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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-01125-1
Product Name/Description	Essure Permanent Birth Control (Australasian Medical & Scientific Ltd - ESSURE System - Contraceptive, tubal occlusion, Insert) Catalogue Number/Order Code: ESS305 All Batch Numbers ARTG number 174123
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	28/08/2017
Responsible Entity	Australasian Medical & Scientific Ltd
Reason/Issue	AMSL is advising that all lots of Essure are being removed due to a temporary suspension of the European EC certificate during the European certificate renewal process. Further, post-market information suggests that some patients may not be fully informed of possible device & procedure related complications, including changes in menstrual bleeding, unintended pregnancy, chronic pain, perforation and migration of the device, allergy/hypersensitivity, or immune-type reactions.
Recall Action	Hazard Alert
Recall Action Instructions	AMSL is requesting Customers: 1.Inspect your stocks and quarantine all Essure kits and then email or call us so we may arrange for your stock to be recovered. We require this information to reconcile this process. 2. If any of the recalled stock could have been possibly transferred from your hospital to another, please immediately let that hospital know of the recall action. It would be appreciated if you would then telephone us so that we can make contact with the hospital supplied from your hospital. This notice should be forwarded to all those who need to be aware of this information within your organisation. This action has been closed out on 19/11/2018
Contact Information	02 9882 3666 - AMSL