On April 16, 2019, the U.S. Food and Drug Administration (FDA) ordered manufacturers of surgical mesh for transvaginal repair of anterior compartment prolapse (cystocele) to stop distributing the products. The FDA found that the manufacturers did not demonstrate the safety and effectiveness of these products.
Since then, the topic of mesh material used in surgery to correct both prolapse and incontinence has become commonly discussed in the news and all over the internet. Because surgical mesh is discussed in many arenas and the terms used to describe these surgeries are vague, confusion exists. Plus, given all of the information out there, it can be hard to understand what to do if you need a surgery for prolapse or incontinence.
This page provides an overview of the important information you should consider if you are considering a procedure that involves mesh.
Step #1: Learn the Key Terms
- Stress urinary incontinence (SUI): Urine leakage with physical activity such as laughing, sneezing, lifting, or exercise.
- Pelvic Organ Prolapse (POP): Dropping of the pelvic organs, such as the bladder, uterus, and rectum, caused by a loss of vaginal support.
- Mid-urethral sling: Placement of synthetic mesh in a strap-like fashion under the urethra to treat the symptoms of SUI.
- Cystocele or Urethrocele (anterior vaginal wall prolapse): Front wall of the vagina sags downward or outward, allowing the bladder to drop from its normal position.
- Enterocele: Support to the top of the vagina weakens, allowing bulging of the small intestine into the vagina.
- Rectocele (posterior vaginal wall prolapse): Rectum bulges upward into the vagina because of a weakened vaginal wall and perineum.
- Uterine Prolapse or Vaginal Vault Prolapse: Upper support of the vagina weakens, allowing the uterus and cervix to drop into the vaginal canal. In women who have had a hysterectomy, the top of the vagina falls.
- Pelvic floor disorders (PFDs): Conditions that affect the muscles of bottom of the pelvis (called the pelvic floor), including pelvic organ prolapse (POP), urinary incontinence, and bowel control difficulties.
Step #2: Find Out About PFDs
Pelvic floor disorders include pelvic organ prolapse, leakage of urine, and bowel problems. Both POP and SUI may be treated with mesh.
POP occurs when the pelvic floor muscles and connective tissue weaken or tear. This causes the pelvic organs to fall into the vagina, similar to a hernia. Women may feel or see tissue coming out of the opening of their vagina as this progresses. The bladder, uterus, small intestines or rectum may be involved in the bulge.
SUI is loss of urine that occurs at the same time as physical exertion such as coughing, sneezing, or exercise due to weak ligaments and pelvic muscles.
POP and SUI have many options for treatment, and surgery is only one of them. Ask your doctor about all the options that would work best for you. Once surgery is planned, there are different surgeries that may work for you, including some that involve placement of mesh material to correct the prolapse or incontinence.
Step #3: Learn How Mesh is Used to Treat POP
Surgical mesh is a flexible, synthetic material. It is made of surgical suture material woven into a fabric. Mesh is used in hernia repairs and surgical treatment of PFDs, including both POP and SUI surgeries.
Mesh has been used for a long time in surgery and is safe.
Permanent synthetic mesh is not the only material used for these procedures. Other types of surgical implants include:
- Synthetic permanent mesh – soft suture material woven into fabric that does not dissolve.
- Synthetic dissolvable mesh – soft suture material woven into fabric that dissolves (goes away) over several months
- Biologic graft material – an implant taken from an animal (often a pig or cow) or another person that is processed and made safe for human implantation. These are placed to help strengthen a repair at the time of surgery, but often dissolve over time.
During POP surgery, the doctor places surgical mesh by making an incision either on a woman’s abdomen or in the vagina:
- Abdominal sacrocolpopexy: During this operation, the surgeon places mesh in the abdomen to repair POP. This surgery uses a piece of mesh to attach the vagina to a ligament located over the tailbone (also called the sacrum). It can be performed through a big incision on the belly or through multiple tiny scars using a robotic or camera (laparoscopic) technique.
- Vaginal POP operations: During this procedure, the doctor positions mesh in the vagina through incisions in the vaginal walls to hold up the dropped organs. Your doctor may tailor the piece of mesh for your specific anatomy or use a preformed “mesh kit” package.
One type of SUI surgery involves placement of a small mesh sling under the urethra (the tube that empties urine from the bladder). This operation is called a midurethral sling.
During a midurethral sling procedure:
- The surgeon makes a small incision in the vagina and then two small skin incisions near the pubic bone or in the groin area.
- Using specially designed needles, the surgeon positions a thin piece of synthetic mesh under the urethra.
- Next, the surgeon pulls the ends of the mesh through the skin incisions and adjusts them to provide the right amount of tension under the urethra.
After the procedure, your tissues grow through the weave of the mesh. This typically takes several weeks and helps to secure the sling. Most women (more than 90%) are happy with the outcome of midurethral sling surgery. Serious complications are uncommon. For a small number of women, sling surgery is not successful, and they may undergo more extensive surgery to correct the leakage.
Midurethral slings are the best-studied incontinence surgery in history. These studies consistently show high levels of success and patient satisfaction. The FDA supports the safety and effectiveness of this surgery. The permanent mesh used in this surgery does not cause the complications that have been in the news related to other types of vaginal POP repair surgery.
The American Urogynecologic Society (AUGS), a physician-based organization dedicated to research, education and the sharing of best practices in Female Pelvic Medicine and Reconstructive Surgery, including topics such as POP and SUI specifically, continues to provide information to the FDA, and many of its members are working to thoroughly study mesh surgery for prolapse and incontinence. AUGS is dedicated to providing information to women struggling with PFDs and the treatments that are available.
Here are some important things to know.
Topics to Discuss with Your Doctor BEFORE Surgery