A product liability lawsuit has been filed against the manufacturer of a vaginal mesh product, Boston Scientific Corporation.

Plaintiff Bonnie B. filed her lawsuit alleging that she suffered severe adverse effects and complications due to the implantation of the vaginal mesh. The Boston Scientific mesh lawsuit purports that the plaintiff was implanted with The Lynx Suprapubic Mid-Urethral Sling System and the Prefyx PPS System.

According to the Boston Scientific mesh lawsuit, Bonnie, a resident of the state of New Jersey, files the lawsuit in West Virginia federal court.

The Boston Scientific mesh lawsuit further purports that Bonnie’s suit alleges the following damages: Negligence; Strict Liability; Breach of Express Warranty; Breach of Implied Warranty; Loss of Consortium; Discovery rule, Tolling, and Fraudulent Concealment; and Punitive Damages.

Bonnies’s claim is filed as part of a large multidistrict litigation, or MDL, centered on allegations that the vaginal mesh caused serious adverse health effects and complications including a severe negative autoimmune response.

According to the Boston Scientific mesh Lawsuit, Bonnie was implanted with the Lynx vaginal mesh in September 2005 and the Prefyx vaginal mesh in March 2007. She was implanted with both implantations in Lourdes Medical Center of Bulington County, Willingboro, NJ.

Boston Scientific Mesh Lawsuit Facts

According to the Boston Scientific mesh lawsuit, the vaginal or pelvic mesh product manufactured by the defendant contains a monofilament polypropylene mesh and/or collagen.

The Boston Scientific mesh lawsuit, however, iterates that although there are claims by the defendant that the product is inert, it in fact “biologically incompatible” with human tissue, according to scientific evidence. Due to this alleged incompatibility, it promotes a negative immune response in patients that have been implanted with the device.

The Boston Scientific mesh lawsuit further contends that the defendant’s products cause a hyperinflammatory response which can lead to additional complications such as chronic pain and a fibrotic reaction. The product also allegedly disintegrates after its implantation and it also produces an adverse reaction with later leads to infection. The body sees the collagen as a foreign entity as it is also derived from animal and/or human tissue.

The vaginal mesh was designed for treatment of POP, known as pelvic organ prolapse, and SUI, also known as Stress Urinary Incontinence.

The defendants had received FDA  approval for the product through the U.S. Food and Drug Administration through a 510(k) process. This process essentially allows manufacturers to expedite the approval process and not have to verify successful clinical studies conducted as long as they can prove that a device is deemed “substantially equivalent” to other predicate devices already on the market.

The Boston Scientific Mesh Lawsuit is Case No. 2:17-cv-03850, in the U.S. District Court for the Southern District of West Virgina. The Vaginal Mesh MDL is In re: Boston Scientific Corp. Pelvic Repair System Products Liability Litigation, MDL No. 2326, in the U.S. District Court for the Southern District of West Virginia.