New Bill Targets Transvaginal Mesh Makers

Representative Edward Markey (D-MA) supports a new bill that aims to help prevent the approval of defective medical devices.

In order to gain support for the bill, Markey recently attended a press conference with Jay Nevarez - a woman who experienced complications following transvaginal mesh surgery that forced her to quit her job and left her unable to walk without assistance, The Boston Globe reported.

Nevarez’s injuries originated from Johnson & Johnson’s Gynecare transvaginal mesh device, which received an expedited approval by the Food and Drug Administration based on its similarity to an older product: Boston Scientific’s Protogen. Markey says this loophole in the approval process allows the Food and Drug Administration to approve certain medical devices, even if there is reason to believe patients may be harmed or killed as a result of the products.

The new bill, called the Safety of Untested and New Devices (SOUND) Act, proposes that the FDA make it a requirement for medical device makers that base their products on older models with safety issues to provide documentation demonstrating that the new product’s design fixed potential issues.

Markey hopes that the new bill will become a part of larger medical device bill that will be voted on at the end of May.

If you or a loved one has been harmed by an unsafe medical device, contact Sokolove Law for a free legal consultation and to find out if a product liability lawyer may be able to help you.