An Arizona woman and her husband are among the latest plaintiffs to file lawsuits against Ethicon Inc. (Ethicon), alleging that the surgical device company’s transvaginal mesh was negligently manufactured and causes irreparable harm to women.

Plaintiffs Darla and James S., a married couple, filed their lawsuit against Ethicon and its parent company, Johnson & Johnson, in January 2019.

Darla alleges she was implanted with Ethicon’s Gynecare Prolene Soft Mesh on Aug. 6, 2016 in Tuscan, Ariz. This implant surgery was part of her treatment for pelvic organ prolapse, a condition where the pelvic muscles are weakened and allow one or more of the pelvic organs to drop out of their usual position. The mesh implant is meant to act as a net, holding the organs in place and reinforcing the patient’s pelvic muscles.

Darla alleges that her mesh implant caused her to develop serious complications. She says she was hospitalized in January 2017 and underwent mesh removal surgery. Darla claims that the mesh had degraded inside of her, making it difficult to remove. She says that she required multiple subsequent mesh removal surgeries, and has suffered significant mental and physical pain, as well as impaired physical ability and deformity.

What is Transvaginal Mesh?

Transvaginal mesh is a surgical product made of a monofilament polypropylene material. According to the FDA, it is meant to treat pelvic organ prolapse or urinary incontinence. It is meant to be permanently implanted as a reinforcement for the patient’s weakened pelvic muscles.

FDA Warns of Mesh Complications

The FDA released warnings about the possible complications associated with transvaginal mesh in 2008, 2011, and 2018. Scientific evidence has shown that the material of the mesh is incompatible with human tissue and often results in a chronic inflammatory response from the patient’s organs. The mesh is implanted is rich in blood vessels and nerves and there is a risk of permanent nerve injury and chronic neuropathic pain. According to Darla’s Gynecare mesh lawsuit, the mesh is prone to degradation and fragmentation.  The lawsuit alleges that erosion and breakage of the mesh may result in pain and discomfort with everyday activities that require movement of the pelvic region. The lawsuit compares the surface area of eroded or broken mesh to barbed wire or saw blades, and claims that sharp edges may slice through internal organs and tissue, leading to bacterial infections, internal injuries, and chronic pain.

Removal Requires Additional Surgery

According to Darla’s Gynecare mesh lawsuit, the integration of the mesh with the patient’s own pelvic tissue, as well as the mesh’s propensity to fragment, makes removal surgery risky and difficult. In Darla’s case, multiple surgeries were required to remove the mesh from her body. In some cases, it may be impossible to safely remove the entire mesh implant. According to The Guardian, as many as 1 out of every 15 women implanted with this type of mesh will undergo removal surgery following complications from the implant.If you have been implanted with Gynecare or other type of mesh and suffered complications, you may be eligible to join a free investigation. Darla’s Gynecare Mesh Lawsuit is Case No. 4:19-cv-00024-EJM, in the United States District Court for the District of Arizona.