A woman has filed a lawsuit against Boston Scientific Corporation, alleging that the manufacturers of the Uphold Vaginal Support System did not properly study the serious adverse effects that result from its implantation.

The Uphold Vaginal Support System is implanted to help treat medical conditions such as pelvic organ prolapse, or POP, and stress urinary incontinence, or SUI.

Defendant Boston Scientific Corporation, headquartered in Massachusetts, is a well-known manufacturer, marketer, and developer of medical device products, specifically including the pelvic mesh products.

In other pelvic mesh lawsuits like this one, the pelvic mesh products allegedly being accused of causing serious adverse side effects include: The Uphold Vaginal Support System, the Pinnacle Pelvic Floor Repair Kit, the Advantage Transvaginal Mid-Urethral Sling System, the Advantage Fit System, the Lynx Suprapubic Mid-Urethral Sling System, the Obtryx Transobturator Mid-Urethral Sling System, the Prefyx PPS System and the Solyx SIS System.

According to the lawsuit, the pelvic mesh products contain collagen and a monofilament polypropylene. The plaintiff claims this material promotes serious adverse effects and a negative immune response.

Due to the design of the product, its insertion is also implanted in through the female pelvis. This causes the adverse effect by which it causes immune reactions and subsequent tissue breakdown. The pelvic mesh lawsuit alleges that the materials used to make the Uphold Vaginal Support System are “biologically incompatible with human tissue.”

The plaintiff alleges these materials “cause hyper-inflammatory responses leading to problems including chronic pain and fibrotic reaction.”

The vaginal mesh lawsuit further alleges that the collagen in the product causes serious adverse reactions that are “causally related” to infection. The collagen, the plaintiff contends, is foreign material. As such, when implanted in the female body, it causes a “non-anatomic condition in the pelvis leading to chronic pain and functional disabilities.”

The collagen product is designed to disintegrate after the medical device’s implantation into the female pelvis. This allegedly causes the serious adverse effects and pain. The collagen is also alleged to be harsh on the female pelvic tissue, causing the mesh to harden.

In 2011, the FDA issued a Safety Communication announcing that, “serious complications associated with surgical mesh for transvaginal repair of POP are not rare,” the lawsuit states.

Also, that year, the American College of Obstetricians and Gynecologists (ACOG) and the American Urogynecologic Society (AUGS) also found that the pelvic mesh, when implanted into the female body, causes serious complications and it further found mechanical and physical changes occurring inside the body.

The FDA had announced that “it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”

The plaintiff alleges that the defendants did not properly study the serious adverse side effects associated with the use of the Uphold Vaginal Support System.

“Defendants knew or should have known that the products unreasonably exposed patients to the risk of serious harm while conferring no benefit over available feasible alternatives that do not involve the same risks,” the lawsuit states.

The Uphold Vaginal Support System Lawsuit is Case No. 2:17-cv-02881, in the U.S. District Court for the Southern District of West Virginia.