Study: Possible link between BRCA1 and BRCA2 mutations and rare breast implant-associated lymphoma

RELEVANCE

Most relevant for: People with BRCA mutation who have textured breast implants.

It may also be relevant for:

• people with breast cancer
• previvors
• people with a genetic mutation linked to cancer risk

Relevance: Medium-High

Strength of Science: Medium-Low

More rating details

Background on BIA-ALCL

People who have saline or silicone breast implants rarely develop breast implant–associated anaplastic large-cell lymphoma (BIA-ALCL). BIA-ALCL is a type of lymphoma, or cancer of the immune system. 

Since the FDA began tracking BIA-ALCL in 2011, 1,380 cases have been reported among approximately 3.5 million women in the U.S. with breast implants. This includes implants placed for breast reconstruction and cosmetic breast augmentation. That means fewer than four of every 10,000 women with implants develop this cancer.

The following common questions help to better understand BIA-ALCL:

What is the risk of BIA-ALCL?    
People with breast implants have a very low risk of developing BIA-ALCL: between 1 in 2,500 and 1 in 40,000 (0.0025% to 0.04%).

Which implants are linked to BIA-ALCL?
In cases reported to the FDA, the majority (96%) of women with BIA-ALCL had textured implants (implants with a roughened surface); however, a few cases of BIA-ALCL have occurred among women with smooth implants.                               

At the FDA's requested, Allergan, the major implant manufacturer of textured implants voluntarily recalled these products worldwide in 2019. Although textured implants and expanders are still available from other manufacturers, most breast reconstruction and augmentation now use smooth (non-textured) implants and expanders.  

What are the symptoms of BIA-ALCL?   
People should report to their doctor the following symptoms in the implanted breast, which are associated with BIA-ALCL:

• Persistent swelling of the breast (often caused by fluid around the implant). This is the most common symptom of BIA-ALCL.
• A lump or hardness of the breast in the surgical scar or around the implant.
• Pain in the breast.
• A lump in the underarm lymph nodes.
• Asymmetry in the breast.
• Skin rash on the breast (this symptom is rare).

Importantly, these symptoms do not mean you have BIA-ALCL. Other breast conditions, such as capsular contracture or a ruptured implant, can cause these symptoms as well.

How is BIA-ALCL diagnosed?
Doctors may use a combination of tests to identify BIA-ALCL, including:

• Ultrasound
• MRI
• Needle biopsy to remove fluid or tissue from the breast and/or lymph nodes
• Laboratory tests that look for evidence of cancer or other causes of the symptoms. A clear diagnosis of BIA-ALCL may require evaluation of fluid or tissue by a pathologist.

When does BIA-ALCL occur?      
BIA-ALCL is typically diagnosed, on average, between 7 to 10 years after mastectomy and reconstruction with textured implants.

What causes BIA-ALCL?               
The cause of BIA-ALCL is unclear, but it may result from the body’s long-lasting immune response to textured implants that becomes a lymphoma in rare cases.

How is BIA-ALCL treated?           
Treatment typically involves surgery to remove the implant and the surrounding capsule of scar tissue. Some patients may require additional treatment, such as chemotherapy, radiation therapy or both. Most people with BIA-ALCL respond well to treatment and have no further problems, but it can be a serious condition for some. In rare cases (under 1%), it can be fatal, especially when it is not diagnosed and treated early.

Should people with textured implants have them removed?
The FDA does not recommend removing textured implants when there are no symptoms of BIA-ALCL. Like any surgery, removal of implants carries risks, which are more common than the risk of developing BIA-ALCL. Women should report symptoms of BIA-ALCL to their doctor.

What is this study about?

This study looked at women with breast cancer who had breast implants. Women with a BRCA1 or BRCA2 mutation who had textured breast implants had a higher risk of developing BIA-ALCL compared to women without BRCA1 or BRCA2 mutations who had textured implants. However, very few women in this study had BIA-ALCL. Because the number of cases of BIA-ALCL was small, researchers could not be certain that this difference is meaningful (as reflected in the wide confidence intervals reported). More research is needed to show whether these differences are real and associated with a BRCA mutation rather than some other factor.

Why was this study conducted?

A Dutch study in 2020 reported that 25% of people with BIA-ALCL had an inherited mutation in BRCA1 or BRCA2. This suggests that people with a BRCA1 or BRCA2 mutation may have a higher risk of developing BIA-ALCL if they have textured implants. It is important to note that until 2019, 95% of breast implants in Europe were textured, compared to about 12% in the United States. The Dutch study also reported more frequent BRCA mutations than we typically see in the U.S.

This study aims to clarify whether having a BRCA1 or BRCA2 mutation increases the risk of BIA-ALCL among women in the U.S. who have textured implants following breast cancer.

Who was included in the study?

Researchers looked at the frequency of BIA-ALCL among 3,546 women with breast cancer who had breast reconstruction with textured implants at Memorial Sloan Kettering Cancer Center (MSKCC). These patients were predominantly treated by one surgeon.

Study findings

In this study, 11 of the 3,546 women (0.3%) developed BIA-ALCL after an average follow-up of eight years after implant surgery. This rate is 10 times higher than previously reported rates of BIA-ALCL among women with textured implants (regardless of BRCA status).

• 520 of 3,546 women were tested for inherited BRCA1 or BRCA2 mutations.
  • 43 of 520 women tested had a BRCA1 or BRCA2 mutation.
    • 7 of 43 women with a BRCA1 or BRCA2 developed BIA-ALCL.
    • None of the 5 women with an Ashkenazi founder mutation developed BIA-ALCL.
  • 4 of  477 women who did not have a BRCA mutation developed BIA-ALCL.

Limitations of the study

• Few BIA-ALCL cases: Few women developed BIA-ALCL (with or without BRCA mutations), meaning the study results are less certain than if a larger group were evaluated.
• Higher BIA-ALCL rate than previously seen: The rate of BIA-ALCL in all women was higher than in other studies. The reason for this is unclear.
• Participation limited to one institution: All participants in this study were treated at one institution by one surgeon and were diagnosed by the same pathology lab. It will be important to repeat this study in different locations to understand if these results apply to all people with BRCA mutations.
• Unknown risk for those without breast cancer: This study suggests that BRCA mutations may increase the risk of BIA-ALCL among women with textured implants who have had breast cancer. However, it is not clear whether the risk is the same for women with BRCA mutations who had implants for cosmetic reasons and never had breast cancer or previvors who had implants for prevention but have not had breast cancer.  
• Few people had genetic testing: Only 14% of women in the study (520 of 3,546) had genetic testing. Individuals who chose to have genetic testing may not represent the general population of women with breast implants. Additional factors about participants who chose to have genetic testing could affect the study results.
• BRCA mutations may raise the risk of lymphoma: BRCA1 and BRCA2 mutations are known to increase the risk of several types of cancers (breast, ovarian and others). Some reports suggest that, generally, people with a BRCA1 or BRCA2 mutation may have a slightly higher risk of lymphoma, even if they have not had breast cancer or implants.
• Too few BRCA carriers of Ashkenazi heritage: Only 5 women had one of the 3 Ashkenazi founder mutations in BRCA1 or BRCA2, and none of them developed BIA-ALCL. It is unclear how the study results apply to these common BRCA mutations.

What does this mean for me?

FDA states that breast implants are not considered lifetime devices. National medical associations recommend that breast implants be changed every 10 to 15 years. For people without symptoms or ruptures, the guidelines do not recommend early implant removal for people without symptoms or ruptures. Surgery to remove implants also has risks.

If you have textured implants, be aware of changes in your breast, and report any of the symptoms that may indicate BIA-ALCL, including fluid around your implant, pain or swelling in your breast that persists or growths or masses near the implant or surgical scars. Discuss with your doctor the current recommendations about when you should remove older implants and about textured implants.

If you have textured breast implants and a BRCA1 or BRCA2 mutation, this study suggests that you may have a higher risk of developing BIA-ALCL. However, this risk remains low, and most women with textured implants, including those with BRCA mutations, do not develop BIA-ALCL.

Among those who do develop BIA-ALCL, most symptoms are resolved with appropriate medical treatment. It is important to report symptoms to your doctor as soon as possible, as some cases of BIA-ALCL can be serious, and in rare cases, it can be fatal.

The use of textured implants in the U.S. has declined since 2019, and the rate of BIA-ALCL is projected to decrease. If you are unsure about your risk or have concerns, talk with your doctor about current recommendations and additional actions that may be right for you.

References

Ghione P, Mandelker D, Arcila ME, Seshan VE, et al. BRCA1/2 impact on the development of implant-associated lymphoma in women with breast cancer and textured implants. Blood Advances. 2025.

FDA: Breast implants. Current as of 12/15/2023. Accessed July 9, 2025.

FDA: Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma. Accessed July 9, 2025. Current as of 02/06/2025.

FDA: Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Current as of 10/23/2019. Accessed July 9, 2025.

XRAY: Update: Stronger guidance about breast implant safety. Posted 12/14/21.

Disclosure: FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to ensure scientific integrity.

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posted 7/14/2025

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