The National Institute for Health and Care Excellence in Great Britain has recommended that the transvaginal mesh be banned for use in treating pelvic organ prolapse.
“The evidence for long term efficacy is inadequate in quality and quantity,” the health watchdog said in its official guidance. “Therefore, the procedure should only be used in the context of research.”
The influential health institute made the following specific recommendations:
- Current evidence on the safety of transvaginal mesh repair of anterior or posterior vaginal wall prolapse shows there are serious but well-recognised safety concerns. Evidence of long-term efficacy is inadequate in quality and quantity. Therefore, this procedure should only be used in the context of research.
- All adverse events involving the medical devices (including the mesh) used in this procedure should be reported to the Medicines and Healthcare products Regulatory Agency.
- Further research should include details of patient selection, long-term outcomes including complications, type of mesh used and method of fixation, and quality of life.
“The recommendations by [the National Institute for Health and Care Excellence] are highly significant, as I think they will make us all re-evaluate the way we use mesh,” mesh expert and former National Institute board member Dr. Sohier Elneil told U.K.’s Sky News.
In the U.K., about 14,500 women undergo mesh surgery to treat incontinence or pelvic organ prolapse, according to a 2012 Department of Health report.
That number is 38 times greater in the U.S., where 100,000 women undergo prolapse surgeries with mesh and 208,000 women undergo incontinence surgeries transvaginally with mesh, according to the FDA’s latest available figures.
The proposed ban comes in the wake of similar actions in Australia and New Zealand. The US FDA has made no such announcements and has given no indication it will follow the example of the United Kingdom, Australia, or New Zealand in spite of the problems reported concerning the transvaginal mesh.
Controversy surrounding transvaginal mesh implants increased this week after a recent BBC Panorama investigation revealed Johnson & Johnson’s Ethicon — one of the largest manufacturers of mesh — did not properly warn doctors about the risks of transvaginal mesh.
BBC Panorama’s investigation put a spotlight on conflicts of interest, weak clinical trials and a poor regulatory system for vaginal mesh in the U.K. The report aired just days before the announcement of the U.K. ban recommendation.
Ethicon, the maker of Gynecare TVT mesh (sold in the U.K. and the U.S.), did not properly inform doctors of the risks, according to BBC Panorama.
The company admitted it did not update its instructions for use for three Gynecare TVT implants with risk data until 2015. Still, the 2015 instructions contain insufficient risk data, Panorama found.
There are more than 28,000 mesh lawsuits in the US involving various manufacturers. If you or a loved one have experienced complications from the transvaginal mesh, please contact Attorney Joe Saunders for a free initial consultation.
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