FDA Announces Evidence Showing Cancer Cases Related To Breast Implants
The scar tissue that forms around breast implants can serve as a site for cancer cells to form, according to a new announcement from the U.S. Food and Drug Administration.
The FDA has learned that 10 cases of squamous cell carcinoma and 12 cases of various lymphomas have been linked to breast implants and reported.
"This is an emerging issue and our understanding is evolving. For this reason, the FDA is asking health care providers and people with breast implants to report cases of SCC, lymphomas, or any other cancers around the breast implant to the FDA," the FDA said in a report.
The cases were uncovered due to a review and collaboration with external stakeholders in an ongoing effort to monitor the safety of implants. It is unclear if the implants themselves are causing the cancer.
The FDA explained that reviewing reports is one way it monitors safety and that in order to clarify it will "gather and review all available data from these sources to evaluate the occurrence of cancers in the capsule around breast implants."
The FDA added in the report that anyone considering breast implants should consider all the risks that come with them, which is consistent with new rules it implemented in October 2021.
Those rules included new labeling requirements for breast implant manufacturers, box warnings and a checklist of potential risks and benefits. Patients are also required to be informed of recent studies about product safety.
"A woman who decides to have breast implants should know that they may not last forever," Dr. Andrea Pusic, the Joseph E. Murray Professor of Surgery at Harvard Medical School said in February.
"That means that she may need a future surgery or have longer-term complications. Surgery is a serious decision, and devices aren't perfect," Pusic added.
Those rules included new labeling requirements for breast implant manufacturers, box warnings and a checklist with potential risks and benefits. Patients are also required to be informed on recent studies about product safety.
"A woman who decides to have breast implants should know that they may not last forever," Dr. Andrea Pusic, the Joseph E. Murray Professor of Surgery at Harvard Medical School said in February.
"That means that she may need a future surgery or have longer-term complications. Surgery is a serious decision, and devices aren't perfect," Pusic added.
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