June 19, 2014 — Scotland’s health secretary Alex Neil has asked the country’s 14 regional health boards to temporarily suspend implants of vaginal mesh until an independent safety review of the devices is complete.
According to the BBC, the health boards agreed to comply with the request. Some have already suspended the procedure.
Mr. Neil plans to review complaints from Scottish women who say the devices are defective, inadequately designed, and were not tested thoroughly before being approved. Many women have complained about complications like chronic pain, erosion, bleeding, scarring, incontinence, and multiple revision surgeries.
In Scotland, every year about 350 women with pelvic organ prolapse are implanted with vaginal mesh, and 1,500 women with stress urinary incontinence, according to The Scotsman.
It is unknown what percentage of these women experience side effects. According to Mr. Neil:
“The percentage of complications is probably substantially under-estimated because of the under-reporting of adverse events … No-one should have to experience the level of suffering that some of these women have had.”
Meanwhile in the United States, nearly 60,000 vaginal mesh lawsuits are pending against several manufacturers. The litigation has been centralized in federal court. Recently, American Medical Systems and Endo Pharmaceuticals agreed to pay $830 million to resolve thousands of lawsuits involving the Elevate, Apogee, and Perigee implants.
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