Transvaginal Surgical Mesh For Pelvic Organ Prolapse (POP) And Stress Urinary Incontinence (SUI) FDA Warning
The U.S. Food and Drug Administration (FDA) released a warning to doctors regarding serious complications arising from the use of transvaginal placement of surgical mesh when treating POP and SUI. The FDA received over 1000 reports from nine different manufacturers over the last three years. They include:
- erosion of the mesh through vaginal epithelium
- infection
- pain
- urinary problems
- recurrence of prolapse and/or incontinence
- bowel, bladder, and blood vessel perforation during insertion
- mesh erosion and vaginal scarring leading to pain and discomfort during sexual intercourse.
The FDA specifically warned healthcare providers to be vigilant regarding mesh erosion and infection. You can view the entire warning here.
Dangerous and defective medical devices are responsible for many injuries and deaths nationwide. Our profession calls this area of law products liability. Consulting an attorney experienced in handling these matters is usually easy. Most lawyers will provide a complimentary initial consultation to evaluate a claim or case and let the person know if they can help.
