What you need to know about Essure
What is Essure?
The Essure contraceptive device, manufactured by Bayer, is marketed as a permanent birth control solution. The device itself is a pair of small metal coils made of nickel that are inserted into the Fallopian tubes of the patient.
How does it work?
The Essure device can be inserted without surgery in a doctor’s office. Once inserted, the coils allow scar tissue to form over them, closing off the Fallopian tubes and preventing the release of eggs into the uterus.
What are the complaints?
Since its approval, thousands of complaints have been filed. Some issues and side effects associated with the device include:
- Persistent pain
- Abnormal bleeding/spotting
- Heavy menstruation
- Allergic reaction to nickel alloy
- Perforation of Uterus or Fallopian tubes
- Failure to prevent pregnancy
- Infant death
- Device migration
Other complaints associated with the product’s manufacturer, Bayer, include under reporting the number of complications to the FDA after the product’s initial safety trials and criticism for not removing the product from the market.
What is the FDA doing?
The Food and Drug Administration required Bayer to add an additional warning label to the packaging, warning users of the side effects and potential outcomes. A doctor’s checklist is being developed to ensure transparency of potential risks between doctor and patients.
The FDA is also requiring Bayer to perform a post-market surveillance study to further investigate the problems and risks associated with the device, as well as to compare the results of the study with risks associated with tubal litigation. Reports on the progress of the study will come out after six months, again after one year, and again at the end of the study in 2023.
What if Essure has harmed me?
If you received the Essure permanent contraceptive implant and have suffered serious injuries, you are not alone. Unglesby + Williams Law Firm is at the forefront of Essure litigation, fighting Bayer in the courts on behalf of over 1000 women. If you have been harmed by the device, contact Unglesby + Williams or call 844-ESSURE-LAW today.
