Essure lawsuits are being filed across the country from women, who have allegedly suffered harmful side effects. We are working with some of the most experienced Essure lawyers across the nation, who are filing Essure lawsuits to help victims get compensation and there is no fee until you obtain a settlement or award. For a free (no obligation) case evaluation call us toll free at 1-800-992-6878 or fill out a contact form online.
FDA investigating Essure
WXYZ-TV Detroit | Published on Apr 2, 2015
Essure Birth Control: Thousands of Women Reporting Severe Medical Reactions
Thousands of women across the United States said the Essure Birth Control device has changed their lives for the worse. The FDA has received over 5,000 Essure complication reports.
What is the Essure Permanent Birth Control Device?
Essure is a non-hormone permanent birth control device that is manufactured by Bayer and was approved by the FDA in 2002. It is made of polyester fibers (PET), nickel-titanium and stainless steel. The device prevents pregnancy by being implanted inside each of the fallopian tubes during a non-surgical procedure. Once in place, the PET fibers cause an inflammatory reaction with the surrounding tissue. Within a few months, scar tissue forms around the device and blocks the egg from entering the uterus to be fertilized, thereby, preventing pregnancy.
Why Are There Essure Lawsuits?
Patients implanted with Essure are seeking to file lawsuits because they have suffered harmful side effects and, in some cases, required surgical removal of the device. So far, thousands of women have reported dangerous side effects after being implanted with the device. In addition, lawsuits are being filed to contest the validity of Essure’s FDA approval by alleging that the inventors of Essure fabricated medical records and concealed adverse events from the FDA.
Timeline of Significant Essure Events
- November 1, 2016 – Congressman Mike Fitzpatrick just issued a statement criticizing the FDA’s Guidance – http://fitzpatrick.house.gov/press-release/fda-issues-final-guidance-essure
- October 31, 2016 – FDA issued final guidance regarding Bayer/Essure
- February 29, 2016 – FDA mandates Essure Black Box Warning.
- December 3, 2015 – FDA reviews the safety of Essure.
- November 9, 2015 – Women who experience chronic pain, bleeding and other side effects, allegedly from Essure, file a lawsuit against Bayer.
- October 22, 2015 – Representative Mike Fitzpatrick discusses legislation to revoke approval for Essure. Read the legislation (PDF).
- September 24, 2015 – FDA held meeting to hear scientific, clinical opinions and patients’ experiences regarding the benefits and risks of the device.
- September 19, 2013 – A physician reported a death of a woman implanted with Essure.
- August 4, 2011 – Inventors of Essure convince FDA to remove contraindication for Nickel hypersensitivity.
- November 4, 2002 – Inventors of Essure gained Pre-Market Approval (PMA) that shields them from lawsuits.
What Are Essure Side Effects?
- Allergic reaction to Nickel
- Perforation of fallopian tubes, uterus or organs
- Unintended pregnancy
Are There Any Medical Studies About Essure?
In October 2015, the British Medical Journal published a study comparing the nonsurgical implantation of Essure and traditional bilateral tubal ligation, or tube tying, surgery. The study found that patients using Essure had a similar risk of unintended pregnancy.
What is the FDA Doing?
In September 2015, the FDA analyzed the history of Essure product reports from patients, doctors and the manufacturer. Between November 2002 and May 2015, the FDA received over 5,000 reports of problems and side effects from using Essure. These reports included four women who died from complications such as infection, uterine perforation and blood clots after undergoing a procedure to remove Essure. Another five women became pregnant and then had miscarriages after the Essure device allegedly punctured the fetal membrane. Read more.
The FDA then released a report regarding their analysis and the most frequently reported patient problems. The most common side effects reported were:
- Abdominal pain (3353 reports)
- Menstrual irregularities (1408 reports)
- Headache (1383 reports)
- Fatigue (966 reports)
- Weight fluctuations (936 reports)
- Patient/device incompatibility such as allergic reactions to the nickel contained in the device (941 reports)
- Migration of the device or device component (482 reports)
- Device operating differently than expected (301 reports)
- Device breakage (259 reports)
- Incorrect position of the device (133 reports)
After these thousands of reports were received, the FDA finally convened a Medical Devices Advisory Committee to hear the benefits and risks of using Essure from experts and patient experiences. A decision from this meeting is still pending and has not been released yet. Since this meeting, the FDA has received more than 2,800 additional comments about the use of Essure. A determination by the FDA, regarding the safety of Essure, is expected in late February 2016.
Why Contact Us?
If you or someone you know has suffered harmful side effects from an Essure birth control device, you may be entitled to compensation for medical expenses, lost income, and pain and suffering, among other losses. We are working with experienced Essure lawyers, who handle these cases. They charge no legal fee unless you receive a settlement or award. For a free (no obligation) case evaluation, call us toll free at 1-800-992-6878 or fill out our contact form online.