Hello, I am Dr. Diane Mitchell, Assistant Director for Science in the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health. I am also an obstetrician/gynecologist.
I am pleased to join you on Medscape today as part of the FDA's Expert Commentary Series. I would like to talk to you about the risks of using surgical mesh to repair pelvic organ prolapse, also known as POP, especially when the mesh is placed through the vagina.
POP occurs when the tissues that hold the pelvic organs in place become weak or stretched. This can allow 1 or more pelvic organs into the vaginal vault.
Some women with POP do not experience any symptoms. Others have symptoms. Symptomatic women can be treated by both nonsurgical and surgical methods.
Surgery can include using sutures alone or using sutures with surgical mesh. It's important to note that surgical mesh has been cleared by the FDA for use in treating many other conditions, such as stress urinary incontinence, abdominal and inguinal hernias.
But I'm talking to you today specifically about surgical mesh used to treat POP. According to industry estimates, in 2010 there were 100,000 POP surgeries with mesh performed in the United States.
At the FDA, we are particularly concerned about complications that can result when the mesh is placed through an incision in the vagina. When mesh is placed abdominally, there appear to be lower rates of complications.
Postmarketing data indicate that repair of POP with surgical mesh is no more effective than POP repair with sutures alone, particularly for certain types of prolapse.
Patients who undergo POP repair with mesh are often subject to complications not experienced by patients who undergo surgery without mesh. For some women, the adverse events of POP repair associated with mesh placement through the vagina can be permanent and life-altering.
Even with these concerns, mesh placed through the vagina for POP repair may be appropriate for patients whom the surgeon believes have a poor chance at success with other surgeries and for whom other treatments are not feasible.
To better understand the complications of using mesh for transvaginal repair of POP, the FDA reviewed scientific literature published from January 1996 through April 2011. We also evaluated the adverse events reported to us for 3 years, beginning in January 2008.
Our review indicates that urogynecologic surgical mesh products are associated with serious adverse events, including mesh erosion through the vaginal wall. This complication can require multiple surgeries to repair, and sometimes the mesh cannot be completely removed, which leads to continued symptoms.
In addition to safety concerns, the research on performance does not demonstrate that mesh repair of POP offers improved clinical benefit compared with non-mesh repair. This is particularly true for transvaginal mesh repair of enteroceles and rectoceles. Some studies do show an anatomic benefit when mesh is used for transvaginal repair of cystoceles, but this benefit may not result in superior clinical outcomes, such as improved patient satisfaction.
The literature review also showed that mesh erosion into the vagina is the most commonly reported mesh-related complication from transvaginal POP repairs. We also found a previously unidentified risk of transvaginal POP repair. That is mesh contraction or shrinkage, and it is associated with vaginal shortening, vaginal tightening, and pain.
Beyond our own review of the available data, we gathered input from the scientific community and the public by convening a panel of outside experts on September 8-9, 2011. The purpose of this meeting was to publicly discuss the existing clinical data and the safety and effectiveness of surgical mesh used to treat both POP and stress urinary incontinence.
The panel generally agreed that, depending on the anatomical areas involved, vaginal placement of mesh for POP repair may not be more effective than repair without mesh, and that clinical studies are needed for premarket evaluation of vaginal mesh for POP repair.
In January 2012, the FDA ordered manufacturers of urogynecologic surgical mesh products to conduct postmarket surveillance studies, also called "522 studies."
These real-world studies will provide the FDA, manufacturers, and healthcare providers with data that can better improve our understanding of the benefits and risks of mesh placed through the vagina for POP repair.
If you as a clinician are asked to take part in postmarket studies, we strongly encourage you. Your involvement can help us provide better information to patients and to you, their healthcare providers. This information will lead to more informed decisions.
In light of our concerns about the use of surgical mesh to treat POP, we issued public safety notifications in 2008 and in 2011 with the following recommendations for surgeons:
Obtain specialized training for each surgical mesh placement technique and be aware of the risks of surgical mesh.
Choose mesh surgery only after weighing the risks and benefits of surgery with mesh vs. all surgical and nonsurgical alternatives.
Be vigilant for potential adverse events from the surgical mesh, especially erosion and infection.
Remember that surgical mesh is a permanent implant that may make future surgeries more challenging. Removal of mesh due to complications may involve multiple surgeries. Complete removal of mesh may not be possible and may not result in complete resolution of complications, which can include pain and the inability to have sexual intercourse.
The FDA continues to gather data and assess the safety and effectiveness of urogynecologic surgical mesh devices by analyzing the published literature, adverse event reports, and postapproval studies. We will also continue to collaborate with professional societies and other stakeholders to better understand the postmarket performance of urogynecologic surgical mesh devices.
As new information becomes available, we will share it promptly with healthcare providers and the public.
If you would like more detailed information about the FDA's findings, as well as recommendations, please review our urogynecologic surgical mesh implants Web section.
And remember: If you have the opportunity to participate in one of the postmarket studies, please do so.
Thank you for taking the time to listen to this FDA Expert Commentary on use of surgical mesh for POP repair.
Detailed findings of the FDA's literature review: Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse
For more information on patient counseling about POP, please visit the FDA Pelvic Organ Prolapse Website