New FDA Warning Outlines Risks Associated With Vaginal Mesh and Pelvic Mesh Devices
FDA Medical Alert
On July 13, 2011, after receiving over 1500 adverse event reports relating to serious injuries caused by the implantation of polypropylene transvaginal device/mesh, the FDA issued a comprehensive medical alert to physicians warning that, in most instances, the risk of serious injury outweighed all purported benefits associated with the use of these devices. Specifically, the FDA found that traditional procedures, which did not utilize polypropylene devices/mesh, should be the primary course of treatment and that implantation of these devices should limited to procedures of last resort.
Recent Research Indicates Serious Risks and Complications
Victims of defective transvaginal mesh and pelvic/bladder support products are filing suit against the manufacturers nationwide following the shocking results of a clinical study. The study was stopped before completion because the problems they were seeing in patients were too severe to continue the research. More than 15 percent of women in the study experience the dangerous and painful condition known as “erosion,” in which the skin splits and the mesh protrudes.
Uses of These Devices
The transvaginal products (mesh, tape and sling devices) are marketed as solutions for the treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP).
Many patients have reported experiencing serious problems, including:
- Pain (during urination/intercourse and/or localized)
- Corrective surgeries
According to a recent article in the Journal of Obstetrics and Gynecology, patients would have been better off with traditional treatment.
Prior Transvaginal Mesh Warnings From the FDA
In 2008, the FDA issued a Safety Alert to doctors and the public. This alert reported that the most frequent complications included:
- Mesh erosion through vaginal wall or other body parts
- Urinary problems
- Recurrence of prolapse and/or incontinence
- Bladder, bowel or vessel perforation
- Vaginal scarring
- Pain during sexual intercourse
- Other problems that led to a significant decrease in patient quality of life due to discomfort and pain.
Transvaginal Device Manufacturers & Types
To see a listing, please click here.
If you or a loved one suffered from pain or complications due to a defective transvaginal mesh or pelvic/bladder support product, conatct the Steinberg Law Firm P.C. at 888-529-4688 or email email@example.com.
Consult A Lawyer on Legal Issues
We encourage you to contact us at 888-529-4688 to discuss your transvaginal mesh case with an experienced personal injury and wrongful death attorney.
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Consult A Doctor On Medical Issue
The Steinberg law firm does not intend, by this web site or otherwise, to dissuade anyone from taking medication without their doctors' approval. Please consult your doctor, not your lawyer, on matters relating to your health. It could be dangerous to stop taking medicines, especially abruptly. Patients should talk to their physicians to decide whether the benefits and risks of transvaginal mesh or pelvic/bladder support devices make it the right choice for them.