April 25th, 2008 was a historic day for the Food and Drug Administration. On that day, a small group of medical doctors, optometrists, psychologists,
and injured patients presented at a Special Hearing of the Ophthalmic Devices Panel, responsible for the approval of medical devices for ophthalmic
use in the United States. The subject of the hearing was post-LASIK quality of life, depression, and suicide.
Insiders acquainted with the FDA approval process for medical devices were horrified as one by one, the presenters alleged deception by individual
LASIK surgeons, cover ups perpetrated by medical device manufacturers, and corruption at the level of the FDA itself. Compelling cases were made for
massive violations of federal law, the failure of the FDA to monitor surgical facilities for LASIK, and deliberate misclassification of severe
complications as simple side-effects, as a means of securing premature FDA approval of the excimer laser.
The mass media attended and filmed the April 25th hearing. Nevertheless, the substance of the above allegations went mostly unreported, despite
discussion of four completed post-LASIK suicides, including excerpts from two actual suicide notes. The American Society of Cataract and Refractive
Surgeons (ASCRS) asserted that individuals with psychological issues post-LASIK certainly had psychological issues all along. But to anyone sitting in
the audience without a preconceived bias, the ASCRS position seemed indefensible. Still, the mass media focused on a 95% percent satisfaction rate, a
statistic put forward by ASCRS, but not yet published in their own peer-reviewed literature. Why?
Fortunately, the entire event was captured on video. Beyond the obviously sad association between severe LASIK complications, depression, suicide, and
medical deception and corruption, the April 25th Special Hearing of the Ophthalmic Devices Panel must be regarded as one of the most interesting
sociological dramas in modern medicine, one which is still being played out.
Judge for yourself the significance of these events, and come to your own conclusions about LASIK, the industry behind it, and the FDA.