A Florida woman claims two types of transvaginal mesh surgical devices have caused her significant injuries and permanent disfigurement and she has become one of the latest to file a federal lawsuit seeking compensation for those claims.
The woman from Pinellas County, Fla., said she was the recipient of two transvaginal mesh devices to treat stress urinary incontinence and pelvic organ prolapse. These surgeries were conducted over a period of 22 months between 2006 and 2008. The woman received the Pelvilace To Trans-Obturator Biourethral Support System and a Gynecare TVT Device, respectively, in those procedures.
The national law firm of Parker Waichman LLP has taken the Florida woman’s case and filed it in U.S. District Court for the Southern District of West Virginia on July 12. This lawsuit joins a growing number filed in that court that are pending in the transvaginal mesh Multidistrict Litigation (MDL).
After receiving two devices, the Florida woman claims she has suffered constant and severe pain, both mentally and physically, due to the defects of the transvaginal mesh devices. In addition, she says the devices have left her permanently physically deformed and caused her to lose some function of bodily organ systems.
Like other lawsuits pending in the transvaginal mesh MDL, this asserts that the mesh device reacts poorly with body tissues where it is implanted and raises the risk of vaginal erosion, infection, extrusion, perforation, chronic pain and/or abscess, according to a firm release announcing the filing. It further claims the makers of these and other devices were aware of their products’ defects but continued to market them as safe and effective.
Thousands of women have suffered similar injuries as a result of defective transvaginal mesh and the amount of lawsuits to be included in this MDL is expected to grow exponentially with time.
In the meantime, the Food and Drug Administration (FDA) has ordered makers of these devices to conduct full post-market safety tests on their transvaginal mesh products. It was the FDA that allowed these devices to flood the market initially by allowing them through the agency’s 510(k) fast-track approval system that grants access to the market for medical devices that mirror a design of an already-approved product. This system does not require much, if any, pre-market safety testing.
The lawsuit against the makers of the Pelvilace To Trans-Obturator Biourethral Support System and Gynecare TVT Device made false statements to the FDA in order to get these devices approved through the “fast-track” system.
Last year, the FDA said that complications caused by defective transvaginal mesh devices were “not rare” and that has prompted a flurry of women to step forward with injury claims similar to this recent lawsuit and others filed before it.
Since the FDA ordered post-market safety testing on the entire class of transvaginal mesh devices, Johnson & Johnson has decided to stop marketing its Prolift, Prolift + M, TVT Secur, and Prosima products.