What was Presented

(obtained from the FDA's website)

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 physician’s 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: LasikSucks4u2.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 consent.        .                                                              

 

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.

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