The FDA recently announced that, “On December 31, 2018, Bayer will stop selling and distributing the Essure device in the United States. Health care providers can implant Essure up to one year from the date the device was purchased. Bayer will continue to implement the FDA’s restriction on sale and distribution of Essure from April 2018, to ensure women are fully informed of the risks associated with the device.”
If you have or had an Essure birth control implant, the FDA has been posting alerts and updates concerning this popular type of contraceptive.
History of FDA Essure Announcements
For the past two years, the FDA has been monitoring complaints and complications involving Essure implants. Here is a history of their press announcements:
2002 – FDA approves Essure
2/29/16 – The FDA states that they will require a “mandatory clinical study for Essure” to “determine heightened risks for particular women.” The FDA also places new requirements on Bayer to update product labeling, including “a boxed warning and a Patient Decision Checklist to help to ensure women receive and understand information regarding the benefits and risks of this type of device.” This announcement is later deemed responsible for a 70% sales drop of Essure in the U.S.
11/15/16 – FDA updates consumers that potential risks associated with Essure include “poking through the fallopian tubes or uterus, persistent pain after the procedure (including pain for weeks or months after the procedure), change in menstrual cycles (bleeding patterns), symptoms similar to those of allergic reactions, [and] symptoms similar to those in autoimmune diseases, such as joint pain and fatigue.”
3/7/18 – FDA Commissioner, Scott Gottlieb, M.D. reports that “the FDA is actively evaluating a significant collection of new medical device reports [12,000 reports were made in 2017] submitted to FDA on the Essure device… More than 90 percent of the reports in 2017 mentioned issues involving potential device removal, which the FDA is further investigating.”
4/9/18 – The FDA informs that they will “restrict the sale and distribution of the Essure device… to only health care providers and facilities that provide information to patients about the risks and benefits of this device.”
7/20/18 – The FDA shares that Bayer has decided to stop the sale of Essure after December 31, 2018.
12/20/18 – Gottlieb tells consumers that the FDA will implement “some additional steps today to make sure the FDA continues to evaluate the product’s long-term safety profile past its scheduled discontinuation from the U.S. market” including extending the study that was imposed on Bayer in February 2016.
Did You Have an Essure Implant?
The FDA has made it clear that Essure is a dangerous medical device that should be closely monitored. Many women weren’t made aware of the risks before having this implant and have suffered due to device migration, breakage, and/or allergic reactions to nickel. You may be able to make a claim against Bayer if you had an Essure implant that:
- Perforated your organs
- Caused a serious infection that resulted in prolonged hospitalization
- Created irregular, prolonged periods or periods that had heavy bleeding
- Made intercourse painful
- Didn’t work and you had an unintended pregnancy
- Caused you to have severe pelvic and/or lower back pain
If you had an Essure implant before November 15, 2016 and later had it removed due to the above difficulties, we want to hear your story. Call us today at (800) 511-3838. The statute of limitations traditionally begins when a product is warned, so call immediately while you’re still able to file a claim!