Johnson & Johnson is facing a growing vaginal mesh multidistrict litigation (MDL) with a new TVT-Exact mesh lawsuit from an Oregon woman.

The woman alleges that as a direct result of the Johnson & Johnson vaginal mesh product, she suffered permanent personal injuries that eventually resulted in the filing of her TVT-Exact mesh lawsuit.

Oregon plaintiff Jodi P. filed the TVT-Exact lawsuit after discovering there was a number of other women who allegedly suffered similar injuries. Jodi claims the company either knew or should have known about the potential vaginal mesh complications associated with this product, but failed to notify her or other patients.

According to her TVT-Exact mesh lawsuit, Jodi opted for the product and had it implanted on Feb. 19, 2016. Jodi and her physician reviewed the advertising materials for the TVT-Exact mesh product, and decided it would be an ideal choice based on the product’s benefits.

However the marketing materials reportedly failed to sufficiently describe potential side effects, some of which Jodi allegedly experienced. Jodi states that she never would have opted for the TVT-Exact mesh product if she had known the potential complications associated with the device.

Overview of Vaginal Mesh Complications

Vaginal mesh is a recent medical innovation that became mainstream in the 1990s, which gynecologists used to treat pelvic organ prolapse (POP) and stress urinary incontinence.

These conditions were often caused by traumatic events like childbirth, which rendered the woman unable to control her pelvic organs. After reaching popularity with the mass market, differing manufacturing companies pursued FDA approval on a variety of differing vaginal mesh products.

This led to many of the vaginal mesh products, TVT-Exact mesh included, receiving approval though the FDA’s 510(k) process. Through this process, a product must prove to be substantially similar to another product already approved. If the new product meets this requirement, then it can go to market without rigorous pre-clinical trials.

While this does guarantee quick consumer access to these products, it also prevents thorough evaluation of the product’s benefits and side effects. Jodi and many other women allege Johnson & Johnson promoted the TVT-Exact mesh product in an aggressive fashion, and failed to notify them of any potential side effects.

Reported vaginal mesh complications can range in severity and can include debilitating pain, mesh erosion, organ puncture, infection, device failure, painful intercourse and organ perforation. Oftentimes patients need to undergo revision surgery to have the vaginal mesh device removed or replaced, to resolve these complications.

The sheer number of vaginal mesh reports has spurred significant legal action against Johnson & Johnson, including the consolidation of vaginal mesh lawsuits into MDL No. 2327. By consolidating these similar claims into a single litigation movement, these claims can be processed faster and will conserve legal resources.

In addition, consolidation also prevents instances of conflicting rulings of different judges and repeatedly reviewing the same evidence. Jodi’s TVT-Exact mesh lawsuit will stand alongside other claims, alleging similar injuries.

This TVT-Exact mesh lawsuit is Case No. 2:17-cv-03451, in the U.S. District Court for the Southern District West Virginia.