LASIK complications

Open Letter from Morris Waxler, PhD

morris_waxler

Has your vision been damaged because of LASIK? Do you know someone whose vision has?

Then visit http://www.helpstoplasik.com/. This site will serve as a means through which we can track and communicate with people who are damaged from LASIK, and want to see it stopped.

I am Morris Waxler, PhD. In 1998, I was the FDA’s chief scientist in charge of the clinical trials research for laser eye surgery, popularly known as LASIK. Based on my recommendation, the Food and Drug Administration approved LASIK. Millions of people worldwide have now had the surgery.

Unfortunately, for a substantial minority, the effects have been catastrophic. Patients report severe dry eyes, unrelenting pain, and problems with their vision that cannot be corrected with glasses or contact lenses. Many of these patients complain about depression, anxiety, and suicidal thoughts. Patients with no mental health history have committed suicide.

This should not have happened. When I was the FDA’s chief scientist in charge of the evaluation of the clinical data submitted for the approval of LASIK devices, we did not have the means to monitor the truth or falsity of industry’s data. As such, we relied on industry to provide us with an honest accounting of all adverse events, including but not limited to complications and side-effects. Unfortunately industry provided a biased accounting of adverse events resulting in a rate of 1.0% rather than 20.0% at six months post-LASIK.

In January 2011, I petitioned the FDA to withdraw its approval “for all LASIK devices and to issue a public health advisory with a voluntary recall of LASIK devices in an effort to stop the epidemic of permanent eye injury cause by lasers and microkeratomes used for LASIK eye surgery.” Thus far, the FDA has not been responsive to my request.

My belief is that the FDA would rather this situation “go away” than deal with it honestly. The FDA does not want to admit that millions of people have now had a surgery that never should have been approved by its own rules. The FDA is now engaged in covering-up a scandal and an epidemic, and its own corrupt practices. This should be exposed, and LASIK should end.

If you have suffered any severe complications from LASIK please visit http://www.helpstoplasik.com/and register to help us stop LASIK.

Morris Waxler, PhD