The Food and Drug Administration (FDA) has decided not to institute a total ban on transvaginal mesh devices, despite a call to do so from the consumer advocacy group Public Citizen.
In a 2011 petition, Public Citizen asked the FDA to halt the marketing of surgical mesh products for pelvic organ prolapse repair, to recall devices currently in distribution, and to reclassify the products as Class III devices, Med Device Online reports. Class III devices, the highest risk devices, are subject to the greatest regulatory control and typically require approval they are marketed, according to the FDA.
The FDA won’t completely ban transvaginal mesh devices but will take action to address Public Citizen’s concerns. The FDA has issued a draft reclassification proposal that moves transvaginal mesh devices to Class III, with proposed premarket approval (PMA) requirements, Med device Online reports. The FDA wrote that there is not enough evidence that all transvaginal mesh products cause serious health consequences or death, but postmarket scrutiny will allow the FDA to monitor the risks. A recall at some future date remains a possibility, according to Med Device Online.
Public Citizen believes transvaginal mesh devices should not be allowed to go through the FDA fast-track 510(k) clearance process, which allows clearance of a device without clinical trials if the device is deemed “equivalent” to one already on the market. The FDA is considering adopting a more rigorous approval process for all implantable devices.
Many women have suffered injuries and serious side effects from transvaginal mesh implants including mesh erosion through the vagina (exposure, extrusion, or protrusion), pain, infection bleeding, pain during sexual intercourse, organ perforation, and urinary problems. Women have filed lawsuits against the transvaginal mesh makers including C.R. Bard, Boston Scientific, and Johnson & Johnson’s Ethicon division.
Though Public Citizen is encouraged by the draft proposals, Michael Carome, director of the organization’s health research group, said Public Citizen is concerned with the length of time the reclassification regulatory hurdles will take, Law360 reports.