A Kentucky couple is suing American Medical Systems (AMS), for allegedly causing the wife to suffer debilitating vaginal mesh complications.

The vagingal mesh lawsuit claims that the defendant had provided a defective vaginal mesh product, which was meant to help support lower pelvic muscles, which had caused the plaintiff to experience severe and painful side effects.

Vaginal mesh is a popular medical device, which is popularly used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), conditions that occur due to weakened pelvic muscles.

Most vaginal mesh products are made from either biologically safe synthetic material or animal tissue, which are implanted in the damaged area of muscle and then acts as a sling to keep the pelvic organs in place.

Plaintiff Lillie M. had been promised the same solution to her problem when AMS’s Elevate vaginal mesh product was implanted by her doctor on March 12, 2012.

Unfortunately, it was not long after the device was implanted that Lillie had started suffering adverse effects from the mesh product. While her specific vaginal side effects were not disclosed in her lawsuit, many women have reported suffering from mesh erosion, mesh tearing, organ prolapse, organ tearing, and infection.

It is likely that Lillie will have, or already has had to undergo corrective surgery to have the vaginal mesh removed, in order to prevent further health complications. Thousands of women have had to do the same, after finding that they were suffering from tissue infection or device failure.

It is important to note that for none of these women, including the Lillie, that no warnings or surgical instructions were provided to decrease the chances of mesh complications.

Overview of Vaginal Mesh Complications

The concern of mesh complications became widespread in 2011, when the FDA declared that these side effects were not rare occurrences. The agency also warned that it was not clear if vaginal mesh was an effective method to treat either POP or SUI.

Currently, the FDA has proposed two ideas to address the risks of mesh complications, which would help reclassify vaginal mesh as a high-risk medical device. This would also require manufacturing companies to submit their vaginal mesh products for pre-market approval, so the FDA can reevaluate the products.

It is important to note that many vaginal mesh products were approved under the FDA’s 510(k) process, which allowed the products to bypass rigorous pre-clinical medical testing.

However, these regulations do not help patients who have already been hit with devastating mesh complications. Lillie and other women have decided to file legal action against AMS and other vaginal mesh manufacturing companies, for failing to protect them against the adverse effects of vaginal mesh.

Lillie’s lawyers state that AMS had the civil responsibility of warning her and other vaginal mesh patients of all side effects associated with their products, because they rely on the given information. Lillie insists that she never would have used the defendant’s vaginal mesh product, if she had known the risks.

So for being allegedly responsible for manufacturing, selling, distributing, and marketing a dangerous product, Lillie and her husband are suing AMS. The charges include: negligence, false advertising, concealing information, and misrepresenting a product.

This Vaginal Mesh lawsuit is filed In Re: American Medical Systems, Inc., Pelvic Repair System Products Liability Litigation, MDL No. 2325, in the U.S. District Court of Southern West Virginia, Charleston Division.