Drug & Device Lawsuit

Vaginal mesh first came to be approved by the FDA as treatment symptoms correlated to pelvic organ prolapse (aka POP).  The condition is characterized by the weakening of the pelvic floor muscles. Beginning 2008, the FDA came to receive complaints, of approximately 4,000, about the devices. From January 2008 through December 2010, the FDA listed more than 2800 Medical Device Reports involving urogynecologic surgery mesh devices that were fount to malfunctions, cause injury or even death.

The device is known by various names such as pelvic mesh, transvaginal mesh, surgical mesh and bladder slings.

The organization came up with a new warning in July 2011.  It stated that vaginal mesh implants are potentially risky and of irrevocable side effects. In fact, the American College of Obstetricians and Gynecologists and the American Urogynecologic Society, around November 2011, came up with a joint statement recommending the limitation on the use of vaginal mesh for high-risk women who fail to respond with other available treatment.

As of date, an approximately 350 vaginal mesh lawsuits is pending in a New Jersey state court alone. The lawsuits, with Johnson & Johnson Company as defendant, claim that the Ethicon Gynecare vaginal mesh system brought serious injuries to the plaintiffs such as extensive bleeding, bowel and bladder perforation, infection, blood vessel damage, painful intercourse and scarring. The cases are set to go on trial in November 2012. Considering that there are 300,000 women receiving the device in 2010 alone, it is foreseen that lawsuits against the makers of the devices will increase.

For the last several years, the FDA has received the complaints of side effects involving the device: 

As of this writing, cases are individually filed and transvaginal mesh lawyers found that nationwide transvaginal mesh lawsuit has not yet been filed.