FDA safety alert: Cancers reported in scar tissue around breast implants
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FDA issued a safety alert Thursday regarding reports of squamous cell carcinoma and various lymphomas in the scar tissue surrounding breast implants.
The reported lymphomas differ from breast-implant associated anaplastic large-cell lymphoma, which the FDA identified as a potential risk in 2011.
Squamous cell carcinoma and various lymphomas have been reported in the capsule around textured and smooth, as well as saline and silicone, breast implants, according to FDA. For some patients, diagnosis did not occur until years after receiving the implants, when they experienced swelling, pain, lumps, skin changes or other symptoms.
“After an initial extensive review, we currently believe that the risk [for squamous cell carcinoma] and other lymphomas occurring in the tissue around breast implants is rare,” Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health, said in a statement. “However, in this case, and when safety risks with medical devices are identified, we wanted to provide clear and understandable information to the public as quickly as possible.”
FDA knows of less than 20 cases of squamous cell carcinoma and less than 30 cases of lymphomas in the capsule surrounding the breast implant. The agency has received 10 medical device reports on breast implant-related squamous cell carcinoma and 12 on various lymphomas related to the implants, but noted that the reports may not represent unique cases.
“Right now, we do not have enough information to say whether breast implants cause these cancers or if some implants pose higher risk than others,” Ashar said in the statement. “For this reason, instances of [squamous cell carcinoma], lymphoma and any cancer located in the scar tissue around breast implants should be reported to the FDA.”
FDA also advised health care providers to characterize all findings and possible diagnoses during diagnostic evaluation of breast implant specimens. It encouraged patients with breast implants to report any problems through MedWatch, the agency’s safety information and adverse event reporting program.
“We continue to engage top cancer experts and are consulting with our Oncology Center of Excellence to ensure a coordinated approach informed by leaders in the field,” Ashar said. “Additionally, the agency continues to closely monitor various data sources, such as the scientific literature, adverse event reports submitted to the agency and is soliciting information from manufacturers regarding any reports they may have regarding [squamous cell carcinoma] and other lymphomas related to the tissue around an implant.”
References:
- Breast implants: Reports of squamous cell carcinoma and various lymphomas in capsule around implants: FDA safety communication. Available at: www.fda.gov/medical-devices/safety-communications/breast-implants-reports-squamous-cell-carcinoma-and-various-lymphomas-capsule-around-implants-fda?utm_medium=email&utm_source=govdelivery. Published Sept. 8, 2022. Accessed Sept. 8, 2022.
- FDA statement. FDA issues safety alert for squamous cell carcinoma and various lymphomas in scar tissue around breast implants. Available at: www.fda.gov/news-events/press-announcements/fda-issues-safety-alert-squamous-cell-carcinoma-and-various-lymphomas-scar-tissue-around-breast?utm_medium=email&utm_source=govdelivery. Published Sept. 8, 2022. Accessed Sept. 8, 2022.
Perspective
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Sameer A. Patel, MD, FACS
Squamous cell carcinomas and lymphomas of various types — different from the breast implant-associated anaplastic large-cell lymphomas (BIA-ALCL) previously reported — have been reported to occur in the breast capsule which forms around breast implants.The number of reported cases of squamous cell carcinomas and various non- ALCL Lymphomas remains quite low, with fewer than 20 reported cases of squamous cell carcinoma and fewer than 30 cases of non-BIA – ALCL lymphomas.
These reports largely have been received through medical device reports as part of the ongoing post-market FDA review of breast implants, as well as through published medical literature.
The incidence, etiology and risk factors for developing squamous cell carcinoma and non-BIA-ALCL lymphomas related to breast implants remains unclear, although some theories exist for its development.
It is important to remember that the number of reported cases remains quite low. However, patients considering breast implants should be informed of this finding. Patients with existing implants should refer any questions to their reconstructive surgeons.
Much attention has been drawn to breast implants over the last several years given their association with ALCL. The more recent findings of squamous cell carcinomas and lymphomas around the breast capsule highlight the importance of continued surveillance of breast implants and continued monitoring for development of such findings.
At present, no good screening modalities exist for any of these types of cancers related to breast implants. Patients who develop new symptoms related to breast implants should seek medical attention through their reconstructive surgeons.
It also is important to remember that breast implants do provide many patients with a reasonable option for breast reconstruction, and that the benefits of breast reconstruction with implants clearly have been demonstrated.
The decision for patients to have breast implants either in the setting of reconstruction or cosmetic augmentation should be done so after a thorough consultation with an informed plastic surgeon. Also, patients with existing breast implants should not be overly alarmed at this time as the incidence appears to be quite low.
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