Increasing Litigation Against Manufacturers of Transvaginal Mesh

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Increasing Litigation Against Manufacturers of Transvaginal Mesh

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Transvaginal mesh is designed to help with problems of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Transvaginal mesh is a synthetic material and is designed to reinforce the area around the organs in the pelvis area. Transvaginal surgical mesh implants or slings have been surgically implanted in millions of women. But, these procedures have been linked to a high rate of serious mesh complications. According to the American Association for Justice, in 2010, approximately 300,000 transvaginal mesh devices were implanted in women in the United States.

Some side effects if transvaginal mesh surgery may be:

Erosion of the mesh through the tissue
Exposure or extrusion of mesh
Feeling of a lump or protrusion in the vaginal opening
Painful sexual intercourse (dyspareunia)
Perforation or puncture of the bladder, intestines, or bowels
Recurrent Pelvic Organ Prolapse (POP)
Urinary problems
Vaginal bleeding
Vaginal chronic drainage, discharge or infections
Vaginal pain or scarring

Unfortunately, after such complications, surgery is often required to remove the mesh and reconstruct damage.

Surgical mesh devices have been successfully used for many years for types of surgery that are not for POP or SUI. Vaginal mesh surgery was approved by the FDA because the product is similar to the forms used in other surgeries that have already received FDA approval. For this type of fast-track approval, manufacturers can use the FDA’s 501(k) approval process. This type of FDA approval means that rigorous clinical testing was not done before manufacturers began selling the devices for this particular type of procedure. Now that so many women have had problems because of the surgery, the FDA has issued a statement recognizing that serious complications are not rare in these procedures.

Many lawsuits have already been filed against transvaginal mesh manufacturers. Johnson & Johnson is stopped sales of surgical mesh products that are suspected in numerous reports of injury and several deaths. J&J’s discontinued 4 types of mesh implants: Gynecare TVT Secur system, the Gynecare Prosima, the Gynecare Prolift, and the Gynecare Prolift (PLUS) M.

If you have had vaginal mesh surgery, notify the surgeon if complications develop. You can call Longo Legal, PLLC if you want to know your rights. Or, if you would just like more information call toll free at (855) 566-4648.

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