| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00243-1 |
| Product Name/Description |
Essure Permanent Birth Control
Product code: ESS-305
ARTG: 174123 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
As part of post-market monitoring Bayer Healthcare has identified that women who undergo both an Essure procedure and an endometrial ablation during the same surgical session may be at increased risks for events known to be associated with each procedure including damage to non-targeted tissue. Performing endometrial ablation after an Essure procedure may be associated with compromised ability to conduct and interpret a modified hysterosalpingogram (HSG); injury to surrounding tissue (e.g. bowel); increased risk of infection; post-ablation tubal sterilisation syndrome; stretching or removal of the Essure micro-insert that could affect the patient’s ability to rely on Essure for contraception. The above risks are assessed as low but should be considered in any woman having undergone both an Essure procedure and an endometrial ablation. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The sponsor is advising the users that:
- Endometrial ablation and the Essure procedure should not be performed on the same day/same surgical session.
- The Essure procedure should only be performed in a woman who has undergone an endometrial ablation if visualisation and accurate localisation of the tubal ostia is possible.
- Endometrial ablation should only be performed after the correct location of the Essure micro-inserts is confirmed by a satisfactory Essure Confirmation Test.
The sponsor will provide updated Instructions for Use (IFU) to all customers. This action has been closed-out on 02/02/2017. |
| Contact Information |
02 9882 3666 - AMSL |