FDA Recalls Transvaginal Mesh for Treatment of Pelvic Organ Prolapse
Posted on April 22, 2019
Source:
Cleveland Clinic
By Marie Fidela Paraiso, MD
As President of the American Association of Gynecologic Laparoscopists (AAGL), I have been fielding calls from colleagues, patients, media and industry about the recent announcement from the U.S. Food and Drug Association, which recalled transvaginal mesh used for the treatment of pelvic organ prolapse (POP).
An important distinction
There’s an important distinction to make here: the FDA has ordered Boston Scientific and Coloplast to stop selling surgical mesh for some—but not all—procedures related to pelvic floor disorders. Some media sources are not conveying that subtlety.
The mesh itself is not defective and it has not been recalled in all applications. The recall applies to mesh used in transvaginal repair of POP. The FDA has not recalled the mesh that is inserted through an abdominal incision (open, laparoscopic or robotic) for POP repair, nor mesh used in midurethral sling procedures for the treatment of stress urinary incontinence.
Transvaginal mesh is not necessarily inferior
I am co-author of a recently submitted a manuscript from the Pelvic Floor Disorders Network with data indicating that the transvaginal mesh procedure is not inferior to native tissue procedures. However, the FDA’s mandate is that researchers prove the mesh procedure to be superior to native tissue repair.
In my experience with the most widely used transvaginal mesh procedure since 2007, it has not been associated with increased complications compared to native tissue repair. There are patients for whom we believe transvaginal mesh procedures are beneficial, especially in women who have had previous failed vaginal procedures, recurrent prolapse, or in patients for whom an additional abdominal procedure may be contraindicated, either because of previous multiple abdominal procedures, abdominal hernia repairs with mesh, or because the patient has medical contraindications to a more lengthy procedure.
Our research shows that transvaginal mesh procedures for pelvic organ prolapse are very time efficient. Following the recall, we are relegated to treating POP with native tissue repairs by vaginal route or abdominal route (open, laparoscopic, or robotic) mesh repairs with sacrocolpopexy. These procedures are very good, but they may not work for or be indicated in everyone.
Mesh remains gold-standard treatment for stress urinary incontinence and abdominal mesh repairs for vaginal vault prolapse
The mid-urethral mesh sling is still the gold-standard treatment for stress urinary incontinence, which is supported by ample evidence. Medical consensus right now is that sling mesh for incontinence is one of the best and safest treatments for urinary incontinence. Additionally, there is sufficient evidence to support the use of mesh repair for vaginal vault prolapse with sacrocolpopexy.
A false impression among patients that the FDA decision applies to mesh slings for incontinence and abdominal mesh repairs for pelvic organ prolapse is problematic and potentially dangerous. There is no evidence to suggest that those who have mesh for these purposes should question the integrity of their procedures or have the mesh removed.
Next steps
For physicians who already have these devices in stock, I recommend contacting patients to discuss alternatives to vaginal mesh procedures for pelvic organ prolapse planned before the recall. There are other, alternative therapies we can offer patients, including native tissue repair and abdominal route mesh repair. Currently, we are awaiting instructions from the manufacturers regarding how they intend to collect any existing inventory.
I expect patients with mesh in-place may be calling their surgeons with recall-related concerns. I recommend reviewing the adverse symptoms associated with vaginal mesh for pelvic organ prolapse with patients. If they are not experiencing the infrequent symptoms of pelvic pain, pain with intercourse, or persistent, abnormal vaginal discharge or bleeding, they should not worry at the present time. They should maintain the follow-up schedule, and contact their physician’s offices if anything changes.
Marie Fidela Paraiso, MD is Professor of Surgery, Cleveland Clinic Lerner College of Medicine & Section Head, Urogynecology and Reconstructive Pelvic Surgery, Cleveland Clinic