Hagele spoke for Sandy Keller, who had LASIK in 1999 for myopia. She experiences serious complications and received a settlement for malpractice and improper referral. She met with the surgeon after taking Valium. She had dry eyes and corneal warpage. Her pupil size was 8 mm, but the ablation zone was 6 mm. The blade jammed her eye, and she developed Diffuse Lamellar Keratitis (DLK). Eight weeks postop, her vision was 6 diopters of hyperopia. A subsequent surgery further reduced the effective optical zone and caused myopia and multiple images. Although she had several contraindications for LASIK, her optometrist referred her to an inexperienced surgeon because he had a financial interest in the center and received $1100 for the referral. She filed a MAUDE report in 2001, but the disposition was that there was no record of her existence. Seven additional surgeries failed to restore her eyesight. She suffers from post-traumatic stress disorder and depression.
6) Dom Morgan said he is legally blind due to the improper use of an investigational laser. He had retinopathy of prematurity at birth and 20/50 vision before the procedure. The suction ring destroyed his retinas, and he was dropped from the clinical study. His data was not reported to the FDA, and he
was sued when he went public. In 2003, he filed a petition on medical devices and refractive surgery. It was ignored. He has corresponded with hundreds of injured, depressed, and suicidal patients. He said FDA has been ineffective in enforcing the policies mandated for the industry and protecting the patients. He said FDA’s receiving funding from the industry creates a conflict of interest and harms credibility. He submitted a letter from Dr. Steven Friedman to FDA’s Office of Criminal Investigation summarizing his physicians actions and a letter from Dr. James Salz explaining why he was not a candidate for the procedure, as well as other documents and correspondence with the FDA. He
directed the Panel to his webpage: lasikdecision.com. He urged the Panel to recommend an independent and unbiased study, survey injured patients, investigate doctors for criminal activity, and issue a moratorium on advertising.
7) David Shell spoke on his experience with LASIK. Prior to the procedure, he was farsighted. The procedure damaged his eyes, causing eye pain, double vision, difficulty reading, poor night vision, and clinical depression. He experiences starbursts, double vision, glare, fluctuating vision, floaters, and
impaired vision in dim light. He showed pictures simulating the visual problems. He testified on dry eyes to the FDA in 2002. Dry eyes cause stinging pain, and he has found no effective treatment for it. He said LASIK has inherent problems: severed corneal nerves, weakened corneas, and high order
aberrations. He urged an independent investigation, reclassification of dry eye and visual quality issues as complications, and that FDA look at safety and effectiveness again.
8) Glenn Hagele spoke for Barry Elbasani, a quadriplegic with limited arm mobility. Due to his disability, he was unable to put on or adjust his glasses or put in contact lenses. Mr. Hagele showed a video of a news story about Dr. Daniel Durrie, who gave free LASIK surgery for people whose arms are
paralyzed.. After the surgery, Mr. Elbasani?s vision was 20/10 and he gained added independence. He and Dr. Durrie founded Focus on Independence, which helps quadriplegics get LASIK from doctors who donate their time and expenses.
9) Glenn Hagele, Executive Director of the Council for Refractive Surgery Quality Assurance, said his Council provides surgeon certification, distributes objective information, and runs the website usaeyes.org. He said that LASIK patients measure success by QOL, so the Council uses that standard. Patient satisfaction is based on expectations. The Council developed the USAEyes CORE
survey (Confidence Opinion Relative to Expectation). Patients from multiple centers and different types of surgery are mailed copies of the survey. In the preliminary data, 89 percent of patients are seldom or never wearing corrective lenses; 98 percent of patients say their quality of day vision is as expected or better, 91 percent for night vision. 96 percent report overall quality of vision was as expected or better. 99 percent reported QOL was as expected or better. 0.9 percent reported QOL worse than expected. 98 percent of the patients said they would recommend the surgery and 97 percent would do it again. He submitted the preliminary data to the Panel and suggested that FDA
look at other endpoints in addition to QOL.
10) Dr. Diana Zuckerman, President of the National Research Center for Women and Families, said that there are problems with self-reports, which are subjective. She said that there are safe, effective, and inexpensive alternatives to LASIK: contact lenses and glasses. The risks must be
weighed against the benefits. She noted that product labeling is important, since patients don’t read the FDA website, which does not appear to be geared toward patients. She said the Panel should address eye pain, dry eye, the need for additional surgery, higher suicide rates, and informed
11) Dr. Lauranell Burch, speaking as a private citizen, said the task force to examine post-LASIK QOL issues is dominated by individuals with conflicts of interest. She mentioned specifically Dr. Kerry Solomon. She said a growing body of evidence indicates that LASIK is harmful and that even satisfied
patients have reduced contrast sensitivity and are unaware of the damage incurred or the long-term effects, such as the risk of flap injury, weakened cornea, permanent pathologic changes to the cornea, altered patterns and density of corneal nerves, complications in future cataract surgery, invalidated intraocular pressure motion, and an increased rate of progressive corneal stromal cell density loss. She said patient satisfaction is not a substitute for objective testing and urged FDA to abandon the QOL study for a study on dry eye and visual quality and that approval be withdrawn pending the outcome of the study.
12) Matt Kotsovolos spoke on his experience with LASIK. Though his vision was corrected to 20/20, he has had debilitating eye pain since the surgery. He said the complication rates were misrepresented and that the procedure is marketed unethically. He said some complications are called symptoms and occur at rates of 20 percent. He cited a study that reported dry eyes in 20 percent of patients and worsened night vision in 15 percent. He emphasized that patient satisfaction is not an accurate measure of complications and that surveys are easily skewed. He raised the issue of LASIK-related depression and suicide and urged a moratorium on LASIK until a comprehensive study of the complications is completed. He asked that dry eyes and night vision disturbances be included in the labeling as complications. He said the FDA is controlled by the industry.
13) Beth Kotsovolos spoke on her experience as the wife of a LASIK patient. She said the complications, including dry eyes, pain, and depression, nearly destroyed her family. She asked the Panel to be objective and asked the media to hold FDA accountable. She asked FDA to investigate post-LASIK depression and suicidal ideation.
14) Dr. Kerry Solomon spoke for Dr. Richard L. Lindstrom, an attending surgeon at the Minnesota Eye Consultants, board member of TLC Vision, former president of the American Society of Cataract and Refractive Surgery (ASCRS), and consultant for AMO, Bausch & Lomb, and Alcon. He has performed numerous surgeries, including surgeries upon friends, family, and colleagues. He said 30 percent of LASIK surgeons undergo LASIK. He said ASCRS is the primary source of information on the field and that a decade of research reinforces the safety and efficacy of LASIK. He said the satisfaction rate for LASIK is higher than for any other procedure and that ASCRS continues to learn about patient satisfaction in order to improve it. The Joint LASIK Study Task Force is a collaboration to better understand the impact of LASIK on QOL. The Task Force includes ASCRS, the American Academy of Ophthalmology (AAO), the National Eye Institute (NEI), and FDA.
15) Dr. Eric Donnenfeld, spoke for the ASCRS. He is a consultant to AMO and Bausch & Lomb and was an FDA investigator for an excimer laser. He said that the majority of patients see better after the surgery than they did with glasses or contacts and that the lifetime risk of infection with contact lenses is over 100 times higher than with LASIK. The LASIK Task Force of the ASCRS reviewed
the world’s literature on dry eye and found that 35 percent of patients had dry eye after the procedure, but 32 percent had it before the procedure. Severe dry eye following LASIK is rare. New treatment options for dry eye are in the process of FDA evaluation. He introduced Nick Anderson, who received a corneal transplant at 9 years old whose vision was subsequently markedly improved when he received LASIK at 15.
16) Dr. Scott Barnes spoke for Dr. Doyle Stulting, who represented ASCRS. Dr. Stulting participated in a clinical trial of LASIK, was a former chairman of the Ophthalmic Devices Panel, and is a consultant to AMO. He said most patients achieve 20/20 vision or better and have less night driving difficulty after than before LASIK. Methods have been developed to correct abnormalities of the ocular system, address unique patient needs, and evaluate the eye in greater detail. Screening procedures have been instituted to identify the patients who might have sub-optimal results. At his center, an initial examination lasts two hours and includes an eye examination, wavefront measurements, detailed analysis of the cornea, measurement of the pupil, assessment of tear production,
evaluation of the ocular surface, and a discussion with the patient. The Task Force will allow further refinement of the screening process. Dr. Barnes of the Warfighter Refractive Eye Surgery Program emphasized the importance of LASIK to the military.
17) Dr. Kerry Solomon, an eye surgeon at the University of South Carolina; an investigator in the LASIK study; and a consultant for AMO, Alcon, and Bausch & Lomb, spoke for ASCRS. He has reviewed the world’s literature on patient satisfaction and found that 95.4 percent of patients are satisfied after LASIK. The review included all articles from LASIK’s inception to 2008. Of 2,915 abstracts found, 309 were identified and entered into the database. Those articles were well-performed, peer-reviewed studies from major ophthalmic journals. The 95 percent satisfaction rate was consistent throughout the studies. The study creates a baseline of knowledge for identifying and reducing risks.
18) Todd J. Krouner, Esq. a plaintiff’s malpractice attorney, said that most of his cases involve high-volume LASIK facilities that fail to properly screen for contraindications such as kerataconus. He urged FDA to encourage effective training; encourage reporting of adverse outcomes; commission an independent study on LASIK patient satisfaction; and report on the findings in a timely basis. He said the industry does not effectively police itself and that training levels vary widely. The screening process requires time and care. Adverse outcomes are under-reported. Voluntary reporting should be
encouraged; mandatory reporting failures should be enforced. He said patient satisfaction should be measured by qualitative and quantitative measures. Visual acuity is only half of one’s vision. He pointed out that even if the negative outcome rate is one only percent, that would be 10,000
patients per year suffering visual disability.
19) Dr. Peter McDonnell of Johns Hopkins University, who was involved in clinical and pre-clinical studies, said he has received federal research funding and has been an industry clinical investigator. He is a consultant for an excimer laser manufacturer. He spoke on behalf of the International Society of Refractive Surgeons of the American Academy of Ophthalmology (ISRS of AAO). He said LASIK is the most studied elective ophthalmic procedure, that it has benefited millions of patients, and that there have been incremental improvements to the procedure. Most complications can be treated without any vision loss, and side effects often resolve after 3 to 6 months. ISRS is dedicated to further improving the technology, techniques, and screening.
20) Dr. Jennifer Morse a psychiatrist, ASCRS consultant, and member of the Joint LASIK Study Task Force, said she had seen the benefits of LASIK in military and civilian populations. Psychological well-being is an important QOL issue. The literature on suicide and depression indicate that they occur due to multiple factors and are too complex to link to a single cause. There is no scientific evidence of any direct link between LASIK and depression or suicide. Studies from other elective surgeries have found associations between pre-operative psychological factors and patient perceptions of surgical outcome. Current data shows that QOL after LASIK is similar to patients who never had vision problems and that users of glasses or contacts have lower QOL scores than LASIK patients. She welcomed the knowledge the QOL study will provide, which will aid in pre- and post-LASIK counseling.
21) Dr. Steve Schallhorn spoke for AAO. While in the Navy, he founded the DoD Refractive Surgery Program, and he is a consultant to AMO. AAO is committed to responding ethically and compassionately to patients’ needs. He said that LASIK is safe and effective and that patient satisfaction is excellent. He said the next step is to focus on QOL. Current studies show an overall QOL improvement after LASIK, but the studies could not fully assess QOL in patients who were dissatisfied. He said the collaborative study will further evaluate underlying factors that impact satisfaction. Due to the low dissatisfaction rates, the study will enroll a large set of patients in order to capture the factors associated with dissatisfaction.
22) Dr. Terylyn F. Bankes was a physician counselor for several LASIK patient support groups. Group members had vision problems and various emotional responses. Many became obsessed with their vision and became estranged from family and friends. She said LASIK problems are well-known in the
ophthalmologic community and that defending the practice is disgraceful. She asked FDA to protect the patients. She told of a patient, Kim Harringer, who had RK surgery 14 years ago, then LASIK in 2006 when her vision regressed. LASIK caused vision problems, which caused suicidal depression. Dr. Bankes said there is a lot of catching up to do with understanding and treating poor outcomes.
23) Dr. Michael Mullery said that the industry has known about the risk of depression and suicide since inception. Bad outcomes are not rare and can result in serious vision loss and blindness. He said allowing the industry to conduct the QOL study is a conflict of interest and is inconsistent with the
scientific method and common sense. He cited the Grifffith University-World Health Organization study that compared suicides in hearing impaired and vision impaired populations. Vision loss was a greater risk factor for suicide, and vision loss was the main causal factor in those suicides, while the hearing loss suicides were linked to several causes. He said he had personally interviewed approximately 75 people with suicidal ideation as a result of LASIK. Since preexisting psychopathology was not the cause of suicidal ideation, screening would not solve the problem. He presented examples from his practice with suicidal and depressed LASIK patients. He said that research on this issue is lacking and urged a moratorium on the procedure until the risks are
understood. He also urged that the labeling reflect the risks.
24) Courtney Henrichs said ASCRS provided her travel. In 2002, she broke her neck skiing and became a quadriplegic. In 2006, she had LASIK through the Focus on Independence Program. Prior to the accident, she had worn contact lenses. After the accident, she wore glasses, which she could not put on, clean, or adjust by herself. She said the surgery improved her independence and her quality of life.
25) Todd Krouner, Esq., spoke for his client, Amanda Campbell, whose husband committed suicide this year. Mr. Campbell’s suicide note states that he was not a candidate for LASIK and that his adverse outcomes including dry eyes, pain, and distorted vision that made life unbearable. He had no known mental illness prior to the surgery. Mr. Krouner said FDA should investigate the association between suicide and depression. He urged FDA to be transparent in its work and respond to FOIA requests in a timely manner.
26) Dr. Roger Davis, a clinical psychologist, said he has communicated with 300 patients with LASIK complications, 100 of whom had suicidal ideation. In a study with the Surgical Eyes Foundation, most patients with suicidal ideation had been told by their surgeon that they were successes. The complication most strongly associated with suicidality was dry eye syndrome. With severe complications, patients develop RSS, which includes depression, suicidal ideation, and post-traumatic stress. Patients consider suicide after having exhausted the search for solutions, feeling like a victim of a corrupt industry, wishing to escape the complications and anxiety, wishing to validate their
suffering, or out of guilt for having the surgery. No pre-existing psychopathology is necessary for patients to develop suicidality. Research has shown psychological crisis after a catastrophic injury. He asked that the study address psychological issues such as deception and informed.consent. He said satisfaction surveys are inadequate for studying depression. He urged a moratorium on LASIK, since the QOL data should have been collected before approval.
27) Jo Ann Wills spoke for her husband, Keith, who had LASIK in 1997. Unknowingly, he was part of an IDE study. The doctor performed seven procedures, first under-correcting, then over-correcting. She said the doctor was deceitful. She said her husband had vision problems: starbursts, ghosting, and multiple images. She said FDA is not adequately policing the industry. She noted that nine of the Panel members wear glasses.
28) Dr. Edward Boshnick, an optometrist in private practice, said he devoted much of his practice to non-surgical treatment of patients with lost quality of vision due to ocular trauma, disease, and LASIK. Complications he had seen included loss of visual acuity. visual distortions, overcorrection and
undercorrection, , dry eye, loss of contrast sensitivity, corneal ectasia, and depression. He said that LASIK presents a significant health crisis.
29) Rebecca Petris, founder of Laser My Eye, said she left her former career in finance due to LASIK complications. Since dry eye is such a common problem, she founded the Dry Eye Company, which runs informational websites and collects products that can help. She said that LASIK-related depression is caused not only by the failed procedure but also by the way the patients are treated
afterward and problems that develop as a result of the complications and lack of solutions. She said that if the industry wanted to help it would partner with consumer groups to bring practical solutions.
30) Lt. Col. Scott Barnes, M.D., a cornea and refractive surgery specialist at Ft. Bragg, said that before becoming an eye surgeon he worked with Special Forces. The Army has created a program to correct the vision of Special Forces soldiers. The soldiers have found that LASIK greatly improves QOL and
their ability to perform their duties. Vision is important in such operations, and the loss of glasses while parachuting can be disastrous. Additionally, if captured, a soldier’s glasses are likely to be taken. He asked that the procedure not be made unavailable.
31) Joseph Schnell spoke on his experience after having LASIK in 2007. Though his doctor said he had a positive result and determined no significant problems in subsequent evaluations, Mr. Schnell regards his vision as inferior to what it was before the procedure. He experiences glare, halos, starbursts, astigmatism, poor dim light perception, double vision, increased floaters, dry eyes, and psychological problems, including anxiety and suicidal ideation. He said what are described as possible side effects are actually universal. He said informed consent was not handled properly.
32) Chairperson Weiss opened the floor to questions from the Panel. Ms. Cofer asked about the metaanalysis and whether or not the studies were representative of standard of care. Dr. Donnenfeld said that well-trained surgeons can achieve results better than those in the metaanalysis, since most
of the results were obtained on old technology. However, there will always be some doctors who are better than others. Complications and satisfaction do not necessarily have a one to one relationship, so complication rates cannot be derived from satisfaction rates. The studies in the metaanalysis varied widely in follow-up time. Ms. Cofer further asked about dry eyes and night vision in the studies. Dr. Donnenfeld said the percentage of patients reporting dry eye before the surgery was similar to the number reporting it after. Chairperson Weiss asked about the rate of severe effects. Dr. Schallhorn said the percentage of complications being discussed were very rare, under one percent. Mr. Bunner asked about informed consent and second opinions. Chairperson Weiss
said that would vary by practitioner.
Donna Bea Tillman, Ph.D., opened the FDA presentation. The meeting’s purpose was to gain information from the public and to hear discussion among the Panel members relating to LASIK and phakic intraocular lens (PIOL). She gave an overview of the medical device review program. CDRH?s mission is to balance risk and benefit in medical devices,
getting devices to market quickly while ensuring safety and effectiveness. FDA does consumer outreach to inform the public and help make appropriate decisions. Because devices span a wide spectrum of risk, there is a spectrum of
regulatory approaches to reviewing a device and three device classes, Class I being the lowest, Class III being the highest and requiring pre-market approval. LASIK and PIOL devices are Class III and were both approved by PMA to the level of a reasonable assurance of safety and effectiveness as defined by 21 CFR 860.7.
Labeling plays a role in ensuring that physicians and patients have access to appropriate information on safety and appropriate use. The physician labeling includes indications, contraindications, warnings, precautions, and a summary of the clinical study. Patient labeling includes a description of the procedure, risks and benefits, and questions to ask the doctor. FDA does not regulate the practice of medicine.
After approval, there is continued monitoring of device performance, including post-approval studies (PAS),
mandatory adverse event reporting, annual reports from the manufacturers, and interaction with the clinical and scientific communities, and monitoring of the literature. Manufacturers make device modifications, and post-approval data can
facilitate updated labeling. Devices are constantly evolving, and FDA has an active role throughout the life cycle of the product.
Kwame Ulmer, M.S., presented on LASIK?s regulatory background. Conventional LASIK was first approved in 1998. The treatment was based on manifest refraction and input by the surgeon. Subsequent developments
include wide beam lasers, small spot tracking lasers, eye trackers, transition zones from optical zone to cornea surface, larger optical zones, Wavefront-guided lasers, eye torsional control, and iris registration. LASIK systems have been
approved for myopic astigmatism and hyperopic astigmatism.
To approve the devices, FDA requires a complete and detailed device description, reviews engineering tests, evaluates the software, and evaluates patient alignment. Maintainance procedures are reviewed.
Labeling ensures that risks and benefits are communicated to the doctor and patient. The contraindications, warnings, and precautions are identical in the patient and physician labeling. Physician labeling includes a detailed device description and a summary of the clinical trial, while patient labeling uses plainer language and includes basic concepts
of vision and refraction as well as a glossary.
One example of a contraindication is keratoconus; patients with keratoconus should not have LASIK surgery. Warnings are the second highest level of risk communication. Patients with dry eyes or severe allergies are warned that LASIK may be riskier for them. Precautions include conditions that should be discussed with the doctor. Precautions
include unstable eyes or a history of corneal disease or injury.
FDA also encourages, via the labeling, that doctors check for undiagnosed dry eye and measure pupil size in dim light.
The LASIK website was launched in 2000 and is frequently updated. There has been an average of 650,000 visits per year. LASIK related injuries is the top search term on the FDA website. The site includes a checklist for patients to see if they are good candidates and outlines of risks and expectations. Patients are informed of the
contraindications, warnings, and precautions. The site explains what symptoms to expect over six months and notes that long term data is not available. FDA does not recommend specific doctors but provides items to consider when
selecting a physician.
Gene Hilmantel, O.D., M.S., gave an overview of the American National Standards Institute (ANSI) laser standard. FDA is evaluating standard Z80.11, which concerns laser systems for corneal reshaping, for recognition. There are two broad categories of standards: horizontal standards that address basic principles applicable to many product lines and vertical standards, which are specific to one kind of device. Standards address terminology, test methods, acceptable levels of performance, and examples of clinical protocols. For ophthalmic vertical standards, there are two
organizations: ANSI and the International Organization for Standardization (ISO). ANSI is the sole US representative to ISO. Use of standards ensures consistency and predictability, reduces data reporting requirements, and results in reduced review time. The FDA Modernization Act allows FDA to recognize voluntary consensus standards and requires FDA to publish a list of recognized standards. FDA recognizes 30 ophthalmic standards.
ANSI Z80.11 for laser systems for corneal reshaping was published in 2007. The pre-clinical section of the standard outlines laser safety requirements. The clinical section outlines a consensus of an adequate clinical study for refractive lasers, calling for staged enrollment and 300 eyes in the study to detect adverse events with an expected
rate of 1 percent or greater. The standard outlines a methodology to determine when refractive stability is attained and calls for effectiveness analyses that assess the predictability of the refractive change and uncorrected visual acuity
(UCVA). The recommended safety analyses include assessment of the percentage of eyes that lose 2 lines or more of best spectacle corrected visual acuity (BSCVA), percentage of eyes with BSCVA worse than 20/40, percentage of eyes with an increase in refractive astigmatism greater than 2 diopters, and the rates of adverse events.
The standard recommends a validated questionnaire to measure subjective outcomes. There should be questions regarding glare, halos, double vision, night driving, and use of spectacles or contact lenses. The scaling system for the ratings should be specified, and the ratings should be used to assess the incidence of clinically significant symptoms and any postoperative change in symptoms compared to preoperative status. Postoperative satisfaction and use of distance correction should also be incorporated in the questionnaire.
The standard also calls for a contrast sensitivity sub-study when features of the laser raise concerns about vision loss or to justify reductions in precautionary labeling. The ANSI standard created a basic structure for pre-clinical and clinical studies and includes comprehensive evaluation of numerous safety and effectiveness standards.
Quynh Hoang, M.S., spoke on FDA?s postmarket review, which FDA conducted in 2006 in response to complaints from patients. CDRH convened an action team that compared postmarket data (AE reports, literature, recall information, and comments on the FDA web page) to premarket data (PMAs, trial protocols and results). The literature survey included 15 articles studying QOL. The action team concluded that the postmarket literature was not comparable to the pre-market data, since the scoring methods differed and the patient-reported outcomes were covered by a very small number of articles. Both pre- and postmarket surveys showed a high level of satisfaction, and the
postmarket literature did not suggest widespread problems. The surveys do not adequately evaluate the effects of rare and severe events. The action team recommended that FDA consider further evaluation of post-LASIK QOL in a clinical setting. CDRH is carrying out that recommendation.
Eva Rorer, M.D., spoke on the LASIK QOL Assessment. Patient-reported outcome (PRO) measures and PRO QOL. A PRO measure comes from the patient without interpretation by the physician or anyone else. It adds an
evaluation measure independent of clinical success. Health-related (HR) QOL represents the patient?s perception of the impact of a health condition and treatment. PRO categories include symptoms, functioning, and perceptions.
Measurement of PRO must be standardized. Questions must be evaluated for their ability to measure. The use of existing instruments is desirable for comparability. A questionnaire should be validated for content validity, criterion validity, construct validity, internal consistency, and test-retest reliability. The questionnaire must be tested in different populations to assess generalizability. Due to the cost and complexity, there are few validated LASIK QOL questionnaires. The first was published in 2000. PRO are assessed during device clinical trials but are not generally used as primary endpoints. PRO data is considered during application review, is incorporated in labeling, and may be used as primary endpoints in post-market studies.
Based on the PMI Action Team’s recommendation, FDA considered a large prospective study to evaluate LASIK outcomes. FDA solicited cooperation with NEI, ASCRS, and AAO to form the joint LASIK Study Task Force, and the Task Force members have committed resources toward a multi-center clinical trial investigating QOL after LASIK. The objectives are to measure levels of satisfaction after LASIK, changes in HR-QOL after LASIK, and factors associated with the level of satisfaction after LASIK. The protocol is not yet finalized, and the group is assessing the appropriate instrument, which will be validated and easy to use in clinical practice as well as premarket and postmarket studies. FDA has an integral role in the study design and execution and will objectively evaluate the information collected. Consumer representation will be included.
FDA initiated a collaborative study with NEI to facilitate use of HR-QOL instruments in device trials. The study will add to the body of knowledge in the field of PROs and validate computer administration of ophthalmic HR-QOL instruments. Outcomes of all studies will be made public and could lead to modification of the FDA website, revised labeling, and modified educational outreach.
Bernard P. Lepri, O.D., M.S., M.Ed., spoke on FDA?s adverse event data collection. The best known program is MedWatch, which monitors for safety information and adverse events post-approval. Reports come from manufacturers, user facilities, healthcare professionals, patients, and consumers. There are two main categories of device reporting: mandatory and voluntary. Mandatory reporting is required of medical device manufacturers and user facilities. Voluntary reporting is by healthcare professionals and consumers.
MedSun is a subset of mandatory user facility reporting that allows interactive two-way collaboration between FDA and MedSun participants. MedSun is a network of highly trained reporters who recognize and report device problems. It is designed to identify, understand, and solve problems and provides regular feedback by newsletters, conference, webcasts, and alerts. MedSun reports are encrypted, stored securely, and accessible only to staff with security clearances.
SightNet was made as a subset of MedSun in 2007 to provide a real-world view of ophthalmic medical device use in a variety of settings. The goal is to amplify signals of potential device problems to aid in timely intervention and risk mitigation. Participants collaborate with FDA and other facilities to understand potential safety issues. Participant sites designate at least one reporter per site and agree to actively participate for at least a year. Reports are confidential. Problems that are reported include problems with labeling, packaging, manufacturing, software, function, and interaction with other devices, as well as human factors and problems with off-label use. FDA aims to collect reports on all ophthalmic medical devices in use and on a wide variety of adverse events. For LASIK, FDA is looking to collect data on adverse events such as infectious keratitis, endemic cases of DLK, abnormal trends in post-op topography, significant losses of BCVA, glare, halos, starbursts, and distortions as well as device failures.
PANEL QUESTIONS FOR FDA
Dr. Heuer asked about existing validated dry eye instruments. Dr. Eydelman said they were incorporated into the NEI-FDA pilot. Ms. Niksch asked about the QOL study protocol and whether there would be psychodynamic profiling questions. Dr. Eydelman said the protocol was not finalized. There is discussion of incorporating several domains of previously validated questionnaires to provide the best questionnaire possible. The questionnaire will be administered pre- and post-surgery. Ms. Cofer asked how it is enforced that the patients actually get the labeling. Dr.
Eydelman said that FDA regulates manufacturers, not physicians. However, the patient labeling is part of the approval package and is downloadable, so it is available. Dr. Musch asked if the ANSI standard should indicate the time post-operative that QOL should be measured. Dr. Eydelman said the times are specified in the ANSI standards. The Panel was provided with a synopsis of the standard, not the actual standard. Dr. Musch questioned the statement that refractive change is not statistically different from zero and that the 95 percent confidence interval does not include zero. Dr. Hilmantel said there was a mistake on the slide. Dr. Musch asked how contrast sensitivity would be measured. Dr. Hilmantel said it is described in detail in the standard. Dr. Musch asked what would be compared among QOL trials. Dr. Rorer said that would be known when the protocol is finalized. Dr. Musch recommended the Centers for Epidemiologic Studies depression instrument as an existing validated instrument for depression.
Dr. Heuer said that epithelial ingrowth requiring reoperation should be considered an important adverse event
for reporting. Mr. Bunner asked how baseline history for a change in refractive state would be evaluated. Dr. Eydelman said the recommendation was to establish the refraction either by history, comparison to the prescription. Chairperson Weiss said that a surgeon can tell by the patient?s glasses whether or not there has been a significant change.
Dr. Huang asked if the public has access to SightNet data. Dr. Lepri said reports and recommendations are
available online, but the information is anonymous. Dr. Eydelman added that the FDA analyzes and summarizes the data before it is released. Chairperson Weiss asked if there was any way to verify that what is happening is being reported. Dr. Lepri said there is no check but that MedSun?s being a voluntary system suggests that the participants will comply. Dr. Eydelman said a cross-check could be run against the mandatory reporting. Ms. Cofer asked if the ANSI standard would supercede the guidance document. Dr. Eydelman said that would be considered if the standard is accepted. Ms. Cofer said that some terms in the ANSI standard, especially regarding symptoms, are very confusing. Dr. Eydelman said that the patient labeling has a glossary but that the Panel can suggest modifications. Ms. Niksch asked if there would be industry representation in the QOL assessment. Dr. Eydelman said there was no such intent at this time. Dr. Heuer asked about centers not subject to mandatory reporting. Dr. Eydelman said most LASIK is done in ambulatory surgical centers, and serious adverse event reporting is mandatory. Dr. Musch asked about the organizations’ financial support of the QOL study. Dr. Eydelman said that precautions were being taken to prevent conflicts of interest.
Commander David J. Tanzer, M.D., Program Director of the US Navy Refractive Surgery Program, spoke on what refractive surgery means to the military. He said he had no financial conflicts of interest and spoke for himself. The military has demanding visual requirements for aviators, Special Forces operatives, and infantry. Modern weapons systems use sophisticated optical devices, and all personnel are trained in chemical and biological protective gear. Contact lenses cannot be worn by personnel deployed to Iraq, Afghanistan, or Korea. Approximately 30 percent of military personnel needs glasses or contact lenses. DoD has performed 45 studies in order to independently validate the safety and effectiveness LASIK as applies to the military.
In a study in naval aviators that randomized 480 aviators over 4 different eximer lasers showed that 94 percent of the eyes treated attained uncorrected 20/20 or better. The majority of eyes showed no change in BCVA or a gain in lines. There were few complications; 0.5 percent experiences a haze that was treated with topical steroids. 100 percent of patients treated to date have returned to flight status.
In the laser comparative trial, 90 percent of all eyes treated were 20/20 or better uncorrected at one month. Most patients show no change or a gain in lines of BCVA at six months. In the keratome comparison trial using the wavefront-guided laser, the majority of patients had excellent uncorrected visual acuity at one month. At 3 months, the
majority of patients have a gain or no change in lines of corrected visual acuity. The overall satisfaction rate for LASIK was 98.1 percent. A night driving simulator test demonstrated that 15 percent of patients were improved at detecting a target after surgery, 25 percent at identifying the target. A flap stability study showed the flap to be stable to a level of force equivalent to a high altitude low opening jump.
The LASIK procedure in naval aviators showed 100 percent of eyes treated at 20/20. 100 percent of patients said they would recommend the procedure. DoD currently has 20 centers for refractive surgery and has performed on over 224,000 eyes. The average age of the patient is 34, and 82 percent of patients are male. Refractive errors range from plus 6 diopters of hyperopia to minus 13 diopters of myopia. Laser vision correction is approved for all aspects of military service and for astronauts. However, the procedure has risks and is voluntary. There has been one DoD medical disability retirement related to laser vision correction. The patient achieved 20/20 but had vision complaints. The procedure has been successful and has shown operational benefits in the military. Satisfaction has been high.
Dr. McLeod asked about patient selection. Dr. Tanzer said the preoperative process is exhaustive, including testing, and patients come pre-screened by optometrists. After all the testing, there is an extensive informed consent process. He said that pupil size does not predict post-operative quality of vision. Dr. Weiss asked how many patients are
screened out. Dr. Tanzer said approximately 10 percent of patients are screened out at the centers but he did not know what percentage of patients were screened out by the referring optometrists.. Ms. Cofer asked about contrast sensitivity testing. Dr. Tanzer said the night driving simulator simulated headlight glare from a rearview mirror. Dr. Edrington asked what reasons are used to exclude a patient. Dr. Tanzer listed cornea physiology, irregular topographies, thin corneas, and refractive instability.
FDA QUESTIONS AND PANEL DISCUSSION
Please discuss any recommendations you may have for modifications to
patient labeling of excimer lasers for LASIK.
Panel Consensus was that
the labeling should include mention of the post-operative difficulty of checking
intraocular pressure; the difficulty of implant measurement for cataract surgery
after LASIK; illustrations of visual symptoms like halo and starburst; strong
wording concerning patients with keratoconus, pellucid marginal degeneration,
and other ectatic disorders; and a distinction between patients with collagen
vascular disease and patients with collagen vascular disease and dry eyes.
There was discussion on addressing psychological issues, but the Panel was
unsure how to do so. There was discussion on hormonal replacement therapy
affecting dry eyes.
Please discuss any
recommendations you may have for modifications to FDA’s LASIK website.
Panel consensus was to
recommend more information on what is meant by ?risk-taker;? photographs of what
the visual disabilities look like; statistics on the frequency of adverse
events, side effects, and complications; a link to the patient labeling; an
emphasis that reading glasses will be needed in middle age; an area on
retreatment; clarification on contact lens removal and refractive stability; and
a link to a valid dry eye instrument, if there is such an instrument. The Panel
recommended rewriting the “When is LASIK not for me” portion of the website to
make it more coherent. The Panel recommended revising the mention of steroid
and the question about the pupils (to correspond to new data). Autoimmune
disease should be distinguished from autoimmune disease with dry eyes. There
should be a better example of potential problems that can occur with a
microkeratome. Any updates from the manufacturers should be included. The
download speed should be improved and the language simplified. The button
?Questions for your doctor? should be on the LASIK site as well as the
FDA is currently
evaluating the ANSI Z80.11 Laser Systems for Corneal Reshaping Standard for
recognition. Please discuss whether you recommend that the FDA recognize the
standard in its entirety, in part, or with specific additions.
The Panel had questions
on topography and collection of data on adverse events. Dr. Eydelman said that
the standard says topography should be performed on all study subjects, so the
Panel had minimal issues with the standard. There was a question as to whether
there would be forced choices to get statistics on post-operative problems like
glare, halo, and dry eyes.
packet for SightNet participants currently emphasizes evaluation for and
reporting of the following LASIK-related adverse events and complications:
infectious keratitis; endemic cases of diffuse lamellar keratitis (DLK);
abnormal trends in post-operative topography; significant losses of best
corrected visual acuity (BCVA); glare, halos, starbursts and distortions; and
device failures. Please discuss any recommendations you may have for revision
of this list of adverse events and complications for which reporting is
The Panel recommended
that, when possible, intraoperative complications, such as flap complications,
be distinguished from post-operative complications, such as epithelial ingrowth.
Reports should include not only significant losses of BCVA, but also significant
visual side effects, such as glares, halos, or starbursts.
thanked the speakers for their testimony. She said both perspectives on LASIK
reported at the meeting are true; the majority of patients do well after LASIK,
but the post-market assessments do not adequately characterize rare, severe
effects or complications. FDA will be working with NEI, AAO, and ASCRS to get
better statistics. There were many issues associated with unsatisfactory
results after LASIK which are not under the purview of the FDA> which were also
discussed. Issues of inappropriately aggressive advertising may fall under FTC
regulations. Though it is not an FDA issue, a surgical procedure should not be
sold as a commodity. Issues of inadequate informed consent may fall under
medical malpractice. She said the FDA and the other organizations will help
make things better for future patients.
OPEN PUBLIC HEARING
Chairperson Weiss opened the public hearing session
session for post-market experience with Phakic Intraocular Lens (PIOL) and
repeated public hearing statement.
Dr. Scott Barnes spoke for Dr. Doyle Stulting, on
behalf of ASCRS. Dr. Stulting is a consultant for AMO. PIOL are rigid plastic
artificial lenses implanted to correct severe nearsightedness in patients who
are poor LASIK candidates. They were first approved in the US in 2004 and have
been used in Europe since 1991. Satisfaction with the lenses has been
excellent, with 99 percent satisfaction. Half of the patients saw better
without glasses after implantation than with before. These patients are
severely nearsighted, and the device meets a true unmet need. He said the
technology is life-altering for those patients and that there is 17 years of
data outside the US demonstrating safety.
Kesia Alexander, Ph.D., spoke on FDA?s PIOL safety
initiatives. Two PIOL PMAs have been approved. Ophtec?s Artisan IOL was
approved in 2004 for patients with minus five to minus 20 diopters of myopia.
The second was in 2005, STAAR?s Visian Implantable Collimer Lens, which was
approved for patients with minus three to minus 15 diopter of myopia. Both
companies are performing post-market studies.
The patient labeling gives an overview of
how the device works, risks and benefits associated with the device, alternative
treatments, and other aspects the patient should consider. The devices are
contraindicated in patients under 21, who have anterior chamber of depth (ACD)
outside the approved range, who have abnormal iris, who are pregnant or nursing,
or who do not meet the minimum endothelial cell density (ECD). Patients are
informed on the limitations and urged to ask questions of the physician. The
contraindications, warnings, and precautions are based on data from the PMAs.
The PIOL website advises the public on
whether or not they are candidates for the treatment, risks and benefits, what
to know before having the surgery, and questions to ask the physician before
undergoing the procedure. The risks include vision loss, retinal detachments,
and visual symptoms. Long-term data on the devices is not available. The
website also gives the patient an overview of what to expect during and
following surgery and when to contact their doctor.
Don Cologero, M.S.,
reported on ophthalmic standards for PIOL. The two published standards are ISO
11979-10, which is recognized by FDA entirely with no additions, and ANSIZ80.13,
which is being reviewed for recognition. Modifications recommended by the Panel
will be presented to ANSI at the time of revision. The standards contain both
pre-clinical and clinical requirements. In the pre-clinical requirements the
optical, mechanical, biocompatibility, sterility, shelf life, and transport
stability testing for PIOL are the same as the requirements for the monofocal
IOLs, except for the clearance analysis requirement. This is analysis of the
location of the PIOL surface with respect to ocular tissue to ensure the minimum
anatomical dimensions acceptable for the PIOL design and the range of powers it
would be available in.
PIOL standard contains the suggested design of a clinical investigation that
will collect the data needed to determine the safety and performance of the PIOL.
It is a non-controlled study with a minimum duration of three years to evaluate
both the maintenance of ECD, and the rate of cataract development. The primary
endpoint is ECD. Changes in ECD in the subjects are compared to the normal rate
of loss. Patients with less than the minimum ECD by age are excluded from the
study. The recommended sample is 300 patients. Enrollment will be in phases:
first 10 patients, then 100, then all remaining patients. Subjects will be
followed for 6 months.
pre- and post-op exams, both ISO and ANSI recommend distance UCVA, BSCVA, near
VA with distance spectacle correction, manifest refraction, cycloplegic
refraction, axial length, anterior chamber depth, intraocular pressure, slit
lamp exam, status of crystalline lens, gonioscopic exam, fungus exam, mesopic
pupil size, pachymetry, keratometry, subject questionnaire, and spectral
standard requires two sub-studies: a study to assess potential PIOL-related
contrast sensitivity losses and an analysis to determine the clearances between
the PIOL and the ocular tissue. Recommended safety analyses include the rate of
ECD change, the rate of cataract development, and the percentage of subjects
that lose two or more lines of BSCVA. The clinical labeling requirements
specify a summary of the clinical results of the investigation, any
recommendations for periodic evaluations after implantation, and any
restrictions in the indications for use.
FDA QUESTIONS AND PANEL DISCUSSION
Please discuss any recommendations you may have for modifications to
patient labeling of phakic intraocular lenses (PIOLs).
Because many Panel members had not yet seen the labeling, the Panel returned to
this question after they had skimmed the labeling and addressed the other
questions. FDA said it would apply the recommendations for modifications to the
website to the labeling. The Panel said cataracts are a concern, as well as the
possible inducement of astigmatism from the corneal wound, so there should be
more information on astigmatism. The labeling should use strong wording on
endothelial cell loss. Information on pupil size should be included. Dr. Heuer
found editorial and typographical errors that he passed on after the meeting.
Please discuss any recommendations you may have for modifications to
FDA’s PIOL website.
The Panel recommended
including a diagram of the two different types of IOLs, indicating there has
been documented endothelial cell loss, indicating that patients should not only
be out of contact lenses a certain period of time but also should have contact
lens stability, and indicating the specifics of the retinal and rear eye
problems. FDA should document the issues with cataract removal in patients with
PIOL. There was discussion of keratoconus and complications in future
procedures. The website does not specifically state that PIOL does not treat
astigmatism, though the labeling does and states that the procedure will not
make the patients free of glasses. If the data shows that the visually
significant astigmatism is a result of the procedure in some patients, the
website and labeling should include the information.
Please discuss any recommendations you may have for future revisions of
ANSI and ISO phakic intraocular lens standards.
After discussions and questions for the FDA, the Panel recommended no additions
to the standards. Dr. Heuer asked that the standards be made available in
future meetings in which a Panel is addressing the standards.
The training manual for SightNet participants currently emphasizes
evaluation for and reporting of the following PIOL-related adverse events and
complications: toxic anterior segment syndrome (TASS); endophtalmitis; explants;
significant endothelial cell density (ECD) losses; corneal decompensation;
significant losses of best corrected visual acuity (BCVA); retinal detachments;
intraocular pressure (IOP) spikes/elevations; cataractogenesis; device
extrusions; device failures/damage. Please discuss any recommendations you may
have for revisions of this list of adverse events and complications for which
reporting is emphasized.
The Panel recommended
adding uveitis and giving more specific information on what is meant by
“significant endothelial cell loss”.
|Is Any Laser Really Safe?|
UNITED STATES DISTRICT COURT
THIRD PARTY COMPLAINT OF EBW LASER, INC.
GE HEALTHCARE FINANCIAL SERVICES, a component of GENRAL ELECTRIC COMPANY, Plaintiff,
Civil Action No. 1:03CV00514
EBW Laser, Inc.
ALCON LABORATORIES, INC., and REFRACTIVE HORIZONS, L.P.
Third Party Defendants.
Defendant, complaining of the Third Party Defendants, alleges and says:
|Speaking of Alcon…AGAIN!|
Some very interesting exchanges can be found in FDA transcripts, exchanges which foreshadowed problems that the victims of refractive surgery knew about, but couldn’t get anyone to pay attention to, because no one was interested. These transcripts are a matter of online public record, meaning that they are to be permanently warehoused on the FDA servers. Yet, some of these transcripts have mysteriously disappeared. When you write to the webmaster for the FDA, at first they’re eager to help you. But eventually, you just get no reply and no documents.
The FDA Alcon Approval Meeting
Background: Meeting was held Aug. 1, 2002 in Gaithersburg, Maryland. The purpose of the meeting was to review the clinical trial results and vote on ALCON’s application for FDA approval of CustomCornea wavefront guided LASIK for the correction of myopia up to -7D. The Surgical Eyes Foundation was represented by Ron Link (founder) and David Shell (a patient) during the open public hearing. A letter from an SE participant was read aloud during the open public forum asking that large pupils and dry eyes be listed as contraindications. Below are notable quotes from that meeting, indexed by their page number on the original FDA meeting transcripts. The quote tell a revealing story of an FDA which have more interest in supporting an unethical industry than in protecting patients.
Page 61 – DR. PETTIT (Alcon): The little asterisks indicate those changes that were statistically significant between the preop and the six-month postop interval and you can see that for almost all of the aberration parameters, they’re actually slightly higher by a statistically significant amount after surgery than before. The trefoil is actually less after treatment but it’s not a statistically significant difference. Now, I should just also mention this is based on a 6.5mm wavefront analysis diameter. This isn’t a surprising finding. It’s well known that LASIK tends to increase the higher-order aberrations.
Page 65: Dr. Brint (Investigator): As clinicians, we know that prior studies of conventional LASIK in general have shown that higher-order aberrations, particularly spherical aberration which is frequently linked to poor night vision, occasionally may be increased after conventional LASIK. These increased higher-order aberrations after conventional LASIK
|The Lastest Hype: What About Wavefront Results?|
There is a 9% dissatisfaction rate.
DR. GRIMMETT: Dr. Michael Grimmett. I just had an observation and would like to hear if you have a comment. You may have none. There may be no answer. I found it curious that despite a very comprehensive analysis and sophisticated technology, that the patients that were unsatisfied or extremely unsatisfied approximated 9 percent. It’s notable that the PERK study (A study of radial keratotomy patients) by comparison, using bear skins and stone knives, had an 11-percent dissatisfaction rate, and I found it curious that one in 10 patients are unsatisfied, despite a phenomenal amount of technology and analysis, and I would like to commend you on a superb analysis and presentation. Do you have a comment why it’s still one in 10 despite all the sophisticated technology or is there no answer to that, sir?
DR. GRIMMETT: Dr. Bradley stated wavefront-guided LASIK does not reduce the level of higher-order aberrations of the preoperative eye, and he also wrote there’s no way wavefront-guided LASIK can correct higher-order aberrations and render super-normal vision. That’s the second statement. Is that not correct?
DR. BRADLEY: Your memory is better than mine, but I can look at the slide.
DR. GRIMMETT: No, I believe I transcribed it correctly.
DR. BULLIMORE: I agree. This is Dr. Bullimore. I agree with the sentiments of both of those statements. Exactly how the second one is worded, we could come back to, but the first one adequately ??
DR. WEISS: Can you repeat the first one again?
DR. GRIMMETT: Sure. Wavefront-guided LASIK does not reduce the level of higher-order aberrations of the preoperative eye.
DR. WEISS: Would that not be confusing to someone? Wouldn’t that be confusing?
DR. GRIMMETT: Michael Grimmett. It may suggest somehow wording in that wasn’t it that the higher-order aberrations were 20 percent higher than the preop eye in the wavefront-guided versus what, 80 percent was the number?
PARTICIPANT: Seventy-seven percent.
DR. WEISS: In here, is there any place saying that LASIK itself increases aberrations and that customized corneal ablation increases them less than conventional treatment?
DR. GRIMMETT: I think that’s the idea.
DR. WEISS: So maybe we could put that wavefront-guided ablation ??
DR. GRIMMETT: Conventional LADARVision LASIK increases higher-order aberrations by that figure 77 percent while wavefront-guided LASIK increases them by whatever, 20 percent, whatever the number is, or you can say reduces them to a 20-percent level, if you want to use the word “reduces.”
DR. BULLIMORE: I would avoid the term “reducing.”
DR. WEISS: I would say each of them increases it because basically whether or not you’re treating the preexistent or what’s induced, the bottom line is you still have more aberrations than you did when you started off.
DR. GRIMMETT: Well, the intent is telling the traffic cop that you’re speeding less than the other speeders.
|The FDA on Clinical Trials|
|It is well-known that manufacturers of devices (lasers, IOLs, etc.) cherry-pick the so-called top surgeons for clinical trials. It’s also well-known that surgeons cherry-pick patients for these clinical trials, including only patients who are likely to have the best outcomes. This is one reason why clinical trials do not really reflect the outcomes that will be seen in the real world in the hands of average surgeons and borderline patients. Let’s “listen in” on an FDA panel meeting:
DR. WEISS: I think we have to be careful about this best physicians talking about lack of data. I’m sure these were good docs and good surgeons, but creating this extra god‑like category, I think we should take out of the discussion.
DR. BANDEEN‑ROCHE: That’s a point well‑taken. That’s a point well‑taken. Nonetheless, I mean, we hardly expect better performance in the field than we do in a clinical trial.
DR. McCULLEY: You don’t have data to support that statement, do you? Do you have data to support that statement? You do. Okay.
DR. ROSENTHAL: With all kinds of devices.
DR. McCULLEY: All right.
DR. WEISS: What I would then like to lead to is since there’s agreement
DR. ROSENTHAL: Wait.
DR. WEISS: Yes.
DR. ROSENTHAL: I want to make sure I said the right thing. Once they go out in the field, they tend to have more problems than they do within the clinical trial.
DR. McCULLEY: But you don’t have data to support that the people who do the trials are the best of the best.
DR. ROSENTHAL: No.
DR. McCULLEY: I think that is opinion
DR. MACSAI: That’s my opinion.
DR. McCULLEY: That is Marian’s opinion, and it should not be in our discussions.
DR. WEISS: So we’re going to take out the “god” factor out of the discussion.
|Why Not ALL of the Black Box Lasers?|
|The FDA has been very ‘choosy’ as to what actions they took against SOME in the LASIK industry regarding ‘Black Box’ Lasers.
Throughout the FDA section of this site, you’ll see the indifferences between what the FDA says, and the actions they TAKE.
The siezure of several lasers does not account for all of the others out there that have damaged numerous people. The FDA has even allowed Ed Sullivan, builder of these lasers, to be involved in conferences with the FDA and the doctors, even AFTER the scrutiny of ‘Black Box’ lasers.
Below is a video regarding Dr. Nick Caro of Illinois, whose practice has resulted in over 50 lawsuits and siezure of his laser by the FDA. And yet, he’s still in practice…
|The following petition was sent to the FDA in an effort to stop the increasing number of Lasik casualties. Although many doctors have abided by the regulations set by the FDA, and have had successful surgeries, there are many based on the reported number of casualties who have not. Actual counts of those casualties are not known due to non-reported cases. Since the FDA cannot totally enforce what they mandate, why should these doctors be allowed to put people at such high risk.|
|With flaws found in LASIK studies, why does the FDA allow doctors who were involved in these studies to continue to do more studies, such as Intacs? Improper data, investigators not properly screening candidates, and lack of responsibility by the Institutional Review Boards who are not 100% efficient are creating casualties who should not be.
If the FDA can believe flawed reports from LASIK research, who’s to say the reports from Intacs studies were not flawed as well?
More on INTACS…
|FDA Inspection Reports of the Nevyas’ Facility|
Click PAGE # to open page in new window
NOTES: Page numbers with an “l” designate the page as landscape. All BLUE font on this page designate links.
FDA Issued Inspection Report of Nevyas Eye Associates facility dated 11/02/1998:
FDA Issued Inspection Report of the Nevyas’ facility dated 05/10/2001:
The 2nd inspection resulted in an FDA483 issued by the FDA.
Although the records requested via the FDA’s Freedom Of Information Act were redacted (edited), the FDA stated:
“There is too much information the general public should not be aware of, not only in the Nevyas’ study, but in all studies”.
This second set was obtained from the FDA’s Philadelphia Office, and included not only the Nevyas’ facility of 05/2001, but that of Ed Sullivan (Exsull), builder of their laser (see above). The inspection was 2 years after the article written in the Journal of Refractive Surgery (Fall Issue – 1995):
Inspection Report of the Nevyas’ facility dated 05/2001 (less edited):
|Before The Nevyas’ Study|
|It started with Ed Sullivan, the guy who built the ‘Nevyas Laser’, a man already under scrutiny by the FDA…
“Ed Sullivan, doing business as ExSull, Drexel Hill, Pa, has been put on notice by the FDA that the agency regards him “clearly as a manufacturer with multiple manufacturing sites” subject to FDA rules and regulations and, if he makes another one of these excimer lasers “which are unapproved devices,” he will be in violation of the federal Food, Drug and Cosmetics Act and subject to legal penalties, according to top-ranking FDA officials within the national Division of Enforcement.” [as written in The Journal of Refractive Surgery – Volume 11 (5) * September/October 1995 * News and can be found at the url address http://www.slackinc.com/eye/jrs/vol115/news1.htm]
And the FDA knew that! From the affidavit Herbert Nevyas submitted to the FDA, it tells of Ed Sullivan building their laser. However, documents show Mr. Sullivan in teleconferences and meetings with the doctors and their liaison with the FDA well after this article was written.
After I received inspection reports even less redacted from the FDA regarding inspections of the Nevyas’ facility, the FDA promised “to do what they could to help me”, but then refused after copies of the inspection reports were returned. In fact Les Weinstein, the CDRH Ombudsman, outright told me (through his secretary) he could no longer have any communication with me. It seems to me (based on my communications with the FDA) that the FDA was more concerned with being sued by the Nevyases for the information released, then by doing the right thing.
The inspection reports of Sullivan’s facility below were obtained via the Freedom Of Information Act. Regardless of these reports and the articles written concerning ‘Homegrown Lasers”, is this what the FDA considers “protecting the public’s safety”?
The FDA issued warning letters regarding the lasers Sullivan built, but STILL allowed doctors to further modify and use these devices on people considering LASIK!
FDA’s LASIK Website
Although I feel the FDA has protected many doctors, companies, and themselves, they still have somewhat of an an informative LASIK Website (Although I believe severely biased given the lack of authority to protect the public).
Not just investigational lasers, but those WITH approval from the FDA…
There were a whole bunch of new MDRs filed in the Maude database during December about breakdowns of Ladarvisions. They make interesting reading. Go to:
(Type in “ladarvision” and search)
“CUSTOMCORNEA” into the search and got this one: “Alcon customcornea & ladarvision 4000 wavefront lasik machines were used to preform enhancement surgery on left eye after original lasik in 2003. Enhancement surgery made eyesight worse; nearsighted again with multiple vision effect when looking at point of light. 2nd, 3rd, 4th opinions from other drs confirm irregularities in cornea from enhancement surgery and all of them say that the alcon customcornea wavefront measurement device and the ladarvision laser should not be used for enhancements because the software is not sophisticated enough and is too unstable.” Not only their machines, but their stock as well:
CODE OF FEDERAL REGULATIONS 812.7
CODE OF FEDERAL REGULATIONS 812.7
And promotion of an Investigational Device.
Some patients may develop severe dry eye syndrome. As a result of surgery, your eye may not be able to produce enough tears to keep the eye moist and comfortable. Dry eye not only causes discomfort, but can reduce visual quality due to intermittent blurring and other visual symptoms. This condition may be permanent. Intensive drop therapy and use of plugs or other procedures may be required.
It does happen! And the people I’ve spoken to with these complications let you know the risks are severely down-played by the FDA. These symptoms are VERY painful!
And doctors want patients to think that DLK and infectious keratitis just happen for no reason…
This FDA panel meeting has a rather disgusting section where concealing the fact that refractive surgery induces dry eye from the consumer is discussed. The panel decided not to require that ALCON disclose that dry eye after refractive surgery is an industry-wide problem… because they hadn’t required other LASER companies to include dry eye warnings in their labeling previously. So they claimed it wouldn’t be FAIR to ALCON to have to admit in their labelling that refractive surgery induces dry eye. How about being fair to patients so that they can be properly informed about LASIK dry eye BEFORE they decide to have surgery?
Loss of corneal nerve density averaging more than 40% at the 3 year point after LASIK? No thank you!
This link will allow you to find transcripts of all Ophthalmic Devices Panel meetings. Click on the year, then scroll down and look for Ophthalmic Devices.
Before you start clicking and reading, it helps to know which meetings were called to review lasers for refractive surgery.
Here’s a link to the summaries of these meetings from 1997 through 2000:
More recent meeting summaries can be found at this link:
Click on “Ophthalmic Devices Panel”, “Past Meetings”.
But! Did Casebeer have a financial interest in any related product? Namely,
Do you find it odd that in the fall of 1998, Dr. Casebeer speaks of his part in
“I put almost two years into helping to develop the Ruiz disposable keratome
What was Dr. Casebeer’s connection to LaserSight when he presented the PMA to
LASERSIGHT BEGINS SHIPMENT OF KERATOME BLADES
Winter Park, FL, (July 27, 1999) — LASERSIGHT INCORPORATED (Nasaq:LASE)
Take the case
Shift over to
And it’s all
‘Bermuda cards’ allow
by Keith J. Croes
An off-shore modification of Visx keycards allows U.S. surgeons to employ excimer laser treatments
A number of refractive
At a rate of $40 per card,
An FDA official charges that
The approved cards, which
“There is definitely a
The reprogrammed cards allow
The THCP official declined to
A U.S. laser center
In a number of public
“We are very sympathetic to
CRS-USA Inc. is pursuing one
“Undergoing surgery with
With the recent approval of
Although Visx has heard
FDA – Your Opinion?
“the FDA says they dont regulate the practice of
“the FDA says they dont
“so the FDA can do something if its wants to. the question is whether the FDA itself is so corrupted by special interests that it doesnt want to. my guess is that it is. how else would research that was obviously deceptive make it through the opthalmic devices panel and be approved? if the fda took some kind of action, it might well have to admit to millions of consumers that they are facing long term damage to their vision. it could cause a lot of embarassment. so the fda
Available to the Public
Available to the Public
Over 1,000 pages of additional documents (now available on CD) are available to the public on request to this website. Please email me for more details.
More FDA BIAS?
Inside the FDA: Reporting of medical device-related
by Malvina Eydelman, M.D. and
I have written several
FDA monitors post-market
Primary responsibility for
FDA’s ability to take
Thus, it is of utmost
Monitoring and understanding
The FDA monitors post-market
This regulation required
The FDA recently established
To better understand
• Serious injuries:
• Malfunctions: Failure of a
•Device-related: The event
There are several guidances
Voluntary reporting to FDA of
MedWatch allows health care
Since its inception in 1973,
The reports capture
The staff of clinicians and
Several immediate actions,
Recommending internal expert
Other internal uses of the AE
I hope that this column gives
2.Kessler DA. Introducing
Need To Contact The FDA?
GOOD LUCK! These wonderful people have helped me extensively ( NOT! ). If you’re expecting help, expect a runaround:
Linda S Kahan – DEPUTY DIRECTOR CDRH
Everett Beers, Dr. – SUPV GENERAL ENGINEE
|CLINICAL TRIALS FOR LASIK FLAWED|
|Reposted with permission
On the subject of LASIK complications, and who knew what and when…let’s just say I can’t wait for some depositions to go public.
Here’s something that is public that may interest you. Hopefully you have read it. If you have, you would know that there was a BIT of a clinical trials problem, with VISX being much more, shall we say ‘problematic’ than Alcon. Now there’s an understatement.
Now why do you think a company would collect contrast sensitivity data and not report same? Hint, LASIK causes loss of contrast sensitivity in all
Hard to believe that less than 25% of LASIK patients in a clinical study would bother to show up for their follow-up appointments! It is in their medical best interests to be followed for a year. What do you think that huge patient population gone missing has in common? What do you think the patients who were included had in common? Why do you think they lied about 12 month accountability? If you were to derive means of several metrics of outcome measure, do you think the differences between these groups would be statistically significant?
How about patients who report being dropped from clinical trials for having bad outcomes?
Why the reliance on subjective survey data of symptoms when the technology to gather objective clinical data was available? And then to present inferior subjective survey data on only a subset of patients… in a format that any Stats 101 dropout drooling idiot can easily recognize as bad science! Who set up these ‘studies’, who was monitoring these clinical trials, who was involved in these clinical trials, and who voted to approve these devices?
If your choices in a subjective survey are on a ‘better’ or ‘worse’ scale with no actual measure of magnitude, then a patient who sees starbursts that are a bit larger after surgery is scored the same way as the patient who is incapacitated by starbursts from headlights that are larger than the cars that generate them. How much sense does this make?
|The FDA produced this quick and easy loophole to remove embarrassing little omissions from your PMA|
– Did you forget a clause forbidding re-use of microkeratome blades?
– Need to change your labeling really fast to cover your behind?
IT is AMAZING how accomodating the FDA can be!
|Microkeratome Blades, And the FDA|
How would you feel if you received an infectious disease or
…the reuse of an FDA “regulated” medical device
Many Microkeratome components used for LASIK are licensed, “regulated” and approved by the FDA solely as single-use, disposable medical devices, but the FDA states the FDA has No jurisdiction to enforce Federal laws regarding these FDA approved medical devices.
Hundreds of LASIK Doctors have admitted reusing these single use blades, but none have lost their medical licenses and only a few have even been placed on temporary probation (to my knowledge).
The FDA does Not
An off-label use of a device explicitly for the potential benefit of a patient (where the benefit clearly outweighs the risk) would be considered a legitimate practice of medicine. However, when there is no patient benefit and/or the risk outweighs any benefit, then Not following the FDA labeling does Not constitute the practice of medicine By definition. Part of the definition of the practice of medicine is to put the patients’ best interests ahead of those of the Doctor.
Why isn’t any practitioner or user of these FDA “regulated” (Class I) medical devices (whether or Not he/she happens to be a Doctor) who uses them in an unnecessarily risky way or who does Not provide informed patient consent under the FDA’s regulatory authority and jurisdiction?
The House of representatives has investigated the FDA regarding allowing
“The Washington Post examined thousands of pages of documents, including FDA records, court filings and internal company reports, and was able to document dozens of cases of patient injuries and device malfunctions after single-use devices were reused over the past decade”
Microkeratome blades get duller every time they are reused which causes irregular flaps made in the cornea, less smooth flaps, epithelial ingrowth, keratitis, and other serious problems.
The FDA hasn’t
They don’t do
“IF Doctors who do “second opinions” after LASIK (this is a big business due to all the people with problems) are used to seeing good results from LASIK, then why aren’t the Damages from reusing microkeratome blades obvious to them?
As odd as it sounds, many patients have told me their Doctors acted as if they did Not believe what they were telling them about their eyes and vision. My own statements about my vision and eye pain, etc. do Not appear in many of my medical records, and some Doctors have one diagnosis but Not others (in some cases I initially found out Only by getting copies of my medical records because some of the Doctors did Not tell me they had put these diagnoses in my records). One Doctor who was on the FDA’s Ophthalmic devices panel said the objective evidence (without reviewing my artemis or confocal exams) was Not consistent with what I said about my vision. I was shocked when he said “I know many patients who would be happy with your vision”. I’m sure that blind people would be happy with my vision, but how does that help with my terrible vision and eye problems that bother me all the time?”
“LaserVue reused microkeratome blades among patients rather than sterilizing or replacing them. Former patients may have been exposed to infectious diseases such as HIV or Hepatitis.”
“I must protest – there could never be legitimate reasons for placing patients at incredible risk of HIV, viral hepatitis, or Mad Cow disease
– all which can potentially be transmitted via the use of unsterilized sharp instruments. There is absolutely no excuse for this. It goes against every medical standard and as well goes against the laser centers licensing by OSHA (a governmental organization that certifies that surgery centers are following the appropriate blood borne pathogen. And I have to say that your organization will lose complete credibility if this type of action is excused. These surgeons and the laser centers put their patients at severe risk. You can’t look back and say no one was injured, so their actions were OK. Mad Cow Disease (Jacob-Creutzfeld) can be transmitted via the cornea (there are documented cases of patients transmitting this disease following corneal transplants) – and this disease may take 20-40 years to show up. As well, HIV is known to be present in tears – and blood is not an uncommon sight with LASIK.”
“I thought surely the eye Doctors’ Academy (that provides the Doctors with the board certification they put in their bios) would have a policy designed to protect patients’ safety. Think again.”
“At this time, the Academy [The American Academy of Ophthalmology] does not have a formal policy on the issue [reusing Microkeratome blades on multiple patients without sterilization].”
|FDA Praises Itself To Committee on Govt. Reform|
Statement of Daniel Schultz, M.D., Director Center for Devices and Radiological Health Food and Drug Administration U.S. Department of Health and Human Services before Committee on Government Reform House of Representatives SEPTEMBER 26, 2006 INTRODUCTION Mr. Chairman and Members of the Committee, I am Dr. Daniel Schultz, Director, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA or the Agency). I consider device safety to be of utmost importance and appreciate your invitation and the opportunity to discuss this issue. Let me say at the outset that I believe FDA currently has many tools to ensure the safety, effectiveness, and manufacturing quality of reprocessed, single-use devices (SUDs). FDA has been actively engaged in the SUD reuse issue for some time, and our efforts have included research, outreach, pre-market review, inspections, and compliance investigations. We have held numerous public meetings and conferences with industry, healthcare professionals, and consumers over the years to determine the extent, magnitude, and changing nature of this practice. FDA has carefully evaluated and conducted research to develop the scientific basis for addressing SUD reprocessing. We have inspected third party reprocessors, evaluated and investigated reports of patient injuries, and reviewed numerous pre-market submissions. Taken together, the Agency believes that these efforts have provided, and will continue to provide, reasonable assurance of safety and effectiveness of reprocessed SUDs for patients. BACKGROUND I will begin with a brief overview of our regulatory authorities for medical devices. A medical device as defined by Federal law encompasses several thousand health products, from simple articles such as tongue depressors and heating pads, to cutting-edge and complex devices such as implantable defibrillators and robotic equipment for minimally invasive surgery. The Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic (FD&C) Act gave FDA specific authority to regulate the safety and effectiveness of medical devices. Medical devices are assigned to one of three “classes.” Class I is the lowest risk category of device and includes items such as adhesive bandages. Class II, or medium-risk category of device, includes devices such as intravenous catheters and powered wheelchairs. Class III is the highest risk category of device and includes devices such as heart valves and coronary stents. THE REGULATION OF REPROCESSED SINGLE USE MEDICAL DEVICES
The reprocessing of SUDs is legally permissible in the United States under the FD&C Act. Currently, only Class I and II SUD device types have been cleared by FDA for reprocessing. No Class III SUDs have been cleared/approved for reprocessing.
In August 2000, FDA issued a guidance document for industry and staff entitled “Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals.” This document set forth FDA’s priorities for enforcing pre-market submission and post-market requirements for manufacturers who wished to market reprocessed SUDs. The guidance document stated that any third party or hospital reprocessor should comply with requirements pertaining to: registration and listing, medical device reporting, medical device tracking, medical device corrections and removals, the quality system regulation, labeling, and pre-market submission. Essentially, third party firms and hospitals reprocessing SUDs were placed in the same regulatory framework as original equipment manufacturers (OEMs).
Prior to issuance of this guidance, reprocessing of SUDs was frequently performed by hospital personnel without regulatory oversight or regard to the level of device risk. In addition, many third party reprocessors contracted with hospitals to perform similar tasks and these contractors did not consistently adhere to FDA’s Good Manufacturing Practice Requirements.
CHANGES ENACTED WITH MDUFMA
In 2002, with enactment of the Medical Device User Fee and Modernization Act (MDUFMA), Congress mandated a number of new requirements for SUD reprocessors including, for certain SUDs, the pre-market submission of data to the Agency that exceeded the requirements for OEMs. In addition to the requirements specified in our 2000 Guidance Document, certain reprocessed SUD types that potentially could pose the greatest risk of infection and inadequate performance following reprocessing and that were previously exempt from any pre-market submission requirements, are no longer exempt.
MDUFMA also created a new type of pre-market submission, called a “pre-market report” (PMR), for Class III reprocessed SUDs that otherwise would have required a pre-market approval application. Among other information, a PMR must include validation data regarding cleaning, sterilization, and functional performance of the reprocessed device to ensure it is substantially equivalent to a legally marketed device. To date, only one PMR has been submitted to the Agency and it was later withdrawn by the firm.
In addition, MDUFMA required a change to FDA’s MedWatch voluntary and mandatory reporting forms (Forms 3500 and 3500A, respectively) to facilitate the reporting of adverse events involving reprocessed SUDs.
Finally, MDUFMA required, as of August 1, 2006, that reprocessed SUDs prominently and conspicuously bear the name, abbreviation, or symbol of the reprocessor on the device itself, on an attachment to the device, or on a detachable label, depending on the physical characteristics of the device and whether the device has been marked by the OEM.
PRE-MARKET REVIEW OF REPROCESSED SUDs
Under the FD&C Act, before introducing a device to market, manufacturers must submit a Notification of Intent to Market a Device (510k) and obtain FDA clearance, unless the device has been exempted. MDUFMA required FDA to identify previously 510(k)-exempt device types that, if reprocessed as a SUD, would now require 510(k) pre-market review, including the submission of validation data. In addition, MDUFMA required that FDA identify SUDs that were already subject to 510(k) pre-market requirements, but that would now also require the submission of validation data. Required validation data include cleaning and sterilization data, and functional performance data demonstrating that each SUD will remain substantially equivalent to its predicate device after the maximum number of times the device is intended to be reprocessed.
The criteria used to determine which reprocessed SUD types would no longer be exempt from pre-market notification requirements and would require 510(k)s with validation data, and which reprocessed SUDs already subject to the 510(k) requirements also would now be subject to the additional requirement of validation data are available on the Internet at:
Using these criteria, FDA identified all previously exempt “critical” and “semi-critical” devices that were high-risk. These devices would no longer be exempt from 510(k) requirements and SUD reprocessors of these device types would be required to submit 510(k)s with validation data and receive clearance in order to continue marketing these devices.
In addition, the requirements and the lists of devices that were newly subject to these requirements were published in the Federal Register. FDA has added other reprocessed SUD types to these lists as we become aware of information that warrants their inclusion.
On June 1, 2004, FDA issued a revised “Guidance for Industry and FDA Staff; Medical Device User Fee and Modernization Act of 2002, Validation Data in Pre-market Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices.” This document describes the types of validation data that FDA recommends be submitted on cleaning, sterilization, and functional performance of certain reprocessed SUDs to ensure that they are substantially equivalent to the predicate device. Additionally, this document describes the timeframe for FDA’s reviews of these validation data submissions, and what actions the Agency intends to take if it finds a reprocessed SUD to be Not Substantially Equivalent (NSE) to the predicate device.
As of September 2006, FDA has received nearly 200 pre-market notification 510(k) submissions for reprocessed SUDs. These submissions cover from one, to as many as several hundred, device models. Of the almost 200 submissions, approximately 67 percent have been cleared by FDA. The remaining were not cleared for such reasons as inadequate validation data, lack of necessary information from the reprocessor, withdrawal of the application by the submitter, or lack of response to FDA’s request for data. (Approximately 88 percent of 510(k)s for all other devices are cleared and approximately 3.4 percent are found NSE to the predicate device.)
FDA’s inspectional program serves as a bridge between pre- and post-market activities. Since 2000, on average, FDA has conducted inspections of reprocessor firms once every two years, a rate considerably higher than the one inspection in four years for OEMs. Of the seven firms currently known to be reprocessing, all have been inspected within the last two years. FDA continues to evaluate newly registered firms to confirm whether they are performing SUD reprocessing and updates its inspectional plan as required.
POST-MARKET SURVEILLANCE FOR REPROCESSED SUDs
Post-market monitoring of device-related adverse events (AEs) and product problems is accomplished through the Medical Device Reporting (MDR) system. MDR reports include deaths, serious injuries, and device malfunctions. Healthcare facilities are required to report deaths suspected to be device-related to both FDA and the manufacturer/reprocessor. They are required to report serious injuries to the manufacturer/reprocessor.
FDA also receives voluntary reports, generally from healthcare professionals, through its MedWatch reporting system. As previously mentioned, under MDUFMA, the MedWatch reporting form 3500A was revised to include a data entry field (D to ask if the device associated with the reported event was a reprocessed SUD. This question was added to the form to enhance the Agency’s ability to quickly identify and investigate reports of problems associated with reprocessed SUDs.
FDA responds to reports of death or serious injury by investigating the report and taking appropriate follow-up actions as needed. Follow-up actions may include enforcement actions and/or the issuance of a public health notification to alert the healthcare community of the Agency’s concerns.
As you know, on January 24, 2006, I and others briefed this Committee about SUD reprocessing. At that time, we provided background information including the current regulatory framework and AE data. Specifically, we searched our Manufacturer and User Facility Device Experience (MAUDE) database for reports from October 22, 2003, to December 13, 2005, that were coded as adverse events associated with reprocessed SUDs. The search produced 176 reports of death, serious injury, and/or device malfunction; however, analysis of these reports did not disclose a clear causative link between a reprocessed SUD and subsequent patient injury or death.
In July 2006, the Agency updated the search to include all reports entered into the MDR, MAUDE, and MedWatch databases between December 2005 and July 2006. FDA has received a total of approximately 434 reports, including MedWatch forms, where the reprocessed SUD field was checked “yes.” Our analysis of these reports determined that many of the devices were not reprocessed SUDs. Rather, they were implanted devices or devices that were designed to be re-usable and, therefore, were not reprocessed SUDs. Of the 434 reports, approximately 65 reports actually involved or were suspected to involve reprocessed SUDs, and were reviewed by FDA. The final analysis of the reports found that the types of adverse events reported to be associated with the use of SUDs were the same types of events that also are being reported for new, non-reprocessed devices. Therefore, it was unclear whether the device, the medical condition of the patient, the medical procedure, or other confounding factors caused or contributed to the adverse event.
FEEDBACK FROM A SAMPLING OF MEDSUN HOSPITAL FACILITIES THAT USE REPROCESSED SUDs
FDA’s Medical Product Safety Device Network (MedSun) is comprised of over 350 hospitals that have been recruited and specifically trained to identify and report device problems. The hospitals in this program are broadly representative of U.S. healthcare facilities. FDA staff talked with representatives from more than 50 of these facilities to obtain feedback on their experience with using reprocessed SUDs.
The MedSun respondents who gave us feedback represented various occupations in hospitals, including materials management, biomedical and clinical engineering, risk management, infection control, surgical services, nursing staff, supply utilization, and equipment management. Staff being interviewed responded overwhelmingly that they view the use of reprocessed SUDs as providing a significant cost savings to their facilities and as being an environmentally sound practice.
There was considerable variation in the devices being reprocessed at the various facilities and the degree of acceptance of this practice by individual practitioners within the facilities. None of the participants we spoke with reported specific problems with SUD-related infections, but they also pointed out that, if an infection occurred, it would be difficult to discern whether the reprocessed SUD was the cause. It also is interesting to note that the participants did not report a greater concern with mechanical problems associated with reprocessed SUDs compared to un-reprocessed SUDs. In general, the participants had a favorable view of reprocessed SUDs used in their facilities. They also stated that they relied heavily on FDA oversight to ensure safety and effectiveness and to provide objective information on reprocessed SUDs.
ONGOING FDA ACTIVITIES
The Agency continues to review and assess the practice of reprocessing SUDs.
CDRH established an active internal work group to ensure that review scientists remain current with the evolving scientific literature and new consensus standards that are relevant to the reprocessing of SUDs.
CDRH has convened a second work group, called the “Post-market Issue Action Team,” to develop a long-term strategy for monitoring, evaluating, and communicating information about reused SUDs.
CDRH continues to submit reprocessor inspection requests to the Office of Regulatory Affairs to schedule inspections of reprocessor facilities to assess conformance with the Quality System Regulation.
CDRH periodically updates its reuse webpage so that healthcare facilities and providers will have current information on legally marketed, reprocessed SUDs. Recently, easy-to-read tables listing FDA requirements for specific reprocessed SUD types were added to the website. In addition, we improved accessibility and added instructions to the publicly searchable FDA pre-market databases. These databases allow the user to search in real-time for recent and past clearances. (http://www.fda.gov/cdrh/reuse/index.html)
CDRH regularly updates guidance to industry and FDA reviewers on validation data requirements for reprocessed SUDS.
CDRH regularly updates the list of reprocessed SUDs subject to the additional pre-market requirements imposed by MDUFMA.
CDRH is conducting research to develop/establish “acceptable” SUD cleaning criteria.
CDRH is collaborating with two local healthcare facilities to help monitor changes in the design of some SUDs and identify new SUDs being reprocessed.
On September 25, 2006, FDA published two rules: the direct final rule for Medical Devices; Reprocessed Single-Use Devices; Requirement for Submission of Validation Data; and a proposed rule for Medical Devices; Reprocessed Single-Use Devices; Requirement for Submission of Validation Data; Companion to Direct Final Rule (proposed rule). These amendments will help ensure that reprocessors submit the data, including cleaning, sterilization, and functional performance data, needed to demonstrate that their device is substantially equivalent to the predicate device.
Available data show that SUDs can be reprocessed with a reasonable assurance of safety and effectiveness. FDA believes that reprocessed SUDs that meet FDA’s regulatory requirements are as safe and effective as a new device. The law and regulations in place are designed to protect the public health by assuring that the practice of reprocessing and reusing SUDs is based on sound science. FDA continues to monitor the performance of these devices and to assess and refine our ability to regulate these devices appropriately.
Mr. Chairman, thank you again for the opportunity to address this important topic. I will be happy to answer any questions.
The FDA can only regulate devices, not doctors. That is their claim to protecting themselves against those already damaged by Refractive Surgery.
|Louisiana Ophthalmologist Fined $1.1 Million by FDA|
|Louisiana Ophthalmologist Fined $1.1 Million by FDA For Clinical Study Violations
A Lafayette, La., ophthalmologist and eye care center he owns have agreed to pay the federal government a total of $1.1 million in civil money penalties for violating federal laws related to the conduct of clinical studies. The violations involved studies of a laser system built by the ophthalmologist for LASIK treatment of nearsightedness.
|Safety, Warnings, & Product Recalls|
Bausch & Lomb – ReNu brand contact lens solution
Is your intraocular pressure being monitored on the Pred Forte? Patients who are on this drug for more than 10 days require ongoing IOP monitoring because of the very real risk of inducing glaucoma. Tonometry is known to give falsely low IOP readings after LASIK, so other measures to assess glaucoma (like GDx optic nerve fiber analysis) appear indicated. Have you noticed any visual field losses?. Are your visual fields even being assesed?
Check out this info on ophthalmic PredForte
Warnings: Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections.
Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation.
Acute purulent infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication.
If this product is used for 10 days or longer, intraocular pressure should be routinely monitored.
Warnings: Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections.
Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation.
Acute purulent infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication.
If this product is used for 10 days or longer, intraocular pressure should be routinely monitored.
By taking this medicine for 6.5 months you are putting yourself at an increased risk for irreversible blindness due to glaucoma. Has your doctor told you this? You need to pin your doctor down regarding what he/she is treating. If not DLK, then what non infectious situation does he/she think he/she is treating. Treating an infectious keratitis with steroids will only worsen the condition.
Also long term topical opthalmic steroids are known to thin the cornea and can lead to corneal perforation.
Also noted here:
EyeWorld February 2006
|Declaration of Helsinki|
The World Medical Association Declaration of Helsinki
World Medical Association Declaration of Helsinki: Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects
Adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964 and as revised by the World Medical Assembly in Tokyo, Japan in 1975, in Venice, Italy in 1983, and in Hong Kong in 1989.
It is the mission of the physician to safeguard the health of the people. His or her knowledge and conscience are dedicated to the fulfillment of this mission.
|21 C.F.R. ?? 812.7 & PROMOTION OF AN INVESTIGATIONAL DEVICE|
|§§ 812.7 Prohibition of promotion and other practices.
A sponsor, investigator, or any person acting for or on behalf
of a sponsor or investigator shall not: (a) Promote or test market an
investigational device, until after FDA has approved the device for commercial
distribution.From the Federal Trade Commission: From the Food and Drug Administration (FDA):
|Understanding pre-market approval: A call for reform at the FDA|
Understanding pre-market approval and labeling differences of two leading customized ablation platforms: a call for reform at the FDA
PURPOSE: To analyze the Food and Drug Administration (FDA) pre-market approval reported data for two currently available wavefront-guided excimer laser systems.
|FDA Document Leaks Revisited|
FDA Document Leaks Revisited
FDA Document Leaks Revisited
James G. Dickinson
After seven months of inaction by FDA’s Office of Internal Affairs (OIA), the FBI has taken over investigation of the most serious breach of security at FDA since the generic drug scandal. At the center of the case is last November’s leak of proprietary product approval documents belonging to laser manufacturer Visx (Santa Clara, CA) to its competitor Summit Technology (Waltham, MA). Now, it will fall to the bureau to identify and locate the as-yet unknown FDA employee who leaked the documents.
This development, along with questions troubling to anyone who has entrusted secrets to FDA, was revealed at a July 31 hearing of the House Commerce oversight and investigations subcommittee, chaired by Joe Barton (R–TX). “If we can’t maintain the confidentiality of documents at the FDA, then we should abolish the FDA,” Barton commented.
Both Summit and FDA respectfully declined to appear at the hearing, citing their sensitivity to the ongoing investigation. But the only two witnesses who did appear—Visx CEO Mark Logan and former FDA device reviewer Mark Stern, who reviewed the Visx premarket approval (PMA) application—provided more than enough food for thought. Their testimony provoked both Barton and subcommittee minority leader Ron Klink (D–PA) to vow that the subcommittee will track the scandal to its end, regardless of the outcome of the November elections. Issues that particularly concerned the congressmen included the following:
*Why would Summit CEO David Muller, who has said he received the leaked documents in an envelope at his home last November 24, throw away the envelope? Barton expressed disbelief that anyone receiving such documents would do so.
Disregarding previous insinuations, subcommittee members accepted the assumption that Stern was not the person who leaked the documents to Summit, since his sympathies, if any, lay with Visx. Barton said he regarded Emma Knight, the lead reviewer of Summit’s PMA application, now reassigned to FDA’s biologics center, as a “major suspect.” Knight was no longer handling the Visx application at the time she was purportedly faxed the Visx “approvable” letter that was found among the documents leaked to Muller.
Stern testified that while working on Visx’s PMA application, he inferred that his assignment as an inexperienced reviewer was intended to slow down that application’s progress while the Summit application was getting speedier treatment from Knight, a far more experienced reviewer. He was not permitted to see any of the Summit application’s documents. (One possible explanation for this constraint may have been FDA Center for Devices and Radiological Health (CDRH) management’s suspicion of Stern. Testimony was given that Visx CEO Logan had been heard to brag that he had Stern in his pocket and that Stern’s mentor at Columbia University had been Steven Trokel, MD, a paid Visx consultant.) Stern said he was rebuffed in his attempts to bring his concerns to the attention of FDA commissioner David Kessler and deputy commissioner Michael Friedman.
CDRH Office of Device Evaluation director Susan Alpert recognized the gravity of the leak as soon as she heard of it. She implemented new document security measures and convened several office meetings at which she unsuccessfully begged the perpetrator to step forward.
According to subcommittee sources, FDA’s OIA investigated the case as if it involved little more than employee misconduct. FDA shared no information with the subcommittee, and not until Barton advised Kessler on July 15 of the scheduling of the July 31 hearing did FDA turn the investigation over to the Health and Human Services inspector general. In less than 24 hours, the inspector general decided it was a criminal matter requiring referral to the FBI. According to a memorandum of understanding between the Department of Health and Human Services and the Justice Department, FDA is required to refer cases immediately when there is a suspicion of criminal conduct.
A subcommittee analysis of FDA records of OIA activities appears to show that the office stopped taking official actions against FDA staff at about the time the Summit case began. For the fiscal year 1995, the office reported 4 employee terminations, 5 resignations, 7 suspensions, 10 letters of reprimand, and 5 letters of admonishment. For the eight months to June 30 of this year, OIA reported only one letter of reprimand.
While not very conclusive, the subcommittee analysis nevertheless paints a picture of an agency that seemed to be struggling hard to sweep a major embarrassment under the rug as Congress was considering reform legislation.
The embarrassment in this case was a federal crime worth 12 months in prison, whether or not bribery was involved—the deliberate leaking of a company’s confidential documents to one of its direct competitors. There has been no suggestion that Summit Technology or any intermediary on its behalf made a “cash or kind” payment or offer of a payment or favor to anyone at FDA. But such evidence is not necessary to make the leak a felony, as FDA should have known at the outset.
Visx insists that the FDA leak greatly damaged it in the marketplace, especially with respect to a future competitive advantage it expected to have over Summit. But it is society that stands to lose the most, if this episode erodes public confidence in FDA’s integrity.
This new incident is strongly reminiscent of the 1988 generic drug scandal in most respects other than evidence of any transfer of gratuities.
In both cases, FDA employees allegedly favored certain companies while retarding the reviews of others. In both, some companies were alleged to have such good connections inside the agency that they could work their wills and gain market advantage through manipulated FDA actions.
In both, upper agency management repeatedly turned a deaf ear to both trade complaints and protests from honest FDA employees.
In both, OIA (formerly the Division of Ethics and Program Integrity) participated in procedures that had the end result of actually sheltering, for a time, agency staff who had violated the law.
Apparently to forestall suspicions that the laser scandal reflects a dysfunctional agency unable to discipline itself, FDA associate commissioner for public affairs Jim O’Hara asserted after the July 31 hearing that the agency had conducted “a very intensive and thorough investigation, in coordination with other agencies” including the FBI. Because FDA statements might jeopardize the ongoing FBI investigation, he added, the agency had decided to remain silent even if it meant looking bad, confident that in the end a retrospective look would show that it had acted properly and diligently throughout the laser ordeal.
That seems a doubtful prospect. FDA has always presented a dense view of its decision-making processes, especially where its interactions with other agencies (in this case, the FBI) are involved. No public accounting of FDA’s investigational decision making in the generic drug scandal has ever emerged. Neither has the agency publicly described its decisional roles in any of the major criminal investigations it has referred to the Justice Department in recent years.
Typically, after an investigation moves to another agency for further development, such as prosecution, FDA steps into the background and stays there. Judging from all the media reports that flowed from the generic drug scandal, for instance, one could conclude that FDA had virtually no role in any of the investigations. All of the public statements emanated either from Congress or the U.S. Attorney’s Office in Baltimore. Yet the agency in fact assembled a special team of excellent investigators who were absorbed into the U.S. Attorney’s office, and who did almost all of the case development against dozens of individuals in industry.
If a day of final reckoning in the laser scandal is reached, the behavior of the OIA will likely be as much a mystery as it is today. Questions that FDA won’t be more willing to answer then than now will likely include the following:
Why wasn’t the obviously criminal leaking of documents immediately referred to the FBI?
Why did OIA wait five months before beginning serious field investigations, such as taking fingerprints of people who might have handled the stolen documents and interviewing those outside the agency who had knowledge of events (such as Visx CEO Mark Logan and Summit vice president of regulatory affairs Kim Doney)?
Why did FDA not give Congress the same degree of cooperation, within the constraints imposed by the ongoing criminal investigation, as during the generic drug scandal?
Why did it take FDA more than nine months to publish the approval notice for Summit Technology’s laser and to release its safety and effectiveness summary?
Why was FDA reviewer Emma Knight not reprimanded if, as has been alleged, she leaked that approval to Summit before it had been internally cleared? (Stern alleged that she gave the company the letter prematurely in order to help Summit’s $110 million secondary stock offering on October 24, 1995.)
There are many other issues intertwined in this investigation. Most will probably not be addressed by the FBI, but should be picked up by Congress as soon as the FBI completes its work. None of these issues was the focus of the recent FDA reform debate. They raise questions about FDA’s basic operating procedures, how it trains its employees, the effectiveness of FDA managers, the adequacy of security measures for company documents, and the efficiency of the agency’s communications, both internally and externally.
Unless these issues are dealt with effectively and soon, there may well be more leaks. And then, as chairman Barton said, we might as well not have an FDA. In his perspective, leaks by FDA make the case for third-party product marketing reviews stronger and less controversial. At least a nongovernmental reviewing organization would have legal liability for any leaks by its employees.
James G. Dickinson is a veteran reporter on regulatory affairs in the medical device industry.
|Incompetency At Its Best|
|All of this information is just a fraction of the incompetence of the FDA. The documents supportive of the facts shown, my experiences, and that of other LASIK casualties trying to obtain help from the FDA proves that this government entity is:
A COMPLETE WASTE!I encourage all to become actively involved in helping to put a stop to the ineffective waste of taxpayers’ money. The fda has ignored too many people, too many times.The health, welfare, and protection of the american people are at further risk as long as the fda remains ignorant and ineffective.
Eliminate FDA’s Dependency on Drug Industry Money, Public Citizen Tells Congress
Letter Urges Lawmakers Not to Reauthorize the Prescription Drug User Fee Act
WASHINGTON, D.C. – Congress should not reauthorize the user fees at the core of the Prescription Drug User Fee Act (PDUFA) because of the unacceptable conflicts of interest the fees create at the Food and Drug Administration (FDA), Public Citizen said today in a letter sent to all members of Congress. The organization urged lawmakers to abolish the user fee system and resume funding this critical public health function entirely from the federal treasury. However, the letter stated that this should not preclude the passage of various amendments currently being considered by Congress that would strengthen the agency’s drug safety functions.
To read the entire press release,