FDA Issues New Requirements for Transvaginal Mesh
The FDA has reclassified transvaginal mesh used for treating pelvic organ prolapse or POP to indicate the risks associated with the product. Now categorized as a high-risk device, the agency is also requiring manufacturers to prove their products are both safe and effective. The new regulations follow years of concerns about transvaginal mesh devices, as well as two previous FDA warnings about the risks linked to surgical mesh.
The new orders were published in a press release on the FDA’s website on January 4. The agency stated that the reason for the new orders was a significant increase in adverse event reports related to these devices over the past several years. The new requirements only pertain to transvaginal mesh used for transvaginal POP repair and does not include mesh used to treat stress urinary incontinence (SUI) and abdominal repair of POP.
Device classification changed
The FDA changed the classification of these devices from a class II, which is given to devices that carry a moderate risk. The new class III categorization indicates the devices are now considered high risk. Some of the risks that have been associated with transvaginal mesh include persistent pain, bleeding and painful intercourse.
One of the most serious risks is erosion of the mesh, which can lead to recurrent infection and is often difficult to repair.
Rigorous PMA now required
The FDA will also require vaginal mesh manufacturers to submit a premarket approval (PMA) application to support the safety and efficacy of their products in treating POP. The devices had been previously approved by the agency using the 510(k) process, which allowed manufacturers to bypass clinical trials by showing their products were similar to those already on the market. The PMA process will need to be completed within the next 30 months. New devices entering the market will also need to undergo the rigorous PMA process.
“These stronger requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” William Maisel, MD, MPH, deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health, was quoted on the agency’s website.
About POP and vaginal mesh
Pelvic organ prolapse is a painful condition that occurs when the tissue in the abdomen weakens and can no longer hold abdominal organs in their proper position. The condition is often associated with age and can lead to pain and pressure, painful intercourse and bleeding from the vagina. In some cases, organs can begin to protrude beyond the vaginal opening.
In the past, POP was treated surgically through the abdomen, as organs were secured back into their proper locations. The introduction of surgical mesh to the procedure was touted as a way to repair POP through the vagina, rather than a larger incision in the abdomen that involved additional discomfort and recovery time. However, reports of serious pelvic mesh complications raised the concern of the medical community and the general population.
Hundreds of women who have been injured by these mesh devices have now filed lawsuits against their manufacturers, including C.R. Bard, American Medical Systems, Boston Scientific and Cook Medical.
Most of those lawsuits are currently pending in U.S. District Court in West Virginia, where they have been consolidated into multidistrict litigation for the purpose of streamlining early trial proceedings for a large number of cases.
- FDA, FDA Strengthens Requirements for Surgical Mesh for the Transvaginal Repair of Pelvic Organ Prolapse to Address Safety Risks, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm
- FDA, UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse: FDA Safety Communication, http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm
- U.S. District Court, Southern District of West Virginia, MDL 2187 C.R. Bard, Inc., Pelvic Repair System Products Liability Litigation, http://www.wvsd.uscourts.gov/MDL/2187/index.html
- Medscape, FDA Reclassifies Vaginal Mesh as a High Risk Device, http://www.medscape.com/viewarticle/856714