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A husband and wife have filed a lawsuit against the American Medical’s Systems, Boston Scientific and TEI Biosciences alleging the companies’ pelvic mesh products caused the wife to suffer significant injury.
Plaintiffs Kelly and Sarah R. Are a husband and wife couple living in Arkansas.
The pelvic mesh side effects lawsuit states that AMS obtained FDA approval to market the Monarc System pelvic mesh product prior to and in 2002 and TEI did the same for its product Xenform System in 2005 and prior.
Both received FDA approval under section 510(k) that “allows marketing of medical devices if the device is deemed substantially equivalent to other legally marketed predicate device is marketed prior to May 28, 1976. No formal review for safety or efficacy is required.”
Xenform is made from in acellular collagen material that is manufactured from bovine skin. According to the pelvic mesh side effects lawsuit, the graft used in pelvic surgeries becomes “biologically incompatible with human tissue.”
“Upon information and belief, collagen products cause hyper inflammatory responses leading to problems including chronic pain and fibrotic reaction. Collagen products disintegrate after implantation in the female pelvis,” the lawsuit states.
Polypropylene mesh has been described as containing inert materials, however the pelvic mesh side effects lawsuit states, “despite claims that these materials are inert, the scientific evidence shows that these materials are biologically incompatible with human tissue and promote an immune response in a large subset of population receiving Defendants’ Pelvic Mesh Products containing these materials.”
The lawsuit goes on to state, “This immune response promotes degradation of the pelvic tissue and can contribute to the formation of severe adverse reactions to the mesh.”
Other pelvic mesh products made by the defendants use either a polypropylene and/or collagen mesh to be used in the vaginal wall.
These medical devices are promoted as “an innovative, minimally invasive procedure with minimal local tissue reactions, minimal tissue trauma and minimal pain while correcting vaginal vault prolapse, stress urinary incontinence, pelvic organ prolapse or rectocele.”
Other Pelvic Mesh Side Effects Lawsuit Allegations
As a result of the allegedly defective products, women have suffered the following adverse effects related to these products including “mesh erosion, mesh contraction, infection, fistula, inflammation, scar tissue, organ perforation, dyspareunia and Karen pain during sexual intercourse), blood loss, neuropathic and other acute and chronic nerve damage and pain, pudendal nerve damage, pelvic floor damage, chronic pelvic pain, urinary and fecal incontinence, prolapse of organs.”
The pelvic mesh side effects lawsuit goes on to state, “in many cases, the women have been forced to undergo intensive medical treatment to locate and remove mesh, including but not limited to, operations to attempt to repair pelvic organs, tissue, and nerve damage, the use of pain control and other medications, injections in to various areas of the pelvis, spine, and the vagina, and operations to move portions of the female genitalia.”
Kelly and Sarah have brought forth multiple counts against the defendants including negligence, breach of manufacturer duty to warn and duty to instruct, breached vendor duty to warn and duty to inspect, strict liability for defective design and failure to warn, breach of express and implied warranties, unjust enrichment, fraud, violation of state Consumer Fraud and Deceptive Trade Practices Act, and loss of consortium (spousal companionship).
The plaintiffs are seeking compensatory, general and special damages for past and future injury, punitive damages, attorneys’ fees and costs, disgorgement of profits and any additional relief as deemed appropriate.
The Pelvic Mesh Side Effects Lawsuit is Case No: 2-16-cv-02192, in the U.S. District Court for the Western District of Arkansas, Fort Smith Division.
Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The vaginal mesh attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. [In general, vaginal mesh lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.
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