FDA is ordering manufacturers of transvaginal surgical mesh and mini-slings to conduct post-market studies to assess safety complications with the devices used to repair women’s pelvic problems.

On Jan. 3, FDA sent 88 post-market study orders to 33 manufacturers of urogynecologic surgical mesh used for pelvic organ prolapse, and 11 post-market study orders to seven makers of single-incision mini-slings used for stress urinary incontinence.

The section-522 study orders come in response to numerous adverse event signals. In addition, published literature has shown little clinical benefit from mesh compared to non-mesh repair and data also suggest little benefit from single-incision mini-slings compared to multi-incision retropubic or transobturator mesh slings, according to the agency.

FDA outlined a series of separate questions for mesh and mini-sling manufacturers to address in their post-market studies.

The agency wants firms to quantify the proportion of women undergoing procedures who are exposed to their device and to identify what type of surgical procedures were performed.

FDA also asks firms to monitor the adverse event rates and to measure quality of life in women through 36 months following implant of the devices.

Additionally, FDA wants companies to assess whether the effectiveness for mesh is statistically “non-inferior” to non-mesh repair, and whether the effectiveness for single-incision mini-slings is non-inferior to multi-incision retropubic or transobturator mesh slings.

The post-market surveillance orders are the latest in a series of actions FDA has taken in the past year in reaction to safety concerns with these implanted surgical mesh devices.

FDA is still considering the panel’s recommendation to reclassify transvaginal prolapse repair devices to the high-risk class III category.

FDA issued a safety alert last July citing 1,503 adverse event reports associated with surgical mesh for prolapse repair between January 2008 and December 2010, a five-fold increase from the 2005-2007 period. (See Also see "Transvaginal Mesh Devices Reassessed: FDA Panel Set For September" - Medtech Insight, 22 August, 2011..)

Then the agency’s Obstetrics and Gynecology advisory panel met last September, recommending the additional post-market data collection. (See Also see "FDA Panel Calls For More Studies Of Mini-Slings For Urinary Incontinence" - Medtech Insight, 19 September, 2011..)

The panel also recommended that mini-slings for urinary incontinence be subject to clinical requirements as part of 510(k) reviews, and that transvaginal mesh products for pelvic organ prolapse be reclassified from moderate-risk class II to high-risk class III devices. (See Also see "FDA Panel: Transvaginal Mesh For Prolapse Should Be Class III" - Medtech Insight, 12 September, 2011..)

In the Jan. 3 study orders, FDA says it is still considering the panel’s reclassification recommendation for the prolapse repair devices. If FDA reclassifies the devices, companies would have to submit clinical data to support PMA approval. But FDA advises firms to consider the data requirements that might be necessary for a PMA submission when designing the 522 studies to potentially fulfill both requirements at once.

Manufacturers of transvaginal mesh kits and slings include Johnson & Johnson/Ethicon, Boston Scientific, C.R. Bard, and Endo Pharmaceuticals/American Medical Systems. These firms, in addition to others, have within 30 days of receipt of the order to submit post-market surveillance study plans to FDA.

FDA Calls For Studies Or Registries

In the 522 study orders, FDA says companies should conduct a randomized clinical trial or a prospective cohort study comparing the mesh devices to a control through three years of follow-up. The agency said that depending on the study design, manufacturers can choose to work together with other surgical mesh firms to establish a single pool of control subjects.

Companies might also consider employing a registry to meet the post-market requirements, either alone or in collaboration with other sponsors. FDA says it is open to facilitating the creation of a multi-sponsor registry.

Additionally, the agency says that if firms believe they have existing data to justify an alternative study design, such as a retrospective cohort study, they should contact the agency to discuss the data.

At the panel meeting in September, American Medical Systems, Ethicon, C.R. Bard and Boston Scientific each discussed studies they already have underway for their single-incision mini-slings, including company-sponsored studies and investigator-initiated studies.

Surgical Mesh And Sling Devices Must Undergo Post-Market Studies

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