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

The causes of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare cancer that develops near implants, are unknown. Results from this study suggest that people with an inherited mutation in BRCA1 or BRCA2 may be at increased risk for BIA-ALCL. However, because very few cases of BIA-ALCL occurred among participants, more research is needed to confirm or refute this finding. (Posted 7/14/2025)

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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

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Background on BIA-ALCL

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

Since the 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 .
  • 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:

  • 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.