Initially marketed as a more effective treatment for pelvic organ prolapse (POP) and stress urinary incontinence (SUI), transvaginal mesh has resulted in painful and serious complications for thousands of women. As a result, the manufacturers of transvaginal mesh are at the center of multiple lawsuits.
What Is Transvaginal Mesh?
Surgical mesh is a net-like material that is used to provide extra support when repairing weakened or damaged tissue. Transvaginal mesh (“TVM”) is a surgical mesh that is used to treat disorders of the female pelvic floor that result in conditions such as stress urinary incontinence (“SUI”) or pelvic organ prolapse (“POP”). SUI is the loss of urine due to physical movement or activity such as sneezing, coughing, and running. POP occurs when the muscles that hold a woman’s pelvic organs in place become weakened, often due to childbirth, and the weakness allows the pelvic organs, such as the bladder, uterus, or rectum to bulge into the vaginal walls. The TVM procedures are performed through the vagina.
Many women have undergone procedures involving the implantation of TVM to treat SUI and POP. Unfortunately, in recent years, there have been many reports of serious complications. In 2008, the FDA issued a safety alert indicating that it had received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with TVM devices. According to the FDA, the most frequent complications included:
- erosion of the mesh through the vaginal epithelium
- urinary problems
- recurrence of prolapse and/or incontinence
- bowel, bladder, and blood vessel perforation during insertion
In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia, which is pain during sexual intercourse.
Mesh erosion and organ perforation require a second surgery to repair the damage caused by the transvaginal mesh implant. However, these procedures can be complex because the transvaginal mesh is designed to stay in the body indefinitely. As time passes, blood vessels and tissues grow around the mesh, which makes removal very difficult. It requires a urogynecologist with specialist training to perform the operation.
Mesh removal surgery can result in pelvic pain, nerve pain, fistulas, and scar tissue. Pelvic physical therapy can help patients manage their symptoms, but additional surgeries are sometimes required.
What Has the FDA Done?
In 2011, the FDA issued an updated safety communication regarding the complications associated with TVM. The alert indicated that complications associated with TVM are NOT rare. The FDA further noted that it has not been demonstrated that POP repair with mesh is more effective than traditional non-mesh repair in patients with POP and it may expose patients to greater risk.
In 2016, the FDA issued a news release stating that it had issued two final orders to the manufacturers of TVM used to treat POP. The first order reclassified TVM from a class II device, which primarily includes moderate-risk devices, to class III devices, which is generally reserved for high-risk devices. The second order requires manufacturers to conduct additional clinical trials to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP if they want to continue selling their product.
What Transvaginal Mesh Lawsuits Have Been Filed?
To date, tens of thousands of lawsuits have been filed against the manufacturers of TVM in state and federal courts throughout the country. The manufacturers include:
- Boston Scientific
- Johnson & Johnson (subsidiary Ethicon)
- Endo Pharmaceuticals (subsidiary American Medical Systems)
- C.R. Bard
- Cook Medical
Numerous different multidistrict litigations (“MDL”) have been established to consolidate and manage the federal cases, with the vast majority pending under one judge in the U.S. District Court for the Southern District of West Virginia. Some lawsuits have gone to trial and resulted in large verdicts for the injured plaintiffs. Others have resulted in settlements. Still others remain pending.
If You’ve Experienced Complications From a Transvaginal Mesh Implant
If you or a loved one experienced complications associated with transvaginal mesh which required you to undergo surgery to remove, treat, or repair the mesh, you may be eligible for compensation for medical expenses, emotional trauma, and lost wages. However, it's crucial that you seek experienced legal representation to make sure your rights are protected throughout the litigation process.
The skilled attorneys at Neblett, Beard & Arsenault are committed to assisting women who’ve been injured by transvaginal mesh used to treat POP and SUI. Schedule a free consultation to learn more.