Comparison of vaginal mesh extrusion rates between a lightweight type I polypropylene mesh versus heavier mesh in the treatment of pelvic organ prolapse
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Abstract
Introduction and hypothesis
The objective of the study was to compare extrusion (vaginal mesh exposure) rates in patients undergoing transvaginal prolapse repair with the trocar-based Apogee and/or Perigee devices (American Medical Systems, Minnetonka, MN, USA) using either the original type I polypropylene mesh (IntePro, American Medical Systems, Minnetonka, MN, USA) or a newer generation lightweight type I mesh (IntePro Lite, American Medical Systems, Minnetonka, MN, USA).
Methods
Data were pooled from three similarly designed prospective multicenter studies evaluating the safety and efficacy of Perigee for correction of the anterior (AC) and/or Apogee to repair the posterior/apical (PC/A) compartments. The first two studies utilized IntePro (mesh density 50 g/m2) and the third utilized IntePro Lite (mesh density 25.2 g/m2). Data were pooled to form IntePro and IntePro Lite groups for comparison. Patient demographics were recorded. Risk factors for vaginal mesh exposure were also considered.
Results
Two hundred and sixty-three patients were implanted with Perigee and/or Apogee with IntePro for a total of 371 heavier mesh implants (174 Perigee, 197 Apogee) compared to 86 patients who underwent Perigee and/or Apogee with IntePro Lite for a total of 116 lightweight mesh implants (60 Perigee, 56 Apogee). Demographics and potential risk factors for extrusion were compared between the two groups. Mean follow-up was 2.0 years and similar between the two groups. In the AC, there were 234 implants, with mesh extrusion occurring in 8.0 % following IntePro compared to 5.0 % following IntePro Lite (p = 0.57). In the PA/C, there were 253 implants, with mesh extrusion occurring in 13.7 % following IntePro compared to 7.1 % following IntePro Lite (p = 0.25). Overall mesh extrusion rates in 487 implants in all compartments were found to be 11.1 % with IntePro versus 6.0 % with IntePro Lite with an estimated odds ratio of 1.93 (95 % confidence interval 0.84–4.44, p = 0.12).
Conclusions
No statistically significant difference in extrusion rates were seen following use of IntePro versus IntePro Lite; however, the 46 % reduction in rate of mesh exposure observed in those receiving the lighter weight mesh may represent clinical importance.
Keywords
Perigee Apogee Extrusion Pelvic organ prolapse Mesh complications Vaginal meshAbbreviations
- AC
Anterior compartment
- PC/A
Posterior compartment/apex
- POP
Pelvic organ prolapse
- RCT
Randomized controlled trial
- POP-Q
Pelvic Organ Prolapse Quantification System
- QOL
Quality of life
- OR
Operating room
- IP
IntePro
- IPL
IntePro Lite
Notes
Acknowledgments
The authors would like to thank the investigators for each of the studies reported in this manuscript as follows:
For the PERIGEE Study: Robert D. Moore (P.I.), Roger D. Beyer, Gopal H. Badlani, Karny Jacoby, Enrique G. Jacome, Sheldon J. Freedman, Michael T. Gambla, and Kurt A. McCammon.
For the PROPEL Study: James C. Lukban (P.I.), Ty B. Erickson, Moises A. Virelles, Seth J. Herbst, Manish Patel, Douglas M. Van Drie, Stuart A. Weprin, James Flaherty, Samuel Zylstra, Roger D. Beyer, Robert D. Moore, Robert W. Vera, John N. Nguyen, and Marc A. Hodroff.
Conflicts of interest
Funding for this clinical study was provided by American Medical Systems, Inc. (AMS). R.D. Moore has served as consultant, speaker, and preceptor for AMS. J.C. Lukban has served as consultant, preceptor, facilitator, and speaker for AMS; consultant and speaker for Novasys; and consultant for Coloplast.
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