Transvaginal mesh and pelvic sling devices manufactured by C.R. Bard are among the surgical meshes that have been implanted in thousands of women during urogynecological procedures to repair pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
Unfortunately, many vaginal mesh and sling devices manufactured by C.R. Bard have been associated with a high rate of complications, leaving many women coping with permanent pain and disability. Women throughout the country have filed transvaginal or pelvic mesh lawsuits against C.R. Bard, seeking compensation for serious injuries, including erosion and extrusion of mesh, perforation of organs, vaginal bleeding, chronic infection, pain and emotional distress.
C.R. Bard Transvaginal Mesh and Pelvic Sling are Dangerously Designed
Lawsuits have been mounting against C.R. Bard over their pelvic sling products and transvaginal mesh devices. The following mesh devices are manufactured by C.R. Bard:
- Pelvisoft BioMesh
- Pelvicol Acellular Collagen Matrix
According to the Plaintiffs in these cases, the mesh devices were designed defectively, meaning that they are inherently flawed and can cause harm. The lawsuits also allege that C.R. Bard knew that its products were dangerous to women, but chose not to warn the public to protect itself.
Experts Report on Safety Issues with Transvaginal Mesh Implants
The U.S. Food and Drug Administration (FDA) reports that the most common complications associated with transvaginal mesh may include:
- Mesh erosion through the vagina (also called exposure, extrusion, or protrusion)
- Pain during sexual intercourse (dyspareunia)
- Organ perforation
- Urinary problems
In July 2011, the FDA warned that complications associated with transvaginal mesh products are “not rare.” The agency said it received 2,874 new reports of complications linked with the devices; 1,503 had POP repairs and 1,371 had SUI repairs. Studies reviewed by the FDA also found that roughly 10 percent of women who undergo surgery to be implanted with transvaginal mesh will suffer from mesh erosion within 12 months.
An expert advisory group convened by the FDA in September 2011 also expressed some concerns about the safety of transvaginal mesh. At the conclusion of the meeting, a majority of the Obstetrics and Gynecology Medical Device advisory panel agreed that the safety, effectiveness and benefits of transvaginal mesh devices in POP repair is not well established and warrants long-term follow-up with patients. The agency proposed reclassification of mesh devices used in the repair of POP from Class 2 to Class 3. This would mean that surgical mesh for POP repair would no longer be able to go through the FDA’s lax 510(k) approval route, and manufacturers would actually have to perform clinical tests to prove that the products are safe and effective. This also means that transvaginal mesh manufactured by C.R. Bard and other companies have not been clinically tested before being sold and implanted in thousands of women.
Need Legal Help Regarding Transvaginal Mesh and Pelvic Sling Devices?
If you or a loved one has suffered from any of the above complications after being implanted with a transvaginal mesh product manufactured by C.R. Bard, you may have valuable legal rights. To learn more about how our firm can help you, please fill out our online form to the right or call us at 1-800-YOURLAWYER (1-800-968-7529).