To ensure informed consent, the FDA should reach out more effectively to mass media about their LASIK warnings and require that physicians using LASIK devices provide short-easy to understand booklets about LASIK risks at least one week prior to the procedure. The information in the booklets should be reiterated by the health professionals, not undermined with reassuring statements such as "this procedure is very safe" or "all my patients are very happy."
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Vision problems after LASIK, such as double vision, night-time starbursts and halos may not be correctable with glasses or soft contacts and, instead, may require expensive specialty hard contact lenses... Treating LASIK-induced dry eye can be very costly. Common therapies to treat dry eye after LASIK include extensive use of artificial tears, ointment or gel for night-time lubrication, use of moisture retaining goggles, commerical eyelid scrubs, prescription eye drops (Restasis), omega-3 supplementation, and plugging or cauterization of the tear ducts.
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Presumably, Dr. Lindstrom did not have the benefit of reading police officer Campbell's suicide note... He states: "No one knows what I am feeling, constant pain, blurred vision, stress that I never had before. If only Dr. Robert P. Selkin had done a pre-op and knew I was not a candidate for LASIK surgery. I just cannot burden my family for a poor decision, eye surgery, which Selkin knew was wrong but only wanted money, and I will not live on drugs, Xanax." He goes on to state, "Do not have LASIK surgery. Tell the media."
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LASIK Surgery Watch says it disputes most of FDA's response to FDA Webview in our publication of an interview with former FDA Division of Ophthalmic Devices Diagnostic and Surgical Devices Branch chief Morris Waxler, who said that FDA was mistaken in approving excimer lasers for LASIK during his tenure (see story). In a 9/13 letter to CDRH acting director Jeffrey Shuren and other FDA and HHS officials and members of Congress, LASIK Surgery Watch says that FDA caveats that its guidance documents only provide guidance "in no way exonerate [it] for approving excimer laser devices for LASIK, a procedure with complications in excess of 20%."
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In a comment on Kantis' complaint about the 18 ads, FDA's Press Office told FDA Webview: "We acknowledge receipt of these ads and will give them appropriate review. Without enough time to review, it is not helpful to speculate on potential regulatory action, nor can we comment on an investigation should we initiate one."
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When it first approved laser devices for LASIK indications in 1998, CDRH "screwed up" in not establishing a standard for acceptable adverse events reported from clinical studies, former branch chief for diagnostic and surgical devices Morris Waxler told FDA Webview in a teleconference interview 9/3... "I think we screwed up," Waxler said of the 1998 approvals. "Nobody's going to admit that. Basically, I think people made some of those judgments incorrectly. We were getting advice from very renowned ophthalmologists -- more renowned than anyone we had in the agency.
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