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.
