A public advocacy group founded by Ralph Nader is asking the U.S. Food and Drug Administration to recall transvaginal surgical mesh products that help repair pelvic organ prolapse and stress urinary incontinence, just as the industry is preparing a broad response.
The complications from such products include vaginal mesh erosion, pain, urinary problems and bleeding, the agency has found. Between 2008 and 2010, there were seven reported deaths related to pelvic organ prolapse (POP) repairs, according to the FDA.
The problem appears to date back to 2008 when the FDA issued a warning that it had received more than 1,000 complaints about surgical mesh products in a three-year period ending in 2007. Last month, the FDA updated the warning and added that these complications are “not rare” and that it had received 2,874 additional reports of complications related to surgical mesh products between Jan. 1, 2008 and Dec. 31, 2010.
The vast majority of adverse events have been noted among products made by Boston Scientific, Johnson & Johnson, American Medical Systems (AMS), Cook, Covidien and C.R. Bard, said Karen Riley, an FDA spokeswoman. Complaints about products made by General Medical Devices and Caldera Medical are much fewer, Riley said.
AMS is based in Minnetonka and now part of Endo Pharmaceuticals. Calls to both the AMS location in Minnetonka and the corporate headquarters were not returned.
Meanwhile, an advisory panel — Obstetrics-Gynecology Devices Panel of the Medical Device Advisory Committee — is scheduled to hold a two-day meeting on Sept. 8 and 9 to discuss and make recommendations regarding the safety and effectiveness of transvaginal surgical mesh for POP and stress urinary incontinence.
Now the industry, led by lobbyist and trade group AdvaMed, is preparing a coordinated response. One of the firms enlisted to manage the communications is NewsPRos, which assists in crisis management, among other areas of expertise. AdvaMed is trying to hold a teleconference next week ahead of the two-day advisory panel meeting.
“For women suffering from pelvic organ prolapse or stress urinary incontinence, surgical intervention and the use of mesh is an important treatment option,” said Jeff Secunda, vice president, technology and regulatory affairs at AdvaMed, in an email.