FDA Links Breast Implants to Cancer, Allergan Issues Global Recall

Top Three Messages for Breast Implant Recipients

  • Specific models of Allergan breast implants are associated with 6x greater risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) versus other textured breast implants.
  • Patients should monitor for symptoms of BIA-ALCL and see a physician immediately if they experience any.
  • Asymptomatic patients do not need to have implants removed even if they know their implants are part of the recall.

This week the U.S. Food & Drug Administration (FDA) announced that Allergan textured breast implants had been tied to the development of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare form of cancer. After analyzing hundreds of adverse event reports of BIA-ALCL, regulators found certain Allergan implants to carry six times higher risk of BIA-ALCL than other textured breast implants. As a result, the FDA asked Allergan to remove all implicated implants and associated surgical instruments from the U.S. market. The manufacturer took things a step further by promptly issuing a global recall of designated implants.

Note: We covered this type of implant in a previous story detailing a secret FDA reporting program that likely delayed this important recall.

Only Allergan Textured Breast Implants Have Been Recalled

For the hundreds of thousands of women who get breast implants yearly, news that a rare cancer may be associated with their implants can be understandably scary. Fortunately, less than 5% of breast implants sold in the United States are textured like the recalled implants, and only specific Allergan implants have been associated with an increased risk of BIA-ALCL. The incidence of BIA-ALCL is still relatively low, even for the recalled implants.

Allergan has instructed all healthcare providers to stop implanting recalled devices immediately and has indicated that customers will receive complete instructions for returning unused implants shortly. At this time, Allergan has not called for implants to be removed from patients who have already received them.

July 2019 Recalled Allergan Textured Breast Implants & Instruments
Source: FDA.gov
Allergan Natrelle Saline-Filled Breast Implants (formerly McGhan RTV Saline-Filled Mammary Implant)
  • Style 163 – BIOCELL Textured Shaped Full Height, Full Projection Saline Breast Implants
  • Style 168 – BIOCELL Textured Round Moderate Profile Saline Breast Implants, also referred to as 168MP (168 Moderate Profile)
  • Style 363 – BIOCELL Textured Shaped Moderate Height, Full Projection Saline Breast Implants, Allergan catalog includes 363LF, or 363 Low Height Full Projection
  • Style 468 – BIOCELL Textured Shaped Full Height Moderate Projection Saline Breast Implants
Allergan Natrelle Silicone-Filled Textured Breast Implants (formerly Inamed Silicone-Filled Breast Implants)
  • Style 110 – BIOCELL Textured Round Moderate Projection Gel Filled Breast Implants
  • Style 115 – BIOCELL Textured Round Midrange Projection Gel Filled Breast Implants
  • Style 120 – BIOCELL Textured Round High Projection Gel Filled Breast Implants
  • Style TRL – Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
  • Style TRLP – Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
  • Style TRM – Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
  • Style TRF – Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
  • Style TRX – Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
  • Style TCL – Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
  • Style TCLP – Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
  • Style TCM – Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
  • Style TCF – Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
  • Style TCX – Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
  • Style TSL – Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
  • Style TSLP – Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
  • Style TSM – Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
  • Style TSF – Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
  • Style TSX – Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
Natrelle 410 Highly Cohesive Anatomically Shaped Silicone Filled Breast Implants
  • Style 410FM
  • Style 410FF
  • Style 410MM
  • Style 410 MF
  • Style 410 FL
  • Style 410 ML
  • Style 410 LL
  • Style 410 LM
  • Style 410 LF
  • Style 410 FX
  • Style 410 MX
  • Style 410 LX
Allergan Tissue Expanders with BIOCELL Texturing
  • Natrelle 133 Plus Tissue Expander (K143354)
  • Natrelle 133 Tissue Expander with Suture Tabs (K102806)

Breast Implant Cancer Is Extremely Rare

Reports of BIA-ALCL began to surface in the late 1990s, but high-quality studies only became available in recent years, with the FDA reaching a determination of risk associated with Allergan implants just days ago. Even with the increased risk associated with these faulty implants, experts estimate that only three women out of every 100 million will be diagnosed with BIA-ALCL each year. That means as many as 500 American women could learn they have BIA-ALCL this year.

With a cancer this rare, it can be difficult to generalize treatment success and prognosis, but studies indicate that BIA-ALCL is relatively treatable. With complete removal of the faulty implant and attached capsular (cancerous) tissue, only about 4% of patients experience a return of BIA-ALCL within five years of operation.

Education and Vigilance Are Key for Breast Implant Recipients

The FDA encourages women with recalled Allergan breast implants to learn and monitor for the symptoms of BIA-ALCL.

BIA-ALCL Symptoms:

  • Persistent pain or swelling around breast implants
  • Changes in the tissue surrounding breast implants

If any symptoms appear, individuals should seek medical attention immediately. For patients who do develop BIA-ALCL (confirmed by a licensed healthcare professional), the FDA recommends they undergo implant and scar capsule removal.

On average, women are diagnosed with BIA-ALCL approximately 9 years after receiving their implants, but time to diagnosis has ranged from 1 to 20 years in studies. This means recipients will need to maintain vigilance for symptoms for the lifetime of their breast implants. You can find more information about the recall and BIA-ALCL here >>

Learn what to do if you’re diagnosed with breast cancer.

BIA-ALCL Patients May Have Legal Recourse

Despite the low incidence of BIA-ALCL with the recalled implants, Allergan may still face lawsuits over this unexpected and serious side effect. In a similar situation, valsartan blood pressure medication manufacturers already face numerous lawsuits from patients claiming they weren’t warned of cancer as a possible side effect. The incidence of valsartan-associated cancer is lower than that of BIA-ALCL, so we may begin to see textured breast implant lawsuits filed in the very near future.

Authored by Katy Moncivais, Ph.D.Medical Editor
Photo of Katy Moncivais, Ph.D.
Katy Moncivais holds a Ph.D. in Biomedical Engineering from The University of Texas at Austin. She’s an experienced Regenerative Medicine Consultant with a demonstrated history of working in the hospital & healthcare industry. Skilled in adult stem cells, medical devices, biomechanics, bacterial and mammalian cell culture, and regenerative medicine, she provides guidance on an array of topics affecting consumers. In her role at ConsumerSafety.org, Dr. Moncivais works alongside the writing and research staff to help deliver fact-based news stories to consumers. Her unique professional history alongside her rigorous educational background allows her to contribute to a variety of consumer-focused topics with a fresh perspective. In addition, Dr. Moncivais reviews portions of medically driven content to ensure scientific accuracy.
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