May 14, 2008

Lasik Patients Tell FDA Panel About Injuries

Although public comments presented to the Ophthalmic Devices Panel of FDA’s Medical Devices Advisory Committee 4/25 included ample reference to physical side effects and complications associated with Lasik eye surgery, the session was dominated by patient anecdotes and professional dispute over reports of severe depression and suicidal thoughts and actions attributed to adverse or sub-optimal surgical outcomes. Common physical complaints by patient advocates and patients claiming to have suffered adverse effects from Lasik surgery included persistent pain and stinging (dry eye), impaired night vision with the appearance of glare, halos or “starbursts,” and loss of visual acuity. But for some individuals, the chronic, unresolved nature of these and other conditions becomes so incapacitating as to lead to career and financial disaster, disruption of marriages and other personal relationships, and even suicide.

Clinical psychologist Roger Davis, who also suffers adverse effects from Lasik surgery, called for an end to, or at least a moratorium on, refractive eye surgery. “Research connecting complications to quality of life provides the ethical basis for informed consent,” he said. “Because this research does not yet exist, refractive surgery cannot be performed ethically, whatever its satisfaction or complication rate.” Davis charged that, all too often, Lasik patients have not been afforded the opportunity to give “real” informed consent to surgery; that the Lasik industry has lied to the public about the nature of risk, and has sought to suppress public awareness of the severity of Lasik injuries in order to maintain public perception of the procedure as safe; and that, given this perception, many injured patients will begin to think of themselves as victims of a medical conspiracy. “Patients feel helpless to communicate their problems, and hopeless in getting the industry to do anything to solve them,” he said, pointing out that helplessness and hopelessness are cardinal features of depression and suicidal ideation.

Former Navy psychiatrist now in private practice Jennifer Morse testified that, however debilitating the adverse events associated with Lasik surgery may be, suicide should never be attributed to a single cause. “Suicide is a product of multiple factors — an individual’s background, personality, coping skills and genetic predisposition,” she said. She asserted that there is no direct cause-and-effect between suicide and adverse effects that can be attributable solely to Lasik surgery. She did, however, call for more research on quality-of-life issues, including patients’ pre-operative and post-operative perceptions of the effects of surgery. “We need to understand the reasons for dissatisfaction, pre-operatively, and steer some patients away from surgery,” she said.

The “no cause-and-effect” assertion by Morse was vigorously disputed by Michael Mullery, also a physician with credentials in the field of psychiatry. Referencing findings of a recent comparative study of suicide among hearing- and sight-impaired individuals, Mullery stated flatly that in some documented cases “Lasik sight loss is the sole cause of suicidality.” He also called for more psychometric studies on the effects of post-surgical sight impairment, and a moratorium on Lasik surgery until such studies are done. Several individuals offered poignant testimony to the alleged link between the act of suicide and Lasik surgery gone bad, including reference to suicide notes from family members expressly relating the act to frustration and despair over their medical condition.

Although FDA recently announced a partnership with the several Lasik surgeons’ organizations, including the American Society of Cataract and Refractive Surgery, to study Lasik safety and quality-of-life issues, critics of the agency complain the partnership represents an inherent conflict-of-interest, and they call for any such research to be conducted by an independent body. Michael Patterson, who has suffered severe adverse results from Lasik surgery, which he attributes to lax FDA oversight of ambulatory surgical facilities and, more specifically, to improper re-use of a single-use microkeratome device, expressed skepticism over the integrity of the FDA/Lasik industry partnership.

Several presenters offered testimony pointing to an exceptional degree of satisfaction with Lasik surgery, as revealed in meta-analyses of the medical literature and patient surveys. Medical University of South Carolina ophthalmology professor Kerry Solomon cited results of a comprehensive review of the world literature since Lasik surgery’s inception. Of 1,581 articles reviewed, Solomon said 19 dealt specifically with patient satisfaction, indicating that more than 95% of patients report satisfactory results with Lasik, even after five years, post-op. This finding is consistent with data presented by U.S. Navy Refractive Surgery Program director David Tanzer,  who reported that more than 98% of naval aviators who have undergone Lasik surgery say they are either “extremely satisfied” (90.9%) or “moderately satisfied” (7.2%) with their results. Tanzer said the procedure is voluntary for members of all the armed services, and is made available, not only to aviators, but to Navy divers, and members of Ranger and Special Forces units who are routinely subjected to the most rigorous physical demands.

Although the 95% patient-approval statistic for Lasik surgery seems generally accepted, critics pointed out that, even if “only” 5% of individuals suffer unacceptable results, considering that 700,000 surgeries are now performed annually, this would nevertheless constitute a public health problem of enormous dimension. In any case, Patterson and others insist no one really knows the full extent of Lasik-associated problems, charging that FDA has received only 140 adverse event reports in its database — a figure that, they assert, represents an absurd undercount. Miami-based optometrist Edward Boshnick, an expert on corneal refractive therapies, said that in his practice alone he has seen at least 200 patients with adverse results from Lasik surgery.

The public testimony was followed by presentations from FDA officials who described several Lasik-related agency activities, including requirements for pre-clinical studies, device labeling considerations, refractive laser and ophthalmic standards, and post-market and quality-of-life assessments. Of particular interest, CDRH chief ophthalmic medical officer Eva Rorer said the agency has recently assumed an “integral role” in the design of a quality-of-life (QOL) instrument, or questionnaire for Lasik patients, to be used in conjunction with clinical trials conducted by FDA and its sister agency, the National Eye Institute.

As the purpose of the advisory panel meeting was to inform panel members of public concerns with respect to Lasik-related issues, and to apprise them of FDA activities in this area, there were no votes taken by the panel. FDA officials responded to questions posed by the panel, and a number of comments and suggestions were offered by panel members for consideration by the agency. Medical College of Wisconsin chairman of ophthalmology Dale Heuer observed that FDA’s informed consent document, for use in clinical trials, may not be understood by some patients, and should be written at a high school reading level; University of California, San Francisco professor of clinical Ophthalmology Stephen McLeod offered criticism of the FDA Lasik Web site, suggesting that it include statistics on adverse events and links to other Web sites relevant to Lasik surgery.

The session was concluded by panel chair Jayne Weiss, ophthalmology professor at Detroit’s Kresge Eye Institute. She thanked all presenters and said her sense of the meeting was that, while Lasik has been of great benefit to a large majority of patients, the problems experienced by some are very real. She acknowledged that the Lasik industry may be fairly accused of “aggressive marketing” (“Lasik sold as a commodity instead of a procedure”) — a situation which she said may, indeed, suggest scrutiny by the Federal Trade Commission; and she said that there is need for more attention to the issue of “adequate” informed consent from prospective Lasik patients.

Unaddressed by anyone other that Patterson was the need for a CDRH compliance program to increase adverse experience or Medical Device Reporting accountability by end-user Lasik device (surgical) facilities.

SourceFDAWeb.com

Posted by Admin at May 14, 2008 04:52 PM