ESSURE PERMANENT BIRTH CONTROL SYSTEM (2016-03-10)

Starting date:

March 10, 2016

Posting date:

April 12, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Healthcare Professionals, General Public, Hospitals

Identification number:

RA-57686

• Reason
• Affected products

Affected products

1. ESSURE PERMANENT BIRTH CONTROL SYSTEM

Reason

This is a field safety notice  that does not include a stock recovery or any physical changes to product currently in use or on the market.

Notification to inform that women who undergo both an Essure procedure and an endometrial ablation may be at increased risk for certain events known to be associated with each procedure. This notice provides advanced notification of an upcoming revision of the Essure product instructions for use (IFU).

Endometrial ablation and the Essure procedure should not be performed on the same day.

In women who have previously undergone an endometrial ablation, the Essure procedure should only be performed if visualization and accurate localization of the tubal ostia is possible. Performing an Essure procedure after an endometrial ablation may be associated with the following: unsatisfactory micro-insert location and increased risk of perforation or creation of false passage.

Endometrial ablation should be performed only after a satisfactory Essure confirmation test to ensure the appropriate location of the Essure micro-inserts.

Affected products