A landmark transvaginal mesh lawsuit will go to trial Tuesday in Sydney, Australia, where more than 800 women claim to have suffered life-changing injuries due to Ethicon, Inc.’s controversial implants.
“We will say that they’ve breached product legislation in Australia and that they’ve been negligent in their manufacture and supply of the implants,” one of the plaintiffs’ attorneys recently told the Courier Mail.
It is estimated that between 90,000 and 100,00 pelvic mesh implants were sold in the country. Transvaginal mesh recipients involved in the class action lawsuit claim that the devices have caused chronic pain and made intimacy impossible. For many of the women, removal of the mesh is not an option.
“Trying to remove the implants has been referred to by surgeons … as trying to remove chewing gum from hair. These implants become so intertwined with the tissue of the pelvis, it becomes very difficult, if not impossible, to remove in its entirely,” the pelvic mesh attorney said.
The Australian transvaginal mesh lawsuit is considered a landmark case both for the number of women involved and the expected length of the trial, which could go as long as six months.
In 2008, the U.S. Food & Drug Administration (FDA) warned that it had received more than 1,000 serious injury reports involving transvaginal mesh implants during the previous three-year period. The agency issued a second warning in July 2011, after the number of reports tripled. The FDA also stated that it no longer considered complications following transvaginal mesh prolapse repair to be rare, and expressed doubt that such procedures offered any additional benefits compared to traditional non-mesh surgery.
Just last year, the FDA issued new rules that, among other things, made transvaginal mesh implants ineligible for the agency’s 510(k) clearance program, which allowed such devices to come to market without the benefit of human testing.
In 2012, Ethicon announced it would end sales of four Gynecare transvaginal mesh devices, attributing the decision to slowing sales. However, the FDA had previously ordered it and other vaginal mesh manufacturers to conduct further research into the risks associated with their products.
Ethicon is named a defendant in more than 50,000 U.S. lawsuits involving its Gynecare transvaginal mesh products. Numerous cases have gone to trial in recent years, with juries delivering verdicts for both plaintiffs and the defense. Ethicon has also reached transvaginal mesh settlements in some cases.
On June 9th, Ethicon won its first verdict in the pelvic mesh litigation now underway in the Philadelphia Court of Common Pleas., following four consecutive losses. Previous juries had ordered the company to pay $2.16 million, $20 million, $12.5 million and $13.5 million to plaintiffs in four other Pennsylvania trials.