The TGA says it is aware of reports of squamous cell carcinoma and various lymphomas in the scar tissue around breast implants, after a number of cases were identified in the US.
The emerging reports of cancers in scar tissue and capsule are distinct from Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) and are “extremely rare”, the regulator says.
It follows an alert by the US Food and Drug Administration (FDA) earlier this month, saying it had found up to 20 SCC cases and up to 30 lymphoma cases in the scar tissue (capsule) that forms around an implant.
The FDA said the cases had been identified via postmarket safety monitoring as well as a preliminary review of published literature.
As of the start of the month, 12 medical device reports had been received about various lymphomas related to breast implants and 10 about SCC, although these represented only “limited data”, the agency said (link here).
Reported signs and symptoms included swelling, pain, lumps or skin changes, and some patients were diagnosed after years of having plants, the FDA added.
“This is an emerging issue and our understanding is evolving,” it said.
“Currently, the incidence rate and risk factors for SCC and various lymphomas in the capsule around the breast implants are unknown.”
In a safety alert last week, the TGA said it was advising patients to routinely monitor their implants, but stopped short of recommending breast implant removal in those without symptoms or other abnormality (link here).
It also noted the reported symptoms could also reflect other breast health issues.
It added: “At this time, there is not enough information to say whether breast implants cause these cancers or if some implants pose higher risk than others.”
“For this reason, instances of squamous cell carcinoma, lymphoma and any cancer located in the scar tissue or capsule around breast implants should be reported to the TGA.”