| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2019-RN-01488-1 |
| Product Name/Description |
Textured Nagor GFX, CoGel and Impleo Mammary Implants
Nagor Mammary Implants Gel-filled-TEXTURED
ARTG 142863
9-cell CoGel gel-filled Nagor mammary implant range - textured
ARTG 277757
Impleo gel-filled Nagor mammary implant range - textured
ARTG 277758 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
25/10/2019 |
| Responsible Entity |
|
| Reason/Issue |
The issue identified with the textured range of mammary implants show grounds that a degree of risk of BIA-ALCL has been linked to this range of devices.
The TGA has undertaken regulatory action in relation to breast implants and tissue expanders sold in Australia. Suspended implants are those that are "macro-textured" - grade 3 and 4 and some "micro-textured" implants associated with higher incidences of BIA-ALCL and other clinical concerns.
This action is being undertaken as a result of the suspension of various textured implants. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Implanting surgeons are alerted to this issue and requested to review the relevant literature in the context of their particular patients on a case-by-case basis.
The TGA does not provide clinical advice as part of its mandate under the Therapeutic Goods Act 1989, however, the TGA website does contain information for health professionals and consumers regarding this matter.
Furthermore, the TGA has been advised that removal or replacement of macro-textured breast implants or tissue expanders in asymptomatic patients is not recommended.
Following receipt of the initial July 2019 TGA proposal to suspend these devices, Surgiplas removed all un-implanted stock of these goods from the supply chain. |
| Contact Information |
1300 244 724 - Allied Scientific |