FDA will take further actions to address concerns in Public Citizen’s petition. The Food and Drug Administration (FDA) has rejected a call by the consumer advocacy group Public Citizen for a total ban on transvaginal mesh devices.
In 2011 Public Citizen asked the FDA to disallow the marketing of surgical mesh products for pelvic organ prolapse repair, to recall transvaginal mesh devices currently in distribution, and to reclassify the products as Class III devices, Med Device Online reports. Class III devices are the highest risk devices, subject to the highest level of regulatory control. Class III devices, for example replacement heart valves, must typically be approved before they are marketed, the agency explains.
Although the FDA won’t completely ban transvaginal mesh products, it will take further actions to address concerns in Public Citizen’s petition. In April, the FDA issued a draft reclassification proposal that would move transvaginal mesh devices to Class III, along with another draft order with proposed premarket approval (PMA) requirements. The FDA wrote then 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 is still possible, according to Med Device Online.
Public Citizen believes the FDA should not allow these devices to go through its 510(k) clearance process
But Public Citizen believes the FDA should not allow these devices to go through its 510(k) clearance process, a fast-track process that allows clearance of a device without clinical trials if the device is “equivalent” to one already on the market. The FDA is being urged to require a more rigorous approval process for all implantable devices.
The FDA reports that many women have experienced injuries and serious side effects with transvaginal mesh including mesh erosion through the vagina (also called exposure, extrusion, or protrusion), pain, infection bleeding, pain during sexual intercourse, organ perforation, and urinary problems. Lawsuits have been filed against the transvaginal mesh makers including C.R. Bard, Boston Scientific, and Johnson & Johnson’s Ethicon division.
Michael Carome, director of Public Citizen’s health research group, said the organization is not pleased with the length of time the reclassification regulatory hurdles will take, Law360 reports.