March 17, 2013

Update on Synthetic Mesh Used in the Repair of Anterior Pelvic Organ Prolapse

It is believed pelvic organ prolapse affects millions of women, however many women do not seek medical intervention due to the nature of the problem. Pelvic organ prolapse occurs when an organ within the pelvic region drops from its normal spot, pushing against the vaginal walls. Approximately 200,000 women will undergo a surgical procedure for pelvic organ prolapse annually. Of the women who undergo the procedure, at least 30 percent will require an additional prolapse repair procedure. Most women with pelvic organ prolapse experience discomfort and pain on a daily basis. Many will also be unable to exercise or engage in sexual relations.
Pelvic organ prolapse primarily occurs when the muscles holding the pelvic organs in place are weakened from childbirth or surgery. Women going through menopause and elderly women are also more likely to suffer from pelvic organ prolapse. When the pelvic muscles and connective tissues—which are largely comprised of collagen and elastin— are subject to repeated or severe strain, they will no longer hold the pelvic organs in place. Candidates for surgical repair of pelvic organ prolapse are generally women for whom conservative management has not offered significant relief. The type of surgical procedure will depend on the site of the prolapse, whether urinary incontinence is present, the overall health of the patient and the specific patient preferences.
An article published last June in the Current Urology Reports Journal reviews the use of synthetic mesh in the treatment of pelvic organ prolapse. Significant data supports mesh use for POP surgeries although the authors of the Journal article also note the risks involved in the use of transvaginalmesh. Fibroblasts—cells which are involved in the synthesis of the connective tissues—are responsible for a decrease in elastin and an increase in the enzyme which breaks down elastin. It is likely that the increased levels of this enzyme, elastase, probably plays a role in the high failure rates of pelvic organ prolapse surgeries which is estimated to be as high as 29%.
While native tissue was widely used prior to the introduction of synthetic mesh—and continues to be used in many cases—the use of native tissue can further break down connective tissues. Biological grafts also have the tendency to break down when placed in an environment known to break down those proteins. Because of this, the use of mesh seems to have a definite advantage over native tissue or biological grafts as they are—in theory at least—resistant to these protein breakdowns.
The authors consider the ideal graft, whether biological or synthetic, to be “sterile, inert, non-carcinogenic, durable, non-inflammatory, inexpensive, readily available and easy to use.” Mesh implants with larger pore sizes are believed to encourage tissue growth and prevent infections when compared with smaller pore mesh. The most common type of mesh used is made from polypropylene and classified as Type 1, macroporous. Type II mesh, Gore-Tex, is microporous which allows limited tissue growth. In turn, that limited tissue growth may lead to higher erosion and infection rates.
The FDA issued a warning regarding synthetic mesh in 2011; the authors of this study present data from four trials as well as summaries from an additional three trials which compare the repair of the anterior vaginal wall through colporrhaphy vs. the use of mesh. Colporrhaphy is a surgical procedure in which narrowing of the vagina is accomplished through the use of sutures. While the mesh procedures resulted in lower rates of anatomic failures, from 3.2-19% of those patients required treatment for vaginal extrusion. Mesh extrusion can result in painful intercourse, vaginal discharge, odor, pelvic pain and bleeding.
Although most extrusions can be treated in a doctor’s office, others require surgical intervention. The article concludes that while there is insufficient data to support the FDAwarning regarding pelvic pain and mesh contraction, the following improvements suggested by the FDA should be implemented: improved regulations, the careful selection of mesh patients, improvement in patient education, open discussions with patients regarding the risks and benefits of mesh treatment, deeper incisions to allow adequate vaginal tissue coverage and the appropriate training of physicians.