Ennis & Ennis, P.A
FDA Strengthens Requirements For Surgical Mesh Years After Thousands Of Women Injured
01/05/2016 - Today the Food and Drug Administration (FDA) issued two final orders to manufacturers to strengthen the data requirements for surgical mesh used to repair pelvic organ prolapse. The first order reclassified the surgical mesh from a class II device, which typically involves moderate risk devices, to a class III device, which includes high risk devices and requires extensive premarket testing and approval process. The manufacturers are required to conduct significant testing and clinical trials on the devices and submit a premarket approval (PMA) application to the FDA which supports the safety and effectiveness of the surgical mesh in the transvaginal repair of pelvic organ prolapse.
The PMA process will require manufacturers of mesh to be used in pelvic organ repair to address safety concerns including severe pelvic pain and organ perforation prior to the FDA granting approval for the products to be marketed. As a practical matter, most manufacturers will simply choose to withdraw their products from the market in lieu of undergoing the testing and clinical trials which will be hereafter required for the approval of the new mesh devices. “These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse, “ said William Maisel, deputy director of science for the FDA’s Center for Devices and Radiologic Health. “We intend to continue monitoring how women with this device are faring months and years after surgery through continued post market surveillance measures.”
If the FDA were truly interested in such long term data, it could obtain information from the nearly 100,000 women who are suffering and have filed lawsuits against the various manufacturers of transvaginal mesh. Many of the women who have undergone pelvic organ prolapse (POP) repair with transvaginal mesh have suffered horrific injuries requiring multiple surgeries to attempt to repair the damage. The FDA issued safety communications regarding transvaginal mesh as early as 2008 and still allowed the product to be heavily used in surgeries, despite the knowledge of the dangers. The FDA convened an advisory panel in September 2011 to solicit recommendations on actions to take regarding surgical mesh for POP repair. It recommended more data was needed to establish the safety of the device. Now, nearly five years later, the FDA is going to require the mesh manufacturers to submit a PMA application for the product’s approval. This is rather like putting the cart before the horse, as the damage has already been done to thousands of unsuspecting women.
The FDA’s new requirements for transvaginal mesh are virtually meaningless. As indicated above, most manufacturers are currently facing thousands of transvaginal mesh lawsuits and will simply withdraw their products from the market if they haven’t done so already. The time to have required the manufacturers to undergo stringent premarket testing and clinical trials was years ago, before injuring thousands of women. Hopefully, this will serve as a wake up call. However, if the FDA’s recent actions regarding Essure are any indication, it hasn’t learned from past mistakes which are doomed to repeat themselves. If you are a loved one has been injured by a transvaginal mesh device, contact the attorneys at Ennis & Ennis, P.A. for a free consultation at 1-800-856-6405 or visit us online at www.Ennislaw.com and fill out an online form.
Vaginal Mesh Lawsuit
If you or a loved one have suffered or been injured by an transvaginal mesh implant you may be entitled to compensation. Contact the vaginal mesh Lawsuit attorneys ofEnnis & Ennis today for a free confidential case evaluation. Our lawyers are standing by to answer any questions you may have regarding your transvaginal mesh injury or a possible vaginal mesh class action lawsuit. Call us toll-free at: 1.800.856.6405 or fill out the free case evaluation form on this page