Johnson & Johnson and its subsidiary, Ethicon Inc., are facing a new product liability lawsuit filed by couple from North Carolina who claim the company’s pelvic mesh is defective.

Plaintiff Julia C. and her husband Joseph are filing this pelvic mesh lawsuit together, seeking various product liability damages from the company.

Julia had the TVT-O pelvic mesh product implanted on March 2, 2010, to treat either her pelvic organ prolapse (POP) or stress urinary incontinence (SUI).

The couple claims that in direct result of the company’s pelvic mesh product, Ethicon’s TVT-Obutrator (TVT-O), she suffered serious pelvic mesh side effects. This had caused major impositions to the patient’s life, and for her marriage to be permanently altered.

Pelvic mesh has been used to treat these problems for years, after women suffer traumatic pelvic injuries such as child birth. Some of the problems associated with either POP or SUI can stem from lack of bladder control to actual organ prolapse.

The pelvic mesh device itself is a hammock like piece material, which is meant to be implanted through the vagina to support the pelvic organs. When pelvic mesh was first innovated decades ago, a number of women were relieved at having a discrete method for treating these problems.

Julia was no different in this, but had reportedly suffered a number of pelvic mesh side effects soon after the product was implanted.

Pelvic Mesh Side Effects

In July 2011, the FDA stated that it had received nearly 4,000 reports of adverse pelvic mesh side effects from 2005 to 2010. In this announcement, the FDA stated that injuries associated pelvic mesh “are not rare” and do not necessarily improve the patient’s quality of life.

The pelvic mesh side effects often reported include:

• mesh erosion
• mesh tearing
• infection
• organ perforation
• device failure
• organ tearing

Many experts point out that a number of these pelvic mesh devices were approved for market under the FDA’s 510(K) policy, where the device did not have to undergo intense pre clinical studies.

The 510(K) policy provides that as long as the device is proven to work at an equivalent level with a similar product already on the market, the device is typically approved.

Joseph and Julia’s pelvic mesh lawsuit is joining the multidistrict litigation (MDL), in which it will stand with a number of claims alleging similar injuries.

Each of these claims similarly allege that Johnson & Johnson failed to warn them of the severity of the pelvic mesh side effects associated with their products, or how common they actually were.

Johnson & Johnson marketed the TVT-O and their other pelvic mesh products as safe and effective treatment options for patients, allegedly failing to disclose the risks associated.

As of early 2015, approximately 70,000 women had filed pelvic mesh lawsuits against manufacturing companies, seeking compensation for their injuries.

The Pelvic Mesh Lawsuit is In Re: Ethicon Inc., Pelvic Repair System Products Liability Litigation, Case No. 2:16CV3843, in the U.S. District Court of Southern Virginia, Charleston Division.