FDA Tightens Regulations over Pelvic Mesh Device
The U.S. Food and Drug Administration (FDA) announced Monday that it has tightened up its regulations for the use of surgical mesh devices in patients with pelvic organ prolapse.
POP occurs when pelvic organs drop due to weakness in the muscles and tissues of the pelvic floor, which tends to occur after childbirth. The lack of support leads to organ prolapse into the vagina. To repair transvaginal POP, doctors can implant surgical mesh that will act as support. However, over the past few years, the federal agency reported that there have been thousands of complaints, such as bleeding and urinary issues, related to surgical mesh.
In response to these complaints, the FDA issued an order that will classify surgical mesh as a class III medical device instead of a class II. Class III devices are considered to be high-risk whereas class II devices are deemed moderate-risk. The agency will also require all companies that make or want to make mesh particularly for POP to submit a premarket approval application that will detail how safe and effective their product is.
Companies that are already manufacturing the product must submit an application within 30 months.
"These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse," said William Maisel, M.D., M.P.H. "We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures."
Maisel is the deputy director of science and chief scientist at the FDA's Center for Devices and Radiological Health.
The FDA reminds women to always ask their doctors about all the treatment options available for POP.
For more information, visit the FDA page here.