Medical Device Industry Prepares to Defend Transvaginal Mesh

The medical device industry is gearing up to fight any suggestion that <"">transvaginal mesh devices should be recalled. According to a report in the Minneapolis Post, trade group AdvaMed is readying a lobbying effort in advance of an FDA hearing on transvaginal mesh complications scheduled for early September.

Transvaginal mesh products made from non-absorbable synthetic materials are marketed by several companies, including American Medical Systems (AMS), C.R. Bard and Mentor. They are used in the surgical treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). While the devices are popular among doctors who treat these conditions, they’ve recently been linked to serious complications.

The FDA first issued a warning for transvaginal mesh complications in 2008. Then in July, the agency issued a second warning, stating complications associated with transvaginal mesh products used in pelvic organ prolapse repair are not rare. In that alert, the FDA said it had received more than 2,800 complaints about transvaginal mesh complications since 2009. Of those, more than 1,500 were associated with pelvic organ prolapse repair, and three involved fatalities. The most recent alert also stated that it is “not clear that transvaginal POP repair with mesh is any more effective than traditional [transvaginal surgery without mesh] … and may expose patients to greater risk.

Karen Riley, an FDA spokeswoman, told the Minneapolis Post that 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. Other manufacturers, including, General Medical Devices and Caldera Medical, have also been named in complaints, but to a lesser extent.

The latest safety communication issued by the FDA prompted the consumer advocacy group, Public Citizen, to petition the agency to issue a recall of the devices.

“Surgical mesh in POP treatment procedures needlessly exposes patients to a wide array of serious risks, many of which can permanently alter women’s quality of life,” Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group, said in a statement announcing the FDA petition. “Even the FDA seriously questions the safety and effectiveness of these mesh products, so they should be removed from the market immediately.”

The FDA’s 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 the safety of transvaginal mesh devices. The panel will be asked to issue recommendations, which could include better warnings, stricter testing protocols, or even a recall of the devices.

To fend off anything as drastic as a transvaginal mesh recall, AdvaMed has enlisted the services of NewsPRos, a firm which assists in crisis management. AdvaMed is also trying to hold a teleconference next week ahead of the two-day advisory panel meeting, the Minneapolis Post said.

“For women suffering from pelvic organ prolapse or stress urinary incontinence, surgical intervention and the use of mesh is an important treatment option,” Jeff Secunda, vice president, technology and regulatory affairs at AdvaMed, said in an email to the Minneapolis Post.

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