medwireNews: The US Food and Drug Administration (FDA) has issued an updated safety alert regarding breast implant-associated anaplastic large cell lymphoma (BIA–ALCL).
The advisory is now in agreement with the World Health Organization’s designation of BIA–ALCL as a rare form of T-cell lymphoma, most commonly reported following textured implants and in patients undergoing revision because of late-onset, persistent seroma.
“Because it has generally only been identified in patients with late onset of symptoms such as pain, lumps, swelling, or asymmetry, prophylactic breast implant removal in patients without symptoms or other abnormality is not recommended,” the update states.
For patients with suspected BIA–ALCL, physicians are recommended to send fresh seroma fluid and capsule portions for pathologic testing, including Wright Giemsa stained smears for cytologic assessment and cell block immunohistochemistry for cluster of differentiation and anaplastic lymphoma kinase biomarkers.
The FDA has now received 359 medical device reports of BIA–ALCL, including nine deaths, but admit that the “exact number of cases remains difficult to determine due to significant limitations in world-wide reporting and lack of global implant sales data.”
All cases of ALCL in women with breast implants should therefore be reported to the FDA.
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