On 8 September 2022, the US Food and Drug Administration (FDA) issued a safety communication informing patients and providers about reports of squamous cell carcinoma and various lymphomas located in the capsule or scar tissue around breast implants. The risk of squamous cell carcinoma and other lymphomas occurring in the tissue around breast implants appears to be extremely rare.
These emerging reports of cancers in scar tissue and capsule are different from Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). More information on BIA-ALCL can be found on the TGA Breast Implant Hub.
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.
Symptoms of these conditions can include swelling, pain, lumps, or skin changes. However, it is important to note that these symptoms can also reflect other breast health issues.
Women with breast implants should continue to routinely monitor their breast implants- external site and consult their implanting surgeon if they have any concerns. At this time, medical experts do not recommend breast implant removal in patients without symptoms or other abnormality.
The TGA is monitoring the occurrence of the disease in Australia and is in communication with other international regulators and experts in Australia.
The TGA strongly encourages you to report all problems associated with medical devices, including breast implants. Your reports help us monitor the performance and safety of medical devices.
Visit the ‘Report a problem or side effect‘ webpage to complete the online form and share any problems you may be experiencing. Please include as much information as you can, including implant/explant dates, model, and serial numbers.
Australian Government, Department of Health and Aged Care, Therapeutic Goods Administration
Published: 20 September 2022