News & Announcements
Update: Important Message About FDA Statement on MUS
posted: April 25, 2019
On April 16, 2019, the U.S. Food and Drug Administration (FDA) issued an unexpected mandate recalling and halting the distribution of all remaining surgical mesh indicated for transvaginal (TV) repair of pelvic organ prolapse (POP), effective immediately. This decision by the FDA comes in the heels of a similar decision in Europe and Australia banning the use of this mesh in patients with pelvic prolapse. According to the FDA, the manufacturers failed to provide reasonable assurance that mesh prolapse repairs were superior to native tissue repairs in the premarket studies required of class III products. SUFU will partner with the following professional societies (AUA, AUGS, ACOG, SGS) in our communications with the FDA regarding their decision on TV POP mesh.
It is important to note, this FDA action is specific to the use of transvaginal mesh for the repair of POP and does NOT apply to the use of vaginal mesh for the surgical treatment of stress urinary incontinence (SUI).
The above represents two parallel, albeit related, issues that are ongoing simultaneously. One has to do with the recall and cessation of mesh for TV prolapse repair. The other has to do with type 1 polypropylene mesh midurethral slings (MUS). These are separate and distinct transvaginal applications of mesh, and should not be treated as a single entity.
Regarding the TV POP mesh issue, a decision has been rendered by the FDA. As of now it remains unclear as to the FDA’s justification for terminating the originally planned three-year extension data asked of the mesh manufacturers. SUFU has corresponded with the FDA following their recent statement, and we continue the dialogue with other professional societies on how best to voice our concerns about the FDA’s stance.
Importantly, we also believe it is crucial to verbalize our concerns that the FDA decision may prematurely and incorrectly affect MUSs. Accordingly, the executive leadership of SUFU feels strongly that a concerted and dedicated effort be placed once again in support of the MUS. While a decision regarding TV POP mesh has already been executed, the figurative MUS “ball” is still clearly in play. There is a strong body of evidence supporting the MUS, which we believe is an important option to preserve for women. For this reason, SUFU will currently focus our attention on preventing slings from following the same fate as transvaginal mesh for prolapse, which has resulted in its being unavailable for use.
I would like to emphasize that we are here to represent our membership objectively and consistent with the evidence in the literature regarding safety and efficacy of any treatment options we have available for our patients. We want to thank all of you who have expressed your opinions and voiced your concerns about this ever changing landscape. I look forward to maintaining close communications with our membership on this important clinical issue.
Kathleen C. Kobashi, MD, FACS