Alleged Vaginal-Mesh Implants Erosion Costs Endo Health Solutions (ENDP) Millions in Settlement Payouts

Settlement has been reached in many vaginal mesh implant cases. American Medical Systems, Inc. (AMS), a division of Endo Health Solutions, Inc., will pay in excess of $54 million to settle some of these cases.

More than 5,400 cases have been filed against this company regarding alleged defects in the implants. Most of the cases filed against AMS and other companies have not been settled. AMS is one of the leading manufacturers of vaginal implants.

The Use of Vaginal Mesh Implants (VMI)

Vaginal mesh implants were designed as a solution for pelvic organ prolapse and female urinary incontinence. When vaginal walls are weakened or stretched, pelvic organs, including the bladder and uterus, expand and obstruct the vaginal wall. In addition, urinary leaking can occur in some patients.

The implants are manufactured with synthetic or natural materials to strengthen the damaged muscle tissue. Normally, they are implanted permanently into the pelvis in the area of the damaged tissue.

The Food and Drug Administration (FDA) first approved vaginal mesh implants in the late 1990s. Since that time, the FDA has approved more than 100 different products for use by more than 40 different companies. Approximately 500,000 VMI operations are performed annually in the United States.

FDA Warning Regarding Vaginal Mesh Implants

In 2008, the FDA reported side effects and complications involving the implants. Many of the defects included wearing away or shrinking of the mesh material. This has led to additional operations to repair the mesh, pain exhibited by women undergoing the procedure, and pain during urination or sexual intercourse. In some cases, injuries have been more severe.

On July 13, 2011, the FDA updated its warning regarding the use of vaginal mesh implants. Though it had previously reported that complications involving the implants were rare, additional evidence received from 2008 to 2010 indicated that complications were more common than once believed.

Rise in Vaginal Mesh Implant Litigation

More than 5,000 lawsuits have been filed against AMS alone for claims of injury due to alleged defective mesh products. The AMS cases have been consolidated in the Southern District of the U.S. District Court in West Virginia. The settlement recently announced is not a global settlement.

It is estimated that more than 28,000 total lawsuits have been filed, including several where jury verdicts exceeded several million dollars. In the past few months, more than 1,000 new lawsuits were filed. The rise in recent filings is believed to be related to the statute of limitations and is tied to the FDA announcement on July 13, 2011. In most states, an injured party has two years to file a lawsuit. The two-year period often begins when the product is first used or when it is first known to cause injury. The FDA announcement two years ago would likely be considered evidence of knowledge of the implant’s defective nature.

Sources:

http://www.drugwatch.com/transvaginal-mesh/brands/
http://www.bloomberg.com/news/2013-06-21/endo-health-unit-pays-55-million-in-vaginal-mesh-accord.html
http://www.fda.gov/MedicalDevices/Safety/alertsandNotices/ucm262435.htm