Transvaginal Mesh Officially a High-Risk Device
The FDA just announced that implanted mesh used for transvaginal repair of pelvic organ prolapse (POP) will now be classified as a high-risk (class III) device. This means that manufacturers will have 30 months to prove the safety and effectiveness of their products.
Transvaginal mesh evolved from mesh used for hernia repair in the 1950s. In the 1970s, researchers began developing the same mesh for use on women, and from the 1990s to present day, this technique is the norm for treating POP and stress uterine incontinence (SUI) after a hysterectomy, menopause or childbirth. Doctors pushed this device as the simpler and less invasive solution to traditional treatments; however, it carries a higher complication rate.
The main complications are mesh erosion and organ perforation. With mesh erosion, the mesh begins to erode and decay into nearby soft internal tissues. This can be extremely painful and can lead to the device even being visible externally. A 2010 independent study found that 10% of 3,733 participants experienced mesh erosion. Further complications occur when the mesh erodes and perforates nearby organs – usually the bladder, urethra, bowel or rectum. A 2011 study of 389 women found a 5.8% chance of organ perforation.
Surgery is the common way to help alleviate these complications. However, since the mesh was designed to stay in the body indefinitely, removal is extremely difficult. Blood vessels and tissues grow and intertwine around the mesh. Surgeons need to perform multiple surgeries to remove the mesh piece by painstaking piece.
The FDA insisted these complications were rare, but in 2011, they retracted and admitted that it can be scarily common. Over 70,000 women have filed suit against the manufacturers of transvaginal mesh and that number is growing. However, it took the FDA over two years to reclassify it as a high-risk device.
With the reclassification, manufacturers will need to submit a premarket approval (PMA) application for their products. The PMA will demonstrate the safety and the effectiveness of their transvaginal mesh product. The FDA previously cleared the use of mesh devices without clinical trials. Manufacturers just needed to show their product was equivalent to those already available.
These stricter guidelines do not apply to those who used the surgical mesh to treat stress urinary incontinence (SUI), which has the same dangerous outcome as POP – erosion into nearby tissue and organ perforation.
Transvaginal mesh is an extremely dangerous device that needs to stop being used. If you or a loved one experienced mesh erosion and/or organ perforation from using transvaginal mesh, please call us at 877-513-9517. We can help.