Companies still market transvaginal mesh products despite potential risks

March 24, 2016, San Diego, CA – A significant number of women will experience pelvic organ prolapse (POP) in their lifetimes. A prolapse occurs when the muscles supporting the pelvic organs weaken and the organs slip out of place and push against the walls of the vagina. The muscles typically weaken years after childbirth, a hysterectomy or menopause. The most common organ to “slip” is the bladder, but other organs that can be involved include the urethra, uterus, small bowel and rectum.transvaginal mesh implant

POPs are relatively common among women in the U.S. About 11 to 19 percent of women are expected to undergo surgery for either POP or urinary incontinence — a symptom associated with the condition — by age 85, according to the independent health information source HealthyWomen. Roughly 200,000 surgeries are conducted every year to correct POP and about 100,000 women have been treated with a transvaginal mesh.

Transvaginal mesh (TVM) products have come under fire in recent years after tens of thousands of women have spoken out against the devices claiming they caused them serious harm. Thousands of cases against TVM manufacturers have been settled in court in recent years, with Big Pharma companies shelling out hundreds of millions of dollars to the plaintiffs.

Why are TVM potentially dangerous?

Complications arising from TVM can be life-altering and, in some cases, life-threatening. In fact, this past January, the U.S. Food and Drug Administration (FDA) reclassified TVM from a moderate-risk device to a high-risk device. The change came after the federal agency reviewed several thousand complaints from women who say they were seriously injured by the devices.

Between January 2005 – three years after the first TVM was approved for use in U.S. markets – and December 2010, the FDA received nearly 4,000 reports of injury, malfunction or death associated with the mesh products. Nearly three-quarters of those reports were received between January 2008 and December 2010 and of those received in those three years, almost half involved surgeries related to POP.

The most common complications reported by women included:

  • Protrusion (also called exposure, extrustion, erosion)
  • Pain (including during intercourse)
  • Infection
  • Urinary problems
  • Bleeding
  • Organ perforation

Less common complications included recurrent prolapse, vaginal scarring, emotional problems and neuromuscular problems.

Some of these complications could require hospitalization and additional surgeries. Some of these complications could also be deadly. Between 2008 and 2010, three reported deaths were determined to be associated with POP repair.

TVM could protrude and perforate other organs

Some of the most serious potential complications from these mesh products are protrusion (or erosion) and perforation of organs. These complications were also some of the most frequently reported by women between 2008 and 2010.

Mesh protrusion occurs when it wears through the wall of the vagina and becomes exposed. Symptoms of mesh protrusion include:

  • Pelvic pain
  • Infection
  • Painful intercourse
  • Vaginal bleeding
  • Atypical vaginal discharge

Mesh protrusion could require additional surgeries to repair the damage and may result in continued side effects, including pain, even after the mesh is removed.

Another serious complication is perforation of nearby organs, including the bladder and rectum. Two deaths reported to the FDA between 2008 and 2010 were determined to be caused by perforation of the rectum. Both women had received a TVM to treat their POP.

Symptoms of organ perforation include:

  • Pelvic pain
  • Infection
  • Pain during intercourse

Perforation could also require additional surgeries to treat.

FDA: No evidence to show TVM better than traditional methods

The FDA issued its first safety communication to patients and doctors in 2008, warning them of potentially serious, but rare, complications of TVM.  In 2011, it updated that warning to say serious complications associated with TVM for POP repair were indeed “not rare.”

That same year, a panel convened to discuss the safety and effectiveness of TVM and to make recommendations. That panel concluded there was not enough evidence to show that transvaginally placed mesh to repair POP improved clinical outcomes any more than traditional POP repair that did not use mesh. In fact, it concluded TVM may pose greater risks to patients.

Manufacturers pull TVM off market, but 5 remain

In 2012, the FDA ordered more than 30 manufacturers of TVM to conduct post-market surveillance studies to address specific safety and effectiveness concerns related to mesh and POP repair. Many manufacturers chose to stop distributing their TVM devices because of the required studies. Those manufacturers included Johnson & Johnson’s Ethicon division, C.R. Bard Inc. and Caldera Medical Inc.

Today, five manufacturers continue to market TVM for treatment of POP, according to the FDA.

A search of the FDA’s post-market surveillance studies database finds four companies still participating in the post-market studies. These include Maryland-based ACell, Inc.; Boston Scientific; Minnesota-based Coloplast Manufacturing US, LLC; and ASTORA Women’s Health, formerly known as American Medical Systems and acquired by Endo Pharmaceuticals in 2011.

On March 31, however, ASTORA Women’s Health will discontinue commercial and manufacturing operations. The Endo subsidiary is due to submit the final portion of its three-year post-market study to the FDA on April 25. According to the site, it will continue to monitor subjects in the study.

Lawsuits settle for millions

Despite pulling TVM devices from the market, companies are being held liable for the products that may have harmed tens of thousands of women over the past several years. Since 2014, lawsuits against some of the largest pharmaceutical companies in the country have been settled for hundreds of millions of dollars.

Just this past January, a woman was awarded $12.5 million after winning a suit against Johnson & Johnson’s Ethicon division in a Philadelphia courtroom. Other individual lawsuits have settled against Johnson & Johnson for $3.27 million and $5.7 million and against Boston Scientific for $100 million. Several mass tort cases have also settled against C.R. Bard for $1.75 million and $200 million and against Boston Scientific for $119 million.

There are still thousands of lawsuits pending throughout the country and women who have been injured by transvaginal mesh products can still participate, but they need to act now. Call the Hood National Law Group today at 1-800-214-1010 for a free case evaluation or fill out the form on the right-hand side of your screen to see if you qualify.