Monday, February 6, 2012

Does Age Play a Role in Transvaginal Patch Complications?

In light of the many adverse events seen among women who have undergone transvaginal mesh surgeries in the past few years, the FDA is considering more stringent controls over approval of the device. Surgeons currently perform as many as 300,000 pelvic organ prolapse and stress urinary incontinence surgeries every year, a large portion of those using mesh in the procedure.

Who Suffers From Pelvic Organ Prolapse?

Women who have gone through childbirth multiple times as well as those who have undergone a hysterectomy or are going through menopause all seem to be more susceptible to pelvic organ prolapse. Additionally, those with a family history of pelvic organ prolapse could be more likely to suffer from POP. Although pelvic organ prolapse is generally a progressive condition which worsens and causes more serious symptoms, in some cases it does not progress and may actually improve with time. When estrogen levels diminish during and after menopause, pelvic organ prolapse is more likely to occur due to the fact that estrogen assists the body in making collagen, a protein which strengthens the supportive pelvic tissues. When there is less collagen in the body, the supportive tissues in the pelvis are more likely to appear, therefore when estrogen decreases, POP becomes more likely.

Is A Woman’s Age a Factor in Pelvic Organ Prolapse?

While older women will be more likely to suffer from POP simply by virtue of the fact that the connective tissues in the pelvic region have had more time to stretch and they have likely gone through childbirth and possibly even menopause or a hysterectomy, the surgery is also performed on women in their forties after giving birth multiple times. One particular study—done in 2002 which involved nearly 700 participants who received the transvaginal mesh patch—resulted in almost universal satisfaction following the procedure.

Some questioned the validity of these results since over four-fifths of the participants were post-menopausal and the average age was nearly 64. This is considered a relatively narrow group of study participants, especially in light of the fact that the procedure is often done on women of childbearing age following the stress of multiple pregnancies. It is likely that the older women were having much more serious symptoms of pelvic organ prolapse as a result of many years of downward gravity on the pelvic ligaments, therefore the relief they received from the surgery could have been more significant.

Who is Most Likely to Have Problems Following a Transvaginal Mesh Implant?

In one of the most comprehensive studies done to date, including nearly twelve thousand women, nearly ten percent of those had some sort of erosion of the implanted mesh within twelve months of the surgery, regardless of whether synthetic or biologic mesh was used in the surgery. It was found that factors which could predispose women to erosion problems included being a smoker or having a hysterectomy simultaneously with their POP surgery. Overall health is also a significant factor in surgery results. When a vaginal approach was used to place the mesh—as opposed to an abdominal incision—there tended to be more adverse results. Older women tended to have more incidences of mesh erosion, even though they were the group who reported the greatest satisfaction with the surgical results. Low estrogen levels—which typically occur in older women—were a factor in erosion as were the size of the mesh implant and the surgical technique variations or skill of the surgeon. Women who kept their uterus during the procedure appeared to have a lowered risk of erosion complications.

How Long Does it Take for Complications to Become Apparent?

Although every surgery and every woman is different, the majority of the mesh erosion problems seemed to develop at least a month post-op. Those who had the surgery via an abdominal incision became aware of erosion problems at around fifteen months, while those who had vaginal incision placement took only an average of four months to realize there were problems. Many women did not report the problems they were experiencing for longer periods of time, either due to embarrassment in discussing the issues with their doctor, or because they believed their problems would resolve in time.

How are Erosion Complications Treated?

Chronic pain, infections or an erosion of the mesh following a pelvic organ prolapse surgery usually requires subsequent surgeries. The typical treatment is to excise the mesh through an incision in the vagina, then re-sewing of the vaginal tissues. Women who only had a small area of erosion were additionally treated with a topical estrogen cream following the surgery. If the vaginal erosion was due to the insertion of a mesh sling, the sling will have to be removed, however this procedure can cause the original symptoms of pelvic organ prolapse to return.

The FDA believes that the number of women coming forward with adverse reports from transvaginal mesh is a significant cause for concern and advises women who have had the surgery to continue with regular check-ups and to notify their doctor if they have any unusual bleeding, discharge or pain. The future of the mesh patch is unclear at this point, however the lawsuits continue to mount.

Author: Sullo & Sullo Attorneys

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