Ethicon Inc. and parent company Johnson & Johnson, are facing a new product liability lawsuit from a woman alleging serious transvaginal mesh side effects.

The transvaginal mesh lawsuit claims that the company failed to warn the woman of the complications associated with their product, resulting in the woman experiencing painful transvaginal mesh side effects.

Maine plaintiff Heather C. is filing this transvaginal mesh lawsuit after she had to endure serious and debilitating complications after having the Gynecare TVT-Exact pelvic mesh device implanted.

Heather had opted to have the transvaginal mesh device implanted to treat her stress urinary incontinence (SUI), and undergone the implant surgery on Sept. 02, 2015.

This is a normal use for the device, as transvaginal mesh is often prescribed to women suffering from either SUI or pelvic organ prolapse (POP). Oftentimes these conditions occur from a traumatic pelvic event like childbirth, with the pelvic organs never fully recovering.

Even though transvaginal mesh has been around since the 1950s, it was not popularly used for POP or SUI until the 1990s. Different manufacturing companies had immediately jumped on this opportunity, noticing women were opting for these devices to discreetly treat their personal medical conditions.

However many patients and legal experts allege this was where the transvaginal mesh movement started becoming problematic, as most of the devices were approved under the FDA’s 510(k) policy.

This means that these transvaginal mesh products were approved without any formal safety review or premarket testing, because the devices proved to work at an equivalent level with a similar product that was already available.

The Gynecare TVT-Exact transvaginal mesh product was no different, as it quickly went to market and was soon at the subject of complaint for many women.

Overview of Transvaginal Mesh Side Effects

Soon after having the mesh product implanted, Heather began experiencing severe transvaginal mesh side effects that had interfered with her daily life.

Eventually, Heather had to undergo revision surgery to have the mesh removed on June 14, 2016, due to the severity of the mesh complications.

Due to the alleged defective nature of the device, Heather had suffered permanent and debilitating injuries that will require chronic medical care.

Heather’s injuries are not uncommon as many women report experiencing transvaginal mesh side effects including: debilitating pain, mesh erosion, infection, organ tearing, and overall device failure.

These transvaginal mesh products are meant to help support weakened pelvic regions, but have been allegedly causing more problems for women instead.

Heather is filing this lawsuit against Johnson & Johnson for failing to warn her against these transvaginal mesh side effects, stating she never would have opted for the device if she knew the risks.

At no point in time did the company disclose the full list of transvaginal mesh side effects of their product to Heather or physicians, nor did the companies provide any relevant studies, Heather claims.

The Transvaginal Mesh Side Effects Lawsuit is Case No. 2:16-cv-06761, in the U.S. District Court of Maine.