Boston Scientific Corp. manufactured and sold a transvaginal mesh device that was never properly tested for safety and efficacy, and ignored warnings regarding the plastic used to make the implant, the plaintiff attorney told a California jury during opening arguments this week in a product liability lawsuit alleging the company’s transvaginal mesh caused serious injuries.
Rosanne Sanchez filed the lawsuit against Boston Scientific in 2012, becoming one of thousands of plaintiffs suing manufacturers of transvaginal mesh implants over claims that the devices were defectively designed and caused injuries. Transvaginal mesh, also known as vaginal mesh, pelvic mesh or bladder sling, is a type of surgical mesh that is used to treat common pelvic floor disorders including pelvic organ prolapse and stress urinary incontinence, causing symptoms such as discomfort and urinary incontinence.
Sanchez and other plaintiffs suing manufacturers of transvaginal mesh claim the devices were defectively designed and could erode inside the body and protrude into neighboring organs causing debilitating, chronic pain; infections; hemorrhaging; painful sexual intercourse; and bladder and bowel incontinence.
Sanchez’s lawsuit alleges that neither her doctor nor Boston Scientific told her that the Pinnacle mesh that was implanted in her uterine cavity had never been tested before it was marketed, even though it was a different shape and made with a different type of polypropylene plastic than earlier models of mesh. Her lawsuit also alleges that the polypropylene used in the mesh carried a warning that it should not be used in permanent implants for humans or be used in parts of the body where it can be exposed to bodily fluids.
Boston Scientific attorneys argued that Sanchez was a nurse who treated chemotherapy patients, and that she was well versed in talking with medical personnel about her serious medical condition. However, Sanchez’s attorneys argued that an issue as personal as bladder and bowel incontinence and painful sexual intercourse could be monumentally embarrassing for any patient to discuss with her doctor or anyone else.
The lawsuit is currently underway in the U.S. District Court for the Central District of California.