Relevant FDA Communications on Urogynecologic Mesh

The following article will give the reader a comprehensive overview of the FDA’s communications to date concerning surgical mesh when used transvaginally in pelvic organ prolapse surgeries. The article An Appraisal of the Food and Drug Administration Warning and Urogynecologic Surgical Mesh, published in the Current Urology Reports (2012, 13:231-239) gives an overview of the FDA’s conclusions regarding the use of surgical mesh in POP surgeries. The first Public Health Notification issued by the FDA came out in 2008 after over a thousand women submitted adverse health reports following transvaginal surgery using gynecologic mesh. Three years later the FDA issued an update to that report regarding the safety and effectiveness of mesh in POP surgery. At this time the agency reviewed the currently available safety data and scientific research on gynecologic mesh.

This article states that it is estimated that over a third of pelvic organ prolapse surgeries implement surgical mesh and that 75% of all these surgeries were done transvaginally. These numbers come from the over 300,000 women who undergo pelvic organ prolapse surgery annually in the U.S. and over 260,000 who undergo a surgical procedure for stress urinary incontinence. The FDA states that as far as SUI surgeries go, “more than 80% were done transvaginally with mesh.” The FDA’s conclusion is that although POP surgery done transvaginally may restore the woman’s body anatomically, there are few if any benefits over surgeries which do not implement urogynecologic mesh. 

The Conclusions of the FDA Regarding Transvaginal Mesh Use

The Current Urology Reports article lists a number of bullet points set forth by the FDA concerning the safety and efficacy of surgical mesh. Regarding the efficacy of the use of urogynecologic mesh in pelvic organ prolapse surgeries, the FDA believes there are no added benefits when using mesh for apical posterior or transvaginal repairs over older techniques which don’t use mesh. Reviews of mesh kits used during an apical repair might appear to be effective a short time following the surgery but long-term results are unknown.

While anatomic benefits are noted when mesh is used in anterior repair, the negative health symptoms which follow the surgery as well as the likelihood of a repeat surgery are routinely seen. Those who push the use of transvaginal mesh do so under the guise of an improved quality of life for women, however statistics simply don’t bear this out. Women who have pelvic organ prolapse surgery using a mesh device show no improvements in quality of life following the surgery as compared to those whose surgery did not include surgical mesh. When abdominal apical prolapse is surgically repaired with mesh, and compared with older surgical procedures which do not use mesh, recurrence appears somewhat less likely.  

Transvaginal Mesh Safety Issues

The principal point made by the FDA regarding surgical mesh safety is that a large number of complications are experienced by those women who undergo pelvic organ prolapse surgery which implements surgical mesh as compared to those women whose surgery does not include the use of surgical mesh. Complications associated with the use of surgical mesh in transvaginal pelvic organ repairs are not especially rare, and it is believed that over 10% of all women who undergo this particular surgical procedure will experience erosion by the end of the first year. At least half of those will undergo surgery to remove the mesh; many women whose surgery included the use of mesh have noted shortening of the vagina, tightening and vaginal pain—all which hinder or preclude normal sexual intercourse. Complications are very common among women who undergo surgery to correct vaginal apical prolapse when mesh is used. These increased numbers of complications dictate that subsequent operations are necessary in order to correct the problems. Overall, the FDA states abdominally placed mesh to correct pelvic organ prolapse suffers fewer problems than transvaginally placed mesh.

The FDA’s List of Shortcomings of Existing Literature

In the article by Current Urology Reports there are five shortcomings listed by the FDA regarding the existing literature on the use of urogynecologic mesh used in the transvaginal POP repair. One of the shortcomings of this literature revolves around the fact that many reports on the subject only offer details on the success of the transvaginal POP surgery—whether “ideal pelvic support” is achieved. Whether or not the women who underwent the surgical procedure were actually relieved of their adverse symptoms is rarely reported. Primary surgical procedures are not separated from repeat surgeries in the overwhelming majority of the literature therefore it is difficult to get an accurate portrayal of whether the initial surgery led to a greater number of problems or whether the subsequent surgery caused additional adverse symptoms.  

The current literature also fails to separate surgeries for stress urinary incontinence from pelvic organ prolapse, categorizing, defining and reporting adverse events in a very inconsistent way. The FDA finds the current research and studies done on pelvic organ prolapse repair using transvaginal mesh are designed poorly or carried out poorly, using “use incompletely documented inclusion/exclusion criteria, have inadequate evaluator masking and fail to account for variable lengths of patient follow up.” Few of the studies have followed women who have undergone POP surgery which employed transvaginal mesh for more than two years—a completely inadequate length of time for a realistic follow-up.

In the end, the FDA believes that complications are “not rare” when urogynecologic mesh is used in a transvaginal pelvic organ prolapse surgery however noted they intend to continue monitoring the overall situation, reporting their findings at a later date. Erosion is among the most frequent negative health outcome reported by women; the mesh can erode through the vagina, bladder or bowel. Infection, pain, excessive bleeding pain during sexual intercourse, perforation of surrounding organs, urinary problems, subsequent prolapse, vaginal scarring or shrinkage, emotional trauma and neuromuscular issues have all been reported by women whose pelvic organ prolapse surgery implemented the use of surgical mesh and was performed transvaginally.

Other Stances Regarding FDA Statements

Several comments came from the American Urogynecological Society regarding the communications from the FDA. This group felt there should be upgrades made to the 510(k) approval process. This process currently allows medical devices and drugs submitted for approval to skip clinical trials if they can show their device or drug is substantially similar to a device or drug which has already gained FDA approval. Most of the current surgical meshes and mesh kits approved for use in pelvic organ prolapse surgeries gained FDA approval under devices which were approved for hernia repair. The AUGS agrees with the FDA that the majority of pelvic organ prolapse can be successfully treated without using mesh, greatly decreasing the risks associated with mesh devices. According to the Current Urology Reports articles, the AUGS recommends that when surgical mesh use is warranted the procedure should only be done by highly trained surgeons and patients should be thoroughly informed regarding the possible risks of surgical mesh. AUGS also states that a national database which includes all those who undergo surgery with urogynecologic mesh should be implemented which would allow the FDA to successfully track both positive and negative outcomes.

As noted in the Current Urology Reports article another group, The Society for Urodynamics and Female Urology, stated they would make no sweeping recommendations for or against the use of transvaginal mesh however they also advise that the FDA review their current 510(k) process of approval. The American Urological Association concurs, adding that surgeons who perform this particular surgery must “undergo rigorous training in the principles of pelvic anatomy and pelvic surgery, be properly trained in specific mesh implantation techniques and be able to recognize and manage the complications associated with vaginal mesh.” This article discussed the communications sent out by the FDA regarding the use of urogynecologic mesh during transvaginal pelvic organ prolapse surgeries. 

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