A woman from Texas has recently filed a AMS mesh lawsuit, alleging that American Medical Systems Inc. failed to warn her against the risks associated with their transvaginal mesh product. The AMS mesh lawsuit alleges that the transvaginal mesh product was supposed to treat her personal gynecological condition, but only compounded her health problems.

Plaintiff Viola C. filed this AMS mesh lawsuit after discovering that transvaginal mesh complications were not considered rare by the FDA and that other women may have experienced similar reactions to the product.

Transvaginal mesh is a surgical product that is used to treat either pelvic organ prolapse or stress urinary incontinence, both of which are caused by weakened lower pelvic muscles caused by traumatic events like childbirth.

Transvaginal mesh is supposed to be made of a biologically safe material that is marketed as providing an extra layer of support in the lower pelvic region to help prevent organ prolapse and help patients maintain a normal life.

American Medical Systems (AMS) is one of several major transvaginal mesh manufacturers in the United States, and markets their products as safe for POP and SUI treatment.

Overview of AMS Mesh Lawsuit

With these benefits in mind, Viola says she agreed to have the AMS Elevate and AMS MiniArc transvaginal mesh products implanted on Jan. 9, 2015.

According to the AMS mesh lawsuit, Viola was suffering from both pelvic organ prolapse and stress urinary incontinence and was seeking a safe and effective treatment method. However, Viola says she began experiencing painful device complications not long after her mesh was implanted.

Even though Viola alleges she followed all recovery instructions, she alleges suffered a multitude of transvaginal mesh complications including extreme pain, internal body tissue erosion, and extreme scarring.

Viola says she had to undergo multiple revision surgeries to resolve these complications. She alleges she later found out that the FDA had issued public warnings describing these transvaginal mesh problems in 2008 and 2011.

The AMS mesh lawsuit points out that on July 13, 2011 the FDA stated that “serious complications associated with surgical mesh for transvaginal repair of [pelvic organ prolapse] are not rare.” The FDA also stated that mesh shrinkage has been indicated in injury reports and scientific literature.

However, the FDA has been receiving transvaginal mesh injury reports since 2005, which spurred the agency to warn doctors and patients that transvaginal mesh can cause serious health problems in patients.

Most recently in 2016, the FDA had reclassified transvaginal mesh products as class III medical devices. A class III designation means that these products pose a risk of serious complications to patients. Viola opted to file this AMS mesh lawsuit soon after discovering these warnings, alleging that American Medical Systems had failed to warn her against these potential side effects.

Over 100,000 transvaginal mesh lawsuits have been filed and has become one of the largest mass torts in the history of the United States, with billions of dollars being awarded to settlements. American Medical Systems is one of the companies facing litigation over transvaginal mesh complications, including Viola’s AMS mesh lawsuit.

Viola states she would not have agreed to have the AMS Elevate and AMS MiniArc implanted if she had been aware of the potential device complications associated with the products. Viola’s AMS mesh lawsuit is seeking damages for negligence and failure to warn.

The AMS Mesh Lawsuit is Case No. 4:18-cv-00681-A, in the U.S. District Court for the Northern District of Texas.