The FDA Requires a New and Improved Warning For The Essure Birth Control Contraceptive Device

Potential Essure patients are now forced to sign a form stating that they have been informed of the risks of Essure

Tuesday, April 17, 2018 - Women that wish to practice permanent, non-reversible birth control along with their health care advisor will now be required to sign a form designed by the FDA that demonstrates that they have been read and understand the known risks of the Essure birth control device. The FDA is holding Bayer, maker of Essure, responsible for complying with the first of its kind medical device warning procedure. The FDA has threatened imposing fines and possible criminal penalties should Bayer fails to meet the specific standards of the warning. Bayer is also required to restrict sales of Essure Contraceptive only to doctors that agree to inform their patients of the risks.

Thousands of women that have experienced unforeseen complications from Essure have sued Bayer alleging that the company and their doctor failed to inform them of the risks. Plaintiffs suing Bayer say they have experienced severe pain, excessive bleeding, infections, swelling and allergic reactions to the coil's metallic composition. Some have complained that the device never adhered to one fallopian tube or the other and had migrated to their uterus, puncturing it. Surgeons performing revision surgery have reported finding the device as far away as the abdominal cavity.

Years earlier the FDA ordered that the company place a "Black Box" warning on the device's packaging that has today been updated to state, "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 the discussion of the benefits and risks of the device."

Prospective Essure patients are also warned to be sure that they are finished having children as the device is permanent and irreversible. Essure stresses that patients make sure to continue to practice birth control for at least 3 months after having the Essure coil implanted as it could take that long for sufficient scar tissue to encapsulate the device and block a man's sperm from reaching the eggs. Essure lawsuits plaintiff's allege they were not warned about the potential for Essure risks and dangers.

Essure was originally heralded as a breakthrough medical device and family planning tool, as effective as its predecessor tubal ligation, yet implanted through the vagina without requiring surgery. Essure was also sold to women as reversible and could be easily removed should a woman decide to get pregnant. Essure consists of two coils that resemble the spring from a ball-point pen and is composed of several metal alloys including nickel, a substance which women are finding to be allergic to. The coils are coated with small fibers that are intended to create inflammation on the fallopian tube requiring the body to produce scar tissue around the device. Unfortunately, the scar tissue buildup can also cause infections and encapsulate the device so effectively as to prevent it from ever being removed.

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
• 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