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Health Canada Wants Boxed Warning on Essure Contraceptive Coil

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Ottawa, Canada: Health Canada has issued information stating that complications have been reported with the use of ESSURE (permanent birth control system).

These include changes in menstrual bleeding, unintended pregnancy, chronic pain, perforation and migration of device, allergy and sensitivity or immune-type reactions. Additional symptoms such as fatigue, nausea, weight gain, headaches and hair loss have also been reported. Some patients have chosen to have their ESSURE inserts removed due to complications.

Some complications may be considered serious. In some patients, these complications have led to the surgical removal of ESSURE, which may include hysterectomy. As a result, the product labelling for ESSURE will be updated including a new Boxed Warning section to reflect this safety information.

Hysteroscopic sterilization using tubal implants is an alternative to other female sterilization techniques such as laparoscopic tubal occlusion using electrocautery, rings or clips. Currently, the only tubal implant system for hysteroscopic sterilization licensed for sale in Canada is ESSURE.

ESSURE is a permanent and irreversible form of birth control. ESSURE micro-insert is a spring like implant that is inserted hysteroscopically into each fallopian tube and expands to conform to the inner walls of the tube. Components of the micro-insert elicit an intended localized benign tissue growth that occludes the tube and anchors the insert in place. The micro-insert is considered a permanent implant.

Unintended pregnancy (including ectopic pregnancy) has been reported in ESSURE users, sometimes due to noncompliance with the need for alternative contraception for at least three months after implantation.

Changes in menstrual bleeding patterns have been reported by women in the months to years after insertion (implantation) of ESSURE. These changes can include heavier or lighter than normal bleeding or irregular periods such as bleeding in the middle of a cycle.

Chronic pain (lasting longer than three months post-insertion) has been reported in some ESSURE users.

Cases of incorrect device location due to migration or perforation have also been reported.



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