The FDA is the big watchdog, and this news has been a long time coming!
Although earlier reports surfaced, this news was widely reported by Reuters on Monday, February 29th, 2017.
FDA said it intends to require the product to carry a "black box" label warning of serious risks such as perforation of the uterus or fallopian tubes and severe allergic reaction. It is asking the public to submit comments on the language to be included in the label warning.
The news of a black box warning only adds to Essure's storied past.
The original approval for Essure was back on November 4th, 2002. Bayer acquired the company that created Essure, Conceptus June 5th, 2013.
Much time has elapsed since the original approval and time on the market.
During this period on the market, regulatory history summary has included but not limited to:
- 2011 Labeling to include nickel sensitivity warning.
- 2012 Five year follow-ups to include in the labeling.
- 2013 Patient side effect risks included chronic pain and device migration with labeling.
- 2016 Patient Decision Checklist and a boxed warning to include on both physician and patient labeling.
You can see more of the PMA (Premarket Approval) history from the FDA here .
More In The Press
On March 3rd, 2017 a press release highlighted the U.S. FDA call for a black box warning for the Essure device.
Safety is one of the major concerns of healthcare practitioners using gynecological devices. Bayer's Essure is an intra-uterine device (IUD) that has been linked with skin rashes and pelvic pain in women (in the U.S.) who have inserted it as a permanent contraceptive solution. This has led women to remove the Essure through surgery.
Source: Coherent Market Insights
Stay Up-To-Date On FDA's Evaluation Of The Essure System
BrokenCoils.com will be reporting new information as it comes in, but you can also check the status updates posted by the FDA directly, here .
Share Your Experience
With the FDA's request for public comments about Essure. You have an opportunity to take action and receive legal help from us, to explore how you or a loved one's story using Essure can receive medical compensation.
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