More than 50,000 federal product liability lawsuits have been filed by women who were injured by transvaginal mesh products implanted to repair pelvic organ prolapse (POP) or female stress urinary incontinence (SUI). Over 5,000 of those cases have been filed against Boston Scientific specifically. According to court documents, the first bellwether trial involving eleven Boston Scientific mesh implant cases will begin on October 14, 2014.
Boston Scientific has been manufacturing transvaginal mesh products since 1996, when the company introduced ProtoGen, the first vaginal sling. After hundreds of adverse reports, Boston Scientific recalled the device in 1999 and settled hundreds of lawsuits for an undisclosed sum in 2003.
Despite the issues with ProtoGen, Boston Scientific has continued to produce, market, and sell similar polypropolene mesh devices that the U.S. FDA now says may be equally as dangerous as ProtoGen. Boston Scientific has sold transvaginal mesh products under the following names:
- Advantage Transvaginal Mid-Urethral Sling System
- Uphold Vaginal Support System
- Prefyx Mid U Mesh Sling System
- Prefyx PPS System
- Prefyx PPS System
- Obtryx Transobturator Mid-Urethral Sling System
- Polyform Synthetic Mesh
According to the FDA, once the mesh has been inserted, many patients experience mesh erosion or extrusion as the tissue begins to form through the porous mesh material, causing extreme pain and infection. By 2010, the FDA estimated that it had received more than 4,000 adverse event reports regarding transvaginal mesh implants, such as:
- Pelvic pain
- Pain during sexual intercourse
- Organ perforation
- Urinary problems
- Vaginal bleeding
- Neuro-muscular problems
- Vaginal scarring and/or shrinkage
Because of the risk of serious injury, consumer advocates as well as legal and medical experts are advocating that transvaginal mesh products be recalled and banned. Many also demand new legislation to prevent injury to more women in the future from these defective mesh implants.
Contact the experienced medical device lawyers of Childers, Schlueter & Smith, LLC for a free initial consultation. We will listen to your story and explain your legal rights to help you choose the best course of action for your claim.