J&J Vaginal Mesh Approved by FDA Based on Similar Device Recalled in 1999

Johnson & Johnson (JNJ), the world’s second-biggest health-care products maker, is battling lawsuits over a vaginal implant based on a similar device pulled from the market more than a decade ago for safety reasons.

The complaints are the latest to implicate the approval process for medical devices at the U.S. Food and Drug Administration, which has cleared faulty hip implants and malfunctioning defibrillators.

In the case of vaginal mesh implants, the FDA continued approving the hammock-like devices made by J&J and other companies based on their similarity to Boston Scientific Corp. (BSX)’s ProteGen even after it was pulled amid safety complaints. Today, the makers of the entire category of implants face more than 600 lawsuits from women who claim the devices caused serious injury.

“The FDA got caught with their pants down,” said Thomas Margolis, a pelvic surgeon in Burlingame, California, who treats patients for mesh complications. “The ProteGen should have told them, ‘Wait a minute, all of these mesh systems are bad.’”

The devices treat incontinence and a condition called pelvic organ prolapse, in which internal organs slump into the vagina. They were allowed on the market as result of the agency’s approval process, known as 510(k), which relies on the notion that if one device has been cleared by the FDA then similar devices need little if any testing in patients.[…]

510(k) System

All were approved through the 35-year-old 510(k) system, used by the FDA to review some 90 percent of device applications each year. The same process was used to clear the 93,000 artificial hips pulled by J&J last year due to high failure rates, as well as hundreds of external heart defibrillators recalled since 2005 by Minneapolis-based Medtronic Inc. (MDT)

Designed to vet low-risk devices such as surgical drapes, 510(k) also become a gateway for items like joint implants and vaginal mesh that can claim a tie to older products, said Diana Zuckerman, president of the National Research Center for Women & Families, a Washington advocacy group that has pushed for more device testing.

Read the rest of the article here.