A History of Transvaginal Mesh

Almost everyone has heard advertisements for lawyers representing women damaged by transvaginal mesh. And the response has been overwhelming. There are almost 35,000 cases filed in one court alone, the federal court in Charleston, West Virginia. Thousands more are filed around the country naming primarily six manufacturers – Ethicon ( J&J), Boston Scientific, American Medical Systems, C.R. Bard, Coloplast and Cook.

Even if there are 50,000 cases filed in the U.S., there are an unknown number of women who are just now finding out they may be suffering mesh complications. Sometimes it masks with other symptoms, pelvic pain, infection, aches in joints in the back and shooting pain down the leg. Women are often told they are “getting old” by doctors who are perplexed by the symptoms. Doctors, too, have been kept in the dark about the downside of mesh which has been established in almost all of the trials so far.

The U.S. Food and Drug Administration (FDA) estimates about 300,000 mesh implant surgeries took place in 2010, hundreds of thousands more in the years before and following. Why did the practice become so common in such a short period of time?

For one thing surgeons went from cutting mesh themselves to the invention and marketing of mesh kits. Complete with stainless steel trocars or implanting devices, plastic mesh and anchors and an aggressive marketing campaign targeting baby boomers, this boosted the use of mesh.

The FDA in its July 2011 warning found mesh complications had grown five-fold. That is when the health agency put out its most dire warning that the benefits of transvaginal mesh may not outweigh the risks and that complications are “not rare.” That is the trigger that began the flood of lawsuits you see today.

One small fact that goes largely unnoticed is that in 2007, the American College of Obstetricians and Gynecologists warned doctors that vaginal mesh and its implantation should be considered “experimental.”

“The procedures should be considered experimental and patients should consent to surgery with that understanding “ said an ACOG Bulletin.

Mesh kits were new and with high profits and heavy marketing they were being readily accepted. Manufacturers were not required to test them on humans in clinical trials prior to their launch, so experimental seems a fitting word. But by September the same year, ACOG in another bulletin eliminated the word “experimental.”

“…patients should consent to surgery with an understanding of the post-operative risks and lack of long-term outcomes data.”

The catch is that insurance doesn’t usually cover any experimental procedure so was the threat of losing insurance money behind the change? Louis Wall, MD thought so and wrote about it in a letter to the International Urogynecological Journal in July 2009. He concluded ACOG had “abandoned its fiduciary duty to be an advocate for patients.” The president of ACOG denied that and said doctors were troubled by the word “experimental.”

A spokesperson from ACOG wrote to WBUR radio in Boston in 2011 to say the confusion was some thought the word “experimental” meant it could only be used for experimental trials, while others felt the word would mean they could not be reimbursed by insurance since there was no code for “experimental.” Then again, insurance generally frowns on procedures that are not the standard of care.

One year after the ACOG bulletin, the FDA issued its first alert that “serious complications associated with surgical mesh for transvaginal repair of POP are “rare.” Three years later, the FDA reversed itself to say complications are “not rare” and the risks may outweigh the benefits of transvaginal mesh.

With a complication rate estimated to be up to 25 percent, there are still no reliable long-term studies on mesh and doctors are not mandated to report adverse events – so it remains a guessing game. Transvaginal mesh also remains on the market.

As one woman said to the FDA panel convened in 2011 to look at mesh after the five-fold increase in complications, “They recall dog food don’t they?”