CONSUMER ALERT
FDA Orders New Reviews of Transvaginal Mesh
On January 4, 2012, long after the U.S. Food and Drug Administration reviewed and cleared the first surgical mesh for the repair of pelvic organ prolapse (POP) in 2001, the FDA announced they have ordered more than 80 post-market reviews by manufacturers of surgical mesh devices used to treat POP.
Transvaginal mesh products comprise a variety of medical devices marketed to surgically treat pelvic organ prolapse and stress urinary incontinence (SUI) in women. Unfortunately, they may have been marketed, sold and implanted in patients without being properly tested. Many serious complications have now surfaced in published reports.
Patients of transvaginal mesh surgery have reported pelvic pain and painful sexual intercourse after the mesh eroded through their vaginal wall. Some women have had to undergo additional surgery to relieve their suffering. Others have continued to experience pain because the transvaginal mesh cannot be completely removed.
The law firm of Janet, Jenner & Suggs, LLC, is investigating cases of these potentially devastating side effects of transvaginal mesh surgery.
Have you been affected? Do not delay — Call (877) 692-3862, or contact us online immediately. Time is of the essence. Our product injury lawyers can provide a free and confidential case evaluation.
Transvaginal Mesh Under Belated Scrutiny
In July 2011, the FDA informed the medical community and patients that “serious complications associated with surgical mesh for transvaginal repair of POP are not rare” (emphasis theirs) and “it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair.”
Months later, in January 2012, the FDA said that, based on the “adverse event reports” it had received, a new review of published literature and a meeting of obstetrics-gynecology device professionals the previous September, the federal oversight agency was ordering a widespread manufacturers’ review of transvaginal mesh devices.
The FDA directive ordered 88 post-market studies by 33 manufacturers of urogynecologic surgical mesh for POP and 11 post-market studies by seven manufacturers of single-incision mini-slings used to treat SUI. The manufacturers were to submit study plans to the FDA that address specific safety and effectiveness concerns related to surgical mesh devices for POP and single-incision mini-sling devices for SUI.
Eleven years after approving the surgical implantation of transvaginal mesh devices for the general public, the FDA said, “data from the studies will enable the agency to better understand the safety and effectiveness profiles of these devices.”
The FDA pledged to provide additional information to the public as it becomes available.
Contact Our Transvaginal Mesh Lawyers Today
If you have had a transvaginal mesh implanted for POP and suffered prolonged pain or other complications afterward, you need not suffer in silence.
Victims of transvaginal mesh complications may have legal rights to compensation from the medical manufacturer of the implanted device. Our law firm is collecting data and documenting cases of the life-altering side effects caused by transvaginal mesh and surgical mesh kits.
Our legal team is made up of accomplished personal injury lawyers, a board-certified physician and registered nurses. Our breadth of experience will significantly increase the opportunity for a positive outcome for our clients and the recovery of substantial damages for the injuries caused by vaginal mesh or surgical mesh complications.
Quick action on your part enhances our ability to protect your legal rights to compensation through the prosecution of a transvaginal mesh lawsuit.
Call (877) 692-3862 or contact us online immediately.
