The risk of developing breast implant–associated anaplastic large-cell lymphoma (ALCL) could be higher among women with breast cancer and BRCA1 or BRCA2 mutations who received textured breast implants as part of their postmastectomy reconstructive surgery compared with patients lacking the genetic mutations, according to a recent study published by Ghione et al in Blood Advances.
Background
BRCA mutations are responsible for the onset of breast cancer in 5% to 10% of cases. Carrying these mutations can also increase the risk of ovarian cancer, pancreatic cancer, and skin cancer.
Breast implant–associated ALCL is a rare T-cell lymphoma that arises near textured breast implants either as a collection of fluid or mass. The malignancy typically develops 7 to 10 years following mastectomy and reconstructive surgery with the implants. Previous studies had uncovered a potential link between textured implants and the development of breast implant–associated ALCL, leading to their recall from the European and U.S. markets in 2019.
In 2023, the U.S. Food and Drug Administration (FDA) reported a total of 1,264 cases and 63 deaths related to breast implant–associated ALCL. While textured breast implants were used in about 12% of reconstructive surgeries in the United States, they were used in up to 95% of surgeries in Europe. Breast implants are generally changed every 10 to 15 years, so there are many women who still have these implants.
Study Methods and Results
In the study, researchers examined the data of over 3,000 women who received breast implants as part of their breast cancer treatment—with the goal of determining whether BRCA1 or BRCA2 mutations were more prevalent among the patients who did or didn’t develop breast implant–associated ALCL following reconstruction with textured implants. Among the patients, 520 of them were tested for BRCA genes. They excluded women with the BRCA1 or BRCA2 mutations who underwent prophylactic surgery to prevent breast cancer.
After a median follow-up of 11.5 years, the researchers revealed that 8.3% (n = 43) of the patients were carriers of BRCA1 or BRCA2 mutations. The age-adjusted rate of developing breast implant–associated ALCL among patients with BRCA1 or BRCA2 mutations was 16 times that of the developing breast implant–associated ALCL among those without the genetic mutations.
In a case-control study with 13 patients who had breast implant–associated ALCL matched with 39 controls, the researchers demonstrated that the frequency of BRCA1 or BRCA2 mutations in breast implant–associated ALCL cases was higher compared with that of the controls.
“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,” detailed lead study author Paola Ghione, MD, a lymphoma specialist at Memorial Sloan Kettering Cancer Center.
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 breast implant–associated ALCL.
Conclusions
The researchers noted that the results of their study underscored the need for women to include their personal history of mastectomy and implants in their medical records long after surviving breast cancer.
“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,” Dr. Ghione indicated. “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. [S]o, it’s important that women know what implants they have, talk with their [physicians], and remember to report this surgery as part of their medical history.” she continued.
Given the low risk of breast implant–associated ALCL, the FDA doesn’t currently recommend removing implants unless the patients experience symptoms like pain, lumps, swelling, or unexpected changes in breast shape. Nonetheless, the researchers advised women with a history or family history of breast cancer to ask their physicians about genetic testing—such as for BRCA1 or BRCA2 mutations—and those who have undergone reconstructive breast surgery to have open discussions with their health-care providers about the types of breast implants available as well as what steps they can take to minimize their risk. This may be especially true if their plastic surgeons suggest replacing patients’ implants.
The researchers plan to continue following-up with the patients involved in the study as well as other patients in a cohort that have had their textured implants removed. Although the study was conducted at a single institution, it included a diverse population and a long follow-up period.
Disclosure: The research in this study was funded by the National Institutes of Health’s National Cancer Institute. For full disclosures of the study authors, visit ashpublications.org.
