The AMS Elevate is allegedly an unsafe transvaginal mesh product, according to allegations from a woman reportedly damaged by the implant.

Plaintiff Viola C. says she was implanted with the American Medical Systems (AMS) Elevate and MiniArc pelvic mesh products in January 2015. She allegedly experienced a variety of complications associated with the AMS Elevate including extreme pain, erosion of her internal bodily tissue, extreme scarring, additional surgery and other injuries.

Viola argues that she would not have experienced the injuries had she not been implanted with the AMS Elevate and MiniArc products.

“As a result of having the AMS Elevate and AMS MiniArc implanted, [Viola] has experienced significant mental and physical pain and suffering, undergone multiple surgeries and revisionary procedures, and she has sustained permanent injuries,” the transvaginal mesh lawsuit claims.

The American Medical Systems Elevate and MiniArc are polypropylene mesh and/or collagen products designed to be implanted into the pelvic floor to treat conditions including pelvic organ prolapse, stress urinary incontinence and their accompanying symptoms.

Although AMS reportedly claims that polypropylene is inert, scientific evidence allegedly shows that the material is biologically incompatible with the human body and can cause a negative immune response in the majority of patients.

According to Viola, the immune response allegedly caused by American Medical Systems Elevate may include inflammation, chronic pain, fibrotic reaction, and other foreign body responses. Viola also alleges that the AMS Elevate and MiniArc can disintegrate in the body, which adds to the immune response.

In July 2011, the U.S. Food and Drug Administration (FDA) issued a safety alert, warning that “serious complications associated with surgical mesh for transvaginal repair of [pelvic organ prolapse] are not rare.” Reports of mesh shrinkage, which the FDA reportedly noted was a “previously unidentified risk,” prompted the safety alert.

Viola claims that AMS misrepresented their products as safe and effective. However, the AMS Elevate allegedly falls short of these representations with high rates of failure, injury, and complications which may require operations to correct.

“The Products have been and continue to be marketed to the medical community and to patients as safe, effective, reliable, medical devices, implanted by safe and effective, minimally invasive surgical techniques, and as safer and more effective as compared to available feasible alternative treatments of pelvic organ prolapse and stress urinary incontinence, and other competing products,” the lawsuit argues.

Because AMS failed to warn her of the potential for serious complications, Viola was allegedly unable to make an informed choice about pelvic mesh implantation.

Additionally, her doctor was allegedly unaware of the issues associated with these devices meaning that they could not provide educated guidance to Viola or make the best choices for her treatment plan. Viola aims to hold AMS accountable for failing to warn her and her physician.

Viola accuses American Medical Systems of defective design/manufacture, failure to warn, negligence and breach of warranty. The American Medical Systems Elevate lawsuit seeks damages, court costs and attorneys’ fees.

The AMS Elevate Lawsuit is Case No. 4:18-cv-00973-O in the U.S. District Court for the Northern District of Texas.