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Conceptus Essure

This article was originally published in The Gray Sheet

Executive Summary

Non-incisional permanent birth control manufacturer releases pivotal trial data from 518-patient, multicenter trial May 7 at the American College of Obstetricians and Gynecologists annual meeting. Of 507 women, or 98% of the study subjects who attempted placement, 92% achieved bilateral placement. The 98% who completed bilateral placement and completed three-month follow-up were able to rely on the device for contraception. In addition, 92% of employed women were able to return to work the next day. The firm submitted its PMA application on April 19 and anticipates going before FDA panel as early as July (1"The Gray Sheet" March 25, 2002, p. 21)...
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