Search Results for Essure Problems

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[Update] FDA: New Postmarketing Study, Black Box Warning for Essure By Zachary Brennan, Michael Mezher - Published 29 February 2016

This article has been updated with more information presented by FDA in a press call Monday and the release of the draft guidance referenced in FDA's announcement.

Categories: News, FDA, Labeling, Medical Devices, Postmarket surveillance

Tags: Essure, Bayer, Essure Problems, Black box warning

Bayer Refutes Congressman's Claims on Essure Safety By Michael Mezher - Published 18 February 2016

Editor's Note: On Wednesday, Focus reported allegations raised by Rep. Mike Fitzpatrick (R-PA) during a press call that Bayer's permanent birth control device Essure is associated with far more reports of fetal death than previously reported by the US Food and Drug Administration (FDA). After publication we received a statement from Bayer Healthcare refuting those allegations. In this article we discuss Bayer's response and clarify certain aspects of the claims made by Rep. Fitzpatrick and Madris Tomes, a consultant who investigated the claims.

Categories: News, US, FDA, Medical Devices

Tags: Essure, Essure Problems, Bayer

Congressman Says More than 300 Fetal Deaths Related to Essure Ahead of FDA Announcement By Michael Mezher - Published 17 February 2016

Rep. Mike Fitzpatrick (R-PA) on Wednesday presented new information raising questions about the safety of the permanent birth control device Essure, claiming the number of fetal deaths related to the device are far greater than what has been reported by the US Food and Drug Administration (FDA).

Categories: News, US, CDRH, Medical Devices, Postmarket surveillance

Tags: Essure, E-Free Act, Bayer, Conceptus, Rep. Mike Fitzpatrick, Essure Problems