Transvaginal mesh implants made of polypropylene or animal tissue were introduced in the United States in the late 1990s, first gaining FDA approval in 1996 as a routine treatment for SUI (stress uterine incontinence) and later POP (pelvic organ prolapse) in 2002. The conditions are often associated with giving birth and aging.
But the switch from earlier abdominal surgical placement to transvaginal placement (requiring vaginal incision) has led to thousands of injuries causing women to experience nerve damage, chronic pain, vaginal scarring, contraction from eroding mesh and organ perforation, even death.
Researchers speculate that adverse complications from transvaginal mesh implantation occur between 15-25 percent of the time, but what is more disturbing is the emergency nature of problems when they do arise.
IC manifests in two ways: 1/ SUI (Stress Urinary Incontinence) and 2/ and more serious POP (Pelvic Organ Prolapse), the latter characterized by weakening of the muscles and ligaments supporting the vagina and leading to a gradual “dropping” of the cervix, uterus, bladder or rectum. IC affects nearly one-third of all women and, although men can be affected, 90 percent of patients are women.
In 2010 alone, 560,000 POP mesh surgeries were performed transvaginally. By 2016, alarm bells began going off when injuries were first reported. By April 2019, the FDA banned use of the transvaginal mesh procedure for POP in the U.S.. Currently, there are no FDA-approved surgical mesh devices legally allowed in the U.S. for transvaginal placement. SUI is less scrutinized since it is considered less dangerous.