Reprinted with permission from www.fdaweb.com
CDRH director Jeff Shuren was told 7/24 he has a “moral, if not a legal, obligation to follow up directly” with a patient who told his Center in a 6/6 MedWatch report that “I intend to end my life soon” because of LASIK-related eye injury. The plea came in an email to Shuren from LASIK victim/activist and CDRH advisory committee consumer representative Paula Cofer. Her email comes as Shuren was presumably hoping the LASIK controversy ─ a technology “too dangerous to be allowed” ─ had been left on the way, way backburner.
“I urgently wish to bring your attention to a MedWatch report which was received by the FDA on June 6, 2012. This report was submitted voluntarily by an injured LASIK patient who expressly states his or her intention to commit suicide:
‘I have chronic aqueous deficient dry eye a/k/a neurotrophic keratopathy or refractory dry eye. My eyes do not tear when they are dry or come into contact with irritants and allergens. This is an extremely painful and degenerative condition though I don’t think I will be around to see exactly how bad it gets because I intend to end my life soon. My doctor claims that it is not possible for this to be a result of LASIK. However, when pressed he said that up to 40% of LASIK patients have some degree of residual dry eye. He is full of contradictions. It depends what you’re asking him and in what context. The answer changes regularly. It took me 6 years to find a doctor that finally told me that this condition is in fact due to LASIK surgery. This is due to a concerted effort by ophthalmologists to cover up for each other. Even though they knew better they sent me on a 6 year quest to find out what I should have been told before the surgery. LASIK causes extreme dry eyes in many people, especially people like me with high risk factors.’
“I happened upon this report,” Cofer tells Shuren, “as I was reviewing the most recent LASIK MedWatch reports contained in the Maude database, which is something that I do routinely in my continuing efforts to raise awareness of the risks of LASIK surgery.
“I am aware of five LASIK-related suicides and believe that this patient is in imminent danger.
“I believe the FDA has a moral, if not a legal, obligation to follow up directly with this patient. Please reply by e-mail within 3 days to advise that you are taking appropriate steps.”