Four hundred Oklahoma women who suffered catastrophic side effects from the use of transvaginal mesh implants are suing the product manufacturers.

According to a news report posted late last week by KFOR-TV, in Oklahoma City, attorneys for the women say they were not properly warned about what could happen if their bodies were not able to tolerate the mesh.

The Oklahoma lawsuit is just the latest development in the ongoing controversy and legal saga surrounding transvaginal mesh.

Transvaginal mesh is used in women to repair tears in the connective tissue of the pelvis and is designed to correct organ prolapse or urinary incontinence. It works by forming a sling-like support to the bladder or uterus to help alleviate urinary incontinence.

However, for many women, the product ends up doing more harm than good. The mesh can become very rigid and sharp once implanted, causing excruciating pain. And even after multiple surgeries, it is often impossible to remove the mesh, because it becomes embedded in body tissue that grows around it. Many women undergo multiple surgeries in an attempt to correct the problem – all to no avail.

Transvaginal mesh is made by several manufacturers including:

  • CR Bard (Avaulta Solo, Avaulta Biosynthetic Support System, Avaulta Plus Biosynthetic Support System)
  • Johnson & Johnson and subsidiary Ethicon (Gynecare Prolift mesh, Gynecare Gynemesh, Gynecare Prolene mesh, Gynecare TVT sling)
  • American Medical Systems (Elevate, Apogee, Perigee, Monarc, Sparc Sling)
  • Boston Scientific (Pinnacle, Uphold System)
  • Ugytex (Dual Knit Mesh)
  • Mentor Corporation (OB Tape)

Earlier this year the first transvaginal mesh case went to trial and the plaintiff, Linda Gross, a 47-year-old South Dakota nurse who complained of non-stop pain after being implanted with Johnson & Johnson’s Gynecare Prolift to strengthen pelvic muscles, was awarded more than $11 million. In that case, the jury found that the manufacturer, Johnson & Johnson, and its subsidiary, Ethicon, failed to warn the Gross and her doctor about the risks of using transvaginal mesh.

Ethicon issued a statement after that ruling saying the company “acted appropriately and responsibly in the research, development and marketing” of the pelvic mesh.

In this latest development – the Oklahoma suit – the lawyer for the plaintiffs claims mesh makers did not properly test their product for use on bladder and vaginal tissue.  Additionally, like Gross – the South Dakota woman – the plaintiffs in the Oklahoma case say they were never adequately warned about what could happen if their bodies did not tolerate the mesh.

FDA Involvement
The U.S. Food and Drug Administration began issuing warnings about the problems with transvaginal mesh back in 2008.  At that time, the FDA cited 1,000 reports of complications associated with the surgical mesh. Among the problems and complications reported were erosion, infection, pain, incontinence and vaginal scarring. The FDA’s 2008 statement went on to say that the complications are not rare. In fact, the FDA statement said that the number of adverse events reported to the FDA for surgical mesh devices for the previous three-year period (2005-2007) was more than 1,000. And that since then, from Jan. 01 through Dec. 31, 2010, the FDA received 2,874 more reports of complications from surgical mesh.

In 2011, the FDA issued yet another warning about the dangers associated with transvaginal mesh. In that report, the FDA said one in 10 mesh surgeries fail.

Vaginal mesh is still being used by physicians, but much less frequently, according to the KFOR-TV report. In addition, several manufacturers are still marketing the product.