Warning of Use of Transvaginal Mesh by U.S. Food and Drug Administration

In a recent Journal of the American Medical Association Surgery (JAMA Surgery) article, the safety concerns of the use of the transvaginal mesh in pelvic organ prolapse (POP) repair has been noted by the U.S. Food and Drug Administration (FDA).The recent article by two physicians was published in the Journal of the American Medical Association Surgery edition published online on Nov. 30, 2016.

The article highlights studies that reveal the incidences and timing of complications related to the use of the transvaginal mesh organ prolapse repair, the amount of vaginal mesh used with mesh erosions and repeated surgery after pelvic organ prolapse repair and urinary incontinence surgery. The study is discussed expertly in the JAMA article by the authors, physicians Bhumy A. Davé, M.D., a female pelvic medicine & reconstructive surgeon associated with Northwestern Medicine, and Anne-Marie Boller, M.A., M.D., FACRS, a colon and rectal surgeon also with the Northwestern Medical Group in Chicago.

The article points out that the recent transvaginal mesh study focused on the clinically important mesh complications (those that require an intervention as opposed to asymptomatic erosions) and it references a statewide database, which minimizes under reporting that occurs when patients change doctors secondary to complications.

In this article, the authors compare four groups of surgical procedures that use different amounts of mesh: (1) POP repair with transvaginal mesh and mesh stress urinary incontinence sling; (2) POP repair with transvaginal mesh and no concurrent sling; (3) POP repair without mesh but with a mesh sling, and (4) a mesh sling alone.

The authors conclude that there is a dose-response relationship between the amount of mesh used and the need for surgical intervention when the mesh erodes.It is well-noted that patients with pelvic organ prolapse and urinary stress incontinence often need surgical intervention because of mesh erosion. There are varying methods of treating healthy patients with either POP or stress urinary incontinence (SUI).

The question was raised: Does placing a mesh sling at the same time as opposed to later increase the risk of mesh-related complications? A study answering this question would guide treatment decisions and reflect a scenario in which the dose response would be clinically important. The bottom line is that it was difficult to estimate the overall rate of mesh complications. The study was primarily focused on the occurrence of mesh complications and repeated evasive surgical intervention within one year after the initial mesh implantation. The highest risk of erosion of the mesh was found in the vaginal mesh plus sling group and the lowest in the SUI sling group. The risk of repeated surgery with an erosion diagnosis was also the highest in the vaginal mesh plus sling group of the patients investigated.

The combined use of mesh and SUI mesh sling was associated with the highest erosion and repeated intervention risk while mesh sling alone had the lowest erosion and repeated intervention risk.
Thus, mesh used for POP is now a class 3 (highest risk) device, upgraded from a class 2 device, while mesh slings remain class 2. The FDA warnings about the use of mesh for vaginal repair of POP, the risk of mesh erosions with slings for SUI, and the proliferation of these procedures highlight the public health need to provide evidence on mesh erosion and repeated surgery occurrence for these therapies.

Kreisman Law Offices has been handling medical negligence cases, birth trauma injury cases, medical device defect cases, and wrongful death cases for individuals and families who have been harmed, injured or died as a result of the carelessness or negligence of another for more than 40 years in and around Chicago, Cook County and its surrounding areas, including Schaumburg, Glendale Heights, Lake Bluff, Grayslake, Crystal Lake, Chicago (Uptown, New Town, Old Town, Bridgeport, Wicker Park, The Loop, West Town, Greek Town), Lisle, Winfield, Zion, River Grove, Clarendon Hills, Lake Forest and Wilmette, Ill.