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


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Women who had or are consideration breast reconstruction with implants

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Checked Breast cancer survivors

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THIS INFORMATION HAS BEEN UPDATED. The FDA issued an update in March, 2018 about Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). This was covered in a more recent XRAY review. On 07/25/19, the FDA 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.

Recent headlines highlighted an FDA report stating that patients with breast implants may be at increased risk for a rare type of non-Hodgkin lymphoma. What is the scientific evidence behind this claim? (4/21/17)

STUDY AT A GLANCE

THIS INFORMATION HAS BEEN UPDATED. The FDA issued an update in March, 2018 about Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). This was covered in a more recent XRAY review, here. On 07/25/19, the FDA 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 FDA report is about:

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

Why is this FDA 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 lymphoma 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 FDA has received 359 medical device reports, including 9 deaths, of breast implant-associated anaplastic large cell lymphoma (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 lymphoma 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 FDA recommendations. 

Based on the current literature and medical device reports, the FDA reported a link between breast implants and anaplastic large cell lymphoma (ALCL). However, the FDA 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 MRI (magnetic resonance imaging) to check for implant ruptures, particularly if you have silicone implants.

Importantly, the FDA also advises that, “Breast implant-associated anaplastic large cell lymphoma 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 lymphoma compared to women who do not have implants, the research literature referenced in this FDA 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 lymphoma 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 lymphoma are:

  • Enlarged lymph nodes
  • 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.

Questions To Ask Your Health Care Provider

  • What symptoms should I look for after I get breast implants?
  • What are the pros and cons of breast implants?
  • Should I have breast MRI 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?

IN DEPTH REVIEW OF RESEARCH

FDA report background:

In 2011 the FDA reported a possible association between breast implants and the development of a rare type of non-Hodgkin lymphoma called anaplastic large cell lymphoma (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 lymphoma as a rare cancer that can occur in women who have breast implants.  

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

This FDA report wants to identify:

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

Population(s) looked at in the FDA report:

This FDA 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 FDA has received 359 medical device reports, including 9 deaths, of breast implant associated anaplastic large cell lymphoma (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 lymphoma 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 lymphoma (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 lymphoma 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 FDA report suggests that a rare type of lymphoma has occurred in some women who have had breast implants. However, the FDA report does state that, “Breast implant associated-anaplastic large cell lymphoma 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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