ClickCease FDA Too Lenient On Device Approval | Medical Malpractice Blog
05/11/09   |   By

FDA Too Lenient On Device Approval | DC Metro Area Medical Malpractice Law Blog

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Posted by: Salvatore J. Zambri, Esquire

An editorial from yesterday’s New York Times challenges the Food and Drug Administration (FDA), suggesting that the agency has been too lenient in approving medical devices.  The article notes that a “vaginal sling,” used to control urinary leaks, that was previously sold by the Mentor Corporation,  a company that was acquired by Johnson & Johnson, has caused serious medical problems for many women throughout the country. In one instance, a woman’s “surgeon inserted a strip of synthetic mesh — Mentor’s ObTape vaginal sling — under her urethra. It stopped the leakage but soon caused pain and bleeding as pieces of the sling worked their way through her vaginal wall. The woman has had five operations to remove bits of the sling, and another is scheduled.”

Last year, the FDA received more than 1,000 reports directly from manufacturers about complications with “vaginal-sling”-like devices, according to the report.  About one-fourth of the complaints concerned “ObTape” specifically.  “The injuries may stem from the fact that far too many medical devices are cleared for sale without undergoing rigorous clinical trials for safety and efficacy.”

Medical devices can be extremely dangerous, and the FDA often does a poor job screening defective products from the public.  If your doctor wants to insert a medical device into your body, ask questions to be sure your physician has sufficiently investigated the device’s safety and effectiveness.

Many Americans are killed or injured each year by defective devices.  For more information about your legal rights, please contact the law firm of Regan Zambri & Long, PLLC  at (202) 463-3030.

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