A public advocacy group, Public Citizen, 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.
Public Citizen wants the FDA to require manufacturers to recall non-absorbable surgical mesh devices and future versions to be subject to more stringent approval requirements.
Mesh products made of non-absorbable synthetic material can erode and cause pain, bleeding and urinary incontinence, Public Citizen, based in Washington, said in a statement. The mesh is implanted through incisions made in the wall of the vagina to reinforce the tissues around the pelvic organs.
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 surgical mesh products made by Johnson & Johnson (JNJ) and Boston Scientific Corp. (BSX) to correct falling pelvic organs in women should be immediately recalled because of painful side effects, the watchdog group said.
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.
The group estimates that 67,500 women had the non-absorbable mesh implanted last year. The Food and Drug Administration received 1,503 reports of complications associated with the material from January 2008 to December 2010 when used to repair pelvic organ prolapse, the agency said in a safety warning July 13.
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.
“Even the FDA seriously questions the safety and effectiveness of these mesh products, so they should be removed from the market immediately,” Michael Carome, deputy director of Public Citizen’s Health Research Group, said in a statement.
The FDA has also said it’s not clear whether the mesh is more effective than surgery without it. Jeff Secunda, a vice president at the Washington lobbying group the Advanced Medical Technology Association, said the mesh “is an important treatment option.”
Recent innovations have helped device makers standardize materials and made the procedure more consistent for surgeons, he said.
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.
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.