Transvaginal Mesh Implants

The U.S. Senate has reportedly drafted and proposed a new piece of legislation that’s aimed at reducing the number of consumers who suffer serious injuries caused by a defective medical device. The bill, which would require manufacturers to conduct ongoing safety studies of these devices after obtaining FDA approval, was drafted in part as a response to the growing number of lawsuits filed against the makers of problematic vaginal mesh implants.

In addition to drafting the legislation, senators have reportedly sent letters to several vaginal mesh manufacturers, including Bard and Johnson & Johnson, requesting additional information about how the devices are checked for safety and how a recall is handled if deemed necessary.

Currently, the U.S. Food and Drug Administration (FDA) allows certain medical devices to be approved under its 510(k) system. Based on these guidelines, manufacturers only have to demonstrate that their product is substantially similar to one already on the market. The Senate has cited the 2010 recall of the DePuy ASR hip implant system, which was approved under the 510(k) rule, as evidence that the guidelines are ineffective in ensuring public safety.

The new draft legislation comes in light of the fact that C.R. Bard (a maker of vaginal mesh implants) is facing hundreds of lawsuits from women who claim that its Avaulta transvaginal mesh system caused pain, bleeding, blood vessel damage, scarring and other complications. Johnson & Johnson faces a similar number of suits from women who say they were injured by the company’s Ethicon Gynecare mesh system. The first bellweather trials in the Johnson & Johnson cases are scheduled to begin in a New Jersey federal court in November 2012.