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 devices have come under increased scrutiny worldwide amid a campaign from patients and advocacy groups who warn that the devices do more harm than good. Hundreds of mesh-related lawsuits are already underway in Scotland as well as in the U.S. and Canada. The European Commission is also conducting its own investigation into the implants.
Scottish Health Secretary Alex Neil asked the country’s 14 regional health boards to suspend use of the mesh while he arranges for an independent review into the growing global outcry against the devices. Some of the boards have already phased out the procedure and others said they would comply with the Neil’s request, the BBC reported.
Scottish regulators plan to present the U.K.’s Medicines & Healthcare products Regulatory Agency with a cadre of cases and let the agency make the final call. MHRA has defended transvaginal mesh products as an important option for women with conditions such as pelvic organ prolapse, although regulators have ceded that some women have been injured by the implants.
Neil told reporters that the outcome of the European Commission report and Scotland’s own independent report would inform next steps in dealing with the devices. For the time being, he’s asked local healthcare providers to refrain from using both transvaginal mesh implants and tension free vaginal tape.
In the U.S., FDA regulators have considered increasing the risk profile for mesh devices as mesh-makers such as Johnson & Johnson (NYSE:JNJ), C.R. Bard (NYSE:BCR), Boston Scientific (NYSE:BSX) and American Medical Systems Holdings have come under fire from patients.
The FDA in 2011 issued safety communications about complications associated with the implants, saying that they may expose patients to unnecessary risk without offering clinical benefit above safer options. The agency’s Obstetrics and Gynecology Devices Panel recommended even then that the devices get high-risk treatment from reviewers. Lawsuits began piling upright away.
In January 2012 the FDA ordered mesh manufacturers to conduct postmarket surveillance studies, and in April 2014 the FDA in April issued a pair of proposals to increase regulatory oversight of the implants, a move that would bump surgical mesh from class II up to class III devices that require premarket approval from the FDA.