How did patients rate their comfort and overall satisfaction with the implanted micro-inserts?
In the Phase II study, a woman’s tolerance to wearing Essure was ascertained at the 3, 6, 12, 18, 24, 36 and 48-month follow-up, and has been rated as “good” to “excellent” in 99% of women at all visits. Women in the pivotal trial consistently rated their comfort in wearing the micro-inserts as very high. One-week post-device placement >95% of women rated their comfort as “good”to “excellent”. At all subsequent study visits >97% of women rated their comfort with wearing Essure as “good” to “excellent”. In the Pivotal trial, women consistently rated their overall satisfaction with the micro-inserts as very high. One-week post-device placement >95% of women rated their satisfaction as “somewhat satisfied” to “very satisfied”. At all study visits through two years of follow-up, at least 98% of women rated their overall satisfaction as “somewhat” to “very satisfied” (this included women who were not able to rely on Essure). At their four-year follow-up, 92% of women rated their overall sat
