October 27, 2017 – San Diego, CA. Recent numbers collected in a study have found a disturbing trend. Doctors who recommend and insert Bayer’s Essure birth control coils are failing to tell and show the mandated FDA black box warning that was applied to the Essure product box. From March 2016 to October 2017 out of 129 women who were implanted 93.8% did not see or were told of the FDA warning. In the same period out of 205 women who were offered Essure 90.2% were not told of the black box warning. This is completely and utterly terrible and failure of the medical community.
Last November, the FDA announced it had approved Bayer’s proposed black box warning and patient checklist for its Essure permanent birth control device.
FDA black box warnings are the highest level warning issued by the FDA. Many times after a black box warning has been applied some drugs or medical devices are recalled. Essure hasn’t been recalled yet.
Advocates and users of Essure have been fighting to get a black box warning on the Essure device for well over a year.
The Essure label was finally updated following more than a year of the U.S. Food and Drug Administration’s own investigations into thousands of reported side effects and a review of public input and professional opinions from a 2015 Advisory Committee Meeting.
Tens of thousands of women report being harmed by Essure, yet the device remains on the market. The addition of the black box warning, patient decision checklist, and updated labeling are steps towards ensuring women get all the information they need to make informed decisions about Essure.
Women need to know about the possible complications with using Essure.
In order for women to understand the possible side effects of Essure, they need to be shown this information that was added to the Essure packaging.
The FDA said in its final guidance it would require Bayer to include a new patient decision checklist because it felt women were not receiving or understanding information regarding the Essure procedure and device.
The checklist highlights the key risks and benefits of the Essure System and both women and their doctors are required to sign it before moving forward with the procedure.
Here is the actual patient decision checklist that women and their doctors will read and sign before moving forward with Essure.
Requirements for Essure Placement and Reliance
I understand that I am not a candidate for Essure if:
- I am uncertain about ending my fertility
- I have had a tubal ligation procedure (“tubes tied”)
- I cannot have two inserts placed due to my anatomy.
- I am pregnant or suspect that I may be pregnant.
- I have delivered or terminated a pregnancy within the last 6 weeks.
- I have an active pelvic infection on the date of the scheduled implantation.
- I have unexplained vaginal bleeding.
- I have a known allergy to contrast dye used during x-ray procedures.
Essure only works when the inserts are successfully placed in both fallopian tubes. I understand if this is not possible in my case, I may need to undergo a repeat attempt at Essure placement or consider a different form of birth control.
I understand that the placement procedure is only the first step in relying on Essure for birth control.
After placement I must:
- Use an alternative form of birth control until my doctor tells me I can stop (typically for 3 months).
- Schedule and undergo a confirmation test after three months to determine whether I may rely on Essure. I understand that payment for this test may or may not be covered by my insurance company.
What is the FDA Back Box warning for Essure?
Here is the actual packaged product warning (black box) from the Essure manufacturer Bayer.
Numbers don’t lie – Women need to see this information before undergoing the Essure procedure.
Tens of thousands of women report being harmed by Essure, yet the device remains on the market. The addition of the black box warning, patient decision checklist, and updated labeling are steps towards ensuring women get all the information they need to make informed decisions about Essure. Because of this miscommunication or non-communication from doctor’s more woman may be harmed from this device. There are currently over 10,000 women who have started the lawsuit process against Bayer.
If you or a loved one were injured as a result of Essure, you may be entitled to financial compensation for lost wages and medical costs.