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Study: FDA report claims women with breast implants may be at risk for rare cancer

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STUDY AT A GLANCE

THIS INFORMATION HAS BEEN UPDATED. The  issued an update in March, 2018 about Breast Implant Associated Anaplastic Large Cell (BIA-ALCL). This was covered in a more recent XRAY review, here. On 07/25/19, the  announced a recall of Allergan BIOCELL textured implants and expanders, due to their association with BIA-ALCL. This was also covered in a more recent XRAY review, here

This report is about:

A possible increased risk of anaplastic large cell (ALCL), a rare type of non-Hodgkin , in women who have breast implants.

Why is this report important?

Patients who are making decisions about breast reconstruction or breast augmentation with implants should be informed of any possible link between anaplastic large cell and breast implants. Their health care providers should also be aware of this link so that they can properly monitor women who have breast implants.

Study findings: 

  1. As of February 1, 2017, the has received 359 medical device reports, including 9 deaths, of breast implant-associated anaplastic large cell (ALCL):
    • 203 cases involved textured implants; 28 involved smooth implants.
    • 186 cases involved silicone implants; 126 involved saline implants.
  2. As this data was derived from a compilation of reports rather than a formal research study, the percentage of women with implants who develop this rare cannot be calculated.

What does this mean for me?

Please read our more recent XRAY reviews to learn more about what is currently known about BIA-ALCL and recommendations. 

Based on the current literature and medical device reports, the reported a link between breast implants and anaplastic large cell (ALCL). However, the report states, “If you have breast implants, there is no need to change your routine medical care and follow-up.” Women with implants should follow standard medical recommendations, which include:

  • Knowing the look and feel of your natural or reconstructed breasts, and notifying health care providers immediately you notice any change.
  • Discussing the possibility of having breast (magnetic resonance imaging) to check for implant ruptures, particularly if you have silicone implants.

Importantly, the also advises that, “Breast implant-associated anaplastic large cell is a very rare condition.” Patients should weigh the risks and benefits of getting breast implants with their health care providers. While women with breast implants may have increased risk of developing anaplastic large cell compared to women who do not have implants, the research literature referenced in this report suggests that the risk is “very low.” During 2017, the American Cancer Society predicts diagnosis of 255,180 breast cancer cases compared to 72,240 non-Hodgkin cases, of which only 1,500 to 2,100 will be ALCL. Using these figures, the occurrence of ALCL in the United States is about 5 cases per million people.

Common symptoms of Non-Hodgkin are:

  • Enlarged
  • Fever
  • Sweating and chills
  • Weight loss
  • Fatigue
  • Swollen abdomen
  • Feeling of fullness
  • Chest pain/pressure
  • Shortness of breath/cough

Breast cancer survivors or people at high risk for breast cancer who experience these symptoms should discuss them with their health care providers.

Posted 4/21/17

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This article is relevant for:

Women who had or are consideration breast reconstruction with implants

This article is also relevant for:

Breast cancer survivors

Women under 45

Women over 45

Previvors

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Expert Guidelines Expert Guidelines

The issued guidelines for use of breast implants: 

  • Breast implant manufacturers are required to include a label warning and a patient decision checklist with all implants:
    • The checklist should include the current incidence rates of breast implant-associated anaplastic large cell (BIA-ALCL) and breast implant illness (BII).
    • The checklist should also include specific information regarding ongoing patient registries.
  • The has provided breast implant manufacturers specific language for an informational card that should be given to all patients following placement of breast implants. The card should include:
    • the serial number, lot number, device style, device size and the unique device identifier (UDI) of the implant.
    • weblinks to the most up-to-date access to the patient device checklist, boxed warning and labeling of the specific implant.
  • In collaboration with the and breast implant manufacturers, the American Society of Plastic Surgeons and the Plastic Surgery Foundation launched the National Breast Implant Registry (NBIR) in September 2018. The purpose of this database is to collect information from plastic surgeons on breast implant procedures to help improve the quality of care for all patients.

Updated: 12/15/2021

Questions to Ask Questions to Ask Your Doctor

  • What symptoms should I look for after I get breast implants?
  • What are the pros and cons of breast implants?
  • Should I have breast after my mastectomy and reconstruction with impants? If so, how frequently?
  • What options for breast reconstruction do not involve implants?
  • What factors should I consider when deciding between different breast reconstruction options?

Open Clinical Trials Open Clinical Trials

The following are studies related to breast reconstruction or no reconstruction after mastectomy.

Updated: 12/30/2021

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Updated: 12/30/2021

Who covered this study?

CNN

9 deaths and rare cancer linked to breast implants, FDA says This article rates 4.5 out of 5 stars

Forbes

FDA links breast implants to cases of rare blood cancer This article rates 4.5 out of 5 stars

New York Times

9 deaths are linked to rare cancer from breast implants This article rates 4.5 out of 5 stars

CBS News

9 deaths linked to rare cancer from breast implants This article rates 4.5 out of 5 stars

How we rated the media

IN DEPTH REVIEW OF RESEARCH

report background:

In 2011 the reported a possible association between breast implants and the development of a rare type of non-Hodgkin called anaplastic large cell (ALCL). However, very few cases had been reported at that time, making it difficult to fully determine the risk.  In 2016, the World Health Organization (WHO) focused new attention on this condition when it recognized anaplastic large cell as a rare cancer that can occur in women who have breast implants.  

The ’s March 2017 report ALCL and breast implants reflects information from medical device reports and published studies that concur with the WHO statement. (The document is a report, rather than a new research study.)

This report wants to identify:

Whether breast implants are associated with the development of anaplastic large cell (ALCL).   

Population(s) looked at in the report:

This report used information from medical device reports and studies in medical literature that includes “case histories and comprehensive reviews of the natural history and long-term outcomes of the disease.”

Study findings: 

  1. As of February 1, 2017, the has received 359 medical device reports, including 9 deaths, of breast implant associated anaplastic large cell (ALCL).
    • 203 cases involved textured implants; 28 involved smooth implants.
    • 186 cases involved silicone implants; 126 involved saline implants.
    • As this data is derived from a compilation of reports rather than a formal research study, the percentage of women with implants who develop this rare cannot be calculated.

Limitations:

The evidence used to make this association is not very strong. The percentage of women with implants in the United States who are diagnosed with anaplastic large cell (ALCL) cannot be calculated because the total number of women who have breast implants is unknown. But given the rarity of this disease, and that only 359 reports have been received over several years, the rate is probably not very high. No large studies have looked at the development of this type of in women with breast implants, or compared the rate of ALCL in women who had reconstruction with breast implants after mastectomy to women who received implants for breast augmentation.  

Conclusions:

This report suggests that a rare type of has occurred in some women who have had breast implants. However, the report does state that, “Breast implant associated-anaplastic large cell is a very rare condition and that more work is needed to confirm this association and determine the exact risk related to breast implants.  Patients considering implants should weigh all of the risks and benefits of breast implants with their health care providers.

Posted 4/21/17

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References

U.S. Food and Drug Administration. “Breast Implant-Associated Anaplastic Large Cell .” Published on March 2017. 

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