Plaintiff Claudia M., a resident of the State of California, filed a Boston Scientific vaginal mesh lawsuit in U.S. District Court on July 7, 2017. The plaintiff is joining multidistrict litigation (MDL) No. 2326 and specifically gearing her complaint against defendants Boston Scientific Corp., Johnson and Johnson Inc., and Ethicon Inc.

According to the short-form complaint in this Boston Scientific vaginal mesh lawsuit, Claudia M. was implanted with Repliform Tissue, Regeneration by Boston Scientific and the Gynecare TVT Device Vaginal Sling by Ethicon on Feb. 28, 2006. Both products were installed at the Kaiser Permanente Hospital in Roseville, Calif.

What are the Problems Associated with Boston Scientific Vaginal Mesh?

Boston Scientific vaginal mesh and other pelvic mesh products created by named defendants are used to treat pelvic organ prolapse (POP) or stress-induced urinary incontinence (SUI).

These mesh products are made of polypropylene and sometimes collagen. Marketing efforts by the makers of these products have asserted that both ingredients are physically inert when implanted in the human body generally and in the pelvic cavity specifically.

Boston Scientific vaginal mesh and other pelvic mesh products made by named defendants in this case were able to circumvent extensive testing that would support the claims of physical safety or inert status.

According to plaintiffs in the Boston Scientific MDL, the products were brought to market through the Food and Drug Administration’s 510(k) process. This process allows for little or no clinical testing of a product prior to release if the manufacturer is able to prove it is substantially similar to another device already on the market.

According to the factual allegations section of the MDL legal documentation in this Boston Scientific vaginal mesh lawsuit, both polypropylene and collagen can be reactive in close proximity to human tissue.

They are believed presently to promote a foreign body immune response in a certain percentage of patient recipients. Swelling and inflammation secondary to this foreign body immune response can lead to the development of fibroid growths and severe pain.

Considered a Class II medical device, implantation of pelvic mesh products made from polypropylene and collagen led to multiple complaints of adverse medical events. These reports eventually resulted in the FDA sending out a safety communication to the medical community on July 13, 2011.

The communication warned that the incidents were not uncommon or rare and followed them with evidence indicating non-mesh treatments for POP or SUI were much less dangerous in the long run.

According to the original Boston Scientific vaginal mesh and other mesh products lawsuit, additional FDA communication identified shrinkage of the mesh product being a problem gaining traction in adverse medical reports. When the mesh loses size over time, the delicate tissues of the female reproductive tract can respond with shrinkage in kind leading to an overall tightening and corresponding pain.

Some patients have been unable to get resolution of their vaginal mesh complications without revision surgery. Vaginal mesh revision surgery can be particularly complex and difficult, since it can require piece-by-piece removal of mesh that may be ingrown into surrounding tissue. Revision surgery can expose patients to a significantly higher risk of complications than those associated with the original implantation.

This plaintiff brings the following counts against the defendants as named: Count 1: Negligence; Counts 2-4: Strict Liability – Design and Manufacturing Defect, Failure to Warn; Counts 5 & 6: Breach – Breach of Express and Implied Warranty; Count 8: Discovery Rule, Tolling and Fraudulent Concealment; Count 9: Punitive Damages.

Claudia M. is asking for punitive and compensatory damages, reimbursement of all attorney’s fees and court costs as well as additional awards as the court feels is just.

The Boston Scientific Vaginal Mesh Lawsuit is Case No. 2:17-cv-03515, in the U.S. District Court for the Southern District of West Virginia, Charleston Division.