FDA Announces New Essure Study
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The United States Food and Drug Administration announced a mandatory clinical study of the birth control implant Essure. The study will examine risks for particular groups of women.
The FDA also announced new plans to change the labels on Essure. A new boxed warning and a Patient Decision Checklist will help highlight potential risks and make sure women understand what they are getting into with the device.
Essure is a permanent form of birth control that has garnered much attention – good and bad – over the years. Essure coils are inserted into the fallopian tubes through the cervix and vagina. Over a three month period of time, scar tissue forms around the coils. This scar tissue creates a barrier, preventing sperm from getting through and therefore preventing pregnancy. Though the FDA insists that Essure is safe and a good option for some women, there have been some scary side effects in some users.
Persistent pain is just one nasty side effect. Some women experience perforation of the fallopian tubes and uterus when the Essure device migrates in the body. Others have experienced abnormal bleeding, allergic and hypersensitivity reactions.
The FDA is also requiring Bayer, the maker of Essure, to conduct a study on the risks of the device in the real world. The results will be compared against more traditional forms of permanent birth control like tubal ligation.
We applaud the FDA for mandating this new clinical study. The results of the study will help medical professionals and Essure users alike better understand the way the device helps – or harms – patients.