A California couple filed a vaginal mesh lawsuit on November 5, 2012, over complications arising after an I-STOP vaginal mesh implant was performed. This lawsuit was filed in the U.S. District Court, Northern District of California (Oakland).

For this lawsuit, the plaintiff lists C.L. Medical, Uroplasty and DOES I-20 as defendants. In the complaint, the woman claims that she received the implant after suffering from pelvic organ prolapse and stress urinary incontinence. However, once she received the implant, she began to suffer from complications commonly linked to vaginal mesh devices, including “hyper-inflammatory responses, fibrotic reactions, relentless pain, mesh erosion, bleeding, infections and hardening of the mesh.”

The plaintiffs’ problems were so bad that she required multiple surgeries to correct it. She believes that these complications were caused because “the I-STOP contains components that are not compatible with human tissue, including polypropylene, and that these components provoke a negative immune response when implanted in the human body.”

Complications from vaginal mesh device implants are not new. In fact, nearly 8,000 lawsuits have been filed over vaginal mesh complications. The number of lawsuits is so large that it has been separated into various Multi-District Litigations (MDLs) that include numerous different manufacturers. In West Virginia alone, vaginal mesh MDLs include five different manufacturers, including Boston Scientific, American Medical Systems, Coloplast, Johnson & Johnson’s Ethicon and C.R. Bard. Other MDLs concerning vaginal mesh implants have been filed in Georgia, California and Minnesota. Most plaintiffs that have filed lawsuits are alleging that the manufacturers of these devices wither knew or should have known how dangerous their products were before giving them to patients. The lawsuits are also accusing the companies of failing to warn and negligence.

Vaginal mesh devices are used to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP). The conditions occur when the female’s pelvic muscles are too weak to properly support her pelvic organs after childbirth or menopause.