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Table 1 Findings at follow-up by HSG in phase II [2] and pivotal [3] trials; data as of December 2001

From: Radiological control of Essure placements

Phase II (n=200)

Pivotal (n=456)

Satisfactory microinsert location at 3 months

194/200 (97%)

437/456 (96%)a

Bilateral occlusion at 3 months (in patients with satisfactory microinsert location)

187/194 (96.4%)

421/437 (96%)

Bilateral occlusion at 6–7 months in patients with satisfactory microinsert location

194/194 (100%)

437/437 (100%)

Satisfactory placement and occlusion after replacement of expelled microinsert

n.a.

9/9 (100%)

  1. aMicroinsert expulsions were noted on the HSG in 14 of these 456 women. Nine of these chose to undergo a second procedure, and all 9 had a successful bilateral placement. These nine women are not reflected here as a successful placements, however, since all had unsatisfactory device location at the initial HSG
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