North Carolina resident recently filed a lawsuit against Boston Scientific Corporation for a faulty transvaginal mesh implant system, and for failure to adequately warn her of the potential risks of implantation.

The plaintiff, Bonnie B., had a Biodesign or Surgisis Urethral Sling, a Coloplast-MPathy repair product, and a Boston Scientific Repliform implanted in her body; her transvaginal mesh implant claim encompasses all three devices. Her complaint covers several counts, including gross negligence, manufacturing defect, failure to warn, fraudulent concealment, breach of express and implied warranty, and violation of consumer protection laws.

What is a Transvaginal Mesh Implant?

A transvaginal mesh implant is used for treating stress urinary incontinence (SUI) and pelvic organ prolapse (POP) in women, which can follow hysterectomy, menopause, or childbirth. Unfortunately, the product has reportedly contributed to serious complications, such as mesh erosion and organ perforation.

Transvaginal insertion of these mesh implants is quicker and easier than abdominal insertion, but the serious complications associated with some of these products has caused thousands of women to file transvaginal mesh lawsuits. Hundreds of thousands of women have already had mesh implanted, and may be at risk.

Pelvic organ prolapse (POP) occurs when weak pelvic muscles allow organs to sag or fall into the vaginal canal. Transvaginal mesh holds these organs up, like a hammock. It is usually the bladder that is affected by POP, though the uterus, rectum, or bowel can also be involved.

Stress urinary incontinence occurs when pelvic muscles weaken, causing the bladder to leak urine during physical activity that increases pressure. Transvaginal mesh implants are the most common treatment for SUI, often called bladder slings. Doctors typically choose transvaginal placement of these implants rather than abdominal because it is considered to be a less invasive surgical procedure.

Some women suffer from vaginal vault prolapse following a hysterectomy, in which case the vagina collapses due to the removal of the uterus. In these situations, mesh is surgically implanted on top of the vagina and sewn into tissues to hold the vagina in one place.

The complications of transvaginal mesh implants include mesh erosion and organ perforation. Mesh erosion occurs when mesh breaks apart and passes through the vaginal wall; this causes bleeding, severe pain, infection, and nerve damage. Organ perforation is the second stage of this complication, as once the mesh erodes through the vaginal wall, it can harm other organs (such as the bladder) with its jagged edge.

Background of Transvaginal Mesh Implant Complications

Problematically, many of the transvaginal mesh products on the market today were approved based on the previous approval of the ProtoGen Sling, a product which was recalled due to safety issues in 1999. The FDA found the ProtoGen Sling had a “higher than expected rate of vaginal erosion.”

In 2008, the FDA reported that complications from transvaginal mesh used for POP treatment were rare. In 2011, however, the agency updated its statement to warn patients and doctors that such complications are not rare, and not limited to one product.

In 2011, the FDA also reported that “it is not clear that transvaginal POP repair with mesh is more effective” than repair without mesh, and may even “expose patients to greater risk.”

Thousands of injured parties have filed transvaginal mesh lawsuits, and some have won between $10 million and $100 million physical and financial damages. If you or someone you know has experienced complications from transvaginal mesh used to treat SUI, POP, or something else, you may have cause to file a transvaginal mesh lawsuit.

The Transvaginal Mesh Lawsuit is Barnes v. Boston Scientific Corporation, et al., Case No. 2:15-vc-11791, in the U.S. District Court for the Southern District of West Virginia.