A group of British researchers have suggested that an alternative material could help prevent the types of life-changing complications that have driven thousands of women to file transvaginal mesh lawsuits against Ethicon, Inc. and other device makers.
Transvaginal mesh – indicated for use in women who suffer from pelvic organ prolapse and stress urinary incontinence – is generally made from polypropylene, a plastic material also used to manufacture food containers, outdoor carpets, and other household items.
“For many years now, surgeons have been treating the problems of urinary stress incontinence and pelvic organ prolapse using the only synthetic material they had on hand — polypropylene,” Sheila MacNeil, PhD, professor of tissue engineering in the department of materials science and engineering at the University of Sheffield, said in a press release announcing her team’s findings.
“However, when much bigger areas of the same material are inserted through the vagina to relieve pelvic organ prolapse, the complication rate is frankly unacceptable,” she continued.
MacNeil and her fellow researchers have proposed using polyurethane instead, asserting that it is stronger and has more elasticity than polypropylene.
As part of their study, the scientists also inserted estrogen into the polyurethane mesh to help speed up the healing process. The addition of estrogen did not reduce strength and elasticity of the mesh.
“Over the last seven years, we have investigated a range of materials and for the past few years, we have focused our efforts on polyurethane, using the method of electrospinning to create a fine mesh which we have fabricated in layers to mimic the structure of human tissue,” MacNeil said. “We have shown through our research that it does not provoke inflammation and retains its strength and elasticity. The addition of oestrogen is a major breakthrough as we have proved its beneficial effects in regenerating pelvic tissue.”
Since 2008, the U.S. Food & Drug Administration (FDA) has issued two warnings regarding the serious complications associated with transvaginal mesh. In 2016, the agency reclassified mesh implants indicated for prolapse repair as Class III (high risk) medical devices, subjecting the implants to stricter regulatory scrutiny.
Transvaginal mesh complications reported to the FDA include:
Tens of thousands of women throughout the United States have filed transvaginal mesh lawsuits since the FDA issued its first warning in 2008. Plaintiffs claim that Ethicon and other device manufacturers failed to conduct proper testing to ensure the safety and efficacy of their implants. They further allege that the defendants concealed the dangers associated with the devices and failed to provide doctors and patients with adequate warnings of their risks.
31 transvaginal mesh trials have been convened over the past several years. Plaintiffs have been awarded multi-million verdicts in 23 cases. A significant percentage of transvaginal mesh lawsuits have also been settled, though thousands remain pending in federal and state courts throughout the country.