• Doctors must weigh pros, cons of synthetic vaginal mesh

    May 2012 

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    Since 2004, women have benefited from the placement of synthetic vaginal mesh for the treatment of pelvic organ prolapse. While controversial, the use of pelvic mesh has shown to reduce recurrence of pelvic organ prolapse by about twice that of traditional methods of repair. Use of this common surgical support tool is making headlines as attorneys advertise lawsuits and health care leaders assess the small, but significant number of women who develop complications from its placement.

    In a statement released in December 2011, the American College of Obstetricians and Gynecologists (ACOG) and the American Urogynecologic Society called for closer monitoring of complications from synthetic vaginal mesh placement and introduced additional standards of care to guide physicians in the evaluation, monitoring and reporting of complications.

    Surgical mesh is an FDA-regulated medical device used for the stabilization and repair of abdominal or other hernias since the 1950s. Pelvic surgeons also began using it as far back as the 1970s for stabilization of the pelvic organs. However, it wasn’t until 2001 that it was approved by the FDA for pelvic organ prolapse treatment. Many patients choose vaginal mesh because the risk of subsequent organ prolapse is reduced compared to traditional stabilization techniques using the patient’s own tissue.

    Further, when traditional natural tissue repair has failed more than once, mesh is often seen as the only viable option. The choice creates a dilemma: stabilization using the patient’s own tissue may not offer a long-term organ prolapse cure, but the risk of side effects is dramatically reduced. Vaginal mesh may virtually eliminate future prolapse but introduces new risks for tissue erosion, organ perforation, intractable pain and a marked risk for additional surgeries.

    Because of vaginal mesh’s current classification as a Class II medical device, controlled research studies were not required to evaluate long-term risks or benefits before it was approved for use. Over time, more side effects are being realized and the Food and Drug Administration (FDA) is now considering reclassifying the device to Class III, which would require clinical trials to compare the outcomes of procedures that use mesh with those that do not.

    A small but significant number of women develop complications from synthetic vaginal mesh placement. 

    Mesh complication rates underreported

    As with any adverse event surrounding a medical device, complications are supposed to be reported to the FDA. Reporting is voluntary for physicians and mandatory for manufacturers, but the true number of adverse events is not known because of a lack of reporting and uncertainties about the total number of mesh placements actually made by physicians. Since 2008, the FDA has received more than 2,800 adverse-event reports after mesh surgical repair − 1,500 of which were placed transvaginally. Approximately 100 brands of synthetic vaginal mesh are sold in the U.S. today, but only about 20 of them are actively marketed for use.

    According to ACOG, the most common complications from vaginal mesh can range from mild, temporary pain and discomfort to partial and complete mesh erosion or growth into and through surrounding tissues. Mesh erosion can infiltrate the vagina, bladder and bowel causing pain and increasing the need for surgical intervention to remove the mesh and repair any damage. In some cases, women may need to undergo more than one surgical procedure and could still suffer from long-term pain and complications.

    Long-term complications need further evaluation, ACOG says

    While research into the long-term risks of vaginal mesh use are limited, Canadian researchers cited in ACOG’s statement have concluded that approximately 18 percent of women will have some form of vaginal mesh erosion up to five years post-op, and of that number, 56 percent will require surgical intervention. Another group of 355 women studied developed intractable abdominal pain after having a mesh procedure, and one-quarter of them continued to report pain even after six months of therapy.

    Health care regulatory committees such as the FDA are recommending more stringent adverse-event reporting guidelines for physicians as well as additional clinical trials to properly evaluate the potential long-term use of mesh for pelvic organ prolapse.

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Page last updated: 8/7/2015 2:31:09 PM
  • What the news means for you

    5 to 20 percent of women may have mesh complications

    Rudy Tovar, MD
    Obstetrics & Gynecology

    Wright, Heather, MDPelvic organ prolapse occurs when the natural supporting structure of the rectum, vagina, cervix or bladder weaken due to a variety of risk factors, triggering abdominal pain and pressure, pain during intercourse or urinary incontinence. In some cases, organs may actually be visible outside the vagina or rectum and will require the placement of a temporary device such as a pessary or surgical intervention to replace organs to their original position.

    “Repair of pelvic organ prolapse often goes by the nickname “bladder tack” or “bladder tuck,” . … The accepted methods for repair include using the patient’s own natural tissue or using a synthetic mesh.” 

    Most women who develop pelvic organ prolapse will likely experience worsening of symptoms as time passes. While preventive measures have not been widely studied, early interventions such as weight loss, treatment of chronic constipation, avoidance of repetitive heavy lifting and early institution of regular pelvic floor exercises (often referred to as Kegels) may prevent development or worsening of the problem. It is not clear whether avoidance of vaginal birth and elective cesarean section as an alternative would prevent development of pelvic organ prolapse.

    Recurrence vs. complications

    Known by many alternative names, repair of pelvic organ prolapse often goes by the nickname “bladder tack” or “bladder tuck,” though these terms aren’t always accurate and it isn’t always the bladder that has prolapsed. Before treating any case of pelvic organ prolapse, patients must be counseled and given a choice of methods for repair. The accepted methods for repair include using the patient’s own natural tissue or using a synthetic mesh. There are positives and negatives to both methods.

    To use natural tissue, the connective vaginal tissues supporting the bladder (in the case of bladder prolapse) are essentially tightened to recreate a shelf, or hammock, on which the bladder can rest. Complications of mesh are avoided, but there is a higher rate of recurrence − currently research shows about 30 percent of women who opt for natural tissue repair will have a recurrence. If the patient chooses mesh, many women will have a decreased degree of prolapse recurrence, but the risk of complications is higher.

    Because of the high number of unreported cases, an exact percentage for mesh complications is unknown, but observational studies suggest a range between 5 and 20 percent. While not every woman notices symptoms right away, the most common complaint that brings patients in for treatment is painful intercourse or reports from their partner that something feels abnormal during intercourse. Other women complain of vaginal discharge and vaginal or lower abdominal pain that will have to be investigated to determine whether it is related to mesh erosion.

    The majority of mesh complications occur in women who have the device placed transvaginally – that is, through an incision in the vagina. There is the option for alternative abdominal laparoscopic placement, which carries fewer complications overall but can still run the risk of erosion into the bladder or bowel, a complication that can require more than one surgery and the help of specialists to repair.

    It is difficult to predict which women will experience side effects from mesh placement. While about three-quarters of women may have no problems and heal well, the remaining 25 percent can face significant challenges. It is important to counsel patients about the risk of mesh erosion prior to the procedure and then take steps to prevent complications. Vaginal estrogen creams are a first-line defense and are often prescribed to patients to help strengthen vaginal tissue and prevent the mesh from being able to erode tissue as easily.

    Treating mesh complications

    Here at UK, we take mesh erosion seriously and use a multidisciplinary approach to treat each case. In order to properly treat mesh complications, we must first determine whether a patient’s symptoms are mesh-related.

    For patients who present without pain, we may be able to reverse erosion through the use of a small mesh excision and the use of vaginal estrogen creams to help strengthen the tissue. In most cases, these creams will need to be used long-term.

    Before undergoing surgery for pelvic organ prolapse, it is important to talk openly with your physician. Ask which method is best for you and why. Don’t be afraid to ask about the surgeon’s experience working with vaginal mesh as well as what his or her complication rates are.

    For women who are currently experiencing pelvic organ prolapse, UK Women’s Health Obstetrics & Gynecology holds a weekly prolapse clinic that’s just for these problems. The clinic can be reached at 859-323-0005.

    Dr. Tovar is medical director of UK Women’s Health Obstetrics & Gynecology and assistant professor of obstetrics and gynecology in the UK College of Medicine.

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