Textured Breast Implants and Cancer Risk: What to Know

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Silicone breast implant

In July 2019, the U.S. Food and Drug Administration (FDA) announced that textured breast implants are linked to cancer (specifically a type of cancer called breast implant-associated anaplastic large cell lymphoma or “BIA-ALCL”). The agency subsequently asked Allergan—a major manufacturer of breast implants—to recall its Natrelle brand textured implants and tissue expanders because of their high association with BIA-ALCL. If you received textured breast implants for cosmetic or reconstructive reasons, here’s what you need to know about the textured breast implants recall.

You Do Not Need to Have Your Textured Breast Implants Removed If You Have No Symptoms

If you have textured breast implants, you do not need to have them surgically removed if you’re not experiencing symptoms. In fact, the FDA does not advise undergoing prophylactic surgical removal of the implants. Surgery can expose you to additional risks, such as infection, and the risk of any given woman developing BIA-ALCL is extremely low.

You should, however, be vigilant for the signs and symptoms of BIA-ALCL, which can include:

  • Fluid collection under or around the implant (called a “seroma”), often years after the initial surgery
  • Hardening or stiffening of the implant, which could indicate a condition called capsular contracture
  • Lump or nodule in or around the breast or in the armpit
  • Pain in the breast
  • Swelling of the breast, particularly if it causes asymmetry
  • Unexplained low-grade infection

If you experience any of these symptoms, see your doctor promptly.

Breast Implant-Associated Anaplastic Large Cell Lymphoma is Extremely Rare

BIA-ALCL is not a breast cancer. It is an extremely rare type of non-Hodgkin’s lymphoma that arises within lymphoid tissues. The FDA first linked textured breast implants and cancer in 2011 but required additional data to confirm the association.

The American Society of Plastic Surgeons estimates the lifetime risk of BIA-ALCL in women with textured breast implants to be no greater than one in 2,207. To put this number in perspective, the lifetime risk for any woman to develop breast cancer is about one in eight. The lifetime risk of a man or woman developing colon cancer is approximately one in 23. Your risk of developing BIA-ALCL increases if you have Allergan textured breast implants, but overall that risk remains extremely low.

BIA-ALCL is Curable

When detected early, BIA-ALCL can be cured by removing the breast implant and surrounding tissue, if the disease has not spread anywhere else in the body. If the cancer has spread to the lymph nodes or elsewhere, chemotherapy or radiation may be required to destroy the cancerous cells. After treatment, doctors usually follow women with BIA-ALCL for two years with repeat imaging scans. Recurrence of BIA-ALCL is rare if a doctor surgically removes all the disease in the early stages.

Only Allergan Implants are Being Recalled

Many companies make textured breast implants, but only those manufactured by Allergan are being recalled. The Allergan Natrelle implants, which use a technology called BIOCELL, have been linked to a majority of BIA-ALCL cases. Allergan has recalled both saline and silicone-filled Natrelle textured breast implants, along with textured tissue expanders (devices used in breast reconstruction surgery to stretch the skin of the chest to accommodate implants after mastectomy). You can view a complete list of the devices and lot numbers subject to the recall at the FDA website.

Allergan Will Provide Replacement Implants Free of Charge

Under its lifetime warranty for textured breast implants, Allergan states it will replace recalled products with smooth breast implants at no charge to women who opt to have the textured implants removed. This warranty covers the product only. Allergan will not reimburse you for surgical costs.

In general, women with Allergan textured breast implants need not panic over the current recall. Instead, you should consult your doctor for an examination to learn if your implants seem healthy, and you should monitor your breast health as normal, but with a special vigilance for the signs and symptoms of BIA-ALCL.

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Medical Reviewer: William C. Lloyd III, MD, FACS
Last Review Date: 2020 Mar 30
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THIS TOOL DOES NOT PROVIDE MEDICAL ADVICE. It is intended for informational purposes only. It is not a substitute for professional medical advice, diagnosis or treatment. Never ignore professional medical advice in seeking treatment because of something you have read on the site. If you think you may have a medical emergency, immediately call your doctor or dial 911.
  1. The FDA Requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants and Tissue Expanders from the Market to Protect Patients: FDA Safety Communication. U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/safety-communications/fda-requests-allergan-voluntarily-recall-natrelle-biocell-textured-breast-implants-and-tissue
  2. Allergan Recalls Natrelle Biocell Textured Breast Implants Due to Risk of BIA-ALCL Cancer. U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/medical-device-recalls/allergan-recalls-natrelle-biocell-textured-breast-implants-due-risk-bia-alcl-cancer
  3. Breast Implant Recall: What You Need to Know. American Cancer Society. https://www.cancer.org/latest-news/breast-implant-recall-what-you-need-to-know.html
  4. An Update on BIA-ALCL: What Patients Should Know About Allergan’s Recall of Textured Breast Implants. American Board of Cosmetic Surgery. https://www.americanboardcosmeticsurgery.org/cosmetic-medicine/an-update-on-bia-alcl-allergan-recall-of-textured-breast-implants/
  5. BIOCELL Product Safety Alert. Allergan. https://www.allergan.com/medical-aesthetics/biocell-product-safety-alert
  6. Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). American Society of Plastic Surgeons. https://www.plasticsurgery.org/patient-safety/breast-implant-safety/bia-alcl-summary