On November 15, the US Food and Drug Administration released an article that suggested that women consider other forms of birth control before using Essure. Essure injury cases (titled: Essure Product Cases and Coordinated Actions) are now being coordinated in Alameda County Superior Court in California. In light of the FDA’s ruling and the current Essure MDL in California, this article is intended to provide information about Essure, specifically how it works and the risks associated with the device.
What is Essure?
Essure is a small, flexible metallic coil (basically a small spring) that is manufactured by Bayer and is composed of mostly titanium and nickel. This device is inserted into the patient’s fallopian tubes. After about three months, scar tissue forms around the coil. This blocks the sperm’s access to eggs, thus preventing pregnancy. According to Bayer, the benefits of Essure include that the device is simple to implant, does not require general anesthesia, and is a permanent form of birth control.
However, certain dangerous side-effects have been discovered that have caused significant harm to Essure patients. Hence the MDL proceeding against Bayer and its subsidiaries. These side effects include:
- Internal bleeding
- Device migration
- Perforated uterine walls
- Chronic pain lasting weeks or months after device implantation
- Allergic reactions
- Failure to prevent pregnancy
The FDA recommends discussing usage of Essure with your healthcare provider to get a clear understanding of the pros and cons of the device. After all, there are other options that are available for birth control that do not have such severe side-effects. Long-lasting birth control options can be in the form of Intrauterine Device (IUD) and birth control implants. Other options that are not as long-term include condoms, vaginal rings, hormone patches, diaphragms, and oral contraceptives.
Essure is now required to carry a patient decision checklist for doctor-patient consults, and a box label warning.