ACOG Statement on FDA Regulation of Surgical Mesh
January 4, 2016
Washington, DC — Hal C. Lawrence, MD, Executive Vice President and CEO of the American College of Obstetricians and Gynecologists (ACOG), released the following statement regarding the Food and Drug Administration (FDA) regulation of surgical mesh:
"We appreciate that today's orders from the FDA maintain class II status for surgical mesh that is indicated for non-transvaginal use to treat stress urinary incontinence and abdominal repair of pelvic organ prolapse. This decision is medically appropriate and reflects the current data regarding these indications.
"Patient safety is of utmost importance to obstetrician-gynecologists and to ACOG. That's why in recent years, ACOG has worked with multiple organizations, including the American Urogynecologic Society (AUGS), to understand the potential risk associated with transvaginal use of surgical mesh. This has led to the development of patient selection guidelines and informed consent recommendations intended to maximize patient safety and the well-being of women in need of treatment for stress urinary incontinence and pelvic organ prolapse."
ACOG's Practice Advisory on the FDA orders can be found here.
The ACOG/AUGS joint Committee Opinion on Vaginal Placement of Synthetic Mesh for Pelvic Organ Prolapse can be found here.
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 approximately 58,000 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