This week the FDA responded to concerns about the safety of mesh implants to treat pelvic organ prolapse (POP) in women. They have been reclassified with its highest risk category and manufacturers of existing products must submit premarket approval applications within 30 months. According to a statement by the FDA, the applications are required “to support the safety and effectiveness” of the mesh products.
POP is caused when the bladder, bowel and uterus are no longer supported by weakened or stretched pelvic floor muscles. Women may develop POP as a result of childbirth, hysterectomy, or menopause. If left untreated, POP can cause pain and urinary leakage.
In the 1990s, gynecologists started using surgical mesh transvaginally to repair POP, reinforcing pelvic muscles and reducing recuperation time. The FDA okayed the [...]