Ask any LASIK patient if he or she was given the FDA-mandated Patient Information Booklet prior to surgery. The answer is usually “no”.
Companies that manufacture lasers for use in LASIK surgery are required by the FDA to provide Patient Information Booklets to LASIK surgeons. In turn, LASIK surgeons are required to provide the booklets to prospective patients prior to surgery. Patient Infomation Booklets provide warnings and other information for patients to consider before consenting to undergo LASIK.
Below are two examples of the FDA mandate regarding Patient Information Booklets. The first example is found in an FDA Approval Order for the VISX laser, and the second is found in the VISX Physician Instruction Booklet.
Prospective patients, as soon as they express an interest in wavefront-guided LASIK for myopic astigmatism and prior to undergoing surgery, must receive from the treatment provider the Patient Information Booklet (as described in your final submission to this PMA supplement). Link
All patients must be given the opportunity to read and understand the Patient Information Booklet and to have all their questions answered to their satisfaction before giving consent for Laser Assisted In Situ Keratomileusis (LASIK). Link
LASIK surgeons also fail to comply with mandatory reporting of complications and adverse events, as evidenced by researching the FDA’s Maude database. See related story.
Obviously, the LASIK industry has done a poor job of policing itself. And the FDA has done an equally poor job policing the use of LASIK devices. As a result, many patients have suffered serious injury and loss of quality of life.
July 27th, 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Amid bad publicity for the LASIK industry, a group of LASIK surgeons announced preliminary findings from an unpublished review of medical studies showing a “95.4% global LASIK satisfaction rate”.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 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 occuring 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.
May 31st, 2008
