A recent article published by the New York Times discusses the ongoing debate over the safety of the birth control device known as Essure.
On the market for 13 years, the device is made up of two small pieces of coiled metal that are inserted into a woman’s fallopian tubes. Once the coils are anchored in place, tissue grows around them, blocking sperm and effectively rendering a woman sterile.
Doctors consider Essure a permanent form of birth control and an alternative to tubal ligation, which requires a woman to undergo a surgical procedure. Because placing the Essure device can be performed in a doctor’s office in about 10 minutes, many women saw it as a more convenient, less-invasive option for permanent birth control.
Within the past few years, however, Essure has been the subject of numerous complaints. In 2014, one woman filed a $1 million lawsuit against Bayer, the manufacturer of Essure, alleging the device migrated from her fallopian tube and became lodged behind her colon, forcing doctors to perform a hysterectomy.
In February 2015, the FDA received a report that a woman had died while having the device placed. Other women have reported headaches, daily bleeding, miscarriages, organ perforation, and autoimmune disorders after undergoing an Essure procedure.
The FDA reports that they have received 4,500 adverse event reports related to Essure. Bayer has been accused of failing to adequately train doctors to perform the implementation procedure. Patients also allege that Bayer deliberately concealed information about organ perforations in women caused by the Essure device.