Vaginal Mesh Recall
In recent months, there has been growing momentum for a vaginal mesh recall to be issued, as thousands of women have experienced severe and life-altering complications from surgical mesh or bladder sling products used to treat pelvic organ prolapse and female stress urinary incontinence. Our law firm represents women throughout the United States who are pursuing a vaginal mesh lawsuit for injuries suffered from these dangerous products and we fully support the recent calls for the FDA to recall vaginal mesh.
>>MORE INFORMATION: Vaginal Mesh Complications
In July, the FDA reported that at least 2,874 reports of vaginal mesh complications were received by the agency between January 2008 and December 2010. Although data suggests that the transvaginal placement of surgical mesh provides no benefits over other methods of treating pelvic organ prolapse, an estimated 75,000 women had the vaginal mesh implanted last year.
The FDA has scheduled an advisory panel meeting for next week on September 8 and 9, during which a panel of outside experts will meet to discuss the recent reports of problems with transvaginal mesh and make recommendations to the FDA about what steps should be taken to protect consumers.
The use of vaginal mesh for pelvic organ prolapse and female stress urinary incontinence has been linked to painful and potentially disfiguring problems, such as:
- Vaginal Mesh Erosion, Protrusion and Extrusion through the Vagina
- Vaginal Mesh Hardening
- Urinary Problems
- Pelvic Pain or Vaginal Pain
- Injury to Nearby Organs
- Difficulty or Pain During Sexual Intercourse
During the FDA advisory panel meeting, it is expected that the agency will consider whether vaginal mesh bladder sling products should be reclassified as a Class III medical device. While this would not necessarily result in a recall of vaginal mesh products, it may have the same effect.
If the devices are classified as Class III medical devices, manufacturers will be required to conduct rigorous pre-market testing before obtaining approval to sell the devices to ensure that the benefits outweigh the risks. By contrast, most of the current vaginal mesh slings on the market were approved under the FDA’s controversial 510(k) approval process, which allowed manufacturers to start marketing these pelvic organ prolapse mesh products without any pre-market studies by establishing that they were “substantially equivalent” to other mesh products that had already been approved by the FDA.
The consumer advocacy group Public Citizen filed a petition (PDF) with the FDA on August 25, calling on the FDA to issue a vaginal mesh recall and ban the marketing of all currently available products to protect consumers.
TRANSVAGINAL SURGICAL MESH RECALL LAWYERS
The vaginal mesh lawyers at Saiontz & Kirk, P.A. will be closely following the FDA advisory panel meetings next week, and urge the FDA to take the necessary actions to protect women from these unreasonably dangerous medical products by forcing the recall of vaginal mesh products designed for treatment of pelvic organ prolapse.
Manufacturers introduced these products without ensuring that they were safe, and they provide no benefits over other available treatment options. As a result the medical device manufacturers’ negligent conduct, women who have experienced complications may be entitled to compensation through a transvaginal mesh recall lawsuit.
To review a potential claim for yourself, a friend or family member, request a free consultation and claim evaluation.