What is the efficacy of female sterilization for contraception?

Updated: Dec 10, 2018
  • Author: Frances E Casey, MD, MPH; Chief Editor: Richard Scott Lucidi, MD, FACOG  more...
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Answer

Answer

The United States Collaborative Review of Sterilization has examined the failure rate of female sterilization. Rates vary according to the procedure performed. The cumulative 10-year failure rate with each method of tubal ligation is as follows: spring clip method, 3.7%; bipolar coagulation, 2.5%; interval partial salpingectomy, 2%; silicone rubber bands, 2%; and postpartum salpingectomy, 0.8%.

The Essure procedure has undergone clinical testing in the United States, Europe, and Australia. Data from preliminary clinical testing demonstrate that the Essure system was 99.8% effective in preventing pregnancy after 2 years of follow-up. However, approximately 1 of 7 women in the Essure clinical studies did not achieve successful placement of both microinserts during the first placement procedure. Some of these women chose to undergo a second placement procedure, achieved successful placement of both microinserts during the second procedure, and subsequently were able to rely on Essure for contraception. Of women who relied on Essure, 98% rated their long-term satisfaction with Essure as "good" to "excellent."

In September, 2015, the Food and Drug Administration investigated patient claims of harm related to Essure placement.  The panel concluded that no evidence of wrongdoing could be found.  However, they suggested the company undertake additional postmarketing analysis evaluating long-term outcomes and provide additional training for providers placing the device.  In addition, new labeling for the Essure device includes recommendations for a patient decision checklist (http://www.fda.gov/Medical/Devices/ResourcesforYou/Industry/ucm529254.htm) intended to support patient counseling and understanding of benefits and risks.  With proper patient selection, appropriate placement and technique, use of backup contraception until time of hysterosalpingogram and evidence-based timing and interpretation of the 3-month hysterosalpingogram, efficacy and patient satisfaction is high.


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