Essure's Fetal Deaths May Be Greatly Understated
A complete search of the FDA adverse events database has revealed many more fetal deaths have been caused by the Essure birth control device than first reported
Friday, April 13, 2018 - Reuters.com reported that " The U.S. Food and Drug Administration may have greatly underestimated the number of fetal deaths among women who became pregnant after using Bayer AG's Essure contraceptive device, according to a private analyst who combed through the agency's public database."
When the FDA was asked how many fetal deaths have occurred in women who use Essure, the agency responded with an official total of 5, a number to be expected in over 1 million Essure implants. That low a number didn't sit well with one of their employees, however, a data analyst who quit the company, started her own medical complaint analytical firm, and decided to blow the whistle on the FDA to expose the true number of fetal deaths she found.
Madris Tomes quit the FDA and founded and manages Device Events. She has revealed that by simply changing the computer search terms to be more inclusive, adverse events from the FDA'a database show that 303 fetal deaths can be linked to Essure, not the 5 the FDA claimed. Ms. Tomes told Reuters.com, "When adverse events go to the FDA, 'death', 'injury' or 'malfunction' are the boxes you check," Tomes said. "My system searches the (fuller) narrative," she said, using keywords such as 'fetal death', 'stillbirth', 'stillborn' and 'miscarriage'. In addition to expanding the search terms of the database search, Madris also expanded the breadth to include the body of the complaint. Previous searches had limited the searches to the subject line only. It has also been revealed that the instructions to fill out when reporting a fetal death to the FDA are flawed and do not include the term "death" if a fetus is aborted or miscarried. As a result, the number of fetal deaths due to Essure could be in the thousands of women who have lost their baby having conceived while on Essure to miscarriage.
Women who have lost their pregnancy to the Essure malfunction are suing Bayer, maker of Essure and allege that they have uncovered evidence that Bayer knew of around 2000 unwanted pregnancies that occurred but reported only about 1/3 of them to the FDA. The FDA has received over 10000 adverse event reports since the agency first approved the birth control device in 2002. Women have complained that the permanent birth control device caused serious side effects that have prompted Essure's maker, Bayer, to update the black box warning label on the product to state the following:
"WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System of Permanent Birth Control during a discussion of the benefits and risks of the device." Filing an Essure lawsuit will allow you to hold the pharmaceutical company accountable for the damage it has caused you or a loved one, while also providing real compensation for your medical expenses, suffering and loss.
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 Groups Document The Device's Failure | 9/22/2018
- 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 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
We will represent all persons involved in an Essure lawsuit on a contingency basis, meaning our attorneys charge never charge any legal fees unless we win compensation in your case. For a free no-obligation consultation please fill out our short online contact form and one of our Essure lawyers will contact you to answer any of your questions.
No-Cost, No-Obligation Essure Lawsuit Case Review If You or a Loved One Suffered from Essure Problems
Onder Law is a St. Louis personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. The Onder Law Firm has represented clients throughout the United States in pharmaceutical and medical device litigation such as Pradaxa, Lexapro and Yasmin/Yaz, where the firm's attorneys held significant leadership roles in the litigation, as well as Actos, DePuy, Risperdal and others, and other law firms throughout the nation often seek its experience and expertise on complex litigation.
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