FDA Warns of Cancer Risk in Scar Tissue Around Breast Implants

The US Food and Drug Administration (FDA) has issued a safety alert, warning of a rare but concerning potential risk of squamous cell carcinoma (SCC) and various lymphomas in the scar tissue around breast implants.

The FDA safety communication is based on several dozen reports of these cancers occurring in the capsule or scar tissue around breast implants. This issue differs from breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) — a known risk among implant recipients.

"After preliminary review of published literature as part of our ongoing monitoring of the safety of breast implants, the FDA is aware of less than 20 cases of SCC and less than 30 cases of various lymphomas in the capsule around the breast implant," the agency's alert explains.

One avenue through which the FDA has identified cases is via medical device reports. As of September 1, the FDA has received 10 medical device reports about SCC related to breast implants and 12 about various lymphomas.

The incidence rate and risk factors for these events are currently unknown but reports of SCC and various lymphomas in the capsule around the breast implants have been reported for both textured and smooth breast implants, and for both saline and silicone breast implants. In some cases, the cancers were diagnosed years after breast implant surgery.

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

Although the risks of SCC and lymphomas in the tissue around breast implants appears rare, "when safety risks with medical devices are identified, we wanted to provide clear and understandable information to the public as quickly as possible," Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices, FDA Center for Devices and Radiological Health, explained in a press release.

Patients and providers are strongly encouraged to report breast implant-related problems and cases of SCC or lymphoma of the breast implant capsule to MedWatch, the FDA's adverse event reporting program.

The FDA plans to complete "a thorough literature review" as well as "identify ways to collect more detailed information regarding patient cases."

Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape, MDedge and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and healthcare topics. She can be reached at sworcester@mdedge.com or on Twitter: @SW_MedReporter.

For more news, follow Medscape on Facebook, Twitter, Instagram, YouTube, and LinkedIn

Credit:
Lead image: Dreamstime

Send news tips to news@medscape.net.

Cite this: FDA Warns of Cancer Risk in Scar Tissue Around Breast Implants - Medscape - Sep 08, 2022.

Commenting is limited to medical professionals. To comment please Log-in.

Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.

My Alerts