On January 4, The New York Times published an article, “FDA Orders Surgical Mesh Makers to Study Risks,” which misrepresents the FDA’s revised statement on surgical mesh. The author inaccurately presented information about the type of mesh that is under further investigation, the estimated prevalence of complications using mesh, and the medical benefits and safety of mesh in patients. The purpose of this response is to provide accurate information for doctors and patients alike, so they fully understand surgical mesh as it relates to the FDA’s statements and have tools to enable informed patient care.
Surgical Mesh and How it Is Used
Surgical mesh is a synthetic material that has been used in types of hernia repairs as well as in surgical treatment of pelvic floor disorders. Surgical mesh is used to treat pelvic organ prolapse (POP), when the bladder, vagina or uterus, or rectum “drops,” and stress urinary incontinence (SUI), leakage of urine with coughing, sneezing, or physical exercise due to weak ligaments and weak pelvic muscles. There are differences in the uses and outcomes related to synthetic mesh used to treat stress urinary incontinence and mesh used for transvaginal or abdominal repair of pelvic organ prolapse.
Mesh and Stress Urinary Incontinence
Mesh used to treat stress urinary incontinence is placed under the urethra (the tube that empties urine from the bladder). This operation is called a mid-urethral sling. Mid-urethral slings can be placed exiting behind the pubic bone (retropubic approach) or exiting near the thigh (transobturator approach). These procedures are standards of care and an FDA advisory panel held in September 2011 concluded that mid-urethral slings are safe and effective. A newer mesh mid-urethral sling called a single incision sling was developed that is placed using only a vaginal incision. The FDA order was directed only at this small subset of sling procedures.
Mesh and Pelvic Organ Prolapse
Surgical mesh can be placed both abdominally and vaginally to treat POP. Mesh is placed abdominally to repair POP as part of an operation called a “sacrocolpopexy.” This operation lifts the vagina to the tailbone using a piece of mesh and can be performed through an open incision in the belly or through multiple tiny scars using a laparoscopic or robotic technique. An FDA advisory panel recently concluded that abdominally placed mesh are safe and effective and do not require further study. Mesh placed vaginally is done through incisions in the vaginal walls. Mesh placed to treat POP can be placed freely or as part of a “mesh kit” procedure.
Although the routine use of transvaginal mesh for the repair of pelvic organ prolapse is not appropriate, there may be particular circumstances when the placement of transvaginal mesh is beneficial and provides the best treatment option for the patient. Placement of transvaginal mesh for pelvic organ prolapse should be done cautiously by experienced surgeons with extensive training in pelvic surgery.
Complications with Surgical Mesh
Surgical mesh is a medical device currently regulated by the FDA. It has existed for years as a method of hernia repair and, in 2001, the FDA determined that it was “substantially equivalent” to use for repair of POP.
The FDA received reports of complications associated with the placement of mesh through an incision made in the wall of the vagina (transvaginal mesh). Some of these complications can have serious consequences. The most frequent complications included erosion through the vagina, infection, pain, urinary problems and recurrence of the prolapse and/or incontinence. In some cases, erosion of the mesh and scarring of the vagina led to discomfort and pain, including pain during sexual intercourse. Some patients needed additional surgery to remove the mesh that had eroded into the vagina. Other complications included injuries to nearby organs such as the bowel and bladder, or blood vessels. The reports have not been linked to a single brand or model of mesh.
As a result, the FDA compiled and evaluated published literature about surgical mesh as well as information included in Medical Device Reports filed with the FDA by doctors and patients. In September 2011, the FDA hosted a panel of experts who represented physicians, researchers, and patients to collect additional information.
The FDA and Future Research
On January 4, 2012, the FDA announced that they would be requiring additional research to address specific safety and effectiveness concerns related to transvaginal mesh for POP and single-incision mini-sling devices for stress urinary incontinence (522 Orders). The research collected from these studies will enable the FDA to better understand the safety and effectiveness profiles of these devices. Updates on the research will be made public on the FDA website as it becomes available. Importantly, no surgical mesh devices for POP or SUI were recalled or removed from the market by the FDA. Also, because of their established safety and efficacy, the FDA has not requested additional research for retropubic or transobturator mid-urethral slings for SUI or abdominal mesh for POP.
There should be discussion between a doctor and a patient that identifies risks, benefits and possible adverse outcomes of all available treatment options. It is the responsibility of the doctor and the patient to be informed about non-surgical treatment options, surgical repairs that use a patient’s own tissues, and repairs augmented with a graft placed abdominally or vaginally.
There are things patients can do to help ensure they have the information they need to make informed choices about their care:
- Alert a doctor of any past problems healing from mesh surgery or rejecting certain material. Patients treated with mesh who are not experiencing any symptoms or side effects (recurring prolapse/incontinence, pelvic pain, etc.), do not need to have the mesh removed.
- Patients considering surgery for SUI or POP should ask their doctor about all of the options available and the pros and cons of each.
- If a doctor is recommending transvaginal mesh, ask why he or she is recommending using mesh versus using live tissues for the repair.
- Visit the patient online community for pelvic floor disorders at www.voicesforpfd.org to ask questions of expert surgeons, connect with other patients, and find information on pelvic organ prolapse, stress urinary incontinence, and other pelvic floor disorders.
- Ask a doctor about his/her experience using mesh and handling complications associated with mesh placement or find a specialist online.
- Ask a doctor what to expect after surgery, what side effects to look out for, and if there are any restrictions after surgery.
- Report any problems related to mesh to the FDA’s MedWatch Adverse Reporting program.
The American Urogynecologic Society (AUGS) believes in the highest standards for patient care and physician education, and supports the FDA’s further investigation of treatment using surgical mesh. For more information, visit www.augs.org or www.voicesforpfd.org.
Matthew D. Barber, MD, MHS
President, American Urogynecologic Society