Mentor Saline Breast Implant

Mentor (Johnson & Johnson)

Not determinedIndexed from FDA records

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:

  1. Bring your device card (the wallet card from your surgery) to your appointment. Your MRI team can identify any device from it.
  2. Call the manufacturer's patient line — the number is on your card. They answer device questions every day.
  3. 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:

  1. Bring your device card (the wallet card from your surgery) to your appointment. Your MRI team can identify any device from it.
  2. Call the manufacturer's patient line — the number is on your card. They answer device questions every day.
  3. 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.
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For information only — your MRI team makes the final decision before any scan. They check every patient, every time.

✅This recall has been resolved
⚠️

FDA Recall Alert

Class II — Moderate

Missing Dome Pack accessory.

💡 What this means for you

This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.

3/26/2017 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class II — Moderate

The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates.

💡 What this means for you

This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.

6/30/2016 · 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.

Regulatory Info

510(k) NumberK130813 ↗
Clearance Date4/10/2013
Product CodeLCJ
✅
All Recalls Resolved

2 past recalls — all corrective actions completed

Data sourced from openFDA. This is for reference only — consult your healthcare provider for medical advice.

Category

Breast

Body Region

Chest

Model

Mentor Saline

MRI Conditions

MR Conditional at 3T or less. Silicone shell with saline fill. Non-ferromagnetic.

Clinical Warnings

Saline rupture immediately apparent.

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Indexed from FDA records. Conditions on this page have not been verified against the manufacturer's instructions for use.