An Ohio couple has filed a lawsuit, citing pelvic mesh erosion injuries that the wife suffered after having a transvaginal mesh implanted. Their lawsuit joins more than 100,000 others filed over the past several years by women who have suffered painful, disabling and often permanent injuries from a medical device that manufacturers claimed would improve their lives – but instead wound up disrupting them.

The Facts of the Case

The couple says that in March, 2013, plaintiff April G. was implanted with a device known as the Supris Sling, which is manufactured and marketed by the defendant, Coloplast.

According to the company website, “Supris is a permanent, synthetic, mid-urethral support sling.” It was designed to treat female stress urinary incontinence, the result of weakened pelvic muscles (sometimes caused by  childbirth, or, in the case of men, prostate surgery). The purpose of the Supris and similar devices is to supply support to internal organs when the weakened pelvic muscles cannot (such as during a cough or sneeze).

Not long afterward, April says she developed a number of painful symptoms. These allegedly included pelvic mesh erosion as well as “foreign body reaction [autoimmune response], dyspareunia [pain and discomfort during intimacy], infections and other injuries.”

What is Pelvic Mesh Erosion?

In a 2017 study published in the Taiwanese Journal of Obstetrics and Gynecology, researchers looked for risk factors for pelvic mesh erosion – among them being the quality of the surgery and the mesh material. Some risk factors included high blood pressure and having had a hysterectomy.

However, a number of scientific studies have shown that the polypropylene used in the construction of mesh devices is “biologically incompatible” with human tissues. The presence of this plastic material can provoke a response from the immune system. This causes the material to degrade, resulting in severe inflammation and infection.

Pelvic mesh can erode the vaginal walls. Eventually, it can break through, resulting in a serious condition known as perforation. If left untreated, other organs of the pelvis and abdomen may be severely injured, including the colon and kidneys.

The consequences of untreated pelvic mesh erosion can be fatal; revision surgery is usually required not only to remove the mesh, but to repair organ damage and treat the original condition. Unfortunately, for some victims, the damage is permanent.

The Allegations

Defendant Coloplast asserts that the polypropylene material used in the Supris is inert (non-reactive with human tissues), and, according to the complaint, has represented the device as “safer and more effective as compared with traditional products and procedures…and other competing Pelvic Mesh Products.”

April and her attorneys state that the device is “defectively designed,” pointing out that it is intended to be implanted in a region of the body “…with high levels of bacteria, yeast, and fungus that adhere to the mesh,” providing ideal conditions for infection and resulting in serious injuries due to pelvic mesh erosion. They allege that Coloplast has failed to warn patients and doctors about possible risks and “misrepresented the efficacy and safety” of the Supris in its marketing and promotions. They further claim the defendant has not come up with any solution for removing the device in the event of complications.

Litigation Continues

Multi-district and individual litigation against eight different manufacturers of  transvaginal mesh devices is currently underway across the country. Nonetheless, these devices continue to be sold and used.  Because side effects such as pelvic mesh erosion can set in months or years after implantation, it is likely that many more lawsuits will be filed.

In addition to recovery for injuries, pain and suffering and medical expenses, spouses of women who have been affected can also sue for loss of consortium.

April and Timothy G.’s Pelvid Mesh Erosion Lawsuit is Case No, N18C-12-032 PEL, Superior Court of the State of Deleware.