American Medical Systems (AMS) Inc. is facing a new transvaginal mesh lawsuit, which alleges AMS and Endo Pharmaceuticals manufactured and produced a defective product that was unsafe for patient use.

This transvaginal mesh lawsuit was filed by a woman from Texas, with the claim alleging the AMS MonArc Subfascial Sling implanted for typical treatment purposes.

Plaintiff Gloria V. alleges she sustained injuries that were allegedly caused by the transvaginal surgical mesh product, which reportedly caused the need for revision surgery. According to the transvaginal mesh lawsuit, Gloria had the MonArc Subfascial Sling implanted on Jan. 14, 2010 to treat her stress urinary incontinence (SUI).

Transvagainal surgical mesh is typically used for pelvic organ prolapse (POP) and SUI, which supports the lower pelvic muscle. POP occurs when pelvic muscles weaken, which can cause internal organs to fall out of place and protrude in the vagina.

SUI is uncontrollable urination that is caused by slight physical movements, with transvaginal mesh products often used as urethral slings.

POP and SUI can occur after physically traumatic events like childbirth, which can permanently damage the woman’s pelvis region. However, the transvaginal mesh lawsuit alleges Gloria experienced mesh problems soon after the product was implanted.

According to the claim, Gloria began experiencing complications such as pelvic pain, urinary problems, urinary incontinence, and certain forms of pelvic organ prolapse involving the small intestine and the rectum wall.

These complications reportedly caused Gloria to undergo revision surgery on May 31, 2017, which removed all of the allegedly defective transvaginal surgical mesh from her body.

Overview of Transvaginal Mesh Complications

The MonArc Subfascial Sling is made of a polypropylene material that is supposed help promote healing in the weakened muscle area. It is designed to spur inflammation in the surrounding muscle, which is supposed to encourage recovery.

However, the lawsuit alleges the polypropylene material is biologically incompatible with human tissue and could potentially spur an adverse immune reaction.

These adverse reactions can potentially lead to infection, chronic pain, painful sexual intercourse, and internal organ injuries. These concerns have been addressed by the FDA several times, including a warning announced on July 13, 2011 that stated post surgical transvaginal mesh complications “are not rare.”

The FDA warning also stated that “mesh shrinkage” was previously mentioned in transvaginal mesh injury reports in conjunction with POP repair, along with published scientific papers that discussed various device problems.

The FDA also stated that the benefits from transvaginal mesh products may not outweigh its potential risks.

The most recent FDA announcement came in 2019, the agency ordered manufacturers of transvaginal mesh products to stop selling and distributing their products for POP repair in the United States. Even though American Medical Systems and Endo were reportedly aware of these complications, the companies allegedly failed to disclose this information to the public.

At all times relevant, Gloria and her physician had been relying on the marketing statements and product information provided by the company. According to the transvaginal mesh lawsuit, Gloria is seeking a multitude of damages including negligence and failure to warn.

This Transvaginal Mesh Lawsuit is Case No. 7:19-cv-00187, in the U.S. District Court of Southern Texas, Mcallen Division.