Adverse Events Associated With Pelvic Organ Prolapse Surgeries That Use Implants

Wong, Keri S. MD; Nguyen, John N. MD; White, Terry MD; Menefee, Shawn A. MD; Walter, Andrew J. MD; Krulewitch, Cara J. CNM, FACNM, PhD; Anderson-Smits, Colin T. MPH; Jakus-Waldman, Sharon M. MD

Obstetrics & Gynecology:
doi: 10.1097/AOG.0000000000000008
Contents: Original Research
Abstract

OBJECTIVE: To estimate the rate of vaginal implant exposure associated with biologic grafts and permanent mesh used for pelvic organ prolapse (POP) surgery, to describe treatments used for these complications, and to estimate response rates to these treatments. The secondary aims were to describe the operative and perioperative complications.

METHODS: This was a retrospective analysis of female members of Kaiser Permanente Southern and Northern California and Hawaii who underwent POP surgeries with biologic grafts and permanent mesh between September 2008 and May 2010. Inpatient and outpatient electronic medical records were reviewed for postoperative adverse events.

RESULTS: During the 21-month period, 1,282 women, mean age of 62 years (±10 standard deviation), median parity of 3 (interquartile range 2–4), and median body mass index of 28 (interquartile range 24–30) underwent prolapse repairs with 1,484 implants with a mean follow-up time of 358 days (±276 standard deviation). Vaginal exposures occurred more often with permanent mesh (53/847 [6%]) than biologic grafts (10/637 [1.6%]) (P<.001). Resolution of vaginal exposure after the first treatment occurred in 24 of 63 (38%), whereas 39 of 63 (62%) required multiple treatments. Surgical excision was performed in 20 of 63 (32%) exposures. Permanent mesh exposures were more likely to require surgical excision (20/53 [38%]) than biologic graft exposures (zero of 10) (P=.02).

CONCLUSION: Vaginal exposure occurred more frequently with permanent mesh than biologic graft, may require multiple treatments, and occasionally require surgical excision.

LEVEL OF EVIDENCE: II

In Brief

Vaginal exposure occurs more frequently with permanent mesh than with biologic graft, may require multiple treatments, and occasionally requires surgical excision.

Author Information

Departments of Obstetrics and Gynecology, Kaiser Permanente, Downey, San Diego, and Roseville, California, and Honolulu, Hawaii; and the Division of Epidemiology, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.

Corresponding author: John N. Nguyen, MD, Southern California Permanente Medical Group, Kaiser Foundation Hospital, Department of Obstetrics and Gynecology, 9449 E Imperial Highway, Suite C327, Downey, CA 90242; e-mail: John.N.Nguyen@kp.org.

Funding provided by the U.S. Food and Drug Administration.

Financial Disclosure The authors did not report any potential conflicts of interest.

© 2013 by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.