Safety Probe of Pelvic Mesh for Stress Urinary Incontinence and Pelvic Organ Prolapse Procedures Underway in EuropeMar 26, 2014
The European Commission has just asked a scientific advisory panel to review the safety of the use of pelvic mesh products in stress urinary incontinence (SUI) and pelvic organ prolapse procedures (POP).
The EU is seeking a risk assessment from the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) panel regarding the mesh devices used to treat SUI and POP in women, and if mesh devices create increased risks of adverse reactions, MassDevice.com wrote. The devices are the focus of tens of thousands of product liability lawsuits in the United States, according to MassDevice.com.
The European Union’s (EU) executive body has requested SCENIHR provide an opinion on the "safety of surgical meshes used in urogynecological surgery," the Commission's request indicates. "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 also indicated, according to MassDevice.com.
Some of the medical device firms that manufacture pelvic mesh include C.R. Bard, Boston Scientific, Johnson & Johnson subsidiary Ethicon, Endo Health Solutions, Cook Medical, and Coloplast. All of these firms are facing mounting lawsuits in federal and state courts in the U.S. over their pelvic mesh devices, MassDevice.com reported.
The EU panel must also look into if specific surgical techniques or a technique-device combination creates increased risks for adverse reactions. According to MassDevice.com, the SCENIHR panel must issue its report by January 2015. The report must also identify high-risk patient groups, if surgical mesh is appropriate in the treatment of other conditions, and if a registry study of pelvic mesh procedures is warranted.
MassDevice.com noted that, in February, a Pennsylvania state judge ordered that a mass tort be created to collect product liability lawsuits that have been filed over pelvic mesh products. Cases have also been consolidated into multidistrict litigation (MDL) under Judge Joseph Goodwin of the U.S. District Court for Southern West Virginia.
Meanwhile, a large number of women have filed lawsuits in Scotland over injuries allegedly tied to pelvic mesh. In fact, some of the women allege that the side effects are so severe that physicians have advised them that they will never be able to have sex, according to The Health Site. Some women also allege serious, unremitting abdominal pain and discomfort.
Pelvic mesh is a small, mesh-like structure meant to be placed just below the woman’s pelvic floor so that the vagina is strengthened in women diagnosed with serious conditions, including SUI and vaginal or uterus prolapse (POP), according to The Health Site. Pelvic mesh is manufactured of either synthetic or biologic material. Based on what attorneys are reporting in mounting and worldwide litigation, implant complications include pain; infections; SUI, POP relapse; excessive vaginal discharge; mesh erosion into area organs; vaginal shrinkage; and bladder, blood vessel, and/or bowel perforation during mesh insertion. According to the U.S. Food and Drug Administration (FDA), the most commonly reported complications tied to transvaginal mesh devices also include bleeding; dyspareunia (pain during sexual intercourse); exposure, extrusion, or protrusion (mesh erosion through the vagina); and urinary problems. The FDA indicates that complications associated with transvaginal mesh implants are “not rare,” and warns that use of these devices may be more harmful when compared to alternative methods.