Essure Surveillance Study Approved
Finally, Bayer’s Essure permanent contraceptive device will be put to the test to see how safe (or dangerous) it really is.
On Friday, The Food and Drug Administration approved the new post-market surveillance study plan submitted by Bayer on its Essure Permanent contraceptive implant. Since the approval date of Essure back in November of 2002, the FDA claims to have received over 9,900 medical device complication reports related to the device. This new study will be done to reassess the dangers associated with the device.
In February, the FDA did require Bayer to add a boxed label warning further explaining the risks associated with the device; this new post-market surveillance study was another requirement. However, the device will remain on the market while the study is performed.
The Study
The newly drafted surveillance study will look at two groups of 1,400 women who chose to undergo either the implantation of the Essure device or laparoscopic tubal sterilization and have not been pregnant within the six weeks prior. Each group will be closely monitored for the side effects that keep being reported to the FDA. Some of the main focuses of the study will include chronic abdominal and pelvic pain, abnormal bleeding, allergic reactions to nickel, and reasons for Essure device removal.
Multiple reports are scheduled in regards to this new study: a six month study will be released in March 2017 and a one year study will be released in September 2017. The final report will not be available until the year 2023.
Unglesby + Williams | Essure Device Litigation
Bayer promises on their website that the product is safe, that most women go home within 45 minutes of getting the procedure, and most women return to their normal lifestyle a day or two after the procedure. To leave a product on the market that has been at fault for such a number of horrific outcomes is not fair to women around the world. Given that this device has been on the market for 10 years, it’s time for a change.
Unglesby + Williams is at the forefront of Essure litigation, fighting Bayer in the courts on behalf of over 1000 women. If you or someone you know has been injured or experiencing side effects from the ESSURE Birth Control Implant, contact Unglesby + Williams or call 844-ESSURE-LAW today.
