The woman says her TVT transvaginal mesh manufactured by Ethicon Inc, a subsidiary of Johnson & Johnson was defective and caused her to suffer serious and permanent injuries when it was designed to treat her bout of pelvic organ prolapse. Transvaginal mesh devices were approved largely through the Food and Drug Administration’s dubious 510(k) fast-track approval system to treat pelvic organ prolapse and stress urinary incontinence.
Millions of women are afflicted with these serious and life-altering conditions and transvaginal mesh was hailed as a new and advanced treatment and quickly implanted in tens of thousands of women across the country.
More than 30 companies manufacture some form of transvaginal mesh, allegedly a slightly adapted form of other surgical mesh devices that have been used for years in other types of surgeries.
After having the TVT transvaginal mesh implanted in a November 2008 procedure, the Empire State woman soon began suffering complications that have been echoed by thousands more women who’ve been fitted with these largely defective devices.
She has endured numerous revision surgeries
She has endured numerous revision surgeries attempting to repair or remove the mesh device but the effects caused by the defective mesh and from the subsequent surgeries are likely to be life-lasting. The woman has decided to file a lawsuit against the manufacturers for failing to do due diligence in researching the safety of their device and for the injuries she suffered as a result.
The woman is being represented by the national law firm of Parker Waichman LLP, a leader in representing victims of defective medical devices. The firm represents several other women who’ve been injured by this and other similar transvaginal mesh devices. The lawsuit representing the New York woman was consolidated with others as part of a federal Multidistrict Litigation in U.S. District Court for the Southern District of West Virginia.
The latest complaint alleges that ” the mesh poses a dangerous and unreasonable risk to women because, among other things, the material used for the mesh is not inert and reacts with the tissues of the body. The further alleges that the Defendants knew about these risks but chose to sell the devices without warning the Plaintiff or the public.”
Last year, the Food and Drug Administration ruled that injuries caused by a defective transvaginal mesh product were “not rare” and they put women at serious risk of short-term complications and permanent injuries.
Transvaginal mesh devices have been linked to serious complications like erosion through the vaginal wall, severe pain, increased risk of infections, bleeding, pain during intercourse, organ perforation, and urinary problems.
Prior to issuing that statement on the risk of injuries associated with transvaginal mesh devices, the FDA previously ordered more than 30 manufacturers of these products to conduct full post-market safety reviews that will likely determine their future viability on the market. Since that order, several companies have stopped selling some transvaginal mesh devices they once manufactured.
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