Breast Implants: Reports of Squamous Cell Carcinoma and Various Lymphomas in Capsule Around Implants (FDA)
08 September 2022
|The U.S. Food and Drug Administration (FDA) is informing the public about reports of cancers, including squamous cell carcinoma (SCC) and various lymphomas, in the scar tissue (capsule) that forms around breast implants. The various lymphomas reported are not the same as the lymphomas described in previous FDA Communications as Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).|
|After preliminary review of published literature as part of our ongoing monitoring of the safety of breast implants, the FDA is aware of less than 20 cases of SCC and less than 30 cases of various lymphomas in the capsule around the breast implant. As of September 1, 2022, the FDA has received 10 medical device reports (MDRs) about SCC related to breast implants and 12 MDRs about various lymphomas related to breast implants.
While the FDA believes that occurrences of SCC or various lymphomas in the capsule around the breast implant may be rare, health care providers and people who have or are considering breast implants should be aware that cases have been reported to the FDA and in the literature. Currently, the incidence rate and risk factors for SCC and various lymphomas in the capsule around the breast implants are unknown.
This is an emerging issue and our understanding is evolving. For this reason, the FDA is asking health care providers and people with breast implants to report cases of SCC, lymphomas, or any other cancers around the breast implant to the FDA.
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