FDA Warning: Cancer Risk from Breast Implants

The U.S. Food and Drug Administration (FDA) is warning people about the risks of additional types of cancers in people receiving breast implants*.  In a recent statement, the FDA cited reports of cancers, including squamous cell carcinoma** (SCC) and various lymphomas**, in the scar tissue that forms around breast implants, adding that these were not the same malignancies as described in previous FDA communications.

The FDA noted that it has received 10 reports about SCC related to breast implants, and 12 about various lymphomas related to breast implants. While the occurrence of such carcinoma or lymphomas in the capsule region may be rare (the FDA is now aware of less than 20 cases of SCC and less than 30 cases of various lymphomas in the capsule around the breast implant), the FDA  said people should be aware that cases have been reported to the FDA and in the literature. (source)

What is the level of risk?

Currently, the incidence rate and risk factors for SCC and various lymphomas in the capsule around the breast implants are unknown.  The FDA said its teams would continue to gather and review available data from sources to evaluate the occurrence of cancers in the scar tissue (capsule) around breast implants.

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“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.”

What are the symptoms users should be aware of?

Reported signs and symptoms include swelling, pain, lumps or skin changes.

What should consumers and healthcare practitioners do?

The FDA has called on those who have received implants to monitor them for “as long as they have them”, and to promptly talk to their health care providers or surgeons if they notice any abnormal changes in their breasts or implants.

If people experience problems with their breast implants, the FDA urged consumers to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

The agency has also called on health care providers to characterize all findings and potential diagnoses while examining breast implant specimens for diagnosis, stating, “Report cases of SCC, lymphomas, and any other cancers in the capsule around the breast implant to the FDA. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.”

*These implants are placed under the breast tissue or chest muscle to augment breast size, or to replace tissue that is lost due to cancer or trauma. The devices in the U.S. are either saline-filled or silicone gel-filled and both types have a silicone outer shell.

**Lymphomas are a cancer of the immune system and squamous cell carcinoma (SCC) is a type of skin cancer.