Dangerous Pelvic Mesh Creates Worries about FDA Safety

After a number of reports about surgical vaginal mesh-associated complications in women, the FDA issued its second warning about the device in three years. A panel will convene in September to determine whether the medical device needs to undergo more testing.

Simultaneously, a group called the Institute of Medicine will issue a report Friday about whether the FDA’s process of approving devices protects patients and promotes innovation in the name of public health. They’re calling into question how the FDA clears devices for the market, in the wake of a new study on 113 recalls from 2005 through 2009 on devices the FDA said could cause serious injury or death.

According to authors of the study, only 21 of those devices had been required to be tested on patients before receiving FDA approval. Of the 113 recalls, 35 were for cardiovascular devices, including automated external defibrillators, or AEDs, and only 12 of them had been required to undergo patient testing.

The agency has not pulled the controversial transvaginal mesh off the market, although an FDA study found that the mesh doesn’t provide any benefit. In 2010, the FDA says, doctors performed at least 100,000 prolapse repairs using surgical mesh, and about three-quarters of them were transvaginal. From 2005 to 2007, the FDA received more than 1,000 reports of adverse events related to the mesh in women treated for pelvic organ prolapse or stress urinary incontinence.

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