FDA Rejects Citizen Petition to Ban Transvaginal Mesh

Regulators at the Food and Drug Administration (FDA) have rejected a petition to ban United States sales of nonabsorbable surgical mesh products for transvaginal repair of pelvic organ prolapse (POP). The petition was filed in 2011 by the consumer advocacy group Public Citizen.

The FDA issued a letter to Dr. Michael Carome, then deputy director of Public Citizen’s Health Research Group expressing sympathy for the petitioner’s concerns and even some level of agreement. However, the FDA did not agree with the proposed remedies, nor that a total ban and recall was necessary.

While the FDA acknowledged worries that transvaginal mesh products pose safety risks to women, it stated that it was already taking steps to counter those concerns. According to the FDA in its response, “There is not sufficient evidence at this time to support a finding that there is a reasonable probability that all nonabsorbable surgical mesh products specifically designed and labeled for transvaginal repair of POP would cause serious, adverse health consequences or death.”

The Future of Pelvic Mesh Products

While the outright ban of nonabsorbable pelvic mesh products is not going to happen, there will be changes in the way the FDA treats these devices in the future. The FDA issued a tentative reclassification order to upgrade transvaginal mesh products to Class III. This would require premarket approval for all related devices.

Furthermore, the FDA has made safety communications about the risks posed by transvaginal mesh required before use and has increased post-market scrutiny. The FDA even stated that there was some evidence that there were measurable benefits to using surgical mesh when transvaginally repairing pelvic organ prolapse.

These actions have not totally placated concerns by consumer organizations who are worried about the side effects of transvaginal mesh, including vaginal scarring, shrinkage, and pelvic pain.

Public Citizen has stated that actions taken by the FDA are “backward” in the case of this product. Furthermore, they believe that while the higher regulatory scrutiny will be good for consumers, the FDA is undercutting its effectiveness in two ways. First, they believe that the FDA’s allowance of 510(k) clearance for transvaginal mesh products goes against purposes of the intensive premarket approval process. Secondly, they worry that the length of time for the installment of the reclassification will hurt women in the meantime.

Despite this fact, many organizations view these actions by the FDA as a step in the right direction. With added oversight, there is hope that the true health risks and benefits of transvaginal mesh can be known.

This response by the FDA does not preclude it from issuing a recall later. Many manufacturers of transvaginal mesh have been sued by patients who have been treated with nonabsorbable pelvic mesh, and researches on the products are still being conducted.

In the end, the FDA has a responsibility to take any accusations of patient risk seriously, so this is not the end of investigations regarding transvaginal mesh products.

Source:

http://www.fiercemedicaldevices.com/story/fda-rejects-petition-ban-transvaginal-mesh/2014-07-16