Some Doctors May Be Ignoring The FDA Essure Warning Requirement

Women currently being implanted with the hazardous Essure Birth Control Device are reporting on social media that they never heard of the warning

Wednesday, June 13, 2018 - The FDA issued a mandate on April 9, 2018, requiring Essure trained doctors to supply prospective Essure patients with the Black Box Warning and complete a checklist that ensures patients have read it and are aware of the potential side effects. Women are already reporting on social media that no such warnings were ever given to them and why would they be. Doctors make money selling Essure and to have a patient read the list of deadly side effects would be tantamount to never having recommended the birth control method in the first place. Anyone who reads the complete checklist would run out of the office in a heartbeat.

The official FDA Issue Side Effects checklist urges patients to make sure they are aware that Essure is irreversible and permanent and several other options such as tubal ligation must be offered. Women must acknowledge that they have reversible options such as the birth control pill. Women are required to state that they are aware they may not be a candidate for Essure if they are pregnant or recently gave birth, had a pelvic infection, have known allergies to contrast dyes used in x-rays, and several other conditions. Women must certify that they are aware that

Essure takes around 3 months to become effective and that they should abstain from intercourse for that period of time. Women are forced to acknowledge that Essure is not effective around 8% of the time. Essure patients must acknowlege that ectopic pregnancies, those that occur outside of the uterus and resulting in potentially life-threatening consequences, can occur. Over 300 cases of fetal death have been reported to the FDA. Cramping, pain, nausea, vomiting, dizziness, and vaginal bleeding are other known side effects. Rashes, itchiness, and other more severe allergic reaction may occur from Essure's "containing metals including nickel, titanium, iron, chromium, and polyethylene terephthalate." Essure patients should be aware that the device can break free from its intended destination on the inner wall of the Fallopian tube and migrate to other reproductive organs, puncture them, and require surgery to have them removed, leaving a woman permanently sterile.

Since the FDA has done so little and refuses to pull the product from the market so that more tests can be done, women are publicizing the device's adverse side effects into their own hands. Essure women who have suffered catastrophic and debilitating i njuries from the Essure Birth Control Device are sharing their experiences on Facebook and Twitter rather than report them only to the FDA. Essure women are skeptical of a government agency that has done little or nothing to come to their aid. The Essure Problems Facebook group is a community of women who have been damaged by the side effects of the Essure Birth Control device. Over 50 women per day post of the problems they are experiencing from Essure. On Twitter.com, Essure Problems has over 2700 followers. Women wonder how many have to join the group in order to get the government to issue a recall for the faulty medical device.

If you or a loved one are contemplating using the Essure Birth Control Device, please visit the FDA's Essure Black Box Warning page located at https://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/UCM488065.pdf

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