Endo Health Solutions Inc, which acquired American Medical Systems Inc., (AMS), the maker of the vaginal-mesh devices, which include the Perigee, Apogee and Elevate implants, said in a statement that is set to resolve an undisclosed number of the vaginal mesh personal injury lawsuits. However, AMs is facing over 5,000 such lawsuits, which have been consolidated: the first lawsuit set to go to court in December 2013. This settlement agreement doesn't address these lawsuits.
The AMS settlement will resolve a small number of vaginal mesh injury lawsuits filed in both federal and state courts. Lawyers representing the plaintiffs stress that no universal settlement has been made. The first cases are set to go to court later this year.
In August 2011, the US Food and Drug Administration issued a report stating vaginal-mesh products should be classified as high risk devices, based on a review of side-effect reports from January 2008 to December 2010. Women' groups are demanding that the devices be recalled.
A copy of the Form 8-K filed with the Securities Commission regarding the potential AMS settlement can be accessed here.