FDA Rejects Petition Of Controversial Transvaginal Mesh Products
By Nick Otto
The FDA has rejected a call for a total ban on transvaginal mesh products filed by consumer advocacy group Public Citizen.
Although the agency does share 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.
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 May 1 response, posted online recently, 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 says, 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 PMA process high-risk devices are subject to.
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.