snip
Carlos Belmonte, founder of the Institute of Neurosciences in Alicante, Spain, and a pioneer in studying the physiological basis of eye pain, explains that corneal nerves don’t completely regenerate after LASIK surgery. “The main risk is that in a very small percentage of cases, this regeneration is pathological, and then you get this neuropathic pain and that is a disaster,” he said. “But this is a risk that happens in surgery.”
In 2007, Belmonte published a study that suggested a form of dry eye pain called ‘phantom’ cornea could occur after LASIK-mediated damage to the corneal nerves. At the same time, Boston ophthalmologist Perry Rosenthal was compiling multiple case reports suggesting that a similar post-LASIK phenomenon was appearing regularly in patients with severe eye pain who had been referred to his clinic. Other researchers have documented phantom pain among patients who have had eye amputations or corneal transplants.
Waxler retired in 2000 and is now an independent regulatory consultant. He gave little additional thought to LASIK until a patient whose eyes had been damaged by the surgery called him about six years ago and angrily asked why it had been approved. Waxler listened, and began talking to other patients with similar stories. “I said, ‘Well, how could this happen?’” he recalled.
Based on his review of medical studies and documents on the FDA’s website, he alleges that many of the problems had been reported all along, but labelled as ‘symptoms’, a category deemed less serious than ‘adverse events’. Waxler made headlines in 2010 and 2011 when he went public to contend that the original studies actually documented an adverse event rate of about 20 per cent. The FDA later responded that symptoms like glare and dry eye are too mild to be considered adverse events.
Meanwhile, more patient advocates were going public with their own stories and documenting them on Facebook groups and multiple websites. One, LASIK Complications, created a page to track LASIK-linked suicides and attempted suicides, based on news accounts and patient reports filed with the FDA.
At a public meeting of the FDA Ophthalmic Devices Panel in April 2008, nearly 20 individuals spoke out against the LASIK procedure: optometrists who had treated patients after the surgery, patients recounting their own ordeals, and two speakers testifying about patients who had killed themselves.
New Jersey financial administrator Matthew Kotsovolos, now 46, was among those who testified. He describes his own misery after a 2006 LASIK eye surgery as “a pain that I am confident that most people do not recognise as existing in this world”. His surgeon considered the procedure a success because Kotsovolos’s uncorrected vision improved to 20/20. Even so, he suffered from constant, debilitating eye pain. “So I pretty much lived in Hell.”
Blogs & Forums
