ACOG Practice Advisory on the FDA's Reclassification of Mesh for Pelvic Organ Prolapse
January 6, 2016
(Reaffirmed July 2016)
Washington, DC — On January 4, 2016, the U.S. Food and Drug Administration (FDA) issued two final orders on surgical mesh to repair pelvic organ prolapse (POP) transvaginally.
- The FDA reclassified these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices.
- The FDA required manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.
It is important to note that the FDA orders apply only to mesh placed vaginally to treat POP. The FDA orders do NOT apply to transvaginal mesh for stress urinary incontinence. It is appropriate that full length midurethral slings remain class II devices and do not require a PMA.
For more information and recommendations for the use of vaginal mesh for the repair of POP, see Committee Opinion #513, "Vaginal Placement of Synthetic Mesh for Pelvic Organ Prolapse," developed jointly by ACOG and the American Urogynecologic Society.
A Practice Advisory is issued when information on an emergent clinical issue (e.g. clinical study, scientific report, draft regulation) is released that requires an immediate or rapid response, particularly if it is anticipated that it will generate a multitude of inquiries. A Practice Advisory is a brief, focused statement issued within 24-48 hours of the release of this evolving information and constitutes ACOG clinical guidance. A Practice Advisory is issued only on-line for Fellows but may also be used by patients and the media. Practice Advisories are reviewed periodically for reaffirmation, revision, withdrawal or incorporation into other ACOG guidelines.
This document reflects emerging clinical and scientific advances as of the date issued and is subject to change. The information should not be construed as dictating an exclusive course of treatment or procedure to be followed.
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The American College of Obstetricians and Gynecologists (The College), a 501(c)(3) organization, is the nation's leading group of physicians providing health care for women. As a private, voluntary, nonprofit membership organization of more than 57,000 members, The College strongly advocates for quality health care for women, maintains the highest standards of clinical practice and continuing education of its members, promotes patient education, and increases awareness among its members and the public of the changing issues facing women’s health care. The American Congress of Obstetricians and Gynecologists (ACOG), a 501(c)(6) organization, is its companion organization. www.acog.org