Last September, the FDA issued a safety alert raising concerns about potential cases of lymphomas and squamous cell carcinoma (SCC) arising in the scar tissue surrounding breast implants. The agency recently released its findings from analyzing SCC cases in individuals with breast implants and updated its recommendations for healthcare providers accordingly.
Following an assessment of abstracts and scientific articles published up to January of this year, the FDA identified 19 documented instances of SCC occurring within the capsule around breast implants. Tragically, three patients among the identified cases succumbed to the carcinoma.
Most often, the diagnosis of skin cancer occurred subsequent to the onset of symptoms, including breast swelling and pain, present in 90% of the examined cases. Additional symptoms comprised the appearance of lumps, changes in skin coloration, and more.
Despite common symptoms, the cases displayed a diverse demographic range. Patients were aged between 40 and 81 at the time of diagnosis, with the cancer detection ranging from seven to 42 years after the initial breast implantation. The type of implant also varied, encompassing silicone gel and saline-filled implants, along with textured, smooth, and foam-covered surfaces.
In its recent safety communication, the FDA acknowledged the rarity of SCC linked to breast implants and underscored that the causes, incidence, and risk factors remain unidentified.
In conjunction with reviewing published scientific literature on SCC cases, the FDA examined its collection of medical device reports (MDRs) regarding the condition in individuals with breast implants. Up to mid-January, the agency received 24 such reports, a notable increase from the 10 previously mentioned in the September safety notice. Nonetheless, due to reporting system limitations, the FDA refrained from categorizing them as unique cases. Overlaps might exist between the reported diagnoses and those detailed in the scientific literature, and injuries and fatalities outlined in MDRs often cannot definitively be linked to specific causes.
Despite these constraints, the FDA observed that the 24 cases logged in its database exhibited similar symptoms and a range of patient information and implant types comparable to those documented in the literature.
Based on its review of scientific articles, the FDA has revised its recommendations for healthcare providers interacting with patients considering or having received breast implants. Doctors are advised to discuss the potential risk of SCC development and various lymphomas in the capsule around breast implants during consultations with patients.
Furthermore, healthcare professionals who identify cases of cancer in scar tissue should promptly report these occurrences to the FDA. Information regarding cancer symptoms and pathology, the patient’s breast implant history, scan results, treatment plans, and outcomes should be included in the report.
The FDA also recommended that treatment plans be tailored on a case-by-case basis, with input from a multidisciplinary team of experts encompassing surgical oncology, plastic surgery, breast surgery, radiology, oncology, and pathology.
Meanwhile, the agency retained its prior recommendations for individuals with breast implants to maintain routine medical care and follow-up schedules. The FDA continues to discourage implant removal based solely on concerns about cancer risk, as long as no symptoms have emerged.
