Women's Health Weekly
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Contraception
PMA supplement supports Essure 4- and 5-year effectiveness
March 31st, 2005
Conceptus, Inc., (CPTS), developer of the nonincisional permanent birth control procedure Essure, announced that it has submitted a premarket approval (PMA) supplement to the U.S. Food and Drug Administration (FDA) in order to extend effectiveness data on the Essure product labeling. The supplemental filing supports an extension of the effectiveness of Essure to 4 and 5 years of follow-up and is expected to be unchanged from the 99.8% effectiveness rate for 1, 2, and 3 years of follow-up. There continue to be no pregnancies to date among patients who had been enrolled in the Essure phase II and pivotal trials. "With our 5-year data, Essure has...
Source: Women's Health Weekly (2005-03-31)
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