> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Rep. Fitzpatrick to Release Essure Investigation Findings
- URL: https://www.fdaweb.com/rep-fitzpatrick-to-release-essure-investigation-findings/
- Published: 2016-02-12T12:00:00.000Z
- Updated: 2026-09-15T02:35:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134751

> Just weeks away from CDRH completing a safety review of Bayer Health’s controversial Essure permanent birth control device, Rep. **Mike Fitzpatrick** (R-PA) now is planning to release investigation findings 2/17 to expose unreported deaths caused by the device and complaints alleging illegal kick-backs from the manufacturer to doctors. Fitzpatrick has been calling for removal of Essure from the market, and introduced the [E-Free Act](https://www.congress.gov/bill/114th-congress/house-bill/3920/all-info?ref=fdaweb.com) in November of 2015\. When releasing his findings, Fitzpatrick will be joined byDevice Events reporting expert **Madris Tomes** and two women allegedly harmed by the device, **Amanda Dykeman** and **Angie Firmalino**.  
>  
>  
>  
>  
>  
> Late last year, CDRH said it will announce findings of its internal Essure safety review by the end of February, at which time it will identify appropriate next steps. In September, FDA and Bayer took [major criticism](http://www.fdaweb.com/login.php?sa=v&aid=D5133428&searchWords=essure&cate=S&stid=%241%24H.1.E75.%24kxUgKlFF.vjtgPPWtut6j1) from an advisory committee for not requiring or conducting a randomized clinical trial to allow the Essure contraceptive on the market 13 years ago. FDA’s Obstetrics and Gynecology Devices Panel heard from dozens of Essure patients who complained about pain and other serious problems following implantation of Bayer’s fallopian tube permanent sterilization coil. They called on the agency and the panel to recommend that the device be withdrawn from the market, but no such formal vote was taken.  
>  
>  
>  
>  
>  
> During the meeting, FDA acknowledged that in the past two years it has seen a dramatic increase in the number of adverse events submitted in relation to the Essure device. A [briefing document](http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/UCM463486.pdf?ref=fdaweb.com) released in advance of the panel meeting said FDA had been exploring various tools for “social listening” as a means to expand its ability to identify and refine new safety signals.  
>  
>  
>  
>  
>  
> A CDRH [notice](http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/ucm473946.htm?ref=fdaweb.com) says the Essure evaluation is a “high priority issue for the agency, and we are working expeditiously to conduct an evidence-based review of the available information... Presently, we are reviewing information from the panel meeting, the public docket, as well as additional medical literature and adverse event reports which have been published or received since the panel meeting. In this review, we are focusing attention on the concerns identified by the public speakers and the feedback and recommendations provided by the panel (see [advisory committee meeting summary](http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/UCM464487.pdf?ref=fdaweb.com) and [panel transcript](http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/UCM467456.pdf?ref=fdaweb.com)).”