Surgical devices maker Encision (PINK:ECIA) found itself the unfortunate target of nearly 50 lawsuits over alleged injuries caused by transvaginal mesh devices that Encision neither manufactures nor distributes.
Scottish health regulators are looking to curb use of transvaginal mesh products while independent investigators look into claims that the medical implants hurt women.
The FDA today issued a pair of proposed orders that would increase regulatory oversight of controversial pelvic mesh products, responding to a long-running public uproar about the implants’ potential for harm to women.
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.
A Pennsylvania state judge ordered the creation of a mass tort this week to collect product liability lawsuits filed over pelvic mesh products against some of the largest names in medical devices.