FDA Rejects Petition to Ban Transvaginal Mesh

The U.S. Food and Drug Administration (FDA) has rejected a call for a total ban on transvaginal mesh products filed by consumer advocacy group Public Citizen.

Although the agency shared some of the concerns filed by Public Citizen’s health research group, the FDA wrote that a complete market withdrawal is not an appropriate way to deal with the serious safety concerns linked to the devices.

“FDA has reviewed your petition and we share some of the concerns outlined there,” the agency wrote in its May 1 response letter, posted online recently. “However, the agency does not believe that a ban or recall of non-absorbable surgical mesh for transvaginal repair of POP is warranted at this time. Further, a citizen petition is not the appropriate mechanism for requesting a reclassification of a device. See 21 C.F.R. 10.30(a) and 21 C.F.R. 860.130. Reclassification petitions must be filed in accordance with 21 C.F.R. 860.123. Your request does not meet the content and form requirements of that regulation.”

The decision is in response to a 2011 petition. Public Citizen had asked the FDA to disallow the marketing of all surgical mesh products for purposes of pelvic organ prolapse repair, to recall transvaginal mesh currently in distribution, and to reclassify the products as Class III devices.

In its response, the agency criticized Public Citizen’s health research group for requesting the reclassification via a citizen petition, rather than through the formal reclassification process. Although the FDA says it won’t completely ban transvaginal mesh products, it does say it will take further actions to address concerns noted in the petition.

In April, the agency issued a draft reclassification proposal that would move surgical mesh used in transvaginal repairs to Class III. It was accompanied by another draft order detailing proposed premarket approval (PMA) requirements.

In the response letter, the FDA writes that there is not enough evidence to indicate that all transvaginal mesh products cause serious health consequences or death. Postmarket scrutiny will allow the FDA to monitor the risks, the agency said, adding that a recall at some future date remains possible.

LawyersandSettlements notes that critics, including Public Citizen, believe the actions taken by the FDA are backward, and that the FDA’s allowance of 510(k) clearance for transvaginal mesh products goes against the intensive pre-market approval process to which high-risk devices are subject.

Still, Michael Carome, director of Public Citizen’s health research group and the petition’s author, has said the group welcomes the agency’s announcement but isn’t as thrilled with the length of time the reclassification regulatory hurdles will take, Law360 notes.
“Obviously we were pleased that they were taking this step, but we know that this is a long overdue action, and we found it disturbing that it had taken so long,” Carome said in the Law360 article.

The safety issue isn’t just stateside, as earlier this year the European Commission’s Scientific Committee on Emerging Newly Identified Health Risks announced its own investigation into transvaginal mesh, according to the Regulatory Affairs Professional Society.