Transvaginal Mesh FDA Warnings
Transvaginal mesh, which is used to reinforce weakened vaginal walls to repair pelvic organ prolapse (POP) or treat stress urinary incontinence, is facing increased scrutiny for serious health risks. The mesh can cause painful, life-altering complications that require additional medical treatment or surgeries.
At Ferrer Poirot Feller Daniel, we force corporations to put responsibility over profits. So if you or someone you love has been injured after receiving transvaginal mesh for POP or SUI, contact our transvaginal mesh lawyers today. We can help you get the compensation you deserve. Talk to our legal staff about your injuries today—just dial (888) 485-8844 or fill out a free initial consultation form.
FDA Reclassifies Surgical Mesh for Pelvic Organ Prolapse
In Jan. 2016, the U.S. Food and Drug Administration issued two orders strengthening clinical requirements for TVM used in the transvaginal repair of POP. The first order reclassifies surgical mesh to a class III device, which generally includes high-risk medical devices. TVM had previously been classified as a class II device.
The second order requires TVM manufacturers to submit documentation that demonstrates the safety and effectiveness of surgical mesh for transvaginal repair of POP.
Risk of Serious TVM Complications
In July 2011, the FDA released a safety alert about the injury risks associated with TVM, stating that “serious complications associated with surgical mesh for transvaginal repair of POP are not rare.” The alert also concluded that it’s unclear whether TVM is more effective than traditional non-mesh POP surgeries and that it may even expose patients to greater risk of injury.
As a result of these findings, the FDA recommended that health care providers:
- Recognize that in many cases POP can be treated without TVM.
- Choose TVM surgeries only after weighing the risks and benefits of all other alternatives.
- Consider that TVM is a permanent implant, which can make future surgical repair more complex.
The FDA is continuing to monitor the effects of surgical mesh used to repair POP and treat incontinence.
We’re Here for You
If you suffer from TVM complications, you understand the emotional and physical trauma they can cause. Don’t let your rights to compensation go unprotected—contact Ferrer Poirot Feller Daniel today. Our transvaginal mesh attorneys want to help you get the compensation you’re owed. Pick up the phone and talk to our legal staff today—we’re available 24 hours a day, seven days a week.
This law firm is not associated with, sponsored by, or affiliated with the U.S. Food and Drug Administration.