Video Testimony 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." - As stated in my presentation (below).
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 potraying 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 me because I simply don't trust them!
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 FDAs 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 ASCRSs 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
persons 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 FDAs receiving funding from the industry creates a conflict of interest
and harms credibility. He submitted a letter from Dr. Steven Friedman to FDAs
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: 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. Elbasanis 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 dont 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 worlds 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 worlds literature on patient
satisfaction and found that 95.4 percent of patients are satisfied after LASIK.
The review included all articles from LASIKs 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 plaintiffs 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 ones 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. Campbells 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 soldiers 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.