Transvaginal mesh implants have been used for years to treat stress urinary incontinence (SUI) or pelvic organ prolapse (POP), which can occur when organs like the bladder and rectum prolapse into the vaginal canal due to weakened pelvic muscles. Unfortunately, in recent years there have been increased reports that many women who have had transvaginal mesh surgeries have suffered complications.
Although transvaginal mesh implants do help some women, sometimes the mesh erodes inside the body, shifting and puncturing organs, blood vessels, or the vaginal canal causing pain, bleeding, or infection.
Boston Scientific’s ProtoGen introduced their first transvaginal mesh product in 1996 but pulled the product voluntarily in 1999 due to safety concerns. Other makers of vaginal meshes, such as Johnson & Johnson, requested permission from the Food and Drug Administration to remove their top selling transvaginal mesh products from the market in 2012. Meshes which were pulled include the Prolift, Prolift+ M, TVT Secur and Prosima in 2012.
Surgical mesh, which has been used since the 1970’s to treat female stress urinary incontinence and pelvic organ prolapse (POP), is manufactured and sold under different brand names.
For example, the Avaulta and the Uretex are sold by C.R. Bard; the Advantage Sling System, Uphold Vaginal Support System, Lynx Suprapubic Mid-Urethral Sling System, Obtryx Curved Single, Obtryx Mesh Sling, Prefyx Mid U Mesh Sling System, Prefyx PPS System are sold and marketed by Boston Scientific; and Ethicon (subsidiary of Johnson & Johnson) sells the Gynecare Systems (several of these products have been taken off the market by Johnson & Johnson).
Manufacturers have the responsibility to produce, market, and sell products which are safe for their intended use. They also have the responsibility to adequately warn users of the potential hazards of using their products. Manufacturers of the transvaginal mesh implants also had the duty to ensure the safety and effectiveness of their pelvic mesh products. If, as the claimants suggest in recent lawsuits, the makers of the transvaginal mesh implants used false and misleading information or failed to adequately test their product leading to the unsafe and ineffective production of the mesh implants manufacturers can be held liable for any damages caused by their products.
Currently, claimants are arguing that some of the mesh manufacturers “actively and intentionally mislead the FDA, the medical community, patients, and the public at large with respect to the safety and effectiveness of transvaginal mesh products.” They also are claiming that manufacturers did not conduct sufficient research and testing, they failed to provide sufficient information about potential injuries and complications which could arise after implantation, and they did not research what could be done if the transvaginal mesh needed to be removed.