5/31/2008

Amid bad publicity for the LASIK industry, a group of LASIK surgeons announced ‘preliminary’ findings from an ‘unpublished’ review of medical studies showing a “95.4% global LASIK satisfaction rate”.

Press releases issued by LASIK industry insiders appeared to link this literature review to the FDA with misleading statements such as, “The FDA reaffirms that LASIK is both safe and effective.” When asked for clarification about the link between the study and the FDA, LASIK surgeon Kerry Solomon admitted that the study was performed independently from the FDA.

Clearly, this literature review was the LASIK industry’s attempt to reframe the discussion of last month’s FDA hearing concerning problems with LASIK. The review has not been published, but surgeons involved in the study report that 19 studies (2,199 patients) were selected from the thousands of LASIK studies in the body of peer-reviewed literature for the meta-analysis. This represents only .013% of patients who have had LASIK world-wide.

Interestingly, many more published medical studies show large percentages of patients experience complications after LASIK, even when the visual outcome is considered satisfactory.

Similarly, a published review of data for the twelve lasers approved by the FDA for LASIK between 1998 and 2004, including current technology, shows that six months after LASIK, 17.5 percent of patients report halos, 19.7 percent report glare (starbursts), 19.3 percent have night-driving problems and 21 percent complain of eye dryness. Based on these data, the lasers failed to meet the FDA’s safety requirements for approval.

Not only did the FDA approve unsafe devices for LASIK, the Agency also failed to enforce reporting of adverse events. When a patient experiences a bad outcome from LASIK, the physician should notify the manufacturer or the FDA by filing a MedWatch report. The medical literature contains hundreds of case reports of serious complications after LASIK, and thousands of medical studies of LASIK showing frequently occurring complications, yet the FDA recently announced that only 140 reports of adverse events after LASIK have been reported through MedWatch in the past decade. Apparently, most LASIK surgeons have never filed a single MedWatch report, even though all LASIK surgeons have patients with complications. And patients are not informed that they may voluntarily file their own MedWatch report. Clearly, adverse events from LASIK have been grossly underreported, and LASIK surgeons are not held accountable. In response to complaints from patient advocates, the FDA added a link to file a MedWatch report on its LASIK website in late May, 2008.