Breast Tissue Expander (All Manufacturers)
Various
What this means for you
MR Unsafe — do not bring into the MRI scanner room. This device cannot safely be in the MRI suite. If a scan is essential, your physician will discuss alternatives.
For information only — your MRI team makes the final decision before any scan. They check every patient, every time.
Regulatory Info
No 510(k) clearance data available for this device.
Data sourced from openFDA. This is for reference only — consult your healthcare provider for medical advice.
Category
Breast
Body Region
Breast
MRI Conditions
All breast tissue expanders contain a magnetic central core used for port location. MRI is contraindicated — the magnetic field can cause displacement, heating, or demagnetization of the internal port. Remove or replace with a permanent implant before MRI.
Indexed from FDA records. Conditions on this page have not been verified against the manufacturer's instructions for use.