Essure Causes Fetal Deaths

Bayer tried to downplay the number of fetal deaths caused by the Essure Birth Control Device by limiting the scope of its adverse event searches

Thursday, July 19, 2018 - It can be challenging to get accurate data regarding the number of fetal deaths caused by the Essure Birth control device. One thing we know for certain is that Essure is classified by the FDA as a Class III device meaning that the FDA cannot guarantee that the device is safe.

Women who have become pregnant after using Essure birth control have reported over 300 incidents of fetal deaths. The main cause has been due to ectopic (outside of the uterus) pregnancies. This is in sharp contrast with the 5 fetal deaths Essure's maker, Bayer AG claims exist and the number given by the FDA's MAUDE database. The reason for the discrepancy is the search criteria used to access the FDA's database of adverse events.

The discrepancy in the number of fetal deaths caused by Essure was first brought to light when former FDA analyst Madris Tomes found thousands of adverse events from the agency's website shows 303 fetal deaths were linked to Essure. When one searches only the subject line of the event entries using the overly specific term "fetal death" only five relevant results appeared. When that search expanded to the entire text of the reports and included terms like abortion, miscarriage, and stillborn, over 300 incidents of fetal death were returned. In addition to 300 fetal deaths, several patient deaths have been linked to Essure infections and organ perforations.

The FDA lists the potential adverse side of Essure as being "bloating, rashes, headaches, fatigue, weight loss, mood swings, depression, allergies, hypersensitivity, joint pain, muscle pain and muscle weakness." In additions to hundreds of other adverse reactions, Essure has been known to puncture the uterus and Fallopian tubes. Essure can break into pieces and has been found as far away within the human body as the abdominal and pelvic cavity when surgeons attempt to remove it.

Essure is made from a combination of Nickel-Titanium, Polyethylene (polyester), Stainless Steel, Platinum, Silver, and Tin that is formed into a soft, flexible birth control device resembling a small spring. The spring coil is interwoven with polyester fibers that irritate the inner walls of the Fallopian tubes. Scar tissue develops to hold the device in place and block fertilization. It takes 3 months for Essure to set in place and women are urged to abstain from having sex for this period of time. Since 2002, doctors have chosen Essure and have told their patients that Essure can be inserted in the comfort and convenience of their office and does not require general anesthesia or invasive surgery. Doctor's assured their patients that Essure could be safely removed when the time came they wanted to become pregnant.

Women wishing to file an adverse event report pertaining to their Essure experience should visit:

https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm. Of all of Essure's hazards, causing fetal deaths are the most misrepresented and underemphasized adverse side effect of Essure.

More Recent Essure Complications Lawsuit News:

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• Essure 2.0 Could Be Coming Soon If It Is Not Already Here | 8/28/2019
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• Women from England Report Essure Disasters | 8/15/2019
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• 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
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• Bayer May Have Double Crossed Essure Women | 5/1/2019
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• Essure Problems Facebook Administrators Take Issue With FDA Handling of Essure Crisis | 1/14/2019
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• 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
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• FDA Whistleblower Madris Tomes Was One of the First to Suspect Essure Problems | 11/9/2018
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