A group of plaintiffs have filed a class action lawsuit against American Medical Systems Inc., the makers and manufacturers of a pelvic mesh device, alleging that the defective medical device resulted in personal injury and other punitive and economic damages.

According to the AMS pelvic mesh lawsuit, the manufacturer, AMS, allegedly caused injuries and damages to the plaintiffs by “wrongful acts, omissions, and fraudulent representations.”

AMS allegedly “authorized and directed the production and promotion of the aforementioned products when they knew, or with the exercise of reasonable care should have known, of the hazards and dangerous propensities of said products,” the AMS pelvic mesh lawsuit states.

According to the AMS pelvic mesh lawsuit, the plaintiffs were implanted with the alleged defective pelvic mesh but began to suffer from complications including but not limited to: urinary problems, extreme pain, discomfort, dyspareunia and other urological and gynecological adverse health effects.

AMS Pelvic Mesh Lawsuit Factual Allegations

American Medical Systems, Inc. is a Delaware corporation. According to the AMS pelvic mesh lawsuit, the defendant developed and manufactured the pelvic mesh product.

The lawsuit iterates that the purpose of the pelvic mesh is to “remediate pelvic organ prolapse and/or stress urinary incontinence by implantation of polypropylene mesh inside the pelvic region of a woman’s body.”

However, the lawsuit claims that despite assertions of the safety and efficacy of the product, scientific data concluded that the polypropylene material is evidently, “biologically incompatible with human tissue and promotes and immune response in a large subset of the population receiving defendants’ products containing this material.”

According to the AMS pelvic mesh lawsuit, the body’s immune response to a foreign object, like the pelvic mesh product, promotes the degradation of surrounding pelvic tissue which can instigate severe adverse reactions.

The AMS pelvic mesh lawsuit contends that the manufacturers marketed and sold the pelvic mesh product on the basis that it was effective, reliable, and safe.

However, the AMS pelvic mesh lawsuit iterates several defects that stem from the alleged defective product. Some of these defects include the use of the polypropylene material in the mesh itself. The use of the material allegedly causes adverse reactions and injuries.

Additionally, the pelvic mesh is inserted into an area of the body with a high level of bacteria, yeast and fungus. The insertion of the material into this location causes tissue breakdown and other adverse health effects and reactions.

Lastly, according to the AMS pelvic mesh lawsuit, “the use and design of anchors in Pelvic Mesh Products which, when placed correctly, are likely to pass through and injure major nerve routes in the pelvic region.”

The AMS pelvic mesh lawsuit cites an announcement made by the U.S. Food and Drug Administration. According to the lawsuit, “the FDA concluded that serious complications associated with surgical mesh for transvaginal repair of Pelvic Organ Prolapse, were ‘not rare.’”

Furthermore, the FDA noted that these complications included neuromuscular problems, vaginal scarring/shrinkage and emotional problems. A large number of these serious side effects required the patient to be hospitalized or undergo surgery.

According to other reports, some of patients’ complications have also had to be treated with revision surgery. The Transvaginal Mesh Center website addresses the complications that may result and are involved with mesh revision surgery.

According to the website, mesh revision surgery carries risks. Some of these risks include, blood clots, uncontrolled bleeding, and risks pertaining to anesthesia. The website iterates that scarring and atrophy can cause muscle numbness and rigidity, making sexual intercourse “difficult or impossible.”

Additionally, “after repeated attempts at excision, some mesh fragments may remain in the body forever preventing the patient from achieving a full recovery. Even in some cases where the mesh is fully removed, the original symptoms of prolapse and incontinence often reappear.”

The AMS Pelvic Mesh Lawsuit is Case No. 3:17-cv-01249-CAB-NLS, in the Superior Court of the State of California, in and for the County of San Diego.