Objectives: Implantable devices treated with phosphorylcholine (PC) have been successfully used in cardiac, ophthalmic, and other applications. This surface modification has resulted in a reduction in the host inflammatory responses. This pilot study tested the safety and efficacy of PC treated polypropylene mesh grafts implanted for the treatment of pelvic organ prolapse.
Study Design: Surgeons from five U.S. sites collected data on subjects implanted with Perigee IntePro Lite+PC. Pre-procedure data collected included demographics and prolapse severity. At follow-up, subjects were assessed for anatomical outcomes (success≤stage I POPQ or Baden Walker), symptomatic improvement, and complications, particularly mesh exposure.
Results: A total of 40 subjects were enrolled with 80% (32/40) of them completing at least 5-7 months of follow-up. Mean patient age was 60 years (range 36-78 years) and the mean BMI was 28 (range 20-40). There were no cases of mesh exposure/extrusion or granuloma formation. The anatomical success rate was 100% at 5-7 months (32/32).
Conclusions: This is the first publication on pelvic mesh treated with PC. There were no adverse events attributed to this surface modification. However, as the numbers are small, the results are not statistically significant. PC surface modification of pelvic mesh shows promise in its application for the reduction of mesh related complications.
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http://dx.doi.org/10.1016/j.ejogrb.2012.11.015 | DOI Listing |
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