The U.S. Food and Drug Administration (FDA) issued a public alert on Thursday after receiving several reports of certain types of cancers in the scar tissue (capsules) that forms around breast implants.
As of Sept. 1, the FDA has received 10 medical device reports (MDRs) about squamous cell carcinoma (SCC) related to breast implants and 12 MDRs about various lymphomas.
“While the FDA believes that occurrences of SCC or various lymphomas in the capsule around the breast implant may be rare, health care providers and people who have or are considering breast implants should be aware that cases have been reported to the FDA and in the literature,” said the FDA in a press release.
According to the FDA, there have been literature reports of SCC and various lymphomas in the capsule around the breast implants for both textured and smooth breast implants, and for both saline and silicone breast implants.
“In some cases, people were diagnosed after years of having breast implants. Some of the reported signs and symptoms included swelling, pain, lumps or skin changes.”
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 issues the following recommendations for people who have or are considering breast implants:
- If you are considering breast implants or if you have them, learn more about the risks and benefits of breast implants.
- If you have breast implants, you do not need to change your routine medical care or follow-up.
- Be aware that cases of SCC and various lymphomas in the capsule around the breast implant have been reported.
- Monitor your breast implants for as long as you have them. If you notice any abnormal changes in your breasts or implants, promptly talk to your surgeon or health care provider.
- If you do not have symptoms, the FDA does not recommend the removal of breast implants because of this safety communication.
- If you have breast implants and experience a problem, the FDA encourages you to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Your report, along with information from other sources, can provide information that helps improve patient safety.
Currently, these recommendations do not change or affect the recommendations previously provided by the FDA on BIA-ALCL.
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