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What You Need to Know about the FDA Breast Implant Recall

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Recently the U.S. Food and Drug Administration (FDA) issued a recall on breast implants manufactured by Allergan. We asked Jay Agarwal, MD, chief of plastic surgery at the University of Utah (U of U) and breast reconstruction surgeon at Huntsman Cancer Institute (HCI), about what patients should know about the recall.

What is the issue?

The FDA requested that Allergan, a pharmaceutical company that makes breast implants and tissue expanders, recall certain types of breast implants in the United States. Allergan has voluntarily honored that request and has issued a worldwide recall on the products requested.

Why did the FDA make this request?

Studies have shown a connection between this type of implant and a disease called breast implant–associated anaplastic large cell lymphoma (BIA-ALCL).

What is BIA-ALCL?

Anaplastic large-cell lymphoma (ALCL) is a cancer of the immune system and a type of non-Hodgkin lymphoma. It’s called BIA-ALCL when the ALCL is related to breast implants. This is not a type of breast cancer. It is typically found in the scar, in the fluid near the implant, or in other parts of the body in cases where it has spread.

What is my risk of developing BIA-ALCL?

According to the FDA, the risk of developing BIA-ALCL is low. We need more research to know whether other factors contribute to that risk. Risk is higher in people with textured implants than those with smooth implants.

Are all implants being recalled?

No. Only textured implants manufactured by Allergan are being recalled.

What about tissue expanders?

Tissue expanders are balloon-like devices that your doctor slowly fills with liquid to stretch out the skin. Doctors replace them with a permanent implant once the space has been created. This usually happens within 6 months.

We have limited data about the risk of BIA-ALCL with tissue expanders, but certain textured tissue expanders are included in the recall.

How do I know if I have textured implants?

Your surgeon should be able to give you information about the type of implant you have. You can request your medical record from the health care team or hospital that performed the surgery. The surgeon may have given you a device card with the manufacturer and implant model name.

How do I know if I have BIA-ALCL?

Only a health care provider can diagnose BIA-ALCL. These are some symptoms:

  • Swelling or pain around the implant
  • Breast lumps
  • Breasts starting to look different

Do I need to have my implants removed?

Not necessarily. The FDA does not recommend that you have the implants removed unless you begin to experience symptoms.

Should I avoid breast implants or reconstruction after my breast surgery?

No. There are plenty of other options available for breast implants and tissue expanders that are not included in the recall. Talk to you doctor about your concerns. Many doctors haven’t used these products in their practice, so the recall would not change your treatment and reconstruction plans. HCI and U of U Health will no longer be using textured implants or tissue expanders.

So, what should I do?

  • Talk to your treatment team about your risk and possible options for you.
  • Keep watching for changes in your breasts.
  • Have regular follow-up visits with your treatment team.

Where can I find information or ask questions?

The best source of information is to talk to your treatment team.

Visit these sites for more information:

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