Summary Safety Review - ESSURE Permanent Birth Control System - Assessing the Risk of Complications and the Potential Need for Device Removal

May 25, 2016

Product

Essure Permanent Birth Control System manufactured by Bayer Healthcare LLC

Potential Safety Issue

Complications including allergic reactions, abnormal bleeding/menstrual changes and the need for device removal

Key Messages

  • Essure is a medical device for women who are interested in permanent birth control.
  • Health Canada carried out a safety review after becoming aware of a large patient studyFootnote 1 and reports regarding safety concerns with the Essure device.
  • As a result of this safety review, Health Canada has recommended increased monitoring of the safety of the Essure system and will work with the manufacturer to issue a risk communication to help clarify information about the device and associated safety concerns. Health Canada will also work with the manufacturer to strengthen the product labelling for Essure regarding these safety concerns.

Overview

Health Canada carried out a safety review due to concerns regarding complications associated with the Essure device after it is inserted into the fallopian tubes. In certain cases, the symptoms have led patients to have the Essure device removed, which requires surgical intervention and may include removal of the uterus (hysterectomy).

Use in Canada

  • The Essure system is an option for permanent birth control (sterilization) in women (without the need for incisions or general anesthesia, and the device does not contain or release any hormones. The device is permanently inserted into the fallopian tubes of a woman's uterus in order to block sperm from reaching her eggs.
  • The system includes two small, spring-shaped inserts (the device), and the disposable delivery tools that assist the medical professional to implant the device.
  • Essure has been marketed in Canada since 2002 and over 8,000 units have been sold from 2002-2014. This figure amounts to approximately 1% of the units sold worldwide over the same period of time.

Safety Review Findings

  • At the time of the review, Health Canada had received a total of 18 reports associated with Essure, with half of those reports received in 2015 alone. The most commonly reported complaints were pain, followed by changes in menstrual bleeding and allergic (immune or hypersensitivity) reactions. Of these 18 reports, at least 10 mentioned surgery to remove the device as a treatment for these complications.
  • The review of the scientific and medical literature also found that up to one-third of women reported changes in their menstrual periods within months to years after receiving the Essure device. The women described that the bleeding was either heavier than usual or was irregular such as bleeding in the middle of a cycle. The causes of the changes in menstrual bleeding may be due to a variety of factors because large community-based surveys of adult women, in general, note similar proportions of individuals that have changes in menstrual patterns over time.
  • Some women have reported symptoms including fatigue, depression, mood swings, bloating, nausea, weight gain, headaches and hair loss. Some of these symptoms have been related to an inflammation or immune-type reaction after having the Essure device inserted. However, such symptoms are not rare in the general population and may be associated with other physiologic and disease states. There is also a lack of studies directly comparing individuals that have the Essure device with those that have chosen another method of permanent birth control (e.g. tubal ligation, often referred to as "having your tubes tied"). It is therefore difficult to determine if the Essure device itself is the cause of these symptoms. In rare cases, true allergic reactions have been reported which may be related to one of the materials used in the Essure device (e.g. nickel).
  • Although several articles with guidelines have been published, there is no standard way of removing the Essure device after the first 3 months of it being inserted (the initial embedment period). The decision is made based on a discussion between the healthcare professional and their patient. Available information suggests that Essure removals often involve removing the woman's uterus (hysterectomy) as well. In many (but not all) cases, device removal has led to resolution or improvement in symptoms.
  • Health Canada's safety review included a review of the Essure Instructions for Use (IFU) and consultation with the Society of Obstetricians and Gynaecologists of Canada (SOGC). Taken together, the discussion suggested the need for more detailed safety warnings in the device's instructions for use (product labelling) and improved availability of information about possible complications associated with Essure so that women can make more informed decisions.

Conclusions and Actions

  • This safety review found that there are risks associated with the use of Essure that need to be better communicated and further monitored.
  • Health Canada is working with the manufacturer to issue a risk communication that includes a general discussion of the Essure device, the types of adverse events reported in Canada and internationally, a summary of Health Canada's safety review activities and recommendations to healthcare professionals and their patients to help better understand the risks associated with Essure.
  • Health Canada will also work with the manufacturer to update the product labelling for Essure so that both healthcare professionals and patients have a better understanding of the risks involved.
  • Health Canada will continue to monitor safety information involving Essure, to identify and assess potential harms. In addition, the manufacturer will be asked to submit to Health Canada the results of an upcoming study on Essure as required by the United States Food and Drug Administration, once it is completed. Health Canada will take appropriate and timely action if and when any new health risks are identified.

Additional Information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international safety information and what is known about the use of this device both in Canada and internationally.

Reference

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