The FDA Failed To Adequately Test Essure Before Allowing It To Come to Market

The FDA has a lot of explaining to do about its cavalier approach to approving dangerous medical devices

Friday, March 22, 2019 - According to former FDA commissioner turned whistleblower Dr. David Kessler, "When it comes to medical devices we've built a system that doesn't work." For the 501 (k), fast track approval process all the manufacturer needs to demonstrate is that their device is "substantially equivalent" to another device that is already on the market. "The 501 (k) provision was meant to be an exception, in essence, a "loophole" became the rule. The vast majority of medical devices today, regrettably, are regulated under this framework." Dr. Adriane Fugh-Berman, Professor of Pharmacology & Physiology at Georgetown University, says that the fast track process causes problems by approving a device based on a device that was previously approved, which in turn was approved because it was similar to yet another device. There is no checks or balances to see if any device in the approval chain had been recalled because it was failing or harmed patients. "Even if the device was recalled because it was dangerous it could still be used as a predicate to having your device FDA approved." National Essure birth control lawyers offering free consultations to families and women harmed by Essure birth control device are available to consult and no obligation.

At the FDA, the lax standards for medical device approval under the 501 (k) provisions have transferred to the premarket approval process. According to Dr. Diana Zuckerman, President, National Center for Health Research, Essure was one of the devices that went through the premarket approval process (PMA). PMA is intended to be the most stringent pathway to get a device approved but the process is not strict enough, and much less strict than the approval process required to bring a new drug to market. New drugs are required to have two clinical trials involving hundreds of patients yet with a new medical device only one small study involving as little as fifty people is required. Angie Furmalino, founder of the Essure Problems Facebook group purchased the DVD's of the July 2002 FDA Essure approval meetings and found that Essure was approved based on a study of a very small number of women studies for a very short amount of time. "The lead investigator presenting evidence on Essure's safety owned stock in (Bayer) this company," and disclosed such information to the panel." Next up was a Bayer paid spokesperson, Gabriel Avena. Essure was approved leaving "open-ended questions" regarding compromising the uterus, tubal perforation, and metal sensitivity.

The US Food and Drug Administration has come under increasing criticism for its use of the 501 (k) fast track approval process to speed medical onto the market. The agency has been accused former commissioner Kessler of being nothing more than a rubber stamp for multinational corporations to bring unproven and dangerous devices to market. The FDA has failed to scrutinize each medical device before it is offered to the public causing doctors to be duped into believing, or should I say assuming, that a medical device like the Essure Birth Control device is safe just because the FDA says so. Rather than take responsibility for the firestorm that is developing surrounding the Essure Birth Control device debacle, FDA commissioner Scott Gottlieb abruptly resigned from his post earlier this month.

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
• 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'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

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OnderLaw, LLC 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. OnderLaw 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.