Search Results for Essure

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Reps Question Gottlieb on Bayer's Follow-Up Essure Studies By Zachary Brennan - Published 31 October 2017

Reps. Rosa DeLauro (D-CT), Jan Schakowsky (D-IL) and Louise Slaughter (D-NY) on Monday sent a letter to FDA Commissioner Scott Gottlieb regarding concerns related to Bayer's postmarket study for its permanent birth control device Essure.

Categories: News, US, FDA, Compliance, Medical Devices, Postmarket surveillance

Tags: Essure, Bayer, Gottlieb, medical device safety

FDA Approves New Labeling for Essure, Closes Trade Complaint Against Bayer By Michael Mezher - Published 15 November 2016

The US Food and Drug Administration (FDA) on Tuesday said it has approved new labeling for Bayer's permanent birth control device Essure, in line with the agency's recently finalized labeling guidance.

Categories: News, US, FDA, Labeling, Medical Devices

Tags: Essure, Boxed warning, Patient decision checklist

FDA Finalizes Guidance on Boxed Warning, Patient Decision Checklist for Essure Devices By Michael Mezher - Published 31 October 2016

The US Food and Drug Administration (FDA) on Friday finalized its guidance requiring a boxed warning and patient decision checklist for Bayer's permanent implantable birth control device Essure.

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

Tags: Essure, Boxed Warning, Patient Decision Checklist

FDA Signs Off on Bayer Study of Essure Following Numerous Adverse Events, Deaths By Zachary Brennan - Published 02 September 2016

The US Food and Drug Administration (FDA) on Friday approved Bayer’s updated postmarket surveillance study plan for its permanent birth control device Essure, which has been linked to four adult deaths, 15 incidences of pregnancy loss and 631 reports of pregnancies in patients with Essure.

Categories: News, US, FDA, Clinical, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Essure, Bayer, adverse events, medical devices

Health Canada to Develop Better Risk Communications on Essure Contraceptive Devices By Michael Mezher - Published 25 May 2016

Canadian drug and device regulator Health Canada on Monday said it is working with Bayer to develop better risk communication for the permanent birth control device Essure after a safety review of the device found the its risks are not adequately communicated.

Categories: News, Canada, FDA, Health Canada, Communication, Medical Devices, Postmarket surveillance

Tags: Essure, Bayer

[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

Congressional Hearings Focus on Compassionate Use, FDA Issues By Zachary Brennan - Published 25 February 2016

Aside from Thursday’s summit on President Barack Obama’s Precision Medicine Initiative (which can be viewed in its entirety here), the Senate and House held two other hearings focused on the inner workings of the US Food and Drug Administration (FDA).

Categories: News, US, FDA, Crisis management, Drugs, Ethics, Government affairs, Medical Devices, Postmarket surveillance, Research and development, Submission and registration

Tags: Essure, compassionate use, right-to-try, Ostroff, Ted Cruz, genetic manipulation

Congressman, Consultant Discuss Goals in Raising Claims About Essure By Michael Mezher - Published 22 February 2016

This article covers a clarification from Rep. Fitzpatrick's office and Madris Tomes, a consultant whose analysis of publicly available data from the US Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database sparked the allegation that Essure was associated with more cases of fetal death than previously reported by FDA.

Categories: News, US, FDA, Medical Devices

Tags: Essure, Rep. Mike Fitzpatrick (R-PA), MAUDE

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

FDA to Announce Next Steps in Essure Review By Michael Mezher - Published 25 November 2015

The US Food and Drug Administration (FDA) says it plans to make an announcement on the birth control device Essure in February 2016, after the agency completes a "high priority" review of the device's safety.

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

Tags: Essure, DeLauro, Fitzpatrick

New Bill Directs FDA to Pull Bayer Birth Control Device By Zachary Brennan - Published 04 November 2015

In an unprecedented move, Rep. Michael Fitzpatrick (R-PA) on Wednesday unveiled a new bill that directs the US Food and Drug Administration (FDA) to withdraw from the market Bayer’s birth control implant Essure.

Categories: News, US, FDA, Government affairs, Medical Devices, Postmarket surveillance, Quality

Tags: Essure, E-Free Act, Bayer, birth control, medical device, FDA

DeLauro Calls for FDA to Pull Birth Control Device By Michael Mezher - Published 12 October 2015

Citing safety concerns and a recent citizen's petition, US Rep. Rosa DeLauro (D-CT) is calling for the US Food and Drug Administration (FDA) to pull the birth control implant Essure from the market.

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

Tags: Essure, Rosa DeLauro, Bayer, Citizen's Petition, Obstetrics and Gynecology Devices Panel