Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles 150 FH and 150 SH. Product Usage: Breast augmentation and Breast reconstruction

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    All Lots: Note:This product was not distributed within the US
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Allergan PLC
Reason for Recall:
The 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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles 150 FH and 150 SH. Product Usage: Breast augmentation and Breast reconstruction

Product Codes/Lot Numbers:

All Lots: Note:This product was not distributed within the US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2465-2019

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