Exposing the LASIK Scam

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 Post subject: FDA panel scrutinizes LASIK safety data
PostPosted: Sat May 24, 2008 5:47 pm 
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OCULAR SURGERY NEWS U.S. EDITION May 25, 2008

FDA panel scrutinizes LASIK safety data

While the advisory panel offered no sweeping changes, it made recommendations to update FDA labeling information on the procedure.

By David W. Mullin

Quote:
Some patients commented on the proposed quality-of-life study to be conducted in 2009 by the FDA, the National Eye Institute, the American Society of Cataract and Refractive Surgery and the American Academy of Ophthalmology. The announcement of the prospective study comes on the heels of syndicated reports in recent months of depression and suicide of patients after LASIK.

Strong calls for change
Todd J. Krouner, JD, argued that the FDA quality-of-life study be carried out independent of the refractive surgery industry, which he sees as embodied in the ASCRS and AAO.

Mr. Krouner, a LASIK malpractice attorney based in Chappaqua, N.Y., said, ?Given the self-interest of the LASIK industry and its surgeons, it is respectfully submitted that any review of LASIK safety, satisfaction or study of correlation between bad LASIK outcomes and suicide should not be delegated exclusively to those who have a vested interest in the conclusion.?


Quote:
Malvina Eydelman, MD, director of the Division of Ophthalmic and Ear, Nose and Throat Devices at the FDA, defended the yet-to-be-conducted study at another point in the meeting, saying, ?I can assure you that every precaution is being taken to eliminate potential conflicts of interest. This study will be conducted in accordance with the regulations governing FDA and NEI clinical trials.?


Quote:
?It is important for the dissatisfied LASIK patient to know that we, the LASIK surgeons, are listening, that we hear them, that we care, and that we are responding in a tangible and constructive fashion,? Dr. Lindstrom said.

The Prospective Evaluation of LASIK Satisfaction (PELS) study will provide insights into the incidences, causes and treatment of patient dissatisfaction from LASIK, he noted.



Full text at: http://www.osnsupersite.com/view.asp?rID=28435

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