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31 July 2016

FDA Mandates Essure Black Box Warning, More Safety Studies

After deliberating for months, the Food and Drug Administration (FDA) has announced that stronger warnings should be given with Bayer’s birth control device ‘Essure’, along with focus on further studies on the device. This announcement took the social media by storm because of all the women who claimed that the faulty device had led to permanent severe injuries as well as deaths of several fetuses.

About Essure and how it works
It is a permanent birth control system which is made up of two nickel and titanium coils. The doctors implant the coils in the fallopian tube of the woman. Then, within 90 days, scar tissue forms over the coil. This blocks the tubes which in turn prevents the fertilization of eggs. However, numerous women have talked about major complications that are related to the coils for example ectopic pregnancies, organ perforation, and severe pain.

FDA takes action
Now, FDA has announced a mandatory post market clinical research of the device to figure out the heightened risks for certain women. Additionally, the device will come in such a packing which includes a black box label along with a checklist which would inform women about all of the risks involved with the use of this birth control method. The manufacturer, Bayer, aims to comply with the FDA.

About the black box warning
The black box label that has been proposed by the FDA will inform women about all of the adverse events that have been reported after the use of Essure. These warnings would include migration of the device from the pelvis to vital organs, perforation of the fallopian tubes, and persistent abdominal pain. The label would also warn that a few cases also needed abdominal surgery.

Women left unsatisfied and angered
Women that have been harmed permanently by the device state that the action proposed by FDA is insufficient and that the device should be recalled. They argue that since conducting further studies would take some time, more women would be left at risk. Additionally, majority of the women had to go through hysterectomies to fix all the problems that the device had caused.
Not only did women take the argument to Washington, they also filed lawsuits against the manufacturers, Bayer. Mike Fitzpatrick, a US Congressman, has also been deeply involved with all of the controversy that surrounds the device. He revealed data which linked the birth control device to deaths of 300 fetuses or more. Mike called for the reversal of the premarket approval of the device and also for taking the product off the market.
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