- In a safety notice, the FDA has received several reports of certain cancers in the scar tissue around breast implants.
- The FDA learned about these reports through continual postmarket reviews of breast implants and ongoing collaboration with external stakeholders.
- As of Sept. 1, 2022, the FDA had received ten reports about squamous cell carcinoma, a type of skin cancer, and 12 reports about various lymphomas related to breast implants.
- Right now, we do not have enough information to say whether breast implants cause these cancers or if some implants pose a higher risk than others, the agency said in a separate report.
- Earlier, the agency added new restrictions and warning labels for breast implants following reports of women who developed breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a cancer of the immune system.
- The FDA said the new lymphoma cases were distinct from BIA-ALCL reported earlier.
- It said the occurrence of cancers in scar tissues around an implant might be rare, and the incidence rate and risk factors are currently unknown.
- Companies have their implants approved by the FDA: Allergan owned by Abbvie Inc (NYSE:ABBV), Mentor, a Johnson & Johnson (NYSE:JNJ) company, Sientra Inc (NASDAQ:SIEN), and Privately held Ideal Implant Incorporated.
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