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Vaginal Mesh: New FDA Warnings

As a healthcare provider one really knows that a serious concern has arisen when it makes the evening news. But in my book, nothing tops the alarm bells that go off when a medical product suddenly appears on the TV screen at my gym followed by the phone number of an out of state legal firm soliciting for clients. This just happened when I was on the cross trainer last week so it seemed important to share the most accurate information I could find about the newest FDA warnings for vaginal mesh.

You may have had some type of surgical mesh used for, say, a hernia repair. This use goes back to the 1950s. In the 1970s GYN surgeons began using the mesh designed for hernia repairs to help reinforce tissues in the vagina to repair pelvic organ prolapse (POP). Up to 50% of women may experience some type of prolapse (Maher, 2010), but only a few percent will need surgical treatment.  In POP, either the bladder collapses down from the upper wall of the vagina (cystocele), the rectum pushes through the lower wall of the vagina (rectocele), or the top of the vagina collapses down the vaginal canal. Yet it was not until 2002 that there was an FDA approved product designed specifically for repairs of pelvic organ prolapse.

Mesh can also be used to elevate the neck of the bladder to treat urinary stress incontinence (SI). Stress incontinence presents with loss of urine with coughing/sneezing/jumping and may be present in 24% of women (Minassian, 2008).  Surgeons began using mesh to treat stress incontinence in the 1990s. The FDA approved a mesh specifically for SI use in 1996.

What is the vaginal mesh and what are the problems?
There are four types of surgical mesh: non-absorbable polyester or polypropylene, absorbable synthetics, animal tissues, and combinations of the above. Most GYN and female urology surgeries use the polyester or polypropylene type of mesh.

Once a drug or device is approved for use, the FDA has a variety of ways in which problems with a product can be reported. For example, you may have noticed the MedWatch option on some WebMD pages, which allows consumers to report suspected problems. Unfortunately, some women (and their doctors) may not connect a new gynecological problem to a past surgery. One member of our staff shared the following personal experience.

I had this repair done about 10 or so years ago for rectocele. The approach was vaginal and surgical mesh was used. It seemed to be perfect initially, however, as time has gone on, I have had pain issues. I get paroxysmal cramping pain along the wall of the vagina where the repair was made. It lasts from 5-20 minutes, and is bad enough to wake me from a sound sleep. These episodes have increased over time.

I have mentioned it to two doctors and one blew it off, and the other looked puzzled and had no ideas to offer. I have not mentioned it to my newest doctor because it seemed pointless — until I saw the FDA article.

Manufacturers are required to keep track of possible adverse outcomes linked to their products. In the first few years there were 1105 reports of possible problems with mesh used for prolapse repair, or for urinary stress incontinence surgery. In the last three years there have been an additional 2874 adverse reports (FDA, 2011).

According to a just-published FDA report (2011), the most common problems reported when mesh was used for repair of prolapse were:

  • Erosion or protrusion of the mesh from the soft tissues
  • Pain, including pain with intercourse
  • Infections in the area of the mesh
  • Urinary tract problems
  • Bleeding from the mesh site
  • Damage to nearby organs

Who is most likely to have problems with mesh repairs for POP?
According to one of the largest analyses of almost 12,000 women, about 10% of women experienced mesh erosion within a year after surgery. This figure includes both synthetic mesh and biologic types (Abed, 2011). Individual studies have found rates that were as low as 1.2 %, as in a group of 446 women derived from a private uro-gynecology clinic (Stephanian, 2008).

Some risk factors have been described which might predispose a woman to have mesh erode into vaginal tissues. Among 322 women who had a 24 month follow up after mesh repair for POP, having a hysterectomy at the time of POP surgery, and being a smoker increased risk for mesh problems (Cundiff, 2008). When the mesh was placed through a vaginal approach (as opposed to an abdominal incision) there were more mesh complications (Visco, 2001). Other risks may include: increasing age, low estrogen levels, size of mesh implant, and variations in surgical technique (Mistrangelo, 2007). Keeping one’s uterus and use of a mesh just for rectocele repair seemed to decrease risk (Caquant, 2008).

How long does it take for the problems to be apparent?
Mesh problems tend to develop at least a month after surgery for POP (Caquant, 2008) as opposed to the immediate recovery period. The average time for an erosion of mesh to occur may vary by surgery. For those with an abdominal incision for POP, it took 15.6 months versus 4.1 months with a vaginal incision placement, for mesh erosion to be a problem.

Is there a cure?
If a woman has developed pain, or infection, or mesh erosion after a POP surgery, the usual treatment is excision of the mesh via vaginal incision. Thirteen such women were referred to a uro-gynecology clinic for mesh removal. It took an average of two surgeries per patient to remove mesh, and repair any resultant prolapse (Margulies, 2008).

What about mesh used for urinary stress incontinence (SI) repair?
While some 33% of POP surgeries involve mesh placement, over 80% of SI surgeries utilize mesh placed through a vaginal incision (FDA, 2011). Often mesh is used as a sling to elevate and support the urethra. Currently the FDA is reviewing the scientific data on the use of mesh for urinary stress incontinence repair for a later report to the public.

What are the problems reported after vaginal sling surgery for SI?
As discussed earlier, there are several types of materials that can be used for surgical repairs. One of the older synthetic meshes used to make a sling (Mersilene®) had a reported erosion rate of 8% requiring surgical removal. While this material has had decreased use in the past 15 years, some of the women with erosion were 20 years out from their SI surgery (Wohlrab, 2009)

In one group of 179 women with complications from synthetic mesh materials, 125 had a sling placed under the urethra for repair for SI. The most frequent problems were bladder outlet obstruction, pain, and narrow mesh/tape exposure. The mesh complications for SI surgery were found to be different than those for POP repair (Skala, 2011).

A thorough search of published reports of sling surgery complications yielded over 1200 articles. Some complications were more related to surgery (e.g., perforation, bleeding) while others would appear later (e.g., urge incontinence, urinary tract infections, and voiding problems). The number of complications also varied with the type of surgery (Daneshgari, 2008). Not all surgeries utilized synthetic mesh; however for the years examined (1995-2007) mesh was an increasingly popular choice.

How are SI mesh problems treated?
There can be several options for treatment. In one study of 21 patients where vaginal erosion occurred, all were treated with a re-sewing of the vaginal tissues. For 18 women this included surgery for mesh removal. When there was only a small area of erosion, three women were treated with topical estrogen vaginal cream after the stitching. Only two patients needed a second surgery to resolve the problem (Kuhn, 2009)

In the event of vaginal erosion of sling material, the sling should be removed. If only a small area is involved, only the exposed mesh need be removed. The area is then re-sewn (Delorme, 2010)

Unfortunately, if the sling is excised, symptoms can return. Following the removal of a mesh sling, some 36% of women developed new symptoms of urinary stress incontinence (Tijdink, 2011).

On September 8-9, 2011 the FDA will be meeting to review the studies evaluating safety and effectives of mesh placed through vaginal incisions. Repair of both POP and SI will be discussed. Until such time as new guidelines might be published, the FDA asks that women (and their doctors) report suspected problems with GYN mesh use to Med Watch.

Additionally the FDA recommends the following to women who are planning, or have had, mesh surgery for prolapse (FDA, 2011):

Before surgery:

  • Be aware of risks associated with POP repair using a vaginal incision
  • Understand that a surgery with mesh might require additional surgery to correct mesh problems–and that in a few cases even repeat surgery may not cure the problem.
  • Ask your doctor about other POP treatment options. If they recommend mesh, have a clear understanding of why this is the preferred option.

After surgery:

  • Continue with routine check ups
  • Notify their doctors if they begin to have persisting vaginal bleeding/discharge, pelvic or groin pain, or pain with sex.
  • Let your doctor know you have mesh. This is especially important if you are planning to have another abdominal/pelvic surgery.
  • If you are unsure if mesh was used , ask your surgeon if you had a mesh placed during your POP repair

For a concise overview of the FDA’s concerns, and other links to more in depth information you can go to the FDA website.

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