Mesh Problems in Pelvic Organ Prolapse Surgery

The increasing number of post-surgical complications reported shows that mesh products, which were primarily designed for use in the abdomen, should not have been approved for use in the pelvis without additional testing. Nonetheless, recent data show that more than 100,000 women still receive plastic mesh every year to treat pelvic organ prolapse (POP).

The United States Food and Drug Administration (FDA), which approved the mesh for use in treating POP, has continued to report increasing numbers of surgical mesh problems. Today, the FDA says that POP, which affects 30 percent to 50 percent of women, can usually be treated successfully without surgical mesh.

William Maisel, M.D., the FDA’s deputy director of the Center for Devices and Radiological Health, was recently quoted in the news media as saying that transvaginal mesh should not be used routinely for all POP procedures, citing evidence studied by the FDA that calls into question the benefits of transvaginal mesh.

POP is a common condition that occurs when pelvic organs sag and drop (“prolapse”) from their normal positions and push against the vaginal walls. It occurs when either:

  • the bladder collapses down from the upper wall of the vagina (known as “cystocele”)
  • the rectum pushes through the lower wall of the vagina (known as “rectocele”)
  • the top of the vagina collapses down the vaginal canal

Often, this happens when the muscles holding the pelvic organs in place become weak from childbirth and/or surgery. Left untreated, POP can cause pain, problems with bowel and bladder functions, and interfere with sexual activity. The most common treatment for POP involves lifting the bladder, uterus and/or bowel out of the vagina, guiding these organs back into place, and then surgically installing transvaginal mesh to provide support and help keep these organs in place. While the transvaginal surgical mesh products were originally intended to help manage these conditions and to alleviate the pain and discomfort, many patients claim that they are in reality exposing them to more serious life-threatening side effects.

The type and number of complications that commonly arise when mesh is used to treat POP differ from those that arise when the mesh is used to treat urinary stress incontinence (USI). They also vary according to the type of surgery and mesh used. The most commonly reported problems and complications with mesh used for POP repair, according to FDA reports, include:

  • Erosion of the mesh and/or protrusion of the mesh from the soft tissues
  • Pelvic pain, including pain with intercourse
  • Infections
  • Urinary tract problems and urinary issues
  • Bleeding
  • Spasms
  • Damage to nearby organs

The most common treatment for the pain, infection and erosion that often follows a pelvic organ prolapse (POP) surgery is removing the mesh via vaginal incision.

Indeed, many women who suffer these kinds of transvaginal mesh complications have had to undergo additional surgeries to have the mesh removed and treat the POP. In some cases in which the mesh becomes too tightly interwoven with scar tissues, the corrective surgery is not possible. These women have very limited options.

According to recent data, the number of complications reported from 2008 to 2010 increased was five times higher than the number reported from 2005 to 2007. These reports include three deaths.

Studies show that approximately 10 percent of women who undergo the procedure experience erosion of the mesh within one year of the surgery. More than half of those women require additional surgeries to remove the mesh. Studies show that approximately two surgeries are required per patient to remove the mesh and repair any POP that may result.

Surgical mesh problems are not always apparent immediately; in fact, they generally develop at least one month after the surgery took place. While the average times for mesh erosions to occur usually varies from surgery to surgery, the average time for erosion to occur for those who had an abdominal incision for POP is 15.6 months. For those with a vaginal incision, it is 4.1 months.

There is reason to believe the number of surgical mesh problems affecting women today is actually higher than reported. This is because reporting the problem requires first that the patients and their physicians accurately identify the problem and realize that the complications are a result of the surgery. While manufacturers are required to accurately document and track all possible adverse outcomes associated with their products, some patients and their doctors do not connect the dots between the gynecological problem and the surgery, and therefore, many surgical mesh problems are not reported. Problems with transvaginal mesh are serious, and it is important to seek appropriate medical assistance and take the necessary steps to diagnose, treat and report surgical mesh problems.

 

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