Transvaginal mesh is a net-like implant that is used to treat pelvic organ prolapse (POP) and stress urinary incontinence in women. However, the design and implantation technique has caused serious complications in tens of thousands of women, such as organ perforation and erosion.
The J&J devices under scrutiny by the FDA are:
- Prosima Pelvic Floor Repair System
- Prolift Pelvic Floor Repair System
- and Prolift MTM Pelvic Floor Repair System
- TVT Secure
Although the above devices are manufactured by Johnson & Johnson, there may be other manufacturers that warrant investigation. Seek medical attention if you have experienced any pain or injury with any vaginal mesh implant. If you are unsure what device you have, call your doctor.
More than 1,000 lawsuits are pending by injured women and the FDA has received thousands of reports of adverse side effects and injuries. J&J will stop selling the four implants mentioned above 600 or more women said the products were to blame for internal injuries.
According to Bloomberg, “an FDA report last year found a fivefold jump in deaths, injuries or malfunctions tied to vaginal mesh for organs that slump, or “prolapse,” because of weakened support. Two months later, an advisory panel urged the FDA to reclassify the devices as “high-risk” products needing human testing.”
The agency reports the following problems linked to mesh:
- Mesh protruding out of the vaginal tissue or exposed
- Urinary problems
- Painful sexual intercourse
- And more.
- Surgery may be required to fix mesh-related complications. Although rare, revision surgery may not fix the problem for some women.
Because synthetic surgical mesh was designed to stay in the body indefinitely, removal of the mesh is extremely difficult. The blood vessels and tissues grow around the mesh, requiring doctors to remove it in pieces, which can take several surgeries.
As with any potential medical situation, consult your healthcare provider immediately before taking any other action.