On September 8, 2022, the FDA published a Safety Communication of new cancers reported in breast implant patients, specifically cancer in the scar tissue (capsule) that forms around breast implants. These new cancers are squamous cell carcinoma (SCC)–now known as Breast Implant-Associated Squamous Cell Carcinoma (BIA-SCC)– and lymphoma. It is important to note that FDA has not stated the there is a direct correlation or causative relationship, simply that the FDA is aware of  less than 20 cases of SCC and less than 30 cases of various lymphomas in the capsules of patients with breast implants. There is no incident rate (risk of occurrence) to report and the FDA believes the occurrences of SCC or various lymphomas in the capsule around the breast implant may be rare.

Are these new cancers reported in breast implant patients a type of breast cancer?

No. The SCC and lymphomas reported are not a cancer of the breast tissue, but of the capsule surrounding the implant. Capsule formation is a normal phenomena that occurs with breast implants. BIA-SCC is not a cancer of the breast tissue itself.

Are the new lymphomas reported the same thing as the already known entity of Breast Implant Associated Large Cell Lymphoma (BIA-ALCL)? 

No. The various lymphomas reported are not the same as the lymphoma described in previous FDA Communications.

What are the signs and symptoms of these new cancers in the capsule around the breast implants?

Some of the reported signs and symptoms included swelling, pain, lumps, and/or skin changes.

What are the risk factors for BIA-SCC and the various lymphomas?

There are so few reported cases of BIA-SCC and the various lymphomas that it is not possible to determine what factors increase patient risk.

For these new cancers in the capsule around the breast implants, does the type of outer shell matter (smooth versus textured)?

The outer shell of a breast implant is either smooth or textured. The already known Breast Implant Associated Large Cell Lymphoma (BIA-ALCL) is currently associated only with textured implants. The new cancers of the breast implant capsule have been found in patients with either smooth or textured outer shells.

For these new cancers in the capsule around the breast implants, does the implant fill matter (saline versus silicone)? 

The new cancers of the breast implant capsule have been found in patients with either saline-filled or silicone-filled implants. 

Is there a specific implant brand associated with these new breast implant associated cancers?

No. There is no particular breast implant brand associated with these new breast implant associated cancers.

Is there a particular age range affected by BIA-SCC and the various lymphomas?

The average age of presentation for these cancer is age 55.8 years. The cancer have been found in patients as young as 40 up to age 81.

How long after breast augmentation with implants are the new cancers appearing?

In some cases, people were diagnosed after years of having breast implants. The average length of time after initial implantation is 22.74 years. The range is 11-40 years after implantation.

Should I cancel my Breast Augmentation with Implants surgery?

The incident rate (your risk) of you getting a cancer of the breast implant capsule is not known at this time. Currently, we know that SCC or lymphoma of the breast implant capsule is a rare finding. Millions of women have had breast augmentation with implants and thus far a total of less than 50 new cancer cases have been reported. The amount of risk you are willing to accept is a personal decision.

I currently have breast implants. Do I need to get them removed?

If you do not have symptoms, the FDA does not recommend the removal of your breast implants. However, the amount of risk you are willing to accept is a personal decision. Please see below for additional recommendations.

I currently have breast implants. What should I do?

If you currently have breast implants, do not panic. I know—easier said than done. Follow the recommendations below:

• Continue routine breast cancer screening with mammograms and/or MRIs.
• If you have silicone-filled implants, continue routine screening for implant rupture (every 5-6 years).
• If you have breast implants, you do not need to change your routine medical care or follow-up.
• Educate yourself. Be aware that cases of SCC and various lymphomas in the capsule around the breast implant have been reported and monitor your breasts for any of the signs or symptoms mentioned above.
• If you notice any abnormal changes in your breasts or implants, promptly talk to your Breast Surgeon, Plastic Surgeon, or Primary Care Physician.
• 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 will help improve patient safety.

What is the FDA doing to find more information about these new cancers of the breast implant capsule?

The FDA will continue to gather and review all available data from medical device reports (MDRs), mandated postmarket studies, published literature, and real-world data from registries and claims databases sources to evaluate the occurrence of these cancers in the capsule around breast implants.

My Final Thoughts

I will be monitoring this emerging issue of new cancers (BIA-SCC and lymphomas) reported in breast implant patients and posting new data to this Plastic Surgery blog and my Instagram account as more information is learned. For now, don’t panic and learn as much as you can so that you can make an informed decision about your next steps. 

Carry on smartly.