Representative Wants to Close Loophole in Current Medical Device Approval Process

March 28, 2012 - PRLog -- LegalView.com, a leading online legal resource, has reported on another story of vaginal mesh complications.

For Jay Nevarez, a mother-of-three in Colorado, undergoing surgery to treat her stress urinary incontinence became one of the worst experiences in her life. As part of her treatment, a transvaginal mesh was surgically implanted, however vaginal mesh has been linked to several serious complications, including severe pain and infection. To learn more about these complications, visit LegalView's vaginal mesh portal, http://vaginalmesh.legalview.com/.

Nevarez claims she had no idea it was very similar to a mesh device that was recalled nearly a decade ago due to several complications.

During a press conference, Nevarez stood next to Rep. Edward Markey (D-MA) in a walker, and told reporters about quitting her job due to the constant pain. Her house is also facing foreclosure.

Nevarez has filed suit against Johnson & Johnson, the maker of the device she received, alleging she was harmed by the device. The device she had implanted, called Gynecare TVT mesh implant, went through automatic pre-market approval by the United States Food and Drug Administration based on its similarity to another product made by Boston Scientific even though it had been recalled shortly after Gynecare TVT was approved.

According to Markey, several other devices were approved well after the original Boston Scientific device was removed from the market, which is extremely troubling.

In a statement aimed at garnering support for legislation that would help to strengthen FDA regulation on medical devices, Markey said that the current law has a loophole that requires the FDA to approve certain kinds of medical devices based on previous similarities even if the agency feels they may harm others. As long as manufacturers can prove that their device is “substantially similar” to others on the market, it can be approved for human use.    

The bill, called the Safety of Untested and New Devices (SOUND) Act, would allow the FDA to require manufacturers of devices based on older devices to provide documentation showing that the new product's design has fixed potential problems. Markey hopes the bill will be added to a larger medical device bill that Congress is set to vote on in May.

So far, neither the Senate nor the House bill that contains wording to close the loophole and the SOUND Act has gained any Republican sponsors.

A spokesperson for Boston Scientific says that they believe in the strength of the FDA's current medical device approval process. Johnson & Johnson did not respond to any requests.

Even though the FDA hasn't lent any official support for the bill, spokesperson Karen Riley did comment that the agency has raised issues about the loophole to Congress in the past and that the bill would bolster the medical device process and “provide appropriate protections for public health.”

If you or someone you love has suffered from the adverse effects of a vaginal mesh implant, please visit LegalView, http://www.legalview.com, to receive a free legal consultation with a medical device attorney.

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