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Vaginal Mesh for Prolapse

 “The FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices”

This topic scares and confuses women and their loved ones as much as any topic I deal with in my practice.  The commercials designed by lawyers to collect patients for their class actions lawsuits are terrifying and, in some cases, deceptive. 

For years, Ob-Gyns have repaired cystoceles and rectoceles as well as uterine prolapse by doing surgery through the vagina.  With many techniques available to correct these problems, most gynecologists would do simple repairs with stitches alone, no meshes.  Unfortunately, many women will see their “bladders” fall again, sometimes very quickly.  So in the late 1990’s, many physicians started adding a mesh to their repair to attempt to improve the surgery.  In the early 2000’s, a few device companies started selling a “kit” to perform these surgeries with mesh.  Some doctors skilled in this type of surgery, could use these products with low risk and overall great outcomes.  Unfortunately, some doctors did not achieve great results and the patients developed problems from the surgery like pelvic pain, pain with intercourse, exposure of the mesh into the vagina, bleeding and discharge to name the most common.  These complications could be devastating for the patients affected.

In 2008, the FDA released a consumer awareness letter that warned the benefits of vaginal mesh surgery are unknown, and there may be significant risks.  Over the next 10 years, the FDA continued to monitor vaginal mesh concerns.  In 2016, vaginal mesh for pelvic organ prolapse was changed to a class III device which means high risk.  They required companies who manufacture these devices to do very expensive studies comparing their devices to surgery that does not involve a device.  Over 3 years, patients who had these surgeries were followed by their physicians and compared to each other.  Based on the FDA’s report Tuesday, they do not see a significant enough benefit in the devices over standard nonmesh-based surgery to allow the device to continue to be on the market.  So as of this week, April 16, 2019, manufacturers of vaginal mesh for prolapse and biologic mesh for the treatment of vaginal prolapse, must remove their devices from the hospitals who use them.  It is also important to note, women who have these devices already do not need to have them removed unless they are experiencing complications.  Even this needs to be carefully considered with a physician.

Very importantly, many options still remain for women who have pelvic organ prolapse.  When women have recurrence of their prolapse after a standard cystocele or rectocele repair, we can still offer more durable non-mesh based procedures or move to an abdominal surgery for prolapse called a sacrocolpopexy that is very durable and the FDA continues to support.  It should also be noted that midurethral slings for the treatment of stress urinary incontinence (SUI) are not included in this FDA move.  As a matter of fact, slings for SUI remain an option for women that offers a very high chance of success with very low risk.

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