Time to rethink: an evidence-based response from pelvic surgeons to the FDA Safety Communication: “UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse”

Abstract

In July of 2011 the U.S. Food and Drug Administration (FDA) released a safety communication entitled "UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse." The stated purpose of this communication is to inform health care providers and patients that serious complications with placement of this mesh are not rare and that it is not clear that these repairs are more effective than nonmesh repair. The comments regarding efficacy are based on a systematic review of the scientific literature from 1996-2011 conducted by the FDA. Our review of the literature during this time yields some different conclusions regarding the safety and efficacy of mesh use in prolapse repair. It may be useful to consider this information prior to making recommendations regarding mesh use in prolapse surgery according to the recent UPDATE.

Transvaginal single-incision mesh reconstruction for recurrent or advanced anterior vaginal wall prolapse

“…Murphy et al [12] in their answer to the 2011 FDA conversation concerning the potential risks of transvaginal mesh highlighted the surgical technique and the experience of the surgeon to be an important factor in minimising the complication rate, especially the rate of exposure. Trials performed by experienced surgeons (who are performing this procedure on a regular basis) showed lower erosion rates [12,25,26]. The further development of meshes into single-incision methods in contrast to former transobturator meshes is consistent with our low rate of complications.…”

“…Many questions remain open: the only true mesh-specific symptom is mesh erosion possibly causing infection, bleeding, dyspareunia; the complications in focus such as dyspareunia, pelvic pain, infections or bleeding also occur in patients with native tissue repair. Only rare data are available on the number of complications [12]. Complications after mesh implant might be a result of high mesh load of large and heavy meshes and the surgical technique (e.g.…”

Transvaginal six-arm mesh OPUR in women with apical pelvic organ prolapse — analysis of short-term results, pelvic floor ultrasound evaluation

“…Supporters of transvaginal meshes (TVM) remind that although complications are more often in TVM meshes, but they are less serious in comparison with abdominal or laparoscopic route. This is one of the reasons why specialists often choose vaginal route [4,5]. There is limited evidence of transvaginal meshes and most of those evaluated so far are no longer available [3].…”

Retrospective comparison between the Prolift and Elevate anterior vaginal mesh procedures: 18-month clinical outcome

“…Transvaginal placement of surgical mesh (TVM) may provide an anatomical improvement compared with the traditional POP repair without mesh, particularly in the anterior compartment [2].…”