In a massive victory in the litigation over transvaginal mesh complications, Endo International PLC’s subsidiary American Medical Systems (AMS) has agreed to settle over 350 vaginal mesh lawsuits.

The vaginal mesh settlement was announced earlier this month by Endo to West Virginia federal judge Joseph R. Goodwin, after numerous similar vaginal mesh lawsuits claimed similar injuries and provided substantial evidence to support these arguments.

The company stated that it had compromised from its initial argument, settling approximately 360 vaginal mesh lawsuits in 12 joint motions to dismiss.

About 30 of these cases alleged similar claims against other mesh manufacturers, like Boston Scientific Corp and C.R. Bard, to which Endo requested that these specific vaginal mesh lawsuits be transferred to their appropriate multidistrict litigations (MDLs).

While the official value of the Endo/AMS vaginal mesh settlements has yet to be disclosed, the company reported that $830 million will be used for settlement funds. Endo had previously announced these settlements in September, stating that it had reached master vaginal mesh settlements with a number of plaintiffs, allowing the company to admit to no wrongdoing or liability.

In April 2014, Endo had initially thought that the vaginal mesh litigation had come to a conclusion, after coming to agreements with several law firms representing the numerous vaginal mesh and vaginal sling plaintiffs; these agreements resolved nearly 20,000 lawsuit in the ongoing vaginal mesh MDL.

The plaintiffs of these vaginal mesh lawsuits mainly consisted of women and their husbands, who alleged the women had defective transvaginal mesh implanted into their pelvic region to treat either their stress urinary incontinence (SUI) or pelvic organ prolapse (POP), resulting in serious and permanent damage.

These plaintiffs allegedly suffered severe debilitating injuries from these vaginal mesh products, including mesh erosion, mesh tearing, infection, and complete device failure.

Overview of Vaginal Mesh Complications

Originally, Endo had predicted that settling these lawsuits would total at least $520 million. This led the company to agree to a $54.5 million vaginal mesh settlement for an unspecified number of these lawsuits in June 2013.

Endo representatives were hopeful that this settlement would resolve many of the lawsuits, as well as allow the company to return to its regular business and investment affairs, acquisitions, and mergers.

Around the same time of Endo’s announcement, the FDA issued two orders that would force the medical community to reclassify vaginal mesh as a high risk device, especially when using it to treat either POP or SUI. The FDA also required vaginal mesh manufacturers to apply for pre-market approval for their devices to adequately determine the safety of their products.

As mentioned before, transvaginal mesh is a medical device that is used as an implementation tool to treat the symptoms of either POP or SUI. When it was first invented in the 1950s, vaginal mesh had been created for the specific purpose of hernia repair, though the product evolved in its uses in the 1970s.

At this time, transvaginal mesh had become well-known for being a permanent solution to treat women who were suffering from a weaker pelvic region after undergoing experiences like hysterectomy, menopause, childbirth, or extreme physical trauma. While it had been initially praised for being a discrete treatment option for such personal conditions, these devices had soon garnered a bad reputation in the medical community.

Numerous patients reported suffering extreme pain after the vaginal mesh had been implanted, often needing the mesh removed to resolve the complications. However, oftentimes there are lasting mesh complications like erosion, infection, and even organ tearing in the worst situations.

In 2011, the FDA announced it had received 4,000 vaginal mesh injury reports, spanning over the course of six years.

Even with the vaginal mesh settlement fund drastically increased to include more plaintiffs, Endo is satisfied that it will satisfy a majority of the vaginal mesh liability claims.

The Endo/AMS Vaginal Mesh MDL is In re: American Medical Systems Inc. Pelvic Repair System Products Liability Litigation, Case No. 2:12-md-02325, in the U.S. District Court of Southern West Virginia.