A woman who had transvaginal mesh surgery and a mesh removal surgery has filed a lawsuit against the makers of the surgical aid.

Plaintiff Teresa L. says she received the Aris Sling by Coloplast Corp and Mentor Worldwide LLC in January 2007 to address her stress urinary incontinence. In December 2016, she alleges she required an additional surgery to remove the sling because the product had eroded.

Stress urinary incontinence is the loss of urine when a person coughs, sneezes, runs or lifts something heavy, all of which place stress in the form of pressure on the bladder. According to the Mayo Clinic, the condition is caused when the muscles and tissues that support the bladder and the muscles in the urethra that control the release of urine weaken.

The Aris-Transobturator Sling System was designed to treat stress urinary incontinence when permanently implanted to support the urethra. The Aris mesh is made of porous, non-absorbable, synthetic monofilament polypropylene.

According to Theresa’s transvaginal mesh lawsuit, polypropylene has been marketed as an inert substance, but “is biologically incompatible with human tissue” that causes a foreign body reaction and chronic inflammatory response in many patients who receive the Aris mesh implanted for pelvic floor repair.

As a result, the body attacks the mesh and nearby pelvic tissue, causing the polypropylene to degrade and the pelvic tissue to suffer from chronic inflammation. The mesh may shrink or contract, causing nerves to become entrapped, infection and chronic pain.

The Aris transvaginal mesh lawsuit alleges the following problems may occur with the product’s implantation:

• Degradation and fragmentation inside the body
• Shrinkage or contraction inside the body
• Intense foreign body reaction
• Chronic inflammatory response
• Chronic wound healing
• Chronic infections in and around mesh fibers
• Nerves entrapped in scar tissue

The mesh complaint also alleges that the Aris transvaginal mesh is still marketed as a safe, effective and reliable device to the medical community and that it is superior to competing products on the market in treating stress urinary incontinence.

FDA Reports on Transvaginal Mesh Surgery

The U.S. Food and Drug Administration (FDA) tracks Medical Device Reports on transvaginal mesh. From Jan. 1, 2008 through Sept. 30, 2011, the FDA received 1,876 reports of complications related to surgical mesh products used to treat stress urinary incontinence.

The FDA said pain, mesh erosion through the vagina, infection, urinary problems, recurrent incontinence and pain during intercourse were among the most common complaints. Other complications reported to the FDA included bleeding, organ perforation, neuro-muscular issues and vaginal scarring. Most of the problems required additional medical intervention, sometimes including another surgery or hospitalization.

According to Teresa’s transvaginal mesh surgery lawsuit, surgeons often allegedly are unable to effectively resolve mesh complications because the mesh integrates with the pelvic tissue, interfering with the ability to safely remove or excise the mesh from the body.

In some situations, the mesh fragments and the pieces migrate to other parts of the body.

The transvaginal mesh complaint alleges the manufacturer did not adequately test the Aris Sling before placing the medical device on the market.

The Transvaginal Mesh Surgery Lawsuit is Case No. 3:19-cv-00115, in the U.S. District Court for the Western District of North Carolina.