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Editorial DECEMBER 2008

Practical Implications of the FDA Notice on Transvaginal Surgical Mesh

Rebecca G. Rogers, MD

Decisions about whether or not to introduce new surgical procedures into practice are never easy.1 Many of us have struggled to stay apace of changes occurring in gynecologic surgery as new, minimally invasive surgeries have been introduced. We are all the product of our training, and letting go of the tried and true is difficult and not always prudent. On the other hand, turning into a dinosaur by never incorporating new procedures is not ideal, either.

With the introduction of tension-free vaginal tape (TVT) in 1995, a new era of surgical innovation emerged. Over the past 13 years, gynecologic surgery has seen enormous changes in the variety of choices and treatments we can offer our patients to treat stress urinary incontinence and pelvic organ prolapse. Some of these innovations were accompanied by controlled studies that supported their use, while others were not.2,3 Despite a lack of evidence, there has been widespread adoption of these new techniques.

Importantly, the way these new procedures have been introduced into our practices has changed.
In the past, surgery was learned from mentors, typically senior surgeons, who either taught us directly as residents and fellows or indirectly as colleagues when discussing or observing cases. Surgical innovation was driven by expert opinion. Innovations are still introduced by surgeons, but are now marketed by companies whose primary allegiance is to their stockholders, not to our patients. Neither method of introducing surgical innovation is ideal or evidence based. The problem is compounded by the relative lack of oversight by the FDA of surgical devices in general, and pelvic surgery devices in particular. For the majority of vaginal mesh and mesh kits, the FDA only requires that a device be equivalent to a predicate device (some other device that has already been approved) without comparative trials that support efficacy and safety of the new surgical innovation. Reporting of adverse outcomes using these devices is largely voluntary, which results in underreporting. Additionally, since only adverse events are reported, the frequency with which problems occur is impossible to determine.

On October 20, 2008, the FDA released a warning regarding the use of vaginal mesh for the treatment of pelvic organ prolapse and urinary incontinence.4 The release was spurred by reports of over 1,000 vaginal mesh-related complications reported by a variety of manufacturers to the FDA’s voluntary reporting program. For the dinosaurs, this report is long overdue. For the cowboy innovators, the report is an obstruction to the continued evolution of gynecologic surgery. For many of us, the report just adds to the confusion about what to do in our practices.

A closer look at the warning to both patients and providers reveals a variety of recommendations that seem reasonable; physicians are encouraged to obtain appropriate training before performing these surgeries, to be aware of the risks, and to inform patients of potential problems. Patients are enjoined to ask surgeons whether mesh needs to be used in their repair, and whether their surgeons have experience with its use and can handle potential complications. This focus on communication is important, but still begs the question of what is best for whom. Comparative studies with adequate follow up remain lacking, so whether it is better for our patients to have native tissue repairs or incorporate vaginal mesh into our surgical procedures for the vast majority of repairs is still unanswered. Interestingly, both the cowboy innovators and the dinosaurs dispute each others’ claims by pointing out the lack of evidence for any definitive statements supporting—or opposing—vaginal mesh use.

In the end, what is needed is better oversight and data to guide practice decisions. Of course, that will take time and planning. In the meantime, we are left with some reasonable, cautionary advice.

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Rebecca G. Rogers, MD, Board Member

REFERENCES

1. Varner RE. “To mesh” or “not to mesh.” The Female Patient. 2008;33(5):38–40.
2. 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(7355):67.
3. Nguyen JN, Burchette RJ. Outcome after anterior vaginal prolapse repair: a randomized controlled trial. Obstet Gynecol. 2008;111(4):891–898.
4. The US Food and Drug Administration. FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence. www.fda.gov/cdrh/safety/102008-surgicalmesh.html. Accessed October 27, 2008..