Johnson & Johnson has been hit with another transvaginal mesh lawsuit by a woman accusing their Ethicon Inc. division of manufacturing a dangerous product.

The plaintiff claims she suffered severe pain and sustained permanent injury after being implanted with the defendants’ Gynecare TVT System.

The vaginal mesh lawsuit was filed by Alabama plaintiff Carol B., who had the mesh product implanted on May 03, 2013 to treat her stress urinary incontinence (SUI). Transvaginal mesh like the Gynecare TVT System is designed to treat SUI by supporting the lower pelvic muscles. These devices are also used to treat pelvic organ prolapse.

Carol alleges in the lawsuit that she “has suffered and continues to suffer significant injury” as a result of the pelvic mesh implant, and will most likely be forced to undergo multiple corrective surgeries.

It is important to note that corrective surgeries are often more complicated and higher risk than the initial mesh implant surgery. Women who have been forced to undergo subsequent surgeries to repair vaginal mesh complications are now suing device manufacturers, like Ethicon, for failing to warn them of the risk of complications.

Overview of Vaginal Mesh Complications

Hundreds of thousands of women have reported vaginal mesh complications, with a number of them opting to take legal action. Legal sources indicate that there are approximately 70,000 vaginal mesh lawsuits pending in the U.S. District Court of West Virginia alone. Tens of thousands of lawsuits have been centralized in other courts across the country.

Johnson & Johnson is one of several major mesh producing companies in America, with Ethicon being its mesh manufacturing division. Like other vaginal mesh producers, Johnson & Johnson sought FDA approval for their product, under the agency’s 510(k) provision.

The FDA 510(k) section allows for the release of a medical device if the product is deemed to be equivalent or of greater efficiency than a similar product already on the market. Under this section, no formal safety reviews or pre-clinical studies are required.

Carol claims that the Gynecare TVT mesh implant had been manufactured defectively, and that the defendants were able to release an unreasonably dangerous product into the market by using the 510(k) approval process to bypass important safety testing.

Carol further alleges that neither she nor her physicians were forewarned of  the potential complications associated with pelvic mesh. She alleges they only learned of these potential problems after she suffered the consequences. Carol claims in the lawsuit that she never would have used the Gynecare TVT System if she had known of the possible risks involved.

So for being allegedly responsible for manufacturing, marketing, selling, and releasing a dangerous product, Carol is suing Johnson & Johnson. The charges include: negligence, false advertising, concealing information, and misrepresenting a product.

This Vaginal Mesh Lawsuit is Carol B. v. Johnson & Johnson, Ethicon Inc., Case No. 2:15-cv-14689, in the U.S. District Court of New Jersey.