Essure Permanent Birth Control: Information for Health Care Providers
On December 31, 2018, Bayer stopped selling and distributing the Essure device in the United States. Health care providers can contact Bayer for more information about device distribution.
On this page:
- Considerations for Patient Selection for Essure
- Training Required for Health Care Providers to Place Essure
- Patient Counseling for Essure
- Considerations for Essure Device Removal
- Ongoing Postmarket Surveillance Study
The FDA recommends that health care providers thoroughly discuss available sterilization and birth control methods with their patients, including their benefits and risks. There are alternatives that health care providers can recommend for women and their partners who desire long term contraception. These alternatives include: tubal ligation, vasectomy, levonorgestrel intrauterine device (IUD) or copper IUD.
Essure is contraindicated in patients who:
- are uncertain about their desire to end fertility
- would be able to have only one coil placed due to their anatomy (including patients with apparent contralateral proximal tubal occlusion or suspected unicornuate uterus)
- have previously undergone tubal ligation
- are pregnant or suspect pregnancy
- have delivered or terminated a pregnancy less than 6 weeks prior to the Essure placement procedure
- have an active upper or lower genital tract infection
- have a known allergy to contrast media
- have suspected or known cancer of the female reproductive organs
- have unexplained vaginal bleeding
Health care providers should ask whether patients considering Essure have an allergy to nickel, titanium, iron, chromium, silver-tin, platinum, stainless steel and a plastic material called polyethylene terephthalate (PET) because the Essure inserts contains these materials. While some patients with nickel sensitivity can tolerate Essure, physicians should discuss with their patients the potential for a reaction to the nickel component as they weigh the benefits and the risks of Essure in each individual case. Women who are allergic or sensitive to any of these materials may have a reaction to this device following implantation with symptoms including:
- rash, itching, and hives but may also include other symptoms not reported in the clinical trials such as chest pain, breathing difficulties and intestinal discomfort such as nausea, diarrhea or vomiting.
Women who cannot or will not agree to have an Essure confirmation test should not get Essure placed. At three months after the getting Essure placed, patients must see a health care provider, who will confirm that Essure has been placed correctly with pelvic imaging (Essure Confirmation Test). The FDA-approved Essure confirmation tests include hysterosalpingogram (HSG) and/or transvaginal ultrasound (TVUS).
Health care provider labeling states that Essure is to be used only by physicians who are knowledgeable hysteroscopists, have read and understood the Instructions for Use and Physician Training manual, and have successfully completed the Essure training program, including preceptoring in placement until competency is established, typically 5 cases.
The FDA takes concerns about Essure very seriously; ensuring the safety and effectiveness of medical products is an agency priority and a core part of our consumer protection role. The FDA requires that Bayer comply with the restriction on sale and distribution placed by the FDA on the device in April 2018, to ensure women are fully informed of the risks associated with the device.
Sale and distribution of Essure is limited to health care providers who agree to review Bayer's Patient-Doctor Discussion Checklist with patients, and give them the opportunity to sign it, before Essure implantation. The FDA has approved this new safety measure to ensure that the device meets our standards for a reasonable assurance of safety and effectiveness.
Health care providers and patients should know that Essure devices may need to be removed after placement. The currently-approved labeling for health care providers provides recommendations on device removal that providers should be aware of. This includes patient counseling, device removal techniques, and other general considerations.
Over the past several years, the FDA has been examining the growing number of adverse event reports associated with the use of Essure. The FDA is aware of reports of many women getting Essure removed because they attribute serious symptoms to the inserts, including pelvic pain, menstrual abnormalities, and suspected allergic reactions. Learn more about the number of device removal reports received by the FDA, the reported reasons for device removal, and reported patient outcome information in the FDA's December MDR update.
In 2016, the FDA approved a change to an Essure post-approval study to gather more information about device removals. Since that time, the rate of device removal for all subjects for any reason in the post approval study has been reported as 8.6 percent after 5 years. The rate of device removal for US subjects and OUS subjects is 6.8 percent and 10.9 percent, respectively. Learn more about this post-approval study.
The FDA will continue to monitor the performance of Essure in women through a revised FDA-approved postmarket ("522") study protocol that extends Bayer's mandatory follow up of women through five years. To learn more about the study you may visit the Essure 522 webpage or find information provided by Bayer at ClinicalTrials.gov (NCT number): NCT03127722.