Other Lymphomas May Be Linked to Post-Mastectomy Breast Implants

 

• The development of anaplastic large-cell lymphomas is a rare, but established, risk of post-mastectomy implant-based breast reconstruction.
• In this study, breast implants after mastectomy were also associated with an increased risk of other non-Hodgkin lymphomas.
• The results suggest that continued monitoring of breast implant-associated malignant neoplasms is warranted.

Aside from the established risk of anaplastic large-cell lymphomas (ALCLs), breast implants after mastectomy were also associated with an increased risk of other non-Hodgkin lymphomas (NHLs), according to results from a population-based cohort study.

Among over 61,000 women who underwent post-mastectomy implant-based breast reconstruction, 15 subsequent NHLs of the breast occurred (standardized incidence ratio [SIR] 5.03, 95% CI 2.82-8.30), of which seven were ALCLs (SIR 41.6, 95% CI 16.7-85.8) and eight were other histologies (SIR 2.84, 95% CI 1.23-5.60), reported Alfred I. Neugut, MD, PhD, of Columbia University Irving Medical Center in New York City, and colleagues.

The eight other histologies included five diffuse large B-cell lymphomas (DLBCLs; SIR 5.26, 95% CI 1.71-12.3), two small lymphocytic lymphomas (SLLs; SIR 16.7, 95% CI 2.02-60.2), and one peripheral T-cell lymphoma, not otherwise specified (SIR 11.8, 95% CI 0.30-65.7), they wrote in JAMA Network Openopens in a new tab or window.

"It is important to appreciate that the absolute risk of lymphoma is extremely low and similar for ALCL and the other NHL histologies," Neugut and team noted. "The FDA is aware of fewer than 30 cases of non-ALCL lymphomas in breast implant capsules vs over 1,300 cases of ALCL. Continued surveillance of breast implant-associated malignant neoplasms is warranted by government and regulatory agencies."

The median time from exposure to event was 83 and 82.5 months for breast ALCL and other lymphomas, respectively, with an excess risk of 14.3 and 10.8 per 1,000,000 persons per year. The excess risks of DLBCL, SLL, and peripheral T-cell lymphoma, not otherwise specified, were 8.5, 3.9, and 1.9 cases per 1,000,000 persons per year.

"Is the risk [of lymphoma] increased because of the breast implants? Yes, absolutely," Neugut told MedPage Today. "I think it would be an obligation of the surgeon to inform the patient that this is a potential long-term possibility, and risk. But we're talking about a very rare tumor, and the absolute risk is not very high."

A black box warning is included on breast implant packaging, stating that breast implants have been associated with the development of ALCL.

In 2022, the FDA issued a safety alertopens in a new tab or window, informing patients and healthcare providers of reports of squamous cell carcinoma and various lymphomas located in the capsule or scar tissue around breast implants.

"These observation rates were limited to case reports, and there are no epidemiological studies we know of that link implants to lymphoma aside from ALCL," Neugut and team noted.

With the results of this study, "at least now you have some reasonable, more precise estimate of what the risk is, so the patient can now factor that into her decision making," Neugut said.

For this study, the authors identified 61,043 women who underwent post-mastectomy implant-based reconstruction from January 2000 through December 2020, using the Surveillance, Epidemiology, and End Results (SEER) 17 database. Median age was 51, 73.6% were white, 8.1% were Black, 10.2% were Hispanic, 7.5% were Asian or Pacific Islander, and 0.4% were American Indian or Alaska Native. Median follow-up was 86 months from the incident primary breast cancer diagnosis.

Five women were diagnosed in the breast contralateral to the primary breast cancer. Zero and five cases reported radiotherapy and chemotherapy, respectively, during their breast cancer treatment.

There was no increased risk of non-Hodgkin lymphoma outside the breast or Hodgkin lymphoma of the breast, and the risk of non-Hodgkin lymphoma of the breast was not increased in women who received mastectomy without immediate implant-based reconstruction (SIR 1.31, 95% CI 0.91-1.83) or lumpectomy with or without radiotherapy (SIR 1.11, 95% CI 0.78-1.52).

"Future studies should further investigate the pathophysiology, presentation, patient- and implant-specific risk factors (including implant type and manufacturer), and treatment of these malignant neoplasms," the authors concluded.

Disclosures

The study was supported by the National Cancer Institute.

Neugut reported serving as a consultant for Otsuka, GSK, United BioSource Corporation, Value Analytics, Cybin DSMB, Merck, and Hospira, and receiving grant funding from Otsuka and Kyowa Kirin.

Co-authors reported relationships with Varian, UpToDate, HPM, Becton Dickinson, and Johnson & Johnson.

Primary Source

JAMA Network Open

Source Reference: opens in a new tab or windowKinslow CJ, et al "Lymphomas of the breast after postmastectomy implant-based breast reconstruction" JAMA Netw Open 2025; DOI: 10.1001/jamanetworkopen.2025.25820.

https://www.medpagetoday.com/hematologyoncology/breastcancer/116879