Sunday, November 25, 2012

FDA Communications on Urogynecologic Mesh

This article will address the communications from the FDA regarding Urogynecologic mesh when used transvaginally in the correction of pelvic organ prolapse. The FDA issued the first Public Health Notification regarding this device in 2008, then in 2011 issued an update on the safety and effectiveness of transvaginal mesh used in repair of pelvic organ prolapse. A Current Urology Reports article, An Appraisal of the Food and Drug Administration Warning and Urogynecologic Surgical Mesh, (2012, 13:231-239) notes that the FDA’s 2011 updated warning included a summary of Medical Device reports as well as reviews of the available scientific literature.

The article reports that the FDA estimates that as many as 300,000 women undergo POP repair each year in the U.S. with another 260,000 going in for the surgical repair of SUI. “…the FDA cites estimates that one out of three POP surgeries used mesh and three out of four POP procedures were done transvaginally. For SUI surgery, more than 80% were done transvaginally with mesh.” The Current Urology Reports article goes on to say that FDA literature essentially concludes that while transvaginal POP repair may restore the anatomy in the area there are no improved clinical benefits over repair which does not use mesh in the repair.

FDA Conclusions Regarding the Use of Urogynecologic Mesh for POP Surgery

The article in Current Urology Reports lists five “bullet points” from the FDA regarding the efficacy of transvaginal mesh. Those points include the fact that apical, posterior and transvaginal repairs which implement surgical mesh show no additional benefits when compared with traditional surgical procedures which do not use mesh. The FDA states that a review of vaginal mesh kits used in apical repair might appear effective in the short term, but the longer-term outcomes are as yet unknown. Although there appears to be “anatomic benefits” associated with anterior repair using mesh, adverse symptoms after the surgery as well as recurrent prolapse and the necessity of repeat surgeries are also noted. As far as an improved quality of life, those women who undergo pelvic organ prolapse which implements mesh appear to experience no greater levels than those whose surgery does not use mesh. Abdominal apical prolapse repaired with surgical mesh does appear to result in less recurrence of prolapse when compared to traditional surgery without mesh yet it does not negate the necessity of recurrent surgery altogether.

Safety Issues Regarding Transvaginal Mesh

As far as safety is concerned, the FDA issued seven “bullet points.” The primary point made by the FDA regarding safety of surgical mesh was that patients treated with mesh have many mesh-related complications not experienced by those who undergo POP surgery without mesh. Mesh complications are not particularly rare, with as many as 10% of women who underwent POP surgery using surgical mesh experiencing erosion within a year of the surgery. At least 50% of the women who experienced erosion were required to have the original mesh surgically excised during an operation. Mesh contractions were fairly widespread, leading to “vaginal shortening, tightening and/or vaginal pain.” When transvaginal mesh is used in the correction of vaginal apical prolapse there is a higher rate of complications which require subsequent operations as compared to traditional vaginal surgery. Finally, so far as safety is concerned, the FDA reports that when mesh is used in abdominal pelvic organ prolapse surgery there tend to be fewer complications than when mesh is used in transvaginal POP surgical procedures.

Shortcomings of Existing Literature

The Current Urology Reports article further lists five shortcomings the FDA feels are present concerning the existing literature on the subject of surgical mesh used in transvaginal repair of pelvic organ prolapse. The first shortcoming is that when detailing the effectiveness of transvaginal repair using surgical mesh the results focus only on whether “ideal pelvic support” has been obtained not whether the woman received relief of her symptoms. There is no separation of primary surgeries as opposed to repeat surgeries—a serious shortcoming so far as getting a realistic idea of which surgical procedures lead to the most adverse symptoms.

In the same vein, SUI and POP surgeries are not separately categorized and adverse events tend to be both defined and reported in an inconsistent manner. The FDA believes many of the current studies regarding the use of transvaginal mesh for POP repair are either poorly designed or conducted and may “use incompletely documented inclusion/exclusion criteria, have inadequate evaluator masking and fail to account for variable lengths of patient follow up.” Finally, there are few studies which follow women who have undergone transvaginal POP surgery using gynecologic mesh which exceed two years.

The article states that the conclusion of the FDA stresses that complications are not rare and that this stance is a change from the original 2008 report. The FDA stated they would continue to evaluate the situation and report on their findings “at a later date.” The most frequent adverse effects reported by women who had undergone transvaginal POP surgery using mesh related to erosion through the vagina, infection, pain, bleeding, dyspareunia or pain during sexual intercourse, perforation of surrounding organs and urinary issues. Recurrent prolapse, vaginal shrinking or scarring, neuro-muscular problems and emotional trauma were also reported negative side effects from mesh surgery.

The Stance of the American Urogynecological Society Regarding FDA Statements

The American Urogynecological Society made several statements regarding the FDA’s response to the problems associated with mesh use including the fact that there must be a better approval process than the current 510(k) procedure which allows any medical device or drug to forego clinical trials and more stringent requirements by declaring to be “substantially equivalent” to a device or drug which has already gained FDA approval. This Society also agrees with the FDA that in most cases POP can be treated successfully without the use of surgical mesh thereby avoiding altogether the risks associated with mesh use in this application.
AUGS does, however, acknowledge that the use of surgical mesh could be warranted under certain circumstances but that the surgical procedure should only be performed by surgeons with sufficient training and on patients who have been thoroughly informed about the potential risks. Finally, the article in Current Urology Reports states that AUGS recommends the FDA require “post-market surveillance for existing and future transvaginal mesh devices for POP repair,” including a “national database for all users of vaginally placed mesh, to comprehensively track both positive and negative outcomes.” (2012, p. 235)

The Society for Urodynamics and Female Urology (SUFU)

The SUFU noted in the Current Urology Reports article that while they will not make universal recommendations for or against the use of vaginal mesh based on the current scientific research, they do recommend a review of the 510(k) process for approval as well as properly trained pelvic surgeons to perform the procedures. The American Urological Association largely concurs, stating that while better data is necessary regarding the use of surgical mesh in transvaginal POP surgeries should it be utilized the surgeon performing the operation 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 detailed the FDA’s communications and recommendations regarding the use of surgical mesh in transvaginal pelvic organ prolapse surgeries.

Author: Sullo & Sullo Attorneys

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