Despite CDRH guidance limiting allowable medical device "complications" to 1%, it has approved lasers used in LASIK vision-correction surgery that exceeded a 20% complication rate in the clinical studies that supported their marketing applications. This is the basis of a 6/11 request by LASIK victim Lauranell H. Burch, who is molecular genetics core facility director at the National Institute of Environmental Health Sciences, that the devices' approvals be revoked. She made the request in identical letters to the Government Accountability Office (GAO) and the HHS Inspector General.
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On Wednesday, June 10, 2009, a jury in New York City returned a verdict of nearly $5.6 million against Kevin Niksarli, M.D., for LASIK malpractice. The verdict consisted of an award of: $2,360,000 for the patient's loss of income; $3,100,000 for the patient's pain and suffering, including loss of life's enjoyment; and $120,000 for the patient's wife's claim for loss of her husband's services and consortium. This is the second largest verdict ever for LASIK malpractice.
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LASIK Patient Advocacy Network founder Scott A. Tolchin has written President Obama asking for intervention to help order a moratorium on LASIK eye surgery procedures due to an alleged increased rate of adverse events related to the procedure. Tolchin's letter notes that patient advocates are planning a briefing on Capitol Hill 6/22 to discuss the moratorium request.
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In a battery of new letters to FDA and its Capitol Hill overseers, protesters who say they have been permanently damaged by LASIK vision-correction surgery escalated their campaign this week to have the agency upgrade patient disclosures and warnings in the labeling of devices used and initiate inspections at ambulatory surgical facilities that, they allege, routinely fail to report adverse events to the agency. They say the letter campaign is to be followed by visits to key lawmakers this month and demonstrations outside FDA headquarters.
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