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Invited Commentary
February 2016

The FDA and the Vaginal Mesh Controversy—Further Impetus to Change the 510(k) Pathway for Medical Device Approval

Author Affiliations
  • 1Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco
  • 2Departments of Obstetrics, Gynecology, and Reproductive Sciences; Urology; and Epidemiology & Biostatistics, University of California, San Francisco
  • 3Department of Obstetrics and Gynecology, University of California, Davis
JAMA Intern Med. 2016;176(2):277-278. doi:10.1001/jamainternmed.2015.7155

In this issue of JAMA Internal Medicine, Sedrakyan et al1 evaluate changes in gynecologic practice in New York following the 2011 publication of a US Food and Drug Administration (FDA) Safety Communication on the use of transvaginally placed surgical mesh to repair pelvic organ prolapse (POP), which occurs when pelvic organs, such as the bladder or rectum, herniate to or beyond the vaginal walls. Prolapse is present in 40% of women, but only 6% report symptoms such as a palpable vaginal bulge, impairment in urinary or bowel function, or decrements in sexual activity.2 Although POP in some women responds to conservative management with pelvic muscle exercises or a vaginal pessary, it is commonly corrected through surgery, with 200 000 inpatient surgical procedures performed annually in the United States. Traditionally, surgical repair of POP was performed by suturing injured or weakened connective tissue to support structures in the pelvic floor. However, this so-called native tissue repair has a high rate of failure, with 30% to 50% of women requiring reoperation.3 Surgical mesh for transvaginal placement, most commonly consisting of nonabsorbable polypropylene, was introduced in 2002 as an implantable device to improve the long-term efficacy of POP repairs by adding strength and support.

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