An Arizona woman who was implanted with a transvaginal mesh device in February 2006 has filed a lawsuit against Boston Scientific, the device’s manufacturer, for injuries she alleges were caused by the device.
National law firm, Parker Waichman LLP, filed the suit, Case No. 2:13-cv-01527, in the U.S. District Court for the Southern District of West Virginia on January 28. The lawsuit alleges that the Obtryx Transobturator Mid-Urethral Sling System is defective and poses a number of serious health risks to women. The suit further alleges that the defendants knew of the risks but did not adequately warn the plaintiff or her doctor.
The mesh material itself is one of the issues in the case. The lawsuit alleges that the mesh used in the device is unfit for use in the female pelvis because the material is not inert. The mesh can react with the tissues of the body, can travel through the abdominal cavity, and can become deeply embedded in the body’s tissues.
Transvaginal mesh implants are intended to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), conditions which become more common after childbirth due to the weakening of the pelvic walls and muscles. Transvaginal mesh is supposed to correct these conditions by providing additional support to the pelvic walls, but the lawsuit alleges that the plaintiff’s implant only caused more issues.
The U.S. Food and Drug Administration (FDA) has warned that complications associated with transvaginal mesh are “not rare.” The agency issued a Safety Communication in July 2011 warning of adverse events associated with transvaginal mesh. These include mesh erosion (extrusion) through the vagina, infection, bleeding, organ perforation, urinary problems, and pain during sexual intercourse. The agency has asked a number of transvaginal mesh manufacturers to conduct post-market safety studies to assess whether the mesh implants cause organ damage and other health issues.