Endo Health Solutions, the parent company of American Medical Systems, indicates that they are the subject of an investigation by several states, which are investigating issues related to possible Medicare and Medicaid fraud associated with pelvic mesh products.
In an annual report filed by the Securities and Exchange Commission, Endo disclosed that it has received subpoenas from state attorney generals in California and other states regarding issues with the transvaginal mesh products.
What Is Transvaginal Mesh?
Transvaginal mesh is surgical mesh device used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women.
The device is made of a fibrous surgical mesh material. Since the 1950’s the mesh was used to treat abdominal hernias, however it is now used mostly for POP.
Nevertheless, there have been reports of a major side effect related to the transvaginal mesh implant, which is erosion.
Erosion happens when the edges of the transvaginal mesh erode through the vagina and nearby organs. This causes a lot of pain, bleeding, serious infection and scarring of the vagina.
Pelvic Mesh Litigation
Throughout the United States women have filed more than 50,000 lawsuits over pelvic mesh problems. Most of the cases have been filed succeeding an FDA warning issued in July 2011.
In 2012 a letter was sent to several manufacturers of these products by the FDA, demanding an additional study and trail be conducted to evaluate the safety of the pelvic mesh products to help establish whether they pose an unreasonable risk of injury for women.
At least five pelvic mesh cases have already gone before juries, two cases going before state court juries and three cases proceeding to trial in federal court.
In July 2012, a California state court jury awarded 5.5 million in damages against C.R. Bard, and a New Jersey State court jury awarded $11.1 million in damages against Ethicon in March of 2013.
However, the first trial for an AMS vaginal mesh claim is scheduled to begin