The Food and Drug Administration (FDA) recently halted sales of surgical mesh devices used for transvaginal repair of pelvic organ prolapse (POP).
In this condition, the muscles and tissues that support the pelvic organs (uterus, bladder, rectum) weaken or loosen, causing them to drop or press into or out of the vagina. The main symptom of pelvic organ prolapse is (seeing or feeling) a vaginal bulge, and it can can co-exist with other conditions such as urine leakage or problems with bowel movements, making it difficult to lead a normal life.
All of these issues fall under what’s called “pelvic floor disorders,” an umbrella term to describe problems that affect the ligaments, muscles, and tissues of the pelvis. Though 30 to 40 percent of women may have some degree of pelvic organ prolapse, about 3 to 8 percent of women have associated symptoms that may lead them to seek care.
The FDA’s move, Yale Medicine specialists say, has left some women confused and concerned—especially since there are several types of surgery used to treat pelvic organ prolapse, and the FDA decision affects just one approach—a transvaginal mesh procedure. This surgery involves making an incision in the vaginal wall and inserting mesh to help hold up the prolapsed (fallen) organs. (The goal is that a woman’s tissue grows into the holes of the mesh to create a supportive wall.)
The FDA said that the manufacturers of the devices used for this type of pelvic organ prolapse repair had not demonstrated a reasonable assurance of their safety or effectiveness by the FDA deadline. Complications reported in lawsuits against the manufacturers—which have resulted in nearly $8 billion in settlements to 100,000 women—include bleeding, pain, inflammation, and infections.
The word ‘mesh’ shouldn’t scare women. There are other options to treat these disorders, and mesh is but one tool in a tool box with many others.
Leslie Rickey, MD, MPH, Yale Medicine female pelvic medicine and reconstructive surgeon
Importantly, the FDA did not place any restrictions on the use of mesh when the prolapse surgery is done through the abdomen. It also does not affect transvaginal use of mesh to treat stress urinary incontinence (SUI), commonly called a “sling” procedure. SUI is urine leakage that happens when women cough, sneeze, exercise, or lift heavy objects. It affects approximately 1 in 3 women and is caused by a weakened bladder sphincter muscle and other surrounding pelvic floor muscles, sometimes due to childbirth and aging, among other factors.
Yale Medicine obstetrician-gynecologists and urologists who subspecialize in female pelvic medicine and reconstructive surgery say they worry women will mistakenly think the FDA ruling involves all pelvic floor surgeries that use mesh.
“The transvaginal mesh used for prolapse is getting confused with the use of mesh slings to treat stress incontinence and laparoscopic procedures for pelvic organ prolapse,” says Leslie M. Rickey, MD, MPH, a female pelvic medicine and reconstructive surgeon. “Women should know that this has nothing to do with treatment for stress incontinence and that the pelvic floor surgeries we do are very well studied and safe. Even though this one procedure is off the table for now, there other good treatment options, both surgical and nonsurgical.”
Oz Harmanli, MD, chief of Yale Medicine Urogynecology & Pelvic Reconstructive Surgery, agrees.
“We need to educate women, especially those who have stress urinary incontinence, that this news from the FDA has nothing to do with the midurethral sling procedure,” he says, speaking of a common procedure that involves placing synthetic mesh to act as a ribbon of support under the urethra. “This is the safest, most effective, and least complicated surgery to treat stress incontinence and has revolutionized surgical management of the condition.”
And, Dr. Rickey adds, women who did have transvaginal mesh surgery for pelvic organ prolapse don’t need to rush to their doctor if it is working well for them—but they should always ask their physician about any concerns they might have. Below, we asked Drs. Rickey and Harmanli questions about mesh and pelvic floor disorders.
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