Patient Information Booklet

Federal law requires that every candidate for refractive surgery be given the Patient Information Booklet... but... few patients ever see one. Why? Because this booklet discloses risks that your surgeon doesn't want you to see. If you are considering refractive surgery, demand to see this booklet. Then, ask yourself why it wasn't offered to you in the first place.

Federal Law requires that every patient who is about to undergo refractive surgery be given the Patient Information Booklet published by the laser manufacturer.

If your surgeon does not give you the Patient Information Booklet, he/she is violating federal law and can be charged with not providing you with full informed consent.

Abuse of this FDA mandate is widespread. Most patients never see a Patient Information Booklet because it's full of warnings that your surgeon does not want you to see. Surgeons are afraid that you'll back out of having refractive surgery if you read the Patient Information Booklet. I've called every laser center in my city, and NONE of the office staff even knew what I was talking about when I asked them to send me a copy.

Here is a sample of the FDA mandate: http://www.fda.gov/cdrh/pdf/p930016s007b.pdf See page 2. "In advance of surgery, all prospective patients must receive the Patient Information Booklet (as described in your final submission to this PMA) from their treatment providers." Each FDA-approved laser has an approval order with the mandate.

A sample Patient Information Booklet is here: http://www.fda.gov/cdrh/pdf/P930016S012d.pdfThe Patient Information Booklet for all FDA-approved lasers can be found on the FDA website.

FDA-approved lasers


More on the FDA:

In May of 2001, I filed a MedWatch report on the FDA website with regard to the Hansatome microkeratome malfunction during my surgery. (This is something that every injured patient needs to do, because your doctor is not required to. Can you believe that???)

Curiously, my report has disappeared from their list of reported Hansatome problems, and has been replaced by a denial on Bausch & Lomb's part that I even exist:

I wrote to the FDA on 7/24/01:

"I filed a MedWatch report on the Hansatome microkeratome in May, 2001. My report has been replaced by a denial from the manufacturer that I exist. Can you please tell me just how often consumer reports are deleted? The microkeratome jammed in my right (first) eye and left a ridge that is clearly visible in photos. Is that not an adverse event? How many other reports have been deleted? Why was this done? To hide this malfunction from the public?"

I never received a response.