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Regulatory / FDAU.S. Food and Drug Administration (FDA) — Safety Communication · September 2022 (updated)

UPDATE: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants

An FDA safety communication about reports of cancers — squamous cell carcinoma and various lymphomas — found in the capsule around breast implants. These are different from BIA-ALCL, and the reported condition appears rare with the evidence still developing.

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What this source says

The FDA reports that it has received reports of SCC and various lymphomas in the capsule that forms around breast implants, that these are distinct from BIA-ALCL, that such cases may be rare, and that incidence and risk factors are not yet known. Cases can be reported to the PROFILE registry.

Why it matters

It is the U.S. regulator flagging a newly recognized safety signal early — while being explicit that the underlying science is not settled.

Key findings

  • The FDA has received reports of SCC and various lymphomas in the capsule around implants.
  • These are distinct from BIA-ALCL.
  • The FDA believes such cases “may be rare.”
  • Incidence, risk factors, and causes are not yet established; cases can be reported to the PROFILE registry.

Limitations

The reported condition is rare and the evidence is still developing: this is based on reported cases, and the underlying incidence, risk factors, and causes are not established.

What this does not prove

It does not establish how common these cancers are, who is at risk, or that implants cause them.

Source / citation

U.S. Food and Drug Administration (FDA) — Safety Communication · September 2022 (updated)

https://www.fda.gov/medical-devices/safety-communications/update-reports-squamous-cell-carcinoma-scc-capsule-around-breast-implants-fda-safety-communication

Last reviewed against the original source: 2026-09-02. Summaries are written in plain language; the original source is authoritative.

Breast Implant Illness Tracker provides education and organizational tools only and does not provide medical diagnosis or treatment.