Safety Communication Includes Additional Squamous Cell Carcinoma and Lymphomas
On September 8, 2022, the U.S. Food and Drug Administration (FDA) released a Safety Communication, noting reports of additional cancer types in the scar tissue that forms around breast implants. Reported cancers include squamous cell carcinoma (SCC) and lymphomas not previously described in FDA Communications. Reports were received for textured and smooth breast implants, including both saline and silicone breast implants.
The additional reports were discovered by the FDA in its continual postmarket review of breast implants. Currently, the FDA has indicated that it is aware of less than 20 cases of SCC and less than 30 cases of various lymphomas in the capsule (scar tissue) around the breast implant. The FDA notes receipt of 10 medical device reports (MDRs) about SCC related to breast implants and 12 MDRs about various lymphomas related to breast implants. The FDA relies on multiple sources, including MDRs, to monitor medical device safety, and will continue to review all data around the safety of breast implants.
The September Safety Communication follows the FDA’s report of April 1, 2022 of 1,130 findings in US and global MDRs of anaplastic large cell lymphoma (BIA-ALCL) associated with breast implants. Breast Implant Associated Lymphoma (BIA-ALCL) a type of non-Hodgkin’s lymphoma – is not a breast cancer. It is a cancer of the immune system). The main symptoms of BIA-ALCL include swelling or presence of a mass or pain in the area of the breast implant.
The FDA has associated breast implants with the possible development of ALCL since 2011. The World Health Organization (WHO) designated breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a T-cell lymphoma in 2016, despite not knowing the exact number of cases due to data limitations.
Textured implants, with rough exteriors, are presumed to cause more inflammation than smooth implants, leading scientists to find more links to BIA-ALCL. Allergan took textured implants off the market in 2019, at the FDA’s request.
Currently, the FDA does not know the rate of occurrences of SCC or various lymphomas in the capsule around the breast implant, but notes that diagnosis can occur years after implanting occurs. Reported signs and symptoms include swelling, pain, lumps and skin changes.
According to the Aesthetic Society, 365,000 breast augmentations were performed in 2021; 148,000 women had implants removed and replaced), and; 71,000 women had implants removed and not replaced. In 2021, the FDA placed a black-box label on breast implants, warning that they had been linked to multiple serious medical conditions.
The FDA does not currently recommend that people who currently have breast implants change their routine medical care or follow-up, but it does recommend monitoring breast implants for any abnormal change. The FDA also recommends filing reports of any problems through the FDA’s MedWatch Safety Information and Adverse Event Reporting program. The FDA also recommends that health care providers who examine breast implants be aware that SCC and lymphomas cases have been reported around the breast implant. Therefore,
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