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?
An updated version of the surgical mesh used for hernia repair in the 1950s, transvaginal mesh was first approved by the U.S. Food and Drug Administration (FDA) in 1996. Transvaginal mesh is a net-like implant typically made of a plastic called polypropylene. It is used to treat POP and SUI, typically after a woman goes through a hysterectomy, menopause, or childbirth. The product gets its name from the surgical technique that’s used to implant the mesh through a woman’s vagina.
Despite being a less invasive treatment for POP and SUI, transvaginal mesh carries a much higher rate of patient complications. These include:
- Mesh erosion
- Nerve damage
- Neuromuscular problems
- Organ perforation
- Painful intercourse
- Vaginal scarring
- Vaginal shrinkage resulting from scar tissue
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 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 urogynocologist 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?
The FDA has received a great deal of criticism regarding its handling of transvaginal mesh complications. The agency did not require manufacturers to conduct studies on the safety and effectiveness of transvaginal mesh products in humans before they received approval. Additionally, even though the ProteGen Sling was recalled by the FDA in 1999, many of the transvaginal mesh products on the market today were approved based on their design.
In 2011, the FDA updated its original Public Health Safety Notification to state that complications from transvaginal mesh are not rare. In 2012, the FDA ordered multiple manufacturers to conduct postmarket studies on the effectiveness of their products for treating POP and SUI. In 2013, the FDA updated its website to include more information for healthcare providers, patients, and other interested parties on the adverse events associated with the mesh used for SUI.
What Transvaginal Mesh Lawsuits Have Been Filed?
American Medical Systems, Boston Scientific Group, Coloplast Corp, Cook Medical, C.R. Bard, and Ethicon are currently involved in multidistrict litigation (MDL) with thousands of women who've been injured from transvaginal mesh.
Although many suits are still pending, there have been a number of large verdicts in transvaginal mesh cases. For example:
- $5.5 million against C.R. Bard in 2012, after Christine Scott and her husband won their transvaginal mesh suit
- $11.11 million against Ethicon in 2013, after Linda Gross won her suit based on her need for 18 transvaginal mesh revision surgeries
- $54 million in 2013, to settle an undisclosed number of lawsuits against American Medical Systems' parent company, Endo Health Solutions
- $830 million in 2014—a second mass settlement for patients using mesh produced by Endo Health Systems
- $100 million jury verdict against Boston Scientific in 2015, after Deborah Barba demonstrated she experienced urinary tract infections and pain during sex following her transvaginal mesh surgery
If You’ve Experienced Complications From a Transvaginal Mesh Implant
If you have experienced complications following your transvaginal mesh surgery, 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.