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Essure Permanent Birth Control Will Become Standard Of Care – Conceptus

This article was originally published in The Gray Sheet

Executive Summary

Conceptus expects its Essure non-incisional permanent birth control device to replace tubal ligation for the estimated 700,000 women undergoing sterilization procedures in the U.S. annually

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Conceptus Essure Contraceptive Approved Three Months Post-Panel Review

FDA's approval of Conceptus' Essure non-incisional permanent birth control device includes a requirement that the company document the placement failure rate with newly trained physicians and identify factors associated with the failure, the agency notes in a Nov. 4 "talk paper" announcing the approval

Conceptus Essure Contraceptive Approved Three Months Post-Panel Review

FDA's approval of Conceptus' Essure non-incisional permanent birth control device includes a requirement that the company document the placement failure rate with newly trained physicians and identify factors associated with the failure, the agency notes in a Nov. 4 "talk paper" announcing the approval

Ob/Gyn Panel Reassured By Conceptus Essure Data, Recommends Caveats

Conceptus will ask FDA to drop a labeling requirement that a hysterosalpingogram (HSG) be performed three months after Essure placement, in the event that the condition accompanies approval of the non-incisional permanent birth control device

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