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

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.

Posted 4/21/17

Share your thoughts on this XRAYS article by taking our brief survey