Gynecological Groups Issues Joint Warning on the Use of Vaginal Mesh for Pelvic Organ Prolapse
In a rare joint release, two professional medical groups have come to the same conclusion. Due to all of the concerns about the dangers of synthetic mesh for the treatment of pelvic organ prolapse (POP), both the American College of Obstetricians and Gynecologists (ACOG) and the American Urogynecologic Society (AUGS) issued a joint recommendation on November 21 that the synthetic mesh should be used only on high-risk women due to the risks involved. The medical groups say the benefit may not outweigh the risk.
The two professional medical organizations also encourage the creation of a patient registry to track the outcomes after a woman is implanted with this permanent medical device that has a unknown complication rate. Currently, there is no national registry so the complication rate is unknown. It is widely believed that the U.S. Food and Drug Administration MAUDE database for complications is virtually unknown and does not reflect the actual number of injured patients who have been implanted with mesh.
Mesh is used when organs such as the uterus, small intestine, rectum, bladder, and top of the vagina drop down and bulge into the vagina, also known as POP. It’s believed that childbirth and certain genetic factors, as well as obesity and a lack of exercise, all contribute to the condition of weak muscles and connective tissue in the pelvic area. It’s also estimated that there are about 350,000 POP surgeries in the U.S. every year, however, not all involve mesh as simple stitches or a biologic material can be used. Synthetic mesh is used in an estimated 75,000 procedures a year.
Synthetic surgical mesh used for POP was cleared by the FDA in 2001 based on its “substantial equivalence” to hernia repair mesh. Unfortunately, under the 510(k) clearance process by the FDA, there is no clinical data required to prove the synthetic mesh is safe for patients or an effective treatment.
According to a FDA Notice issued July 13, 2011, complications of synthetic mesh for POP or stress urinary incontinence (SUI) include mesh erosion into the vagina and organs, infection, and debilitating pain.
The two professional medical associations recommend that synthetic mesh placement and success rates be compared to the use of native tissue harvested from the person and its long-term consequences.
The Florida transvaginal mesh injury attorneys at Farah & Farah are talking to women whose lives have been forever compromised by the use of synthetic surgical mesh. Call us at (800) 533-3555 to see how we can help seek compensation for your injury.