The FDA’s release includes new labeling for Essure contraception, the addition of a Black Box warning, and proposed patient checklists. The new guidelines assert that patient acknowledgment is key.
Essure Safety: Black Box Warning
Essure is a female sterilization device implanted in the fallopian tubes. Shaped like a coil, Essure is comprised of nickel, titanium, iron, chromium, and tin metals. Essure was approved by the FDA in 2002.
Originally approved under Conceptus, Inc., Essure has been listed as a class III, high-risk device. The FDA has now proposed an example warning that will be added to Essure safety labeling.
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.
Immediate Effects After Implantation
On September 24, 2015, FDA arranged a meeting between the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to discuss Essure safety trial data, risks, and strategies to limit the adverse outcomes.
The FDA lists a number of common reactions that occur in the weeks following implantation, such as:
- Hypersensitivity reactions
- Persistent pain
- Irregular vaginal bleeding
- Fallopian tube or uterine perforation
- Unintended pregnancy
- Need for device removal
Long-Term Risks Linked To Essure
The FDA checklist works to inform women of the various side effects linked to Essure, in addition to confirming that the risks are adequately understood. The agency urges physicians to include probabilities or rates of adverse events in the checklists, in addition to “recognition of available alternative contraceptive modalities and their safety and effectiveness.”
According to the FDA, the "rate of perforation" ranges from 1% to 4%.
Extended risks have been linked to Essure, including:
- Continued pain or new pain, such as abdominal, pelvic, or back pain
- Allergic reactions, such as rash and itching
- Weight changes
- Hair loss
- Mood changes, such as depression
- Perforation of the uterus or fallopian tubes
- Migration in the abdomen or pelvis
- Bowel damage
- Surgery, such as hysterectomy
More than 500,000 permanent sterilization procedures are performed each year. Though the FDA has released recommendations to inform the public about the risks and benefits linked to Essure birth control, thousands of women have already dealt with life-changing injuries.