Putting the FDA notifications in perspective

Issue: BCMJ, vol. 51 , No. 8 , October 2009 , Pages 351-353 Clinical Articles

We fully support notifying physicians who are unaware of the releases described in Dr Fenster’s article and welcome the opportunity to open a dialogue that will put these notifications in perspective. The U.S. Food and Drug Administration is a conservative organization that does not publish such notifications lightly or without considerable supporting evidence. In this case, the warnings about surgical mesh use for pelvic organ prolapse and stress incontinence highlight a longstanding controversy among female reconstructive pelvic surgeons.

The use of surgical mesh is not new to reconstructive pelvic surgery. The sacral colpopexy is well established as the gold standard for the repair of vaginal vault prolapse, yet this procedure, which is more than 50 years old, is generally done with surgical mesh.[1] However, the FDA release does not address the sacral colpopexy, but is directed at procedures that place surgical mesh vaginally. The surgeons who developed these transvaginal mesh procedures for prolapse were no doubt unhappy with the poor long-term success rates for traditional repairs of pelvic organ prolapse. They were inspired by the success of the sacral colpopexy as well as by level I evidence supporting the value of mesh in hernia surgery. This group of reconstructive pelvic surgeons worked to develop minimally invasive approaches using mesh to reinforce vaginal repairs of pelvic organ prolapse. Such surgical innovation is not new, but these procedures are unique in that much of the development was funded by the surgical device industry. Regrettably, while considerable resources were marshaled to develop these devices, minimal corporate funds were dedicated to proving clinical efficacy. In fact, these devices have been heavily marketed with minimal evidence for safety or efficacy, which is a primary concern of many of the opponents of these procedures. One exception to this trend is the midurethral sling. The initial retropubic midurethral sling, the tension-free vaginal tape (TVT) device, was developed by Ulmsten as a treatment for stress urinary incontinence.[2] By the time Johnson & Johnson began marketing the device nearly 10 years ago, there was already considerable prospective evidence of its efficacy and safety. Subsequent randomized clinical trials comparing it to the gold standard, the retropubic urethropexy, demonstrated equivalent efficacy.[3,4] Complications with the TVT, while different from those following retropubic urethropexy, were not more common, and TVT had clear advantages over retropubic urethropexy in terms of patient recovery.[5] In fact, a Cochrane review concluded that TVT placement was followed by lower risk of reoperation compared with Burch retropubic urethropexy.[6] The success of TVT use rapidly led to new approaches to the midurethral sling, with level I data supporting equivalent efficacy with comparable complications rates for the transobturator midurethral slings.[7,8] While surgical complications are attributable to the use of mesh, the low incidence of these complications is outweighed by the long-term success rates of 90% for curing stress urinary incontinence. The risk-benefit ratio of surgery in general is an important consideration. All surgeries have a risk-benefit ratio that is influenced by both the potential for beneficial outcomes and the risk of complications. This ratio is different for all surgical procedures and, as highlighted in the FDA notifications, explaining this is an essential component of the informed consent process. As part of the conversation with the patient that the process requires, the surgeon must explain that the risk-benefit ratio for any given procedure is not necessarily the same for all patients. For example, a vigorous, sexually active 40-year-old with stage III prolapse and no risks for recurrence might find the possible increased efficacy of a transvaginal prolapse repair reinforced with mesh does not outweigh the risk of mesh erosion, pelvic pain, or dysparunia. In contrast, a sedentary, abstinent 80-year-old with two previous failed repairs that did not use mesh might find the prospect of a more durable repair does outweigh the potential risk. What makes these discussions difficult is the paucity of data comparing nonreinforced with reinforced repairs, a concern considered in an article about ethical issues and new surgical devices in the Journal of Obstetrics and Gynaecologists Canada.[9]

We agree with the recommendations proposed in the FDA notifications. Clearly, physicians intending to perform these procedures should seek training that not only includes the surgical technique but also an understanding of potential complications and how to manage them. Moreover, as with any surgical procedure, a frank discussion with a patient about the anticipated outcomes and the potential complications for that patient in particular is an essential component of the informed consent process for reinforced repairs. This discussion is simplified in patients considering a midurethral sling for stress urinary incontinence, as there is ample evidence that the procedure has a favorable outcome in the majority of patients. When it comes to transvaginal reinforced repairs for prolapse, there is less evidence. We believe that manufacturers marketing these surgical devices have a responsibility to fund research that not only clarifies the efficacy of their products but also establishes their complication rates and safety. These data will identify subpopulations for whom the transvaginal reinforced mesh repairs have favorable risk-benefit ratios.

Competing interests
In 2005 Dr Cundiff received fees for organizing continuing education for BARD Urologic, a company that makes surgical mesh kits.


1. Nygaard IE, McCreery R, Brubaker L, et al. For the Pelvic Floor Disorders Network Abdominal Sacral Colpopexy: A comprehensive review. Obstet Gynecol 2004; 104:805-823.
2. Ulmsten U, Falconer C, Johnson P, et al. A multicenter study of tension-free vaginal tape (TVT) for surgical treatment of stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 1998;9:210-213. 
3. Ulmsten U, Johnson P, Rezapour M. A three-year follow up of tension free vaginal tape for surgical treatment of female stress urinary incontinence. Br J Obstet Gynaecol 1999;106:345-350.
4. Ward K, Hilton P. United Kingdom and Ireland Tension-free Vaginal Tape Trial Group. Prospective multicentre randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence. BMJ 2002;325:67.
5. Novara G, Galfano A, Boscolo-Berto R, et al. Complication rates of tension-free midurethral slings in the treatment of female stress urinary incontinence: A systematic review and meta-analysis of randomized controlled trials comparing tension-free midurethral tapes to other surgical procedures and different devices. Eur Urol 2008;53:308-309. 
6. Bezerra CA, Bruschini H. Suburethral sling operations for urinary incontinence in women. Cochrane Database Syst Rev 2001;(3):CD001754.
7. Barber MD, Kleeman S, Karram MM, et al. Transobturator tape compared with tension-free vaginal tape for the treatment of stress urinary incontinence: A randomized controlled trial. Obstet Gynecol 2008;111:611-621.
8. Laurikainen E, Valpas A, Kivelä A, et al. Retropubic compared with transobturator tape placement in treatment of urinary incontinence: A randomized controlled trial. Obstet Gynecol 2007;109: 4-11.
9. Ross S, Robert M, Harvey MA, et al. Ethical issues associated with the introduction of new surgical devices, or just because we can, doesn’t mean we should. J Obstet Gynaecol Can 2008;30: 508-513.

Drs Cundiff and Wilkie are clinical professors in the Department of Obstetrics and Gynaecology at the University of British Columbia.

Geoffrey W. Cundiff, MD,, David Wilkie, MD,. Putting the FDA notifications in perspective. BCMJ, Vol. 51, No. 8, October, 2009, Page(s) 351-353 - Clinical Articles.

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