The European Commission asked a scientific advisory panel to look into the safety of surgical procedures to treat urogynecological conditions using mesh products, which have embroiled their makers in tens of thousands of product liability lawsuits in the U.S.
The EU’s executive body asked its Scientific Committee on Emerging and Newly Identified Health Risks for an opinion on the "safety of surgical meshes used in urogynecological surgery," according to the commission’s request.
"Based on the latest scientific and technical knowledge the committee is requested to assess the risk of meshes used in urogynecological surgery and more generally for other uses," the commission said.
The EU wants the SCENIHR panel to assess the risks associated with using the meshes to treat stress urinary incontinence and pelvic organ prolapse in women, determining whether some mesh products carry a higher risk. Medical device companies including C.R. Bard (NYSE:BCR), Boston Scientific (NYSE:BSX), Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon, Endo Health Solutions (NSDQ:ENDP), Cook Medical and Coloplast (CPH:COLO B) are facing a raft of lawsuits in federal and state courts in the U.S. over their respective pelvic mesh offerings.
The EU panel is also charged with investigating whether certain surgical techniques or a combination of technique and specific device carry a higher risk. The SCENIHR panel has until January 2015 to issue its report, which must also identify high-risk patient groups and whether surgical mesh is appropriate in treating other conditions. The panel will also decide if a registry study of pelvic mesh procedures is warranted.
Last month, a Pennsylvania state judge ordered the creation of a mass tort to collect product liability lawsuits filed over pelvic mesh products. Cases have also been consolidated into multi-district litigation under Judge Joseph Goodwin of the U.S. District Court for Southern West Virginia.