Transvaginal Mesh Collateral Damage Too High for TVM Settlement

January 21, 2018, 1:30PM. By Jane Mundy

“The Transvaginal Mesh settlement offered by Boston Scientific isn’t enough to cover the collateral damage my family has suffered.”

Houston, TXAlthough Jordan will receive compensation from Boston Scientific for transvaginal mesh injuries, she says the settlement cannot cover the collateral damage suffered not only by her injuries but also by her family.

Jordan suffered from pelvic organ prolapse after childbirth back in 2007 so upon her doctor’s advice, she had the transvaginal mesh implanted. (Most women suffer some degree of prolapse after giving birth, typically corrected with simple pelvic floor exercises.) Jordan’s doctor, like most health professionals about a decade ago, was likely “sold a bill of goods” by medical device manufacturers like Boston Scientific, promising that transvaginal mesh was the next best thing to sliced bread. But no doctor could guarantee to their patients that the mesh wouldn’t come with complications.

“I am worse off now than I was before getting it. I’ve lived in pain for the past 10 years, so long that I can’t imagine life free of pain,” says Jordan. “But that’s only part of it. My husband and I can no longer have sex and it’s a wonder that we’re still together. And I can’t lift anything more than about 10 pounds, including my son. I can’t play soccer with him like I did with his brother; I couldn’t pick him up when he cried. Did Boston Scientific and all the attorneys on both sides take collateral damage into account when they agreed on this settlement?”

Boston Scientific Settlement

Boston Scientific last October announced a settlement to resolve an aggregate of about 44,000 transvaginal mesh cases and claims. In its filing with the U.S. Securities and Exchange Commission, the medical device maker said that “approximately 15,500 [of those cases and claims] have met the conditions of the settlement and are final. All settlement agreements were entered into solely by way of compromise and without any admission or concession by us of any liability or wrongdoing.” The company said 48,500 product liability claims had been filed involving its TVM device. (Boston Scientific first reached an agreement to settle more than 25,000 vaginal mesh lawsuits nationwide for about $119 million in April 2015.)

British Medical Journal transvaginal mesh Review

A recent review in the British Medical Journal (December 2017) found that many transvaginal mesh products were approved with little, if any, clinical testing. The study concluded that, “Transvaginal mesh products for pelvic organ prolapse have been approved on the basis of weak evidence over the last 20 years. Devices have inherited approval status from a few products. A publicly accessible registry of licensed invasive devices, with details of marketing status and linked evidence, should be created and maintained at the time of approval.”

Although the FDA in 2016 labeled the transvaginal mesh products “high risk” and found that there was “no evidence that transvaginal mesh provides any additional benefits when compared to more traditional surgery for treatment of pelvic organ prolapse,” its warnings came too late and the agency failed to protect thousands and thousands of women like Jordan. Rather than spend money to study the safety of its devices, many mesh manufacturers chose to stop making the devices. Meanwhile, the FDA has been accused of being asleep at the wheel and it has been accused of failing to:

• adequately evaluate the safety and efficacy of medical devices and procedures;
• establish a comprehensive register of mesh products and procedures;
• provide adverse reporting systems to accurately represent health consumer outcomes;
• act on international evidence and warnings including those of the FDA;

Details of the transvaginal mesh settlements have not been disclosed. Jordan thinks she will wind up with less than $100,000. That amount doesn’t even compensate for loss of wages – she was unable to return to work full-time and her insurance company denied her long-term disability benefits. “I’m hopeful that some of this money will pay for surgery to get all of this mesh removed once and for all,” says Jordan. “I’ve already gone through one surgery that was unsuccessful. “Maybe one day I’ll be able to get my life back. And my husband’s, and my son’s…”