Background
Transvaginal mesh is used to treat women who suffer from Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). POP occurs when the muscles or tissues surrounding pelvic organs become weakened or stretched. This may lead to organs bulging or "prolapsing" into adjoining areas, including the bladder, uterus, bowels, or rectum which can result in urinary incontinence and pain and discomfort during sexual activity. POP often occurs after childbirth or following a hysterectomy and is fairly common, occurring in thirty to fifty percent of women in their lifeti me. Stress Urinary Incontinence (SUI) is the leakage of urinary fluid during physical activity. SUI can occur during daily activities such as coughing, sneezing, laughing, and exercise.
Transvaginal mesh was developed to be an improvement over traditional surgical techniques used to treat POP and SUI. However, the FDA has been concerned about complications arising from transvaginal mesh since 2008 when the FDA warned about "rare" but serious complications like pain, infections, erosion of the mesh, and the inability to engage in sexual intercourse.
New Warnings
Recently, the FDA has come to the conclusion that these complications are "not rare" and that they "may expose patients to greater risk" than traditional repairs performed without transvaginal mesh. The FDA review found that the mesh-related complications can be debilitating and complete removal of the mesh may not be possible. Patients have also been warned that they may have to endure multiple surgeries in-order to remove the mesh device.
Click here to see the full FDA warning regarding Transvaginal Mesh
Recall demanded
Recently, the consumer advocacy group Public Citizen has called upon the FDA and the manufacturers of transvaginal mesh to Recall these devices while the FDA evaluates the latest data on these devices. The FDA has also suggested that the makers of transvaginal mesh may be required to provide further safety data in order for these devices to remain on the market. Johnson and Johnson, American Medical Systems, and Boston Scientific are a few of the largest manufacturers of transvaginal mesh devices.
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