Overview: Parker Waichman LLP, a national personal injury law firm, has filed a lawsuit on behalf of Arizona woman implanted with the Obtryx Transobturator Mid-Urethral Sling System. She alleges that the transvaginal mesh device, manufactured by Boston Scientific, caused substantial injuries due to the defective nature of the device. The lawsuit, which names Boston Scientific as Defendants, was filed on January 28th in the U.S. District Court for the Southern District of West Virginia, Charleston Division.
- Parker Waichman LLP has filed a lawsuit alleging that her transvaginal mesh implant caused injuries
- The lawsuit was filed on January 28th in the U.S. District Court for the Southern District of West Virginia, Charleston Division; Boston Scientific Corp. were named as Defendants
- The FDA has warned that complications from transvaginal mesh, such as mesh erosion and organ perforation, are not rare
Product: Obtryx Transobturator Mid-Urethral Sling System
Manufacturer: Boston Scientific
Side Effects & Complications
- Mesh erosion
- Pain during sexual intercourse (dyspareunia)
- Perforation or puncture of the bladder, bowels, intestines, and blood vessels near the vaginal wall
- Recurring Pelvic Organ Prolapse (POP)
- Vaginal bleeding
- Urinary problems
- Chronic vaginal drainage, discharge, or infection
- Vaginal scarring and shortening
Lawsuit Alleges Defective Design, Unreasonable Risk
According to a press release by Parker Waichman LLP, the Plaintiff was implanted with the Obtryx Transobturator Mid-Urethral Sling System in February 2006. She alleges that, as a result of receiving the mesh, she suffered from a number of adverse side effects. Allegedly, the transvaginal mesh was defectively designed and therefore presents an unreasonable risk of injury to women. For instance, the suit claims, the mesh used is not inert; this means that it can react with the tissues of the body and become deeply embedded within it, leading to organ perforation, urinary problems and other serious health issues. Some women require multiple surgeries in attempt to remove the mesh. Furthermore, the lawsuit holds the Defendants liable for the Plaintiff’s injuries because they allegedly knew about these defects but never warned her, her doctor or the public.
Transvaginal Mesh Background
Transvaginal mesh implants are designed to correct stress urinary incontinence and pelvic organ prolapse, conditions that are often caused by the weakening of pelvic walls and muscles. The lawsuit, however, alleges that the mesh does more harm than good. Transvaginal mesh implants were never clinically tested for safety or efficacy because they were approved through 510(k), which exempts these requirements. An advisory panel for the FDA previously recommended that the devices be reclassified as “high risk” in order to prevent this lack of testing in the future. The agency has also warned that complications from the device are “not rare” and noted that there is little evidence showing that transvaginal mesh offers benefits over non-mesh methods.