To Protect Women’s Health, FDA Orders Remaining Transvaginal Mesh Products off the Market
Responding to safety concerns, the US Food and Drug Administration (FDA) recently banned manufacturers from selling surgical mesh used to treat pelvic organ prolapse (POP).
Approximately 50 percent of women over age 50 experience symptoms of pelvic organic prolapse. Age, menopause, and childbearing contribute to a weakening of pelvic muscles that hold the bladder, uterus, and rectum in place. As pelvic muscles age and stretch, they can allow these organs to drop into, or out of the vagina. Symptoms of POP include urinary and fecal incontinence, feelings of vaginal pressure, and pain during intercourse.
Options for Pelvic Organic Prolapse
POP is a common issue for women more often discussed with a gynecologist than in public. Non-surgical options include exercises to strengthen pelvic muscles, the use of a supportive pessary, and lifestyle changes like weight loss and smoking cessation.
In the mid-1990’s, surgeons began using surgical mesh to fashion a sort of sling to relieve symptoms of POP. Manufacturers soon entered the market with surgical mesh kits. By some estimates, around 200,000 women each year undergo surgery to implant surgical mesh to treat POP. By 2011, the FDA circulated an alert that the use of mesh kits could cause complications without relieving symptoms.
Unknown Consequences of Transvaginal Mesh
Since then, the serious consequences of some mesh implant procedures have come to light, including:
- Pain, infection, scarring, incontinence
- Growth of tissue around mesh, or extrusion of mesh through the vagina
Implantation of transvaginal mesh is considered permanent. Removal of mesh that has eroded or is causing pain can lead to further surgical repair and complications. Because of these risks, the FDA recently ordered manufacturers of transvaginal mesh kits to stop distributing their products in the US.
In April, the FDA determined that the two remaining manufacturers of transvaginal mesh products could not demonstrate “a reasonable assurance of safety and effectiveness.” Noted Dr. Jeffrey Shuren, the director of the FDA’s Center for Devices and Radiological Health, “In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term.”
Litigation involving transvaginal mesh is enormous. In 2018, 73,000 people filed legal action against manufacturers of mesh products. If you had gynecological surgery involving the use of transvaginal mesh and suffer pain or were injured, speak with an experienced attorney about your options.
Experienced Malpractice Attorneys
At Schochor, Federico and Staton, P.A., we serve patients injured through negligence and medical malpractice. We fight for your right to compensation when you suffer an injury due to poor standards of medical care. Contact us today or call 410-234-1000 to schedule a free consultation concerning your case.