New Congressional Legislation Seeks to Stem The Flood of Unsafe Medical Devices Making it to Market

The Medical Device Safety Act could have a profound change upon the way medical device manufacturers do business and the legal liability they are exposed to

Friday, October 26, 2018 - The Medical Device Safety Act has been proposed in direct response to the shortcomings of the FDA exposed in the film "The Bleeding Edge." The film interviews Dr. David Kessler, a former chairman of the FDA, amongst others, who claim that unsafe medical devices are being rushed to market via the FDA's 501 (k) fast-track program. Dr. Kessler states that the 501 provision was designed to get exceptional medical devices that could save lives to market quickly as long as it could be shown that the device was substantially the same as another device already on the market. The tables turned, however, when a flood of medical devices, too many for the FDA to test individually applied to the FDA for approval. Kessler states the fast-track provision was designed to be an exception but is now the rule. As many as 98% of all medical devices allude FDA scrutiny by taking the 501 (k) fast-track approach and make their way to the consumer. In addition, a medical device rushed to market can still qualify for Class III status insulating the device's manufacturer from legal liability (punitive damages) should the device be proven to cause injury or death. According to www.medtruth.com, "The Medical Device Safety Act aids victims of Essure and allows them to seek legal recourse and ensures medical device manufacturers are incentivized to maintain the safest and most effective products for all patients."

The Medical Device Safety Act was introduced by US Congressman Brian Fitzpatrick as an amendment to the Federal Food, Drug, and Cosmetic Act. The new law will apply retroactively to those who suffer from the Essure birth control device and have filed lawsuits against Bayer. According to www.govtrack.us, "(H.R. 2164: Medical Device Safety Act) amends the Federal Food, Drug, and Cosmetic Act to declare that an action for damages or a person's liability under state law is not affected by the federal prohibition on state or local requirements regarding medical devices. This bill is retroactively effective and applies to pending civil actions." National Essure attorneys representing patients harmed by Essure birth control device are available for a free consultation.

Congress women Rosa DeLauro (CT-03) and Louise Slaughter (NY-25), co-sponsors of the MDSA, address the tens of thousands of Essure victims as well as the tens of thousands more that are sure to come forward with their Essure complaints by saying, "The U.S. has a systemic problem with medical device oversight and unfortunately the Food and Drug Administration is not doing its job as a regulatory agency. Faulty medical devices, such as St. Jude defibrillators, Essure contraception, and power morcellators have had tragic and life-changing effects on the lives of American families across the country. Congress should step up and pass both the Medical Device Safety Act and the Medical Device Guardians Act to give patients more resources needed to ensure their health and safety."

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
• 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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