Allergan Recalls Textured Breast Implants Prompted by FDA Request

 

By Sandra Dalton, Staff Writer

Today, July 24, 2019, The U.S. Food and Drug Administration (FDA) announced that Allergan has initiated a voluntary worldwide recall of certain models of its textured breast implants. The recall is in response to a request by the FDA that the breast implants be recalled from the U.S. market due to the risk of implant-associated anaplastic large cell lymphoma (BIA-ALCL). According to the FDA the specific products affected by the recall have been linked to significant harm and death.

Recalled Allergan Breast Implant Products

The recall is worldwide and affects Allergan’s BIOCELL textured breast implant products as well as tissue expanders which are used prior to breast augmentation or reconstruction. Affected products include:

  • Natrelle Saline-Filled breast implants
  • Natrelle Silicone-Filled breast implants
  • Natrelle Inspira Silicone-Filled breast implants
  • Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants
  • Natrelle 133 Plus Tissue Expander
  • Natrelle 133 Tissue Expander with Suture Tabs

Unused breast implants and expanders involved in the recall are to be removed from doctor’s offices and suppliers.

If You Have the Recalled Implants

For women who already have the implants, the FDA has issued a safety communication. It does not recommend having the implants removed if you are not experiencing symptoms, but does recommend talking to your doctor if you have questions or experience BIA-ALCL symptoms such as:

  • Breast swelling
  • Breast pain
  • Other breast changes

Women who develop BIA-ALCL must have the implants and surrounding scar capsule removed. It is a more extensive procedure than simply removing the implant.

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