| TGA Action ID |
RC-2025-RN-00897-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Sterile Silicone Breast Implants - Motiva Implant Matrix SilkSurface PLUS with Qid, Motiva Implant Matrix Ergonomix Round SilkSurface with Qid, and Truefixation SmoothSilk Sterile Silicone Breast Implants with Qid |
| ARTG Number |
282776, 282777, 373251 |
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The TGA has conducted a post-market review of breast implants with micro transponders, related to the risk of image artifacts due to interference between the QID micro-transponder and magnetic resonance imaging (MRI).
Such image artifacts could potentially lead to inadequate evaluation of the implant, or potential missed diagnosis of breast lesions should the artifact obscure the lesion. The TGA has determined that this potential risk of image artifacts in MRI images outweighs the claimed benefits of QID led device traceability, given Australia’s existing traceability system.
On the 16th of October 2025, TGA cancelled (removed) these devices from the ARTG. |
| Instructions for Customers/Users |
Surgeons should:
· inform patients (in particular, high-risk breast cancer patients) about the potential risk of the device’s interference with MRI quality and potential insufficiency of MRI as a stand-alone diagnostic tool. The impact of the QID micro-transponder on imaging may not be known until after the MRI has been undertaken
· instruct their patients to follow the guidance available in the Patient Information Leaflet, to appropriately advise their radiologist and/or radiographer of their implant and its MR Conditional nature; and
· consider additional imaging if concerned, dependent on the patient’s clinical circumstances.
Radiologists and radiographers should:
· anticipate the presence of artifacts on MRI of patients with these breast implants; and follow the “instructions for patients undergoing MRI” as stipulated with the instructions for use leaflet, if available. Consider seeking such instructions available within the IFU online. |
| Action Commencement Date |
22/01/2026 |
| Responsible Entity |
|
| Contact Information |
regulatory@ebosmedtech.com - LifeHealthcare |