This is a review of 8 separate clinical studies of women who had these devices and their problems attributable to their use. Pain was reported in 1-9%, heavier menstrual bleeding in 1-20%, and other less frequent issues. There were pregnancies reported but most were related to women not using alternative contraception in the first 3 months after insertion. I was interested that they reported perforations at time of placement of less than 1% to 3%. At Lakeshore Surgical Center we have removed over 150 Essure’s and have seen one perforation, one imbedded in the wall of the uterus and several that were not correctly placed but not perforated out of the uterus.
The introduction to this article notes that there have been a rapid rise in number of complaints and that the FDA had decided against removal of the devices from the market. I would have liked the article to acknowledge that there are a small number of patients that are very much affected by the Essures. Most women do very well with these devices but some do not.
“Obstetrics and Gynecology” Volume 129, number 1,pp 10-19 “Hysteroscopic Sterilization with Essure: Summary of the U.S. Food and Drug Administration Actions and Policy Implications for Postmarketing Surveillance”