Vaginal Mesh Lawsuits Have Senate Seeking Increased Safety Measures

Los Angeles, CA, December 20, 2011 – Nadrich & Cohen LLP reports that the U.S. Senate has proposed a new piece of legislation 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.

Currently, the Food and Drug Administration allows certain medical devices to be approved under its 510(k) system. Based on these guidelines, manufacturers need only to demonstrate that their product is substantially similar to one already on the market. The Senate cites 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.

In addition to drafting the legislation, senators have 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.

C.R. Bard is facing hundreds of lawsuits from women who claim that its Avaulta transvaginal mesh system caused scarring, pain, bleeding, blood vessel damage 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.

Since 2008, the FDA has received thousands of complaints from women who allege serious side effects caused by mesh devices. In June 2011, an updated safety warning was issued, warning both physicians and consumers of the potential risk.

In November 2011, the American College of Obstetricians and Gynecologists (The College) and the American Urogynecologic Society (AUGS) issued a joint statement recommending the limited use of transvaginal mesh. The FDA is continuing its ongoing safety review of vaginal mesh implants but as of yet, there are no plans to issue a recall of these products.

Nadrich & Cohen LLP is actively investigating claims from women in all 50 states who say they were seriously injured by a vaginal mesh device. For more information about filing a defective medical device injury lawsuit, call 1-800-722-0765 or visit the firm’s online mesh resource center at www.VaginalMeshLegalClaims.com.

Nadrich & Cohen LLP is a California-based law firm which specializes in representing injured persons in complex individual and class action lawsuits nationwide. The firm is currently investigating claims from clients who have been harmed by dangerous prescription drugs, defective medical devices and faulty consumer products.

Jennifer Poole
National Client Intake Coordinator
Nadrich & Cohen LLP
12100 Wilshire Blvd., Suite 1250
Los Angeles, CA 90025
800-718-4658
www.personalinjurylawcal.com

This release was published on openPR.