Endo AMS Settles 10,000 Vaginal Mesh Lawsuits for $400M

Los Angeles, CA: Endo International plc has reached a settlement agreement that reportedly will resolve most outstanding American Medical Systems (AMS ) trans vaginal mesh lawsuits. The medical device manufacturer has agreed to pay more than $400 million to resolve the lawsuits, which claim the AMS vaginal-mesh implants eroded in some women and left them in pain.

The master settlement will resolve more than 10,000 outstanding AMS lawsuits in the US at an average of about $48,000 apiece, Bloomberg reports. AMS expects to fund the payments under all settlements in 2014, 2015, 2016 and 2017.

Based in Minnesota, AMS is a major manufacturer of transvaginal mesh medical devices, which are support systems designed to correct pelvic organ prolapse, (POP) and stress urinary incontinence (SUI).

The FDA received a number of adverse reports regarding AMS transvaginal mesh. These reports have resulted in thousands of lawsuits filed against the company by women who may have been implanted with the following AMS mesh:

• AMS Apogee Vault Suspension System
• AMS Elevate Prolapse Repair System
• AMS Monarc Sling System
• AMS Perigee System
• AMS Sparc Sling System

In July 2011 an FDA advisory panel advised that TVM mesh, including AMS transvaginal mesh, be reclassified from moderate risk to high risk (Class III) of harming patients if it fails, and that move requires more studies to determine if it' safe and effective and will also require pre-market clinical testing for new mesh products. (Moderate-risk devices need only show that they are "substantially equivalent"to existing products.)

Sources close to the Endo settlement stated that some 5,000 AMS vaginal mesh lawsuits remain outstanding.

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Published on Oct-1-14