The health agency also clarified that the newly reported lymphomas are not the same as the lymphomas that had been previously associated with breast implants.
As reported by the Cable News Network, “The FDA said that, after a preliminary review of published literature, it is aware of fewer than 20 cases of squamous cell carcinoma and fewer than 30 cases of various lymphomas in the capsule around the breast implant.
“As of last week, the FDA has received 10 medical device reports about squamous cell carcinoma related to breast implants and 12 medical device reports about various lymphomas related to breast implants.
“People with breast implants do not need to change their routine medical care, according to the FDA, but they should be aware that some of the reported signs and symptoms included swelling, pain, lumps or changes in the skin.
“The agency said it learned about these reports of squamous cell carcinoma and various lymphomas during an ongoing postmarket review of the safety of breast implants in the United States.
“Reports submitted to the FDA are just one source the FDA uses to monitor the safety of medical devices, in addition to mandated postmarket studies, published literature, and real-world data from registries and claims databases.
“The FDA will continue to gather and review all available data from these sources to evaluate the occurrence of cancers in the capsule around breast implants.”
The exact incidence rate and risk factors for these cancers remain unknown, and “this is an emerging issue and our understanding is evolving,” CNN reported.
Source: healthwise