F.D.A. tightens rules for transvaginal devices

Jan 04, 2016, 5:30 PM EST
Source: ERJ/flickr
Source: ERJ/flickr

Safety risks have prompted the U.S. Food and Drug Administration to issue two orders to manufacturers of surgical mesh used in transvaginal repair procedures. The orders mandate them to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse transvaginally, or through the vagina. The F.D.A.'s announcement reads:

The FDA issued one order to reclassify these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices, and a second order that requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.
 
The orders will require manufacturers to address safety concerns, including severe pelvic pain and organ perforation, through a rigorous PMA pathway to demonstrate safety and effectiveness. The actions apply only to mesh devices marketed for the transvaginal repair of POP.
 
 
Over the past several years, the FDA has received thousands of reports of complications, including bleeding, organ perforation and urinary problems, involving the use of mesh for transvaginal POP repair, the agency said.
 
These devices have been used by surgeons since the 1950's to repair abdominal hernias. In the 1970s, gynecologists began implanting surgical mesh for the abdominal repair of POP and, in the 1990's, for the transvaginal repair of POP.
 
The FDA noted that an advisory panel of experts in 2011 recommended that more data was needed to establish their safety.
 
The tightened regulations don’t apply to mesh used for other indications, such as stress urinary incontinence or treatment of pelvic organ prolapse through the abdomen, the FDA said.
 
“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” said William Maisel, deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health, in a statement. “We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.”
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