Pelvic Mesh - FDA Urges Reclassification
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- Created on Wednesday, 11 January 2012 14:24
Last week the FDA announced that they are considering the recommendation to reclassify pelvic mesh from Class 2 to Class 3, when used transvaginally to repair pelvic organ prolapse. The FDA only has the ability to 'recommend' this reclassification as they have appointed an advisory committee – the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee – to oversee the safety and effectiveness of transvaginal surgical mesh products.
The implications of this reclassification are as follows: Class 3 devices are required by the FDA to pass a series of random clinical trials to determine the safety and effectiveness of the product. Class 2 products have much more leniency in their approval process and are not required to pass such stringent tests.
Back in September 2011, this same advisory committee determined that the above recommended reclassification is unnecessary, even though they found plenty of supporting evidence acknowledging the risks involved with these mesh devices. While the committee decided there wasn't enough evidence at that time for a reclassification, the FDA is now asking them to take another look. Up to 10% of the women that have received pelvic mesh implants transvaginally will experience some level of complication.
The FDA concluded in their 01/04/2012 statement:
The manufacturers will be required 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. Data from the studies will enable the agency to better understand the safety and effectiveness profiles of these devices. Read more.
Some steps that the FDA and their appointed advisory committee are taking to gauge the safety and efficacy of pelvic mesh will include many post-market studies required to be submitted by manufacturers of these devices. They will also study all available literature on the matter as well as collaborate with medical professionals.
The most common side effects include perforation/tearing of the mesh through the vaginal walls and/or internal organs, pain during intercourse, bleeding, and incontinence.
If you have experienced any negative side effects from pelvic or surgical mesh, implanted transvaginally, you may have limited time to seek recovery. Manufacturers of these devices may have known that their mesh products, when used in this manner, increase risk to the patient while not offering any significant benefits over alternative methods of treatment. For more free information about what options are available to you, contact one of our qualified pelvic mesh experts today or watch our most recent 'as seen on television', nationally publicized alert.
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