Victims injured by defective medical devices filed a lawsuit. Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, has filed a lawsuit on behalf of a woman who was implanted with two transvaginal mesh products, the Gynecare Prolift Anterior Pelvic Repair System and the Gynecare TVT System.
The suit, which was filed on July 12th in the U.S. District Court for the Southern District of West Virginia, Charleston Division (Case No. 2:12-cv-03122), is one of the many cases that have been consolidated into the multidistrict litigation as part of the In Re: Ethicon, Inc. Pelvic Repair System Products Liability Litigation (MDL No. 2327). Ethicon, Inc., Ethicon Women’s Health and Urology, Gynecare and Johnson & Johnson have been named as Defendants.
According to the Complaint, the Plaintiff is a woman from Thomas County, Georgia who was implanted with the Gynecare Prolift Anterior Pelvic Repair System and the Gynecare TVT System in February 2008.
She received the devices in an attempt to correct her stress urinary incontinence (SUI) and pelvic organ prolapse (POP), for which they were approved, marketed and sold.
The lawsuit alleges that, instead of alleviating her symptoms the mesh implants caused a host of injuries. Furthermore, the suit alleges that this damage is permanent, causing substantial physical deformity and the loss of her bodily organ system. The lawsuit is claiming significant mental and physical pain and suffering on behalf of the Plaintiff.
Safety concerns over the transvaginal mesh have grown in recent years
Safety concerns over the transvaginal mesh have grown in recent years. In 2008, the U.S. Food and Drug Administration (FDA) said that the complications associated with surgical mesh, such as erosion of the vaginal tissue, appeared serious but rare.
In July of 2011, the agency updated this information by warning the public that these events are in fact not rare. The FDA also said that there was no clear evidence to show that transvaginal mesh has any advantage over non-mesh alternatives in treating POP.
In January, it asked 33 manufacturers, including Johnson & Johnson, to provide three years of post market safety data on the devices.
The lawsuit alleges that the Defendants sold the mesh implants to thousands of women, even though they knew about the dangers associated with their product. According to the Complaint, transvaginal mesh creates an unreasonable risk of:
- Chronic pain and/or abscess
Erosion is when the mesh migrates from its intended position, cutting into other tissues and organs. Because the material used in the mesh is not inert, the suit alleges that it reacts with the tissues in the body and can become embedded elsewhere.
Johnson & Johnson recently decided to stop selling the Prolift, Prolift + M, TVT Secur and Prosima transvaginal mesh implants.
Prolift was first launched in 2005, the device has not been officially approved by the FDA
When the Prolift was first launched in 2005, the device has not been officially approved by the FDA. J&J said that the mesh was so similar to another product that formal review was unnecessary.
The agency disagreed, and asked the company to cease sales until the proper materials were submitted. Recently, court documents revealed that Johnson & Johnson continued to sell the Prolift in direct defiance of these orders.
Parker Waichman LLP continues to offer free lawsuit consultations to victims of transvaginal mesh injuries. If you or a loved one experienced complications following POP and SUI surgery with transvaginal mesh, please visit the firm’s transvaginal mesh injury page at yourlawyer.com. Free case evaluations are also available by calling 1-800-YOURLAWYER (1-800-968-7529).
Contact: Parker Waichman LLP
Gary Falkowitz, Managing Attorney