WASHINGTON -- When Jay Nevarez underwent surgery four years ago with a vaginal mesh implant to relieve her urinary incontinence, the mother-of-three from Colorado said she had no idea that the device inserted in her pelvis was very similar to one that had been recalled nearly a decade earlier because of postsurgical complications, including persistent pain and infections.
Standing with her walker alongside Representative Edward Markey (D-MA) at a press conference at the Capitol on Thursday morning, Nevarez recounted her days filled with constant pain, which forced her to quit her job as a truck driver and left her unable to walk unassisted.
“It’s a question of loss,” she said. “I lost my job and my health, and am in the process of losing my home.”
Nevarez has filed a lawsuit against Johnson & Johnson/Ethicon, manufacturer of the Gynecare TVT mesh implant. Her device had received automatic approval by the US Food and Drug Administration based on its similarity to another product -- Boston Scientific’s ProtoGen, which was removed from the market shortly after Gynecare TVT was approved.
What’s more troubling, Markey said, is that other vaginal mesh devices based on ProtoGen received FDA approval well after the original device was removed from the market.
“There’s a loophole in our current law that actually requires the FDA to approve certain kinds of medical devices even if they have reason to believe [the devices] may harm or even kill patients,” said Markey at the briefing aimed at garnering support for legislation that would strengthen FDA regulations of medical devices.
The bill, called the Safety of Untested and New Devices (SOUND) Act, would enable the FDA to require manufacturers of devices based on older devices that have safety issues to provide documentation demonstrating that the new product’s design has fixed potential problems. In an interview following the briefing, Markey said he hoped the legislation would be added to a larger medical device bill that Congress is set to vote on at the end of May.
So far, however, neither the Senate nor the House version of that large bill contains wording to close the loophole, and the SOUND act has failed to enlist any Republican sponsors.
Boston Scientific spokesperson Denise Kaigler said the company believes in the “strength” of the FDA’s medical device review process and added that the agency “routinely requires the submission of extensive testing results and scientific data.” Johnson & Johnson/Ethicon did not respond to requests for a comment.
While the FDA hasn’t lent its official support to the bill, spokesperson Karen Riley said the agency has raised issues about this loophole to members of Congress and added that addressing this in new legislation would bolster the medical device program and “provide appropriate protections for public health.”
On average, the FDA clears 28 devices a year based on a previous device that was already approved but since recalled. A new device is five times as likely to be recalled with a design flaw if it is based on an older device that was itself pulled for safety problems, according to Riley.
“We’re stuck in the position of allowing these devices to get on the market,” said Riley. “We can only turn them down if there was a mandatory recall of the older product, not a voluntary one, and those mandatory recalls are very rare.”
Deborah Kotz can be reached at email@example.com. Follow her on Twitter @debkotz2.