Essure Groups Document The Device's Failure

When the government fails to do its job and alert the public that a popular medical device poses life-threatening dangers, market forces usually step in to do the job

Saturday, September 22, 2018 - Essure is a Class III medical device that was required to undergo the FDA's stringent pre-market approval (PMA) process and was approved for sale on November 4, 2002. Since then, tens of thousands of women have complained of the life-threatening side effects the birth control device causes. A recent issue of Time magazine cites more than "16,000 lawsuits (that) have been filed against Bayer over Essure, with women citing complications like migraines, hair loss, organ perforation, and even unintended or dangerous pregnancies, according to ConsumerSafety.org." Other complications from Essure include the device migrating to other parts of a woman's reproductive system and puncturing the uterus, severe bleeding, and the need for a radical hysterectomy in order to remove the device. No medical device has been the focus of more complaints by patients than Essure. Over 750,000 women worldwide have been implanted with the birth control coil and many are calling it a "ticking time bomb."

The Essure problem was largely ignored by the FDA for years prompting numerous resources to develop over the internet that allow those harmed by a faulty medical device to tell about their experience in the hope of alerting others. Upwards of 45000 women who are experiencing Essure's debilitating side effects have joined the Essure Problems Facebook group. These Essure women may have alerted millions of potential and existing Essure patients through their social media accounts to be aware of Essure's potential to do harm to them. Celebrity activist Erin Brockovich and a US congressman joined in and have urged the FDA to remove Essure from the market pending further testing of the device.

The FDA now requires doctors and potential Essure patients to fill out a comprehensive questionnaire that shows both patients and physicians understand the potential hazards Essure poses. The FDA describes the process as follows: "On April 9, 2018, the FDA restricted sales of the Essure device to only doctors and healthcare facilities who use the FDA-approved "Patient-Doctor Discussion Checklist - Acceptance of Risk and Informed Decision Acknowledgement". Sale and distribution of Essure are limited to health care providers who agree to review this checklist with patients and give them the opportunity to sign it, before Essure implantation. The FDA has approved this new safety measure to ensure that the device meets our standards for a reasonable assurance of safety and effectiveness."

Finally, the Netflix documentary The Bleeding Edge combines many sources to focus discontent on the Essure birth control device and may have served as the final nail in Essure's coffin.

As a result of the increased awareness generated by the FDA's questionnaire, The Essure Problems Facebook group, and the FDA's MAUDE database, Essure sales plummeted over 75%. In lieu of the adverse publicity that the film and others have generated, Bayer has decided to pull Essure from the market effective at the end of 2018 due to what it calls economic reasons.

More Recent Essure Complications Lawsuit News:

• The Medical Devices Safety Act Seeks To Make It Easier To Sue Bayer And Other Medical Device Manufacturers | 9/3/2019
• 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
• Immense Discrepancy Found In The Number of Essure Complaints Versus Those Reported by the FDA | 6/21/2019
• 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
• Unwanted Pregnancy Is An Ongoing Problem For Essure Women | 3/1/2019
• Essure Was Preceded By The Safer and Less Expensive Mirena IUD | 2/26/2019
• Doctors May Be Covering Up Essure's Failure | 2/19/2019
• Essure Doctors Act More Like Bayer Commissioned Salespersons When Selling Essure to Their Patients | 2/13/2019
• The E-Sisterhood ASHES Seeks to Improve the FDA's Medical Device Approval Process | 2/8/2019
• Essure Doctors Ignore The Product Discontinuation Order And Are Still Recommending The Birth Control Device | 2/6/2019
• Metal Hypersensitivity Can Cause Unbearable Essure Side Effects | 1/30/2019
• Were Essure Doctors Instructed by Bayer to Lie to Patients | 1/28/2019
• Women Experiencing a Condition Known as Sterilization Regret May Want Essure Reversed | 1/23/2019
• Essure Women May Have Been Lied To By Their Essure Gynecologists | 1/18/2019
• 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
• Essure Symptoms Are Real And Having The Device Removed Will Relieve Them | 1/4/2019
• 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
• New Congressional Legislation Seeks to Stem The Flood of Unsafe Medical Devices Making it to Market | 10/26/2018
• Communicating With Other Essure Women is the Key to Finding the Essure Removal Doctor That is Right For You | 10/24/2018
• Essure Doctors Participate In Bayer's Unethical Marketing Campaign | 10/16/2018
• The FDA Takes Credit For Stopping Essure Sales | 10/10/2018
• Blowing The Whistle On The Essure Birth Control Device | 10/2/2018
• Essure Doctors May Not Be Objective When Dealing With Essure Problems | 9/28/2018
• Bayer's Essure Defense Press Release | 9/27/2018
• Essure Doctors Could Be On Bayer's Payroll Around the Globe | 9/25/2018
• Essure Problems May Be Just Beginning | 9/20/2018
• Essure Is Certain to Fail At One Point Or Another | 9/18/2018
• Essure Complications Trigger A Worldwide Health Crisis | 9/13/2018
• Essure's Life-Ruining Side Effects | 8/31/2018
• Essure Complication Could Be Permanent | 8/30/2018
• Essure's Problems Are Global In Scale | 8/27/2018
• Is Your Gynocologist Merely An Essure Salesperson? | 8/23/2018
• An Avalanche of Product Liability Lawsuits Could Put Bayer Out of Business | 8/20/2018
• 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
• Bayer Continues to Deny Adverse Side Effects of Essure Birth Control | 7/30/2018
• Essure Removal Complications Will Last Decades | 7/26/2018
• Bayer Announces Essure Will Be Taken Off The US Market | 7/24/2018
• Essure to be Removed From the Market in The United States | 7/22/2018
• Essure Causes Fetal Deaths | 7/19/2018
• Essure Birth Control Removal Complications | 7/17/2018
• Choosing The Essure Birth Control Device Was Flawed Logic for Many | 7/12/2018
• Making Informed Essure Birth Control Decisions | 7/9/2018
• Stricter FDA Restriction Being Ignored by Physicians | 7/2/2018
• Essure Removal Presents Challanges and Difficulties | 6/28/2018
• Essure Warnings Spreading Throughout the World | 6/25/2018
• Essure Market Removal Remains Elusive | 6/21/2018
• Essure Causes Hundreds of Adverse Side Effects | 6/18/2018
• 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
• Family Planning Options Including Essure | 6/4/2018
• There Is More To Essure Than Convenience | 5/28/2018
• Essure Removal Complications | 5/23/2018
• Women Elaborate Their Essure Problems | 5/21/2018
• Essure Victims Lobby the FDA to Take Essure Off The Market | 5/16/2018
• Essure Side Effects and Removal of the Device | 5/11/2018
• Social Media Trumps the FDA Adverse Event Reporting System | 5/8/2018
• Changes to the Essure Product Description | 5/4/2018
• Permanent Birth Control Options For Women | 5/1/2018
• Family Planning Professionals Recommend Essure | 4/25/2018
• 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
• Essures Features and Drawbacks | 12/18/2017
• Consumer Reports Analysis of the Essure Birth Control Device | 12/15/2017
• Bayer Defends Essure Safety Record | 12/11/2017
• Essure Complaint Forums | 12/6/2017
• 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