Comments to the FDA on “Medical Devices: Ophthalmic Devices; Laser-Assisted In Situ Keratomileusis (LASIK) Devices; Establishing a Docket”

September 14, 2009

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Comments of the National Research Center for Women & Families
on
“Medical Devices: Ophthalmic Devices; Laser-Assisted In Situ Keratomileusis (LASIK) Devices; Establishing a Docket”
[Docket No. FDA-2009-N-0488]

The National Research Center for Women & Families submits the following comments regarding the laser-assisted in situ keratomileusis (LASIK) and the post market experience associated with the use of LASIK devices.

More than 8 million people in the U.S. to date have had vision-corrective LASIK procedures.  But the surgery is not without risks; potential adverse reactions include blindness, reduced vision, and a number of other eye injuries.  Although a 95% satisfaction rate has been reported, that figure is overstated.  Underreporting of problems is common because often issues do not emerge immediately after surgery-sometimes weeks, months, or even years go by before complications arise.  And, even a problem rate of 5% would translate to 400,000 people-certainly not an inconsequential number of dissatisfied patients.

Although the guidelines of the FDA’s Center for Devices and Radiological Health (CDRH), only allow approval for medical devices with “complication rates” below 1%, the FDA has approved lasers used in LASIK surgery that had reported complication rates of more than 20% in the clinical studies used to support their approval applications with the FDA.[1] Of the 14 FDA approvals for LASIK lasers, not one single safety and effectiveness study reported adverse events in less than 1% of eyes. And, the clinical trial studies included no long-term follow up, thus leaving no way to detect any late-onset complications.

The FDA’s mission is to ensure that medical products are safe and effective.  For LASIK, it is essential that we remember that safe alternatives-glasses and contact lens-are less expensive and readily available.  The risks of LASIK have to be examined in that context.

In 2008, the FDA held a public hearing to listen to testimony from patients and doctors, including testimony from patients who reported that LASIK surgery left them with blurry vision, double-vision, and problems with night vision, among other complications.[2] The public testimony also included personal stories of depression, suicide or suicidal ideation, and other psychological problems that had been the results of adverse LASIK outcomes.

Research studies have documented difficulties with night vision and dry eyes, the latter of which can be extremely painful.[3] One study found that approximately half of the LASIK patients experienced dry eyes within the first week.[4] Another study indicated that 20% of the LASIK patients had dry eyes for more than 6 months.[5]

An analysis of FDA Summaries of Safety and Effectiveness for the twelve LASIK lasers approved by the FDA from 1998 through 2004, found that six months after LASIK, 8% of patients reported halos, 20% reported glare, 19% reported night driving problems, and 21% reported dry eyes that were worse, or much worse, than before surgery.[6] Other complications have been reported, including infection, inflammation, haze, free caps (where the flap was completely cut off), flap striae (wrinkles), and flap dislocation.  A 2008 study published in the American Journal of Ophthalmology by Dr. Jorge Alio and his colleagues from Miguel Hernandez University Medical School reported that 28% of the eyes treated with LASIK needed re-treatment within 10 years because of under-correction, over-correction, or regression.  The percentage of patients was even higher: 35%.[7]

Given the severe and potentially life-long nature of many of these complications, it is not surprising that reports have indicated elevated rates of suicide among LASIK patients.  For example, in 2008, preliminary findings of an Emory Eye Center study suggested a four-fold increased suicide rate among cornea donors who had LASIK surgery, compared to cornea donors who had not had LASIK.[8]

Recognizing the profound negative impact that LASIK can have on quality of life, some doctors have revised their post-operative information packets to include language regarding risk of possible psychological damage from an ideal or less-than-ideal LASIK procedure.[9]

Are patients adequately warned of these risks before deciding to have LASIK surgery?  The problems are rarely publicized and patients do not seem to have informed consent when they have LASIK surgery.  Also, since LASIK is a relatively new procedure (first approved in the United States in 1998), very little long-term data even exist to be made available to the public.

The FDA’s web page on LASIK would better serve people considering LASIK surgery if the FDA placed the following statement in a more prominent spot (instead of at the bottom of the page):  “It is also important to note that no laser company has presented enough evidence for the FDA to make conclusions about the safety or effectiveness of enhancement surgery.”[10]

Also, the FDA should require that patient receive booklets about LASIK procedures and the booklets should be short, easy to understand and focused on risks and benefits.  The information in the booklets should be reiterated by the health professionals, not undermined with reassuring statements such as “this procedure is very safe” or “all my patients are very happy.”

Sincerely,

Diana Zuckerman, President
National Research Center for Women & Families

The National Research Center for Women & Families is a nonprofit dedicated to improving the health and safety of adults and children by using research to develop more effective programs and policies.  We do not accept funding from drug or medical device companies.


[1] Lauranell H. Burch, Ph.D. letter to Government Accountability Office (GAO) and the HHS Inspector General (June 11, 2009) available at http://www.lasiknewswire.com/Ltr-GAO-11Jun09.pdf.

[2] FDA, 110th Meeting of the Medical Devices Advisory Committee, “Summary Minutes, Medical Devices Advisory Committee” April 25, 2008, available at http://www.fda.gov/ohrms/dockets/ac/08/minutes/2008-4353m1.htm.

[3] Sugar A, et al., “Laser in situ keratomileusis for myopia and astigmatism: safety and efficacy: a report by the American Academy of Ophthalmology.”  Ophthalmology.  2002 Jan; 109(1): 175-87.

[4] Hovanesian JA, Shah SS, Maloney RK, “Symptoms of dry eye and recurrent erosion syndrome after refractive surgery” Journal of Cataract & Refractive Surgery.  2001 Apr; 27(4): 577-584.

[5] Shoja & BeharatiEuropean Journal of Ophthalmology. 2007 Jan-Feb;17(1):1-6.

[6] Bailey MD, Zadnik K.  “Outcomes of LASIK for myopia with FDA-approved lasers.”  Cornea.  2007 Apr; 26(3): 246-54.

[7] Alio J et al. “Ten-year follow up of laser in situ keratomileusis for myopia of up to – 10 diopters.”  American Journal of Ophthalmology 2008; 145: 46-54.

[8] Sabine Vollmer, “Some link depression, failed LASIK.” (February 3, 2008, The News Observer) available at http://www.newsobserver.com/150/story/920341.html.

[9]Ocular Surgery News, “Surgeon Shares Refractive Surgery Trends in Clinic in Australia” (May 18, 2009) available at http://www.osnsupersite.com/view.aspx?rid=40013.

[10] U.S. Food and Drug Administration (2009).  What should I expect before, during, and after surgery?