In 2009, Illinois resident Carolyn C. had Johnson & Johnson and Ethicon’s Prolift Gynecare and Gynecare Gynemesh PS vaginal mesh implants surgically implanted. She is now one of tens of thousands of women suing the companies for negligently selling the medical devices, which have been linked to severe and sometimes permanent injuries.

In her vaginal mesh lawsuit filed in October in U.S. District Court in Minnesota – the location of a centralized multidistrict litigation – Carolyn says the defective products caused her to suffer serious bodily injuries, including extreme pain, bladder spasms, continued urinary incontinence, erosion of her internal bodily tissue, and other injuries identical to those described in FDA Public Health Advisories in October 2008 and again in July 2011.

The products are implantable, mesh, pelvic floor support devices designed to treat pelvic organ prolapse and relieve pain, discomfort, and bladder control issues that accompany the condition. The vaginal mesh implants should strengthen weakened vaginal walls in patients suffering from pelvic organ prolapse by supporting the urethra in women with stress urinary incontinence.

On Oct. 20, 2008, the FDA issued a Public Health Notification after receiving more than 1,000 complaints that had been reported over a three year period related to vaginal sling implants, according to Carolyn’s vaginal mesh lawsuit.

Nearly three years later, the FDA updated its prior public health notification, warning that complications arising from transvaginal placement of mesh to treat pelvic organ prolapse are not rare. Between Jan. 1, 2008, and Dec. 31, 2010, the FDA had received more than 2,800 complaints about vaginal sling complications. The agency also noted that there is no evidence that the transvaginal placement of mesh is any more effective in treating the condition than traditional, non-mesh techniques.

Vaginal Mesh Lawsuit Settlements

In a matter of a month in 2014, two separate juries awarded more than $45 million in vaginal mesh settlement awards to two women after finding that Boston Scientific Corp.’s transvaginal mesh inserts were defective.

Plaintiffs in both cases argued that the mesh inserts eroded inside their bodies, causing organ damage and pain.

In 2012, the FDA ordered manufacturers to study rates of organ damage and complications linked to vaginal mesh products, which are typically manufactured from a porous synthetic or other organic material.

Plaintiffs in tens of thousands of vaginal mesh lawsuits against a slew of manufacturers say vaginal mesh implants have caused them to suffer physically, emotionally and financially. Many of the litigants have undergone surgeries to remove the devices, which purportedly erode inside the body, damaging organs and causing extreme pain.

In December, a federal jury found Johnson & Johnson’s Ethicon liable for selling faulty vaginal mesh devices and failing to warn both patients and doctors of the potential side effects such as pain, bleeding and infection. Plaintiffs were awarded $3.27 in that case.

That verdict came on the heels of an $11 million award in a New Jersey vaginal mesh trial and a $1.2 million verdict in Texas. In addition to Johnson & Johnson, there are more than two dozen manufacturers of vaginal mesh implants, including Boston Scientific and C.R. Bard.

The federal judge presiding over more than 30,000 vaginal mesh lawsuits in a multi-district litigation in West Virginia urged vaginal mesh manufacturer C.R. Bard to settle thousands of lawsuits based on multi-million dollar jury verdicts and the potential for the company to be on the hook for billions more.