The Ethicon Prolift pelvic repair mesh product is the focus of a lawsuit by a woman implanted with the device in July 2008.

Plaintiff Betty P. joins hundreds of other patients in her claim that Johnson & Johnson and Ethicon knew of the defective nature of the hernia mesh, but pushed the product on the market, anyway.

In January 2005, the Ethicon Prolift mesh product was marketed and sold as the Prolift System to treat female pelvic problems such as pelvic organ prolapse and stress urinary incontinence.

The Prolift did not obtain FDA approval because of a loophole that allowed the mesh to be introduced directly on the market because of the product’s similarity to a mesh product that had obtained the FDA’s approval.

Even though surgical mesh products have been used to repair abdominal hernias since the 1950s, gynecologists started using surgical mesh made specifically for the treatment of pelvic organ prolapse and stress urinary incontinence in the 1990s.

Ethicon began manufacturing kits that included the mesh, tissue fixation anchors and insertion tools. These medical devices targeted women suffering from problems stemming from weakened or damaged vaginal walls.

Ethicon Prolift Contains ‘Biologically Incompatible’ Material

The Ethicon mesh was marketed as being inert, but the Ethicon Prolift lawsuit says “scientific evidence shows that this mesh material is biologically incompatible with human tissue and promotes an immune response in a large subset of the population … This immune response promotes degradation of the polypropylene mesh, as well as the pelvic tissue, and can contribute to the formation of severe adverse reactions to the mesh.”

The Ethicon Prolift lawsuit alleges other problems as well.

According to the complaint, the Ethicon mesh was designed to be inserted transvaginally, allowing the mesh to come into contact with bacteria, yeast and fungus that can adhere to the mesh. This contamination can lead to increased risk of immune reactions and tissue breakdown. The insertion of the mesh is a “blind” procedure because the doctor cannot see where he is placing the product, increasing the risk of nerve damage and injury to internal organs.

The Ethicon Prolift lawsuit says that anchors used in the Ethicon Prolift kit “are likely to pass through and injure major nerve routes in the pelvic region” when the anchors are placed properly. Mesh particles can shed from the mesh, causing an increased inflammatory response in nearby tissue. Those particles also can migrate, causing further injury.

The mesh shows a tendency to “gradually elongate and deform when subject to prolonged tension inside the body.” Some patients experience the opposite problem of the mesh shrinking once it is implanted.

When Ethicon Prolift mesh becomes “improperly matted to the delicate and sensitive areas of the vagina and pelvis,” the patient can experience pain during normal daily activities such as intercourse, walking or having a bowel movement.

The FDA has said that it is not clear that transvaginal repair of pelvic organ prolapse with mesh is any more effective than non-mesh repair of the condition. In fact, the FDA concluded that using mesh for repair of pelvic organ prolapse may result in further surgeries due to mesh complications, and complete mesh removal could be impossible in some cases.

The Ethicon Prolift Lawsuit is Case No. 2:17-cv-03059 in the U.S. District Court for the Southern District of West Virginia.