To the Editor:
The excellent study by Gariepy et al. provides important information about the comparative effectiveness of the Essure device (hysteroscopic sterilization) compared to two different laparoscopic sterilization techniques (silicone rubber band compared to bipolar coagulation).
According to the Food and Drug Administration (FDA), Essure sterilization is a nonsurgical procedure that is 99.8% effective at permanently preventing pregnancy over 5 years, when used correctly. That statistic is apparently based on effectiveness when proper placement and occlusion is achieved. However, the study of Gariepy et al. indicates that if one takes into account the women who do not return for the mandatory hysterosalpingogram, women undergoing an Essure procedure will have a 10% pregnancy rate over 10 years, which is 3-4 times as high as the laparoscopic rates.
Between 2002, when Essure was approved by the FDA and December 2014, approximately 1500 reports of adverse reactions were reported to the FDA, including pregnancy, hemorrhage, pelvic pain, and menstrual irregularities. More than 14,000 women have reported problems with Essure on a Facebook page (http://www.facebook.com/#!/groups/Essureproblems/) created by U.S. patients to share information and support each other, and our Center has surveyed more than 900 of them. Although not a random sample of women with Essure problems, it is important to note that our survey found consistent patterns of reported complications. The most common include chronic pain in the pelvic area (26%), autoimmune symptoms such as fatigue (27%), hair loss (20%), depression (14%), heavy bleeding (14%), and allergic symptoms (8%). Fifteen percent required a hysterectomy to remove the device.
Gariepy et al. reported that there were more than 650,000 Essure sterilization procedures worldwide, based on industry statistics for Essure kits sold. However, physicians and patients have reported to us that doctors often use at least 2 kits per patient because of difficulties in correctly threading the Essure devices in the Fallopian tubes. In addition, “kits sold” includes those not yet implanted. An accurate estimate of the number of women in the US with Essure implants is essential for interpreting the implications of pregnancies and complications reported by US women to the FDA and in the media; a smaller denominator makes the adverse outcomes reported by thousands of women more worrisome to physicians and patients.
There are clear advantages to a sterilization procedure that does not always require hospitalization or general anesthesia, but more require hospitalization or general anesthesia, but more research is needed to determine the rate of long-term complications and effectiveness. Bayer is making changes to Essure, and it is essential that the older and newer versions of the device be carefully studied in long-term research to determine safety and effectiveness. Despite the advantage of a quick recovery, we expect that patients would be much less willing to undergo the Essure procedure if they were told they would have a 10% chance of pregnancy within the first 10 years, as well as the risk for chronic pain and autoimmune symptoms.
Lauren Abla Doamekpor *
National Center for Health Research, 1001 Connecticut
Avenue Suite 1100, Washington, DC 20036, USA
* Corresponding author. Tel: +1-202-223-4000
E-mail address: email@example.com
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- Gariepy AM, Creinin MD, Smith KJ, Xu X. Probability of pregnancy after sterilization: a comparison of hysteroscopic versus laparoscopic sterilization. Contraception 2014;90:174-81.
- FDA Website. Essure Permanent Birth Control. Available at http://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/ucm371014.htm (Retrieved December 10, 2014)
- Conceptus. Essure permanent birth control. Available at: http://www.essure.com/what-is-essure (Retrieved February 2, 2015)