Adverse events associated with pelvic organ prolapse surgeries that use implants.

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.

Perioperative complications and reoperations after incontinence and prolapse surgeries using prosthetic implants.

OBJECTIVE: To estimate the perioperative complication and reoperation rates associated with slings and prolapse repairs using mesh and biologic grafts. METHODS: Analysis of all female members of Kaiser Permanente Southern and Northern California and Hawaii who underwent sling procedures or pelvic organ prolapse surgeries using implanted grafts or mesh between September 1, 2008, and May 31, 2010. Physicians' Current Procedural Terminology Coding System, 4th edition, International Classification of Diseases, 9th Revision, and surgical implant logs were used to identify the procedures performed, implants used, perioperative complications, and readmissions and reoperations within 12 months of the index surgery. RESULTS: During the 21-month period, 4,142 women (mean age 57 years [standard deviation 12.2], median parity 3 [interquartile range 1-4], median body mass index 28 [interquartile range 25-32]) underwent 3,747 (71%) slings and 1,508 (29%) prolapse repair procedures using implanted prostheses. Trocar-related bladder perforations (51 of 3,747 [1.4%]) occurred more commonly than urethral perforations (2 of 3,747 [0.05%]) in sling procedures (P<.001). There were no trocar-related injuries for prolapse repair kit procedures. Mesh-related reoperations after sling procedures were performed for voiding dysfunction or urinary retention (49 of 3,747 [1.3%]), vaginal mesh erosion (30 of 3,747 [0.8%]), and urethral erosion (3 of 3,747 [0.08%]). Reoperations after prolapse procedures were performed more often for vaginal mesh erosion (29 of 858 [3%]) than for biologic graft infection (2 of 650 [0.3%]; P=.01) and were performed more commonly after anterior (19 of 307 [6%]) compared with apical (9 of 487 [2%]) or posterior vaginal mesh repairs (1 of 64 [2%]; P=.018). CONCLUSION: Reoperations for mesh-related complications occurred most often after transvaginal mesh placement in the anterior vagina.