After holding a meeting with patients and attorneys regarding the birth control implant Essure, the FDA Commissioner issued a statement regarding the device and the concerns of those he met with. Bayer, the maker of the device, estimates that more than 750,000 women worldwide have had the device implanted since 2002 (Gottlieb, 2018). In 2016, the FDA ordered Bayer to conduct a postmarketing study in order to be able to better evaluate the safety of the device “when used in the real world” and make sure that women who are considering the device are informed of all risks.
Mild side effects of Essure can include cramping, vomiting, dizziness or lightheadedness, and device expulsion. More serious side effects can include perforation, fainting, device migration, and hypervolemia (fluid buildup in the blood).
Additionally, the FDA issued a black box warning for Essure to better inform potential users about the risks associated with the product. It reads as follows:
WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System for Permanent Birth Control during discussion of the benefits and risks of the device.
If you have suffered complications after receiving an Essure implant, do not hesitate to speak to one of our experienced personal injury attorneys by filling out a contact form here.
References
Gottlieb, S. (2018, March 07). Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA activities related to the ongoing post-market review of Essure and FDA’s commitment to keep women informed. Retrieved March 07, 2018, from https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm600052.htm