A British health watchdog reportedly plans to recommend that the National Health Service there ban vaginal mesh implants to treat pelvic organ prolapse, citing “serious but well-recognized safety concerns.”
In recommending that the implants be limited to research use only, the U.K.’s National Institute for Health & Care Excellence said “evidence of long-term efficacy [for implants treating organ prolapse] is inadequate in quality and quantity,” according to the BBC.
Randomized, controlled trials “showed no added benefit of using mesh compared with native tissue repair,” according to the NICE report. “[W]hen complications occur, these can be serious and have life-changing consequences.”
More than 92,000 women had vaginal mesh implants in England between April 2007 and March 2015, the BBC reported, citing NHS data. About one in 11 women experienced problems with the implants, according to the data.
The proposed ban does not mention the use of pelvic mesh to treat female urinary incontinence, the British news service said.
In the U.S., tens of thousands of product liability lawsuits have been filed against medical device companies over their respective pelvic mesh offerings.
Last month a federal appeals court upheld a plaintiff’s $27 million win over Boston Scientific (NYSE:BSX) in a product liability lawsuit brought over its Pinnacle pelvic mesh, a month after Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon was hit with a $57.1 million verdict in a pelvic mesh case out of Pennsylvania.