Women with breast cancer who were also carriers of the BRCA1 or BRCA2 mutation and received textured breast implants as part of their reconstructive surgery after mastectomy were 16 times more likely to develop breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare T-cell lymphoma, compared with similar women without these genetic mutations, according to a study published today in Blood Advances.
"Our findings show that BRCA1 and BRCA2 mutations are a significant risk factor for developing this type of lymphoma, confirming earlier suggestions of a possible role. It's possible that implant-associated lymphoma is yet another cancer that can arise because of these genetic mutations," said lead researcher Paola Ghione, MD, a lymphoma specialist at Memorial Sloan Kettering Cancer Center (MSKCC). She adds that the analysis underscores the need for women to include their personal history of mastectomy and implants long after surviving breast cancer itself.
This is the first large study to look at whether the BIA-ALCL occurrence is higher among women who have a BRCA mutation, which is also responsible for the onset of breast cancer in 5-10% of cases. Carrying a harmful mutation in the BRCA 1 or BRCA 2 gene increases the risk of several cancers, including those of the breast, ovaries, pancreas, and skin.
Earlier studies had shown an association between textured implants and the development of BIA-ALCL, leading to their recall from the European and U.S. markets in 2019. BIA-ALCL is a type of T-cell lymphoma that arises near textured breast implants, either as a collection of fluid or mass. It usually develops seven to 10 years after women undergo mastectomy and reconstructive surgery with implants.
In 2023, the U.S. Food and Drug Administration (FDA) reported a total of 1,264 cases and 63 deaths related to BIA-ALCL. While textured breast implants were used in about 12% of reconstructive surgeries in the U.S., they were the go-to in Europe, used in up to 95% of surgeries. Breast implants are generally changed every 10 to 15 years, so there are many women who still have these implants in their bodies, Dr. Ghione explained.
"If we look at the absolute numbers [seen in this study], it's still fairly rare, but the important thing to note is that when we look at women with this genetic predisposition, there is a big jump in the percentage with this lymphoma," she said. Other factors, including the type of implant filling (saline or silicone), age at breast cancer surgery, and prior cancer treatments (radiation or chemotherapy), were not found to be associated with developing BIA-ALCL.
In this study, Dr. Ghione and her colleagues pulled from MSKCC's unique cohort of over 3,000 women who had breast implants as part of their breast cancer treatment and are followed over time to assess for complications. Within this group, 520 women were tested for the BRCA genes. They compared the prevalence of BRCA1 or BRCA2 mutations, confirmed through testing, between women who did and did not develop BIA-ALCL after reconstruction with textured implants only; smooth surface devices are not thought to carry the risk of lymphoma, Dr. Ghione explained.
Women were followed for a median of 11.5 years. Of the 520 women with breast cancer tested for BRCA, 8.3%, or 43 patients were carriers of BRCA1 or BRCA2 mutations. The age-adjusted rate of developing BIA-ALCL for women with BRCA1 or BRCA2 mutations was 16 times the rate of BIA-ALCL among women without the genetic mutation. The researchers also conducted a case-control study with 13 BIA-ALCL cases matched one to three with 39 controls, which showed that the frequency of BRCA1 or BRCA2 mutations in BIA-ALCL cases was significantly higher than that of the controls.
"The implants that are put in place now are theoretically safe; however, there are still a lot of women who are living with textured breast implants, so it's important that women know what implants they have and talk with their doctor and remember to report this surgery as part of their medical history," Dr. Ghione said, further advising women to ask about genetic testing, including for BRCA 1 or BRCA 2 mutations, especially if they were diagnosed or have family members diagnosed with breast cancer at younger ages.
Given the low risk of BIA-ALCL, the FDA does not recommend having implants removed unless women are having symptoms. Symptoms can include pain, lumps, swelling, or unexpected changes in breast shape. However, the researchers said the study's findings should prompt women who have had reconstructive breast surgery because of breast cancer to have open discussions with their health care team about the type of breast implants they have and what steps they can take to minimize any risk. This is especially true if their plastic surgeon is suggesting it's time to replace the implants.
This study did not include women with the BRCA1 or BRCA2 mutations who underwent prophylactic surgery to prevent breast cancer.
Dr. Ghione and team will continue to follow these women, as well as others in the cohort that have had textured implants removed. This study is limited in that it is from a single institution, though it included a diverse population and a very long follow up.
This study was funded by the National Institutes of Health's National Cancer Institute.
