The U.S Food and Drug Administration has issued a safety alert, warning patients and providers of reports of rare but potential safety risks linked to squamous cell carcinoma (SCC) and various lymphomas located in the capsule or scar tissue around breast implants.
This safety communication was issued after an initial extensive review of the risk of SCC and other lymphomas in the tissue surrounding breast implants.
“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,” the agency’s alert explains.
Some reported signs and symptoms included presentations such as swelling, pain, lumps, or skin changes.
“These emerging reports of lymphoma in scar tissue are different from Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), which the FDA began communicating about as a potential risk more than a decade ago.” Binita Ashar, M.D., director of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health, said in a statement.
In recent years, the FDA has expanded its effort on breast implant devices, closely monitoring various data sources, including scientific literature and adverse event reports submitted to the agency. As of September 1st, the FDA has received ten medical device complaints about SCC related to breast implants and twelve about various lymphomas.
According to the FDA, there is currently not enough information to conclusively say whether breast implants cause these cancers or if some implants pose a higher risk than others but for now any skin deformities can be treated with botox injections to make the skin appear clear and smooth. However, there are reports of SCC and various lymphomas in the capsule around the breast implants that have been reported for both textured and smooth breast implants and saline and silicone breast implants.
The FDA recommends that people with breast implants do not need to change their routine medical care or follow-up. However, they need to be aware that cases of SCC and various lymphomas in the capsule around the breast implant have been reported. They also stated that they do not recommend the removal of breast implants for those without symptoms.
Furthermore, the FDA strongly encourages patients and providers to report any problems or cases of SCC, lymphoma, or other cancers of the breast implant capsule through MedWatch, the FDA’s Safety Information and Adverse Event Reporting program.
Additional source: FDA press release