GAITHERSBURG, Md. - More than 200 people filled a conference room this morning to listen to report after report from patients suffering from complications of vision-correcting eye surgery.
In the first hour of a public hearing, more than a dozen patients and patient advocates stepped to the microphone to tell an advisory panel of the Food and Drug Administration about their years of eye pain, night driving problems and suicidal thoughts.
"You have a serious problem on your hands," said Michael Patterson, a lasik patient from Atlanta.
Patterson and others asked the FDA to stop lasik, which stands for laser-assisted In situ keratomileusis. They also asked for stronger warnings about the surgery's risks and urged the FDA to better track complications and to monitor false claims in surgeon's advertisements.
Some also questioned the impartiality and expertise of the panel. Patterson pointed to one panel member, Dr. Andrew Huang, a professor of ophthalmology at Washington University in St. Louis, and shouted, "We don't need your expertise."
Patterson claimed Huang failed to follow safe lasik procedures during surgery.
Among those attending were lasik patient Matthew Kotsovolos and his wife, Beth, of Raleigh.
Matthew Kotsovolos, who experienced debilitating complications after lasik surgery, called the hearing a sham. He referred to a news release put out by a trade group for laser surgeons claiming that the FDA considers lasik to be safe and effective.
Beth Kotsovolos told the panel that because of lasik, her children almost lost their father.
The FDA panel could recommend changing regulatory guidelines for the vision-correcting laser or it could do nothing.
The American Society of Cataract and Refractive Surgery has said that only
about 3 percent of lasik patients experience complications, but other data and
research suggest problems may be more common and long-lasting.
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Posted by Admin at April 25, 2008 04:11 PM