The Food and Drug Administration issued a safety alert Thursday after receiving reports that some breast implant recipients have developed squamous cell carcinoma (SCC) and various lymphomas in the capsule or scar tissue around the implants.
The FDA had received 10 medical device reports about SCC related to breast implants and 12 about various lymphomas related to breast implants, as of Sept. 1. The agency stated that the incidence rate and risk factors for SCC and other lymphomas associated with breast implants are unknown.
Some reports described patients who were diagnosed years after receiving breast implants and who presented with swelling, pain, lumps or skin changes. The agency said that there is currently not enough information to say whether breast implants cause these cancers or if some implants pose a higher risk than others.
These reports are separate from Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), cancer that has been tied to implants, and about which the FDA first warned more than a decade ago, the alert stated.
As of April, there have been 59 deaths connected to BIA-ALCL and 1,130 cases, according to FDA data. A patient with bilateral BIA-ALCL is counted as two cases.
“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,” the FDA said in the safety communication.
Breast implants have been a key topic of product safety issues for years.
In October 2021, the FDA restricted the sale of breast implants, limiting the products to healthcare providers and facilities that review a decision checklist with patients. The agency cited Johnson & Johnson and Allergan, which recalled some implants in 2019 due to safety risks.
Along with the restriction of sales, the FDA also implemented a new boxed warning for implants. The moves followed testimony before a 2019 advisory panel, where patients discussed the health effects they have suffered and the lack of warning regarding risks associated with implants.
In January, the FDA’s Center for Devices and Radiological Health released a finalized plan for addressing sex- and gender-specific issues in medical device design and performances, including improving data collection and analysis.
The center said in a statement that it aims to “deepen our understanding of how medical devices work for women and continue our efforts to help assure that medical devices – those developed specifically for women, and those developed for all people – optimally align with the considerations of usability and performance in women.”
