Essure is a widely used device intended to provide permanent birth control for women. According to the FDA, the permanent sterilization device Essure is 99.8% effective at preventing pregnancy if used correctly over 5 years.1 However, a study published in Contraception in April 2014 found that Essure is far less effective than previously reported by the FDA and by Bayer, the company that sells Essure. If one takes into account the women who do not have correct Essure placement or sufficient occlusion, or do not return for a mandatory 3-month follow-up test to confirm that the procedure worked, 10% of women undergoing an Essure procedure will become pregnant within 10 years.2 This is 3-4 times higher than the pregnancy rate for women who use surgical methods to permanently prevent pregnancy.2
The National Center for Health Research’s Dr. Diana Zuckerman and Dr. Laurén Doamekpor recently published a response to this study, also in Contraception, highlighting the need for more research to examine and verify the long-term effectiveness and safety of Essure. Their response also briefly described their survey of more than 900 women who have reported experiences of chronic pain, heavy bleeding, autoimmune symptoms, depression, and other adverse events as a result of Essure.3
The authors of the original study also published a reply in the same journal to Dr. Zuckerman and Dr. Doamekpor’s article, expressing similar concerns about the lack of sufficient data on the safety and effectiveness of Essure.4 Accurate information about how well Essure works and its long-term safety are essential so that women who do not want more children can make an informed choice regarding their contraceptive options.
- FDA Website. Essure Permanent Birth Control. Available at: href=”http://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/ucm371014.htm”>http://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/ucm371014.htm. Retrieved December 10, 2014. ▲
- Gariepy AM, Creinin MD, Smith KJ, Xu X. Probability of pregnancy after sterilization: a comparison of hysteroscopic versus laparoscopic sterilization. Contraception 2014; 90:174–181. ▲
- Zuckerman DM, Doamekpor LA. (in press) More Data Are Needed for Essure Hysteroscopic Sterilization Device. Contraception. 2015 ▲
- Gariepy AM, Creinin MD, Smith KJ, Xu X. (in press) Probability of pregnancy after sterilization: a comparison of hysteroscopic versus laparoscopic sterilization. Contraception. 2015 ▲