An Essure black warning was issued in February 2016 after the FDA received numerous complaints alleging serious device complications. Between November 2002 and May 2015 over 5,000 Essure injury reports were submitted to the agency.

According to a CNN report, the Essure black box warning was issued after numerous women reported uncontrolled bleeding after the device was implanted. Complaints also alleged that women experienced unwanted pregnancies, miscarriages, and stillborn children. Other injury reports indicated coil migration, pelvic and bowel perforations, and severe allergic reactions. The FDA asked for public comment on the issue between October and December 2016.

The Essure black box warning emphasizes the importance of understanding the risks and benefits of the permanent contraceptive, and the need for doctors to thoroughly discuss potential side effects with patients. In addition to a thorough discussion, doctors should go through a patient checklist to determine if Essure is suitable for each patient.

The FDA is requiring Bayer HealthCare to conduct a post-market study to observe device complications reported by patients. This study is designed to help provide data on Essure complications so the FDA and the medical community can better understand the risks associated with Essure and compare them to a traditional hysterectomy.

Overview of Essure Black Box Warning and Complications

The Essure birth control device was approved by the FDA in 2002 through a quick approval process due to its unique treatment features. The Essure birth control device is currently the only form of non-surgical female sterilization in the country and is touted as the superior choice compared to traditional tubal ligation.

Unlike hysterectomies, Essure coils are minimally invasive and do not require a long recovery period for patients. The Essure contraceptive consists of two metal coils that are implanted into each fallopian tube which spur tissue growth. The metal coils consist of nickel and other metals which are supposed to be biologically safe for implantation. After the tissue grows around the coils, sperm to egg fertilization is blocked and sterilization has been reached.

Since its release, Essure contraception has been implanted in hundreds of thousands of women with the general patient population preferring the device for its convenient features. Unfortunately, thousands of women have reported experiencing serious Essure complications, with some requiring revision procedures to remove the coils.

Among the complications reported included bloating, rashes, excessive bleeding, organ perforation, pelvic pain, miscarriage, and ectopic pregnancy.

Since its approval over 4,500 Essure injury reports have been filed with the FDA and consumer advocacy groups are calling for a complete market removal. Some consumer advocates even state that Essure should never have been approved to enter the market due to the unreasonable risks it presents to patients.