Immense Discrepancy Found In The Number of Essure Complaints Versus Those Reported by the FDA

Bayer and the FDA have made it as difficult as possible for consumers to ascertain the actual number of Essure complaints

Friday, June 21, 2019 - The US Food and Drug Administration officially received 6000 Essure adverse event reports in the latest report issued by the FDA. This is in addition to around 12,000 reports the year before. Each Essure patient reporting required revision surgery to remove the device. To date, most Essure complaints center around the device breaking or moving intact and perforating the uterus causing intense pain and bleeding. Essure device lawyers represent persons and families harmed by Essure birth control device due to device malfunction and offer a free consultation before filing a lawsuit claim.

The FDA MAUDE database has been proven to dramatically underreport medical device complaint in the past. It has been discovered that the algorithm in use by the FDA that returns search results is woefully inadequate and fails to include a number of related search terms. For example, a few years ago, former FDA IT manager-turned-government-whistleblower Madres Thomes quit the agency to start her own medical complaint research firm when she discovered over 300 incidences of fetal death that could be attributed to those who were using the Essure birth control device. A standardized FDA MAUDE database search at the time revealed only 5. According to Reuters.com, "Madris Tomes, founder, and chief executive officer of Device Events, said her analysis of thousands of adverse events from the agency's website shows 303 fetal deaths were linked to Essure." The FDA failed to return such related search terms as abortion, ectopic pregnancy, stillbirth, and miscarriage in their results. Other deaths may have occurred from infections and organ perforations.

If the FDA underestimates such important defects as Essure causing death, how many more reports of Essure malfunctions go undetected by MAUDE database searchers? If the current ratio applies, the 6000 reported revision surgeries could be increased significantly. According to Reuters, when U.S. Representative Mike Fitzpatrick was made aware of the fetal death misrepresentation, the congressman "sent the FDA a copy of Tomes' report and urged the agency to review the "immense discrepancy" in numbers. As improbable as it may seem that hundreds of thousands, not six thousand, women have had to have the Essure birth control removed because of the pain it has caused, consider the fact that virtually every woman that goes to the Essure doctor that implanted the device tells the women that Essure could no possibly be causing the symptoms they describe and that the symptoms are "all in their heads." It has also been shown that Essure doctors are receiving legal but highly unethical financial compensation, accounted for as speaking and training fees, but actually based loosely each year on the number of Essure devices they sell.

As a result of all of the above, government legislation is pending that will force Essure doctors to report each and every Essure complaint patients make directly to the FDA. It is also the responsibility of the FDA to make its MAUDE database more accurate and accessible. For more information on the actual numbers of adverse events related to the faulty Essure birth control device you may reach Madris Tomes, founder and chief executive officer of Device Events at her web site: https://www.deviceevents.com/

More Recent Essure Complications Lawsuit News:

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• Essure 2.0 Could Be Coming Soon If It Is Not Already Here | 8/28/2019
• Suffering Essure Women Are The FDA's Long-Term Study | 8/23/2019
• Women from England Report Essure Disasters | 8/15/2019
• Essure Doctors Mislead Women To Believe The Procedure Is Non Surgical | 8/9/2019
• Essure Crazy Tweets Are Too Common To Be Coincidental | 8/6/2019
• The Medical Devices Guardians Acts Will Force Doctors to Report Essure Patient Complaints | 7/26/2019
• Use Caution When Preemptively Removing Essure | 7/18/2019
• Essure Causes Ectopic Pregnancies | 7/15/2019
• Essure Women May Elect Preventative Surgery To Remove It Before Extensive Organ Damage Occurs | 7/9/2019
• Essure Removal Doctors Finds The Device Calcifies Causing Excruciating Pain and Potential Organ Perforation | 7/3/2019
• The FDA May Have Ignored Thousands Of Essure Complaints | 6/27/2019
• Updated Information and Support Groups For Essure Victims | 6/12/2019
• Update on The Medical Devices Safety Act | 6/6/2019
• Essure Women Around the World Document Their Horrible Experiences On YouTube | 5/31/2019
• The FDA And MAUDE Reporting System Are Under Fire For Under Reporting Adverse Events | 5/27/2019
• Women Met In Washington DC With Representative in Congress To Lobby For The Medical Devices Safety Act | 5/21/2019
• The Medical Devices Safety Act Could Open a Flood of Litigation Against Bayer | 5/17/2019
• Essure's Primary Problem Is That The Device Does Not Stay Put Within The Fallopian Tubes Where It is Intended | 5/7/2019
• Bayer May Have Double Crossed Essure Women | 5/1/2019
• Women May Seek To Have Essure Removed Before Complications Start | 4/30/2019
• Doctors, Planned Parenthood, and Bayer Inc. Themselves Continue To Recommend Essure | 4/25/2019
• The Medical Device Safety Act Seeks To Hold Medical Device Makers Accountable | 4/22/2019
• Commission-driven Essure Sales Representatives May Be To Blame For Bribing Doctors to Recommend Essure | 4/8/2019
• Essure Removal Can Create a Never-Ending Nightmare | 4/4/2019
• Gynecologists Push Essure Over Proven Conventional Birth Control Procedures | 4/1/2019
• The FDA Failed To Adequately Test Essure Before Allowing It To Come to Market | 3/22/2019
• Nickel Hypersensitivity Could Leave Essure Women With An Itchy Rash Covering Their Entire Body | 3/18/2019
• Essure Lawsuits Are Increasing Now That Bayer Cannot Hide Behind The FDA Any Longer | 3/15/2019
• Look To Bayer's Annual Report For Accurate Lawsuit Data | 3/13/2019
• Planned Parenthood Continues To Advise To Use The Essure Birth Control Device | 3/9/2019
• Essure Sales Continue Unabated in 2019 | 3/6/2019
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• Doctors May Be Covering Up Essure's Failure | 2/19/2019
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• The E-Sisterhood ASHES Seeks to Improve the FDA's Medical Device Approval Process | 2/8/2019
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• Women Experiencing a Condition Known as Sterilization Regret May Want Essure Reversed | 1/23/2019
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• Essure Problems Facebook Administrators Take Issue With FDA Handling of Essure Crisis | 1/14/2019
• Bayer Says Essure is Safe and Taking it Off The Market is Purely Business Decision | 1/9/2019
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• Women Should Formally Register and Tell Their Essure Birth Control Horror Stories | 12/31/2018
• Essure Problems Will Continue For Decades to Come | 12/22/2018
• The big Essure question is to ask is if the device will eventually fail most of the millions of women who are using it. | 12/19/2018
• FDA Foot-dragging Protected Bayer While Putting Women's Health at Risk | 12/14/2018
• Doctors That Fail to Recognize Essure Complications Commit Medical Malpractice | 12/4/2018
• Essure Removal Proceedures Usually Require Surgery | 11/29/2018
• Bayer Issues New Essure Problems Denial | 11/23/2018
• Essure Removal Is Major Surgery, Not The Walk In The Park That Implanting The Device Was | 11/19/2018
• FDA Whistleblower Madris Tomes Was One of the First to Suspect Essure Problems | 11/9/2018
• Essure Migration Can Destroy a Woman's Uterus | 11/7/2018
• Comparing The Essure Birth Control Device With Tubal Ligation | 11/2/2018
• Doctors Should Be Held Accountable For Covering Up Essure Symptoms | 10/30/2018
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• Blowing The Whistle On The Essure Birth Control Device | 10/2/2018
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• Bayer's Essure Defense Press Release | 9/27/2018
• Essure Doctors Could Be On Bayer's Payroll Around the Globe | 9/25/2018
• Essure Groups Document The Device's Failure | 9/22/2018
• Essure Problems May Be Just Beginning | 9/20/2018
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• Essure's Life-Ruining Side Effects | 8/31/2018
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• Essure Woman Used as Human Guinea Pigs | 8/10/2018
• Women Seeking Essure's Removal From Their Bodies May Never Know if The Procedure Was a Success | 8/8/2018
• Netflix Documentary Slams The Essure Birth Control Device | 8/6/2018
• Bayer Stands Behind Essure | 8/2/2018
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• Making Informed Essure Birth Control Decisions | 7/9/2018
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• Essure Removal Presents Challanges and Difficulties | 6/28/2018
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• Some Doctors May Be Ignoring The FDA Essure Warning Requirement | 6/13/2018
• The Essure Birth Control Device Can Cause Permanent Sterility | 6/8/2018
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• Women Elaborate Their Essure Problems | 5/21/2018
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• Social Media Trumps the FDA Adverse Event Reporting System | 5/8/2018
• Changes to the Essure Product Description | 5/4/2018
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• The FDA Requires a New and Improved Warning For The Essure Birth Control Contraceptive Device | 4/17/2018
• Essure's Fetal Deaths May Be Greatly Understated | 4/13/2018
• Essure Problems Posted on Facebook Group | 4/9/2018
• Bayer's Warning To Women About The Essure Device | 4/2/2018
• Essure Fails To Live Up To Its Promises | 12/29/2017
• Bayer Essure Warning May Have Come Too Late | 12/27/2017
• Essure Women Write About Their Experiences | 12/20/2017
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• Consumer Reports Analysis of the Essure Birth Control Device | 12/15/2017
• Bayer Defends Essure Safety Record | 12/11/2017
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• Leading Birth Control Options | 12/1/2017
• Women Organize To Alert Others of the Dangers of Essure Birth Control | 11/28/2017
• The FDA May Have Underestimated Essure-related Fetal Death Numbers | 11/22/2017
• Women Are Experiencing Essure Problems In Record Numbers | 11/15/2017
• Women Complain About Essures Adverse Side Effects | 11/7/2017
• The Essure Birth Control Device May Have Unwanted Side Effects | 11/1/2017

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