Unhappy LASIK patients urge FDA to take action

By Susan Heavey
GAITHERSBURG, 28 april 2008- Patients unhappy with their laser eye surgery urged U.S. health regulators to do more to limit poor results, saying complications from the LASIK procedure have taken a toll on their sight and emotions.
Blurred vision, dry eyes, glare and double-vision have led to depression and in some cases suicide, several patients told a U.S. Food and Drug Administration advisory panel.
"Since LASIK, I am visually handicapped," said patient David Shell, adding that he has near constant eye pain and depression. "My eyes never feel comfortable... 10 years have passed and I still suffer from this problem."
Millions of Americans have had successfully undergone LASIK, or laser-assisted in-situ keratomileusis, which uses a laser to reshape the eye's cornea, making them less dependent on glasses or contact lenses.
Surgeons and other industry representatives told the FDA's outside advisers most LASIK patients are satisfied with their vision. They noted depression is a complex condition and that no studies show a direct link to laser eye surgery.
Still, the FDA is taking another look at the surgery after receiving 140 reports of side effects and device malfunctions between 1998 and 2006.
The FDA wants its panelists' advice on what information it would add to its website or product labeling to help those considering undergoing LASIK.
"Most of the patients who are having these procedures are fairly satisfied and are doing well. Clearly there is a group who are not satisfied and do not get the kind of results they expect," Daniel Schultz, head of the FDA's device center, told reporters on Thursday ahead of the meeting.
Several unhappy patients at the advisory meeting faulted their surgeon for not ruling them out as a poor candidates for LASIK, or for failing to stress the severity of possible side effects.
The FDA, which has said the surgery is safe and effective regulates LASIK devices but not the surgeons or clinics that offer the procedure.
Stock analysts have said the FDA focus on the procedure could further hurt LASIK companies, which have already seen the softening U.S. economy dampen demand for the elective surgery that is usually not covered by health insurance.
LASIK device makers include Advanced Medical Optics Inc, Alcon Inc and Bausch & Lomb, among others. TLC Vision Corp and LCA-Vision Inc run LASIK clinics.
Eric Donnenfeld, an ophthalmologist at New York University Medical Center, said the surgery aims to improve patients' lives.
"The reality is that, following LASIK, the great majority of our patients see as well or better than they ever saw with their glasses or contact lenses with which they were unhappy," he told the advisory panel.
Still, some patients said that while their vision had improved, dry-eye and other side effects were overwhelming.
The FDA is also planning to begin a study on LASIK patient satisfaction in 2009 along with the National Eye Institute and two industry groups: the American Society of Cataract and Refractive Surgery and the American Academy of Ophthalmology.
Patient and consumer advocates at Friday's meeting objected to the groups' involvement with the study, citing conflicts of interest. Industry representatives said it would help them understand why some patients are unhappy with their LASIK results.

FDA Advisers Find LASIK Safe But Oversold

By Peggy Peck
26 april 2008 -- Laser-assisted in situ keratomileusis (LASIK) is safe and well accepted, an FDA advisory panel concluded today.
Although overzealous marketing may lead to inappropriate use of LASIK, such questionable clinical decision-making does not detract from the device's overall safety, found the agency's Ophthalmic Devices Advisory Committee after a day of hearings.
Jayne Weiss, M.D., of the Kresge Eye Institute in Detroit, who chairs the panel, said that based on available information "the vast majority of patients with LASIK do very well and are very happy and see very well."
Dr. Weiss said that one common theme during public testimony that occupied most of the morning session was "aggressive marketing. The other was LASIK as a commodity. The FDA does not regulate marketing, but I agreed that it is a problem."
Another issue, she said, was patient selection. The testimony suggested that there was "inadequate informed consent and the fact that some patients were poor candidates. That comes under malpractice and that is something that the field should monitor."
She said the day's hearing was "really a referendum on the performance of LASIK by some surgeons who should be doing a better job."
Nonetheless, Dr. Weiss said it was clear from testimony that the FDA's "LASIK postmarketing assessment surveys don't adequately address the severity of adverse effects."
The panel cited three major concerns -- the possibility of cataracts, endothelial cell loss, and induced astigmatism. It recommended that these concerns be reflected in the LASIK label.
The panel said that intraoperative complications such as flap complications should be differentiated from postoperative complications in the list of adverse events that must be reported to the FDA. Moreover, adverse events should include halos and glares as well as significant loss of visual acuity.
The panel suggested labeling changes to more fully state what and how problems can occur, including extreme blurriness, haze, glare, halos, and starbursts. It also suggested that the label take note of possible depression or psychological problems.
The panel agreed that LASIK labeling should include additional information or guidance about postoperative intraocular pressure, additional guidance for implant measurement for post LASIK cataract surgery, and stronger cautionary language concerning risks in patients with a strong history of keracatonis. The panel also recommended adding language about risks associated with hormone replacement therapy or a history of depression.
The panel also recommended that the FDA's LASIK Web site should include photographic illustrations of visual disability, detailed statistics as to risk of side-effects or complications, and an expanded explanation of the benefits of LASIK, i.e. that improving distance vision will mean the need for reading glasses.
The advisory panel set aside the entire morning for public testimony, much of it dominated by patients and family members of patients who claimed that LASIK surgery left them disabled, depressed, and in some cases suicidal.
A father told the story of his son, a law student who had LASIK because he had developed dry eye as a result of contact lens use. Before LASIK, the son was successful, outgoing, with no history of mental health issues, his father said.
Before surgery, the son was told that postoperative glare and halos would be no worse than with contacts. According to the father, after surgery the son had large starbursts and halos at night, triple overlapping images, and ghosting off white objects in low light, as well as painful dry eye.
The father read a suicide letter in which his son wrote that he fell into a suicidal depression because of his eye problems.
But the panel also heard testimony from a number of patients and surgeons who praised the surgery. An Army ophthalmologist testified that members of the Army's special forces units were especially pleased with LASIK results.

FDA Approves Bifocal LASIK Surgery

ROCKVILLE, Md., July 12 -- The FDA has approved a bifocal LASIK approach in which one eye will be treated for myopia and the other presbyopia.
The new device, called CustomVue Monovision LASIK, will reduce the need for reading glasses for adults 40 and older who have laser in-situ keratomileusis surgery to correct distance vision, said Daniel Shultz, M.D., director of the FDA's Center for Devices and Radiological Health.
The approval covers an eye mapping system using wavefront-guided treatments.
As part of the approval the FDA has requested a post marketing study following 500 patients for six months after surgery to characterize both quality-of-vision and quality-of-life issues associated with the procedure.
The surgery is a procedure in which the surgeon cuts a flap in the outer layer of the cornea in order to remove a small amount of tissue. The flap is then replaced. The CustomVue device would correct all nearsightedness in the dominant eye and only part of the nearsightedness in the other eye.
According to the FDA, patients considering the CustomVue Monovision LASIK surgery should first wear monovision contact lenses to determine whether they can tolerate having one eye under-corrected.
The surgery permanently changes the cornea, and side effects may include sensitivity to bright lights. These may be visual disturbances such as halos around lights and night-driving glare. Other potential side effects are double vision and visual fluctuation.