A Retrospective Analysis of the Adiana® Permanent Contraception System in Clinical Practice

Abstract

To assess intra-operative characteristics of the Adiana Permanent Contraception procedure when performed in a community practice setting. Retrospective medical chart review. 5 obstetric and gynecology clinical practice sites in the U.S. 127 patients who had an Adiana procedure. Patients underwent the Adiana procedure between July 2009 and September 2010 and intra-procedure variables were reviewed. Preliminary data for patient characteristics, bilateral matrix placement, procedure setting, time, distention media type and balance, anesthesia regimen and intra-procedure adverse events were obtained. Patients were 37.0 ± 6.6 years of age (range 21-50) on average. Bilateral matrix placement was successful in 124 out of 127 patients (97.6%). Most procedures were conducted in office (n = 78 or 61.4%), while the others occurred in the hospital (n = 28 or 22.1%) or in an ambulatory center (n = 21 or 16.5%). Glycine was the most common distention media and was used in 77 (61.1%) procedures. The average amount of distention media was 1411.0 ± 962.1 cc (range 300-4500) with an estimated loss of 44.0 ± 69.0 (range 0-200). Out of all patients, 23 (18.1%) received a NSAID prior to the procedure. Paracervical block (PCB) was the most common anesthesia regimen and was administered in 49 (38.5%) cases.Tabled 1Procedure VariablesDistention Media Glycine77 (61.0%) Sorbitol20 (15.8%) Other/unknown30 (23.2%) Amount, cc1411.0 ± 962.1 (300-4500) Loss, estimated, cc44.0 ± 69.0 (0-200)Anesthesia Regimen NSAID23 (18.1%) Paracervical block (PCB)49 (38.5%) Intravenous (IV)27 (21.3%) General11 (8.7%) Unknown40 (31.5%) Open table in a new tab There were no adverse events related to fluid overload. No perforations or serious intra-procedure adverse events occurred. Preliminary analysis shows that the Adiana procedure performed in the community setting is associated with high bilateral placement rates, proper distention media management and no serious intra-procedure adverse events.