Women have been significantly injured by vaginal mesh implants to treat Pelvic Organ Prolapse and Stress Urinary Incontinence. This type of mesh was originally developed for use in the repair of abdominal hernia and was then subsequently approved, through an abbreviated FDA process known as 510k, where transvaginal mesh implants were promoted by the manufacturers to be a substantially similar application. Unfortunately, many women have developed serious complications, including erosion of the mesh through the vaginal wall and/or other pelvic organs, inability to have sexual relations, painful sexual relations, and frequent infections. Many have needed additional surgeries to remove the mesh.
Transvaginal mesh has become a symbol for all that is wrong with the current system for evaluating medical technology. The product was never thoroughly evaluated for use in pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Because of lax … Continued
As of the date of this update, lawsuits are pending against four primary transvaginal mesh defendants: American Medical Systems, Boston Scientific, Ethicon (Johnson & Johnson) and Bard in consolidated state actions in Delaware, Boston and New Jersey. Additionally, all federal … Continued
The FDA has released a warning to medical professionals about serious complications with transvaginal surgical mesh repair of pelvic organ prolapse (POP).
FDA issued a warning about transvaginal surgical mesh products in October, citing over 1,000 reports of complications relating to surgical mesh manufacturers, including Bard Avaulta.