Natrelle 410 Anatomical
Allergan/AbbVie
MR Conditional — conditions not yet documented here. We have a Conditional label for this device but the specific scan conditions (field strength, SAR / B1+rms, monitoring requirements) aren't in our records yet. Treat as Not determined and let your MRI team confirm before any scan.
Here's what to do next — you're going to be okay:
- Bring your device card (the wallet card from your surgery) to your appointment. Your MRI team can identify any device from it.
- Call the manufacturer's patient line — the number is on your card. They answer device questions every day.
- Tell your imaging center about your device when you book. They screen every patient before every scan — no one will scan you unless it's safe.
Don't schedule an MRI based on this page alone — your MRI team verifies every device.
What this means for you
MR Conditional — but the conditions are not yet on file. The label exists. The scan rules (field, SAR, monitoring) do not. Treat as Not determined and let your MRI team confirm before any scan.
Here's what to do next — you're going to be okay:
- Bring your device card (the wallet card from your surgery) to your appointment. Your MRI team can identify any device from it.
- Call the manufacturer's patient line — the number is on your card. They answer device questions every day.
- Tell your imaging center about your device when you book. They screen every patient before every scan — no one will scan you unless it's safe.
For information only — your MRI team makes the final decision before any scan. They check every patient, every time.
FDA Recall Alert
Class I — Most SeriousThe firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-length element string in the UDI data chain of the 2D barcode, which is not formatted to the GS1 standard.
💡 What this means for you
This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.
11/5/2019 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousThe firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-length element string in the UDI data chain of the 2D barcode, which is not formatted to the GS1 standard.
💡 What this means for you
This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.
11/5/2019 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousThe firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-length element string in the UDI data chain of the 2D barcode, which is not formatted to the GS1 standard.
💡 What this means for you
This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.
11/5/2019 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousThe action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
💡 What this means for you
This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.
7/23/2019 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousThe action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
💡 What this means for you
This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.
7/23/2019 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousThe action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
💡 What this means for you
This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.
7/23/2019 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousThe action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
💡 What this means for you
This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.
7/23/2019 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousThe action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
💡 What this means for you
This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.
7/23/2019 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousAllergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shipped was beyond the 47 month shelf life.
💡 What this means for you
This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.
6/17/2015 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousAllergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the products shipped were beyond the shelf life.
💡 What this means for you
This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.
6/17/2015 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousAllergan is recalling the NATRELLE 410cc Re-Sterilizable Breast Implant Sizer because the expired product was shipped to the user level.
💡 What this means for you
This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.
6/7/2015 · View on FDA.gov
⚕️ This information is for reference only. A recall does not necessarily mean your device needs removal. Consult your healthcare provider for medical advice.
Category
Breast Implants
Body Region
Chest
Model
Style 410
MRI Conditions
MR Conditional at 3T or less. Form-stable highly cohesive silicone gel. Anatomical (teardrop) shape.
Clinical Warnings
FDA recommends periodic MRI for silent rupture screening. Textured surface — monitor for BIA-ALCL.
Indexed from FDA records. Conditions on this page have not been verified against the manufacturer's instructions for use.