title: Adverse events associated with pelvic organ prolapse surgeries that use implants.
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).
  
  
  CONCLUSIONS
  Vaginal exposure occurred more frequently with permanent mesh than biologic graft, may require multiple treatments, and occasionally require surgical excision.
  
  
  METHODS
  : II.
authors.affiliation: 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.
authors.forename: Keri S
authors.initials: KS
authors.lastname: Wong
authors.forename: John N
authors.initials: JN
authors.lastname: Nguyen
authors.forename: Terry
authors.initials: T
authors.lastname: White
authors.forename: Shawn A
authors.initials: SA
authors.lastname: Menefee
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Walter
authors.forename: Cara J
authors.initials: CJ
authors.lastname: Krulewitch
authors.forename: Colin T
authors.initials: CT
authors.lastname: Anderson-Smits
authors.forename: Sharon M
authors.initials: SM
authors.lastname: Jakus-Waldman
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001672:Biocompatible Materials / Q000009:adverse effects*; D020878:Device Removal; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D056887:Pelvic Organ Prolapse / Q000601:surgery*; D011183:Postoperative Complications / Q000628:therapy; D011475:Prosthesis Failure / Q000009:adverse effects*; D019919:Prosthesis Implantation / Q000009:adverse effects; D012189:Retrospective Studies; D013526:Surgical Mesh / Q000009:adverse effects*
chemical_list: D001672:Biocompatible Materials