The European Union’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has been charged with investigating the safety of pelvic mesh products. In the United States, these implantable devices are the subject of tens of thousands of product liability lawsuits.
SCENIHR has been asked for an opinion on the “safety of surgical meshes used in urogynecological surgery.” The EU wants the panel to assess the risks associated with using the mesh devices to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP) in women, MassDevice.com reports. In addition, the panel will examine whether some mesh products carry a higher risk than others.
In the U.S., thousands of lawsuits have been filed in state and federal courts against medical device companies including C.R. Bard, Boston Scientific, Johnson & Johnson subsidiary Ethicon, Coloplast, and Endo Health Solutions, MassDevice reports. In February, a Pennsylvania state judge issued an order creating a mass tort to collect product liability lawsuits involving pelvic mesh products, and other cases have been consolidated into a multidistrict litigation in the U.S. District Court for Southern West Virginia.
In 2008, acting on reports filed in the previous three years, the U.S. Food and Drug Administration (FDA) issued a Public Health Notification about serious complications associated with mesh implants, the most common of which are mesh erosion through the vagina (also called exposure, extrusion, or protrusion), pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. The FDA updated the advisory in 2011 to warn that such complications are “not rare,” and to advise women and their doctors that mesh devices not only may not be more effective than traditional non-mesh surgeries for POP but may even “expose patients to greater risk.” The agency directed more than 30 manufacturers to conduct post-market safety studies to investigate the effects of mesh implants and possible health concerns.
The SCENIHR panel has until January 2015 to issue its report, MassDevice says. The panel is also charged with assessing whether certain surgical techniques or particular combinations of technique and device carry a higher risk.