A study found that one in 6,920 women with breast implants will develop anaplastic large-cell lymphoma (ALCL) in the breast before they reach the age of 75.
Even though the numbers are low, researchers call for counseling about the risk for women considering breast implants as cosmetic or reconstructive surgery.
The study, titled “Breast Implants and the Risk of Anaplastic Large-Cell Lymphoma in the Breast,” was published in the journal JAMA Oncology.
“Since the introduction of breast implants in the 1960s, their safety has been debated extensively, even resulting in a temporary ban (1992-2006) on silicone-gel implants for cosmetic indications by the U.S. Food and Drug Administration (FDA),” researchers wrote.
The association between breast implants and breast-ALCL was first reported in 2008, when researchers described five cases of breast-ALCL in women with breast implants. Since then, several other case reports have sustained this association.
Nevertheless, “the precise relative and absolute risks of breast-ALCL in women with implants are unknown,” researchers wrote.
So researchers examined the nationwide Dutch pathology registry to identify all cases of breast-ALCL in the country from 1990 to 2016.
Among the 43 cases found, 32 were in women with breast implants. Macrotextured implants were found in 23 of 28 patients with breast-ALCL for whom the type of breast implant was known. Microtextured implants were found in the remaining five patients. No smooth or polyurethane covered implants were seen in breast-ALCL patients.
Among the 146 controls who had other lymphoma types in the breast, only two had breast implants. This means that women with breast implants were 422 times more likely to develop breast implant-associated ALCL (BIA-ALCL) than any other breast lymphoma.
While this seems like a lot, an analysis at the absolute risk for BIA-ALCL showed that only one out of 6,920 women with implants will develop the disease before the age of 75.
Of 32 patients with BIA-ALCL, three were from families with high breast cancer risk, and proven BRCA mutations were found in two of them. “Future studies should investigate the possibility that BRCA1 and BRCA2 mutations might increase the risk of BIA-ALCL,” the team noted.
The researchers called for mandatory comprehensive counseling for women considering breast implants for cosmetic or reconstructive reasons. Women with breast implants should be made aware of the risks and symptoms of BIA-ALCL because the outcomes in cases that are diagnosed at early stages are excellent.
They also call for registry programs for breast implants and other medical devices so that health risks posed by their use can be monitored.
“Breast implants are associated with increased risk of breast-ALCL, but the absolute risk remains small. Our results emphasize the need for increased awareness among the public, medical professionals, and regulatory bodies, promotion of alternative cosmetic procedures, and alertness to signs and symptoms of breast-ALCL in women with implants,” the researchers concluded.