FDA Rejects Petition for Total Ban on Transvaginal Mesh
The U.S. Food and Drug Administration (FDA) has rejected a consumer advocacy group’s petition to remove all transvaginal mesh from the market, saying that a total recall is not the proper way to handle safety concerns surrounding the implants.
In a response filed on May 1st, the agency said that while it does agree with certain concerns brought by Public Citizen, they should not be addressed via a request for complete market withdrawal. The group should have considered a formal reclassification process to go about asking to categorize the devices as Class III, and recall transvaginal mesh products currently in distribution. Included in the 2011 petition was a request that the FDA stop the marketing of all surgical mesh products due to their possible association with mesh erosion, chronic pain, pain during sexual intercourse and other complications that are often debilitating and can permanently damage a woman’s quality of life.
FDA Drafts Proposal in April to Reclassify Transvaginal Mesh as Class III
A month before the FDA rejected Public Citizen’s petition, the agency drafted a reclassification proposal that would categorize transvaginal mesh as Class III. Included in the April proposal were documents that detailed new requirements for premarket approval (PMA) of the devices.
The FDA has not made an executive decision on this matter at this time, stating in its response to Public Citizen that not enough evidence has been collected to confirm an association between all transvaginal mesh devices and the risk for severe health problems. Post-market surveillance data will allow the agency to further monitor the issue, who vowed to take further action to address Public Citizen’s concerns, the FDA said.
According to court documents, thousands of women have come forward over the past few years to file transvaginal mesh lawsuits alleging similar injuries to those noted in the Public Citizen petition. More than 60,000 of these claims are now pending in separate federal multidistrict litigations now pending in the U.S. District Court, Southern District of West Virginia. These cases involve products from the Johnson & Johnson subsidiary, Ethicon, Boston Scientific, Corp., C.R. Bard and American Medical Systems, as well as other companies.
Two separate consolidated litigations involving Ethicon and C.R. Bard have also been established in New Jersey’s Atlantic County Superior Court, where thousands of additional claims have been filed, court records indicate.
Considering a Vaginal Mesh Lawsuit? Call Us.
If you or a loved one suffered chronic pain, infection, pain during sexual intercourse or another complications associated with mesh erosion, call our Firm to file a vaginal mesh lawsuit: (877) 779-1414.