The Food and Drug Administration has been busy at work with Essure, a permanent non-surgical birth control implant by Bayer AG. Moreover, by all accounts with the recent news as reported in the media. Thousands of women have been affected by and died with having the Essure device.
The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. According to the FDA website
In an article on the Daily Hornet, the headline reads:
FDA Reports 10,000 Essure Injuries and 30 Deaths.
The FDA has updated their ongoing safety review of Essure, a permanent sterilization implant made by Bayer. Essure is now linked to more than 10,000 reports of serious injuries and dozens of deaths.
These Essure problems could not have happened all of a sudden, could it?
The short answer is a resounding NO.
The FDA had been dealing with Essure since the original approval back in 2002. That means it has been 15 years of review, research, discovery and uncovering the effects of the device.
What Is Essure?
Essure is a permanently implanted birth control device for women. Essure does not require a surgical incision.
Essure was developed by Conceptues Inc. a subsidiary of Bayer AG.
To see what the FDA says about Essure, you can view the FDA source here.
Need To Talk To A Lawyer About Essure?
If you want to talk with a lawyer but unsure of what comes next, please contact us for a no obligation review of your Essure experience.
FDA Essure Activities
The FDA keeps a log of all activities they do to monitor Essure.
Keep tabs on what has taken place and what is currently underway with the FDA's efforts to monitor the safety of Bayer's birth control device.
Essure Benefits and Risks
As of May 24, 2017.
The FDA continues to believe that the benefits of the device outweigh its risks, and that Essure’s updated labeling helps to assure that women are appropriately informed of the risks.
Even with all that has transpired, the FDA believes the Benefits outweigh the Risks.
You can view the FDA reporting of Essure Benefits and Risks here.
You can see another article on Broken Coils about one of the side effects of Essure, Unintended Pregnancy here.
What Women Should Know About Essure
To get a better understanding of what is involved, the FDA has compiled a great resource about what women should know about Essure here.
You can keep up to date on how the FDA is mandating labeling of Essure Birth Control. A Black Box update was the most recent news.
Essure FDA Announcement Label Changes
Posted 11/15/2016 the FDA released this announcement "Essure Permanent Birth Control System by Bayer Healthcare: FDA Announcement - Label Changes" View the FDA announcement here.
Essure's Regulatory History With The FDA
As mentioned earlier in this post, the FDA's work with Essure has been busy since 2002.
FDA Takes Action To Better Understand Saftey of Essure
In February of 2016, the FDA made an announcement declaring their intention to understand the safety of Essure better.
“The actions we are taking today will encourage important conversations between women and their doctors to help patients make more informed decisions about whether or not Essure is right for them,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health.
“They also reflect our recognition that more rigorous research is needed to better understand if certain women are at heightened risk of complications.”
You can view the press release here.
Information for Patients Considering Essure
The FDA wants to help people better understand the Essure and has offered resources on their webpages providing:
Reporting Essure Problems To The FDA
There are details you need to have ready to report issues you may be having with Essure to the FDA.
You can review the information you need to report Essure problems to the FDA here.
Free Essure Case Review
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