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FDA device director supports closing approval loophole (1)

On Behalf of | Mar 7, 2012 | Product Liability

Last month, we wrote about federal legislators’ efforts to close the loophole in the U.S. Food and Drug Administration’s medical device approval process. Now, it appears that a top official with the device division of the FDA agrees that such a change should be made. Hopefully, this will spur the legislation and prevent dangerous or defective products from making it to the marketplace in the future.

The movement to close the approval loophole, which we detailed in our previous personal injury blog post, was largely motivated by the vaginal mesh products manufactured by New Jersey-based Johnson & Johnson. More than 300,000 women have reportedly used the device to treat weakened pelvic muscles, and Johnson is now facing hundreds of products liability lawsuits from patients who have suffered internal injuries as a result of the faulty vaginal mesh product.

Vaginal mesh was approved under the FDA’s 510(k) program, which is used to process about 90 percent of the medical products that are approved in the United States every year. Under a loophole in the program, devices that are “substantially equivalent” to previously approved versions must be automatically approved. This is so even if the previous version of the product has been recalled for safety reasons.

It is believed that Johnson & Johnson’s vaginal mesh was approved under such a loophole, based on a similar product manufactured by Boston Scientific in the 1990s. Although that earlier product was recalled due to safety concerns, it sufficed as a “substantial equivalent” of Johnson’s mesh.

We will continue our discussion of this topic in a second blog post later this week.

Source: Bloomberg, “Medical Device Loophole Needs Closing by Congress, FDA Device Chief Says,” Alex Nussbaum, Feb. 28, 2012

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