FDA warns on lymphoma risk associated with breast implants

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FDAThe FDA this month warned of an association between breast implants and the development anapestic large cell lymphoma.

The federal watchdog warned that the rare T-cell lymphoma can develop following implants, based on data the agency, and other health and regulatory bodies worldwide, have been collecting since 2011.

The exact number of cases “remains difficult to determine,” the FDA said, though data indicates that the occurrence of BIA-ALCL is more common following the implantation of breast implants with textured surfaces over those with smooth surfaces.

The FDA said it has received a total of 359 medical device reports on cases of BIA-ALCL, which included 9 deaths. Of the 231 reports which included data on the implant surface, 203 were reported textured while only 28 were reported as smooth implants. Of the reports which mentioned fill types, 186 were reported as gel filled while 126 were reported as saline filled.

The FDA said that the condition occurs most frequently in patients undergoing implant revision operations for late onset, persistent seroma.

The agency said it is continuing to collect and evaluate data on cases of lymphoma linked to breast implants, but warned that current data on fill and surface type are limited. The federal watchdog also said it is unable to report on the incidence or prevalence of the issue.

The federal watchdog warned healthcare providers to not engage in prophylactic breast implant removals for patients without symptoms or abnormalities as the issue has generally only been identified in patients with late onset of symptoms such as pain, lumps, swelling for asymmetry.

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