Artoura Breast Tissue Expanders with Smooth Surface

FDA-Cleared Indications

• Breast reconstruction following mastectomy.
• Temporary expansion of breast skin and soft tissue before placement of a permanent breast implant.

Clinical Applications

• Staged breast reconstruction after mastectomy.
• Creation of a breast pocket by gradual saline expansion.
• Preparation of the chest wall for placement of a permanent breast implant.

Reported off-label uses

• Use in selected reconstructive procedures not directly covered by the device labeling may be reported in clinical practice, but requires individualized surgical judgment and informed consent.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• The surgeon selects the expander shape and size based on chest-wall dimensions, skin condition, planned reconstruction, and the desired breast volume.
• Expansion is performed over multiple visits by injecting sterile saline through the device's fill port; the schedule depends on healing and tissue tolerance.
• The device is generally placed during surgery under anesthesia and is intended as a temporary device, not a permanent breast implant.
• Patients with infection, inadequate soft-tissue coverage, poor wound healing, or other serious surgical risks may not be candidates; the treating surgeon evaluates contraindications.
• MRI compatibility depends on the exact model and its components. Patients should provide the device identification information to the MRI facility before scanning and follow the manufacturer's current MRI conditions.