The Essure® Insert Placement Procedure and the Essure Confirmation Test comprise the Essure procedure. Both are equally important, and instructions for completing each should be followed exactly.
Bayer is providing this information to you for informational and educational purposes only. This is not intended for training. You and your staff must be properly trained in all aspects of providing the Essure procedure. For complete placement procedure, please refer to Instructions for Use and Physician Training Manual
Note: The following overview is not intended to act as a substitute for the complete Essure Placement Procedure. Please refer to Section XIII of the Essure Instructions for Use for complete details.
Adverse Events in Phase II/Pivotal Premarketing Studies
The majority of women experienced mild to moderate pain during and immediately following the procedure. Pain was managed with oral nonsteroidal anti-inflammatory drugs (NSAIDs) or oral narcotic pain reliever. The majority of women experienced spotting for an average of 3 days after the procedure.
|Phase II Trial||Pivotal|
The following adverse events were rated as “possibly” related to the insert or procedure during the first year of reliance in the Pivotal trial (approximately 15 months post-device placement). Percentages reflect the number of events divided by the number of participants in the trial. When numerous episodes of the same event were reported by one participant, each report was counted as a separate event. Therefore, percentages may overrepresent the percentage of women who have experienced that event.
In the Phase II trial, 12/206 (5.8%) women with at least 1 insert reported episodes of period pain, ovulatory pain, or changes in menstrual function. Some patients have reported pelvic pain that may be device-related. If device removal is indicated, this will require surgery. Please refer to the Instructions for Use for more information.
|Pivotal Trial Adverse Events by Body System, First Year of Reliance*
(N=476 patients implanted with at least
|Musculo-skeletal||Back pain/low back pain||43||9.0%|
in menstrual flow
|Vaginal discharge/vaginal infection||7||1.5%|
timing not specified
The following adverse events have occurred (in clinical trials and/or commercial usage) or may potentially occur during the Essure placement procedure and with wearing the insert, however, there is the potential that unknown risks exist. Symptoms other than those listed in the sections below have been reported to FDA by women implanted with Essure, although they were not seen in the clinical trials supporting Essure approval. The more common symptoms reported include headache, fatigue, weight changes, hair loss and mood changes such as depression. It is unknown if these symptoms are related to Essure or other causes.
Possible adverse events that have been reported within 24 hours following the Essure placement procedure include; nausea/vomiting, dizziness/lightheadedness, vaso-vagal response/syncope, pain, dysmenorrhea, uterine bleeding/spotting, infection, fluid overload, anesthetic complications, detachment difficulties and unsatisfactory insert location.
Essure® is indicated for women who desire permanent birth control (female sterilization) by bilateral occlusion of the fallopian tubes.
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.
Essure is contraindicated in patients who are uncertain about ending fertility, can have only one insert placed (including contralateral proximal tubal occlusion or suspected unicornuate uterus), have a known abnormal uterine cavity that makes visualization of the tubal ostia impossible, and/or abnormal tubal anatomy or previous tubal ligation (including failed ligation), are pregnant or suspect pregnancy, delivered or terminated a pregnancy less than 6 weeks prior to the Essure procedure, have an active upper or lower genital tract infection, have unexplained vaginal bleeding, have a gynecological malignancy, or have a known allergy to contrast media.
The Essure insert was determined to be MR-conditional according to the terminology specified in the American Society for Testing and Materials (ASTM) International, Designation: F2503-05.
The most common (≥10%) adverse events resulting from the placement procedure were cramping, pain, and nausea/vomiting. The most common adverse events (≥3%) in the first year of reliance were back pain, abdominal pain, and dyspareunia.
This product does not protect against HIV infection or other sexually transmitted diseases.
You are also encouraged to report side effects or quality complaints of products to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-10881-800-FDA-1088. For Bayer products, you can report these directly to Bayer by clicking here.