Johnson & Johnson vaginal mesh lawsuits another blow to the FDA's device review process

October 20, 2011 by Arezu Sarvestani

With high profile recalls in hip implants and defibrillators in the recent past, the FDA's medical device review process takes another hit it doesn't need as health care giant Johnson & Johnson weathers a storm of transvaginal mesh complaints.

Transvaginal mesh

The FDA's medical device review process is again under scrutiny as lawsuits pile up against health care leviathan Johnson & Johnson (NYSE:JNJ) for transvaginal mesh devices that may do more harm than good.

Lawsuits claiming negligence against mesh-makers have also implicated the FDA's review system for continuing to clear new mesh products under the 510(k) system, despite the predicate device being pulled from U.S. shelves.

Boston Scientific Corp.'s (NYSE:BSX) ProteGen mesh, cleared in 1996 and pulled from the shelves a year later, was used as a predicate device for clearing subsequent mesh products, despite more than 120 adverse event reports on the original design at the time, Bloomberg reported.

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"The FDA got caught with their pants down," California pelvic surgeon Thomas Margolis told the news service. "The ProteGen should have told them, 'Wait a minute, all of these mesh systems are bad.'"

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