Inflammation May Be Key
The BIA-SCC and implant-associated lymphoma cases likely stem from the body’s reactions to foreign material and scar tissue, according to Dr Euhus.
“It has been known for a long time that chronic irritation and inflammation can promote the development of lymphoma and squamous cell carcinomas,” Dr Euhus said. “We have seen this in burn scars, in the chest cavity in association with certain infections, and around medical implants of all kinds.”
“The trouble with the breast is that, because there’s communication with the nipple, there can be some bacteria” and more opportunity for thickened scar tissue to develop, explained Anne M. Wallace, MD, a professor of surgery and director of the University of California, San Diego’s Comprehensive Breast Health Center.
“Probably what’s happening in these circumstances is inflammation,” she added.
In their review of BIA-SCC cases, Goldberg et al also proposed that “chronic inflammation/irritation from the breast implant and epithelialization of the capsule play a significant role in the disease process.”2
Education, Screening, and Diagnosis
Clinicians and patients should keep in mind that BIA-SCC and implant-associated lymphomas are “very rare occurrences, and awareness — not overreaction — is currently the best course,” Dr Euhus said.
“I’ve been a breast surgeon for 28 years and have never personally seen one of these cases,” Dr Wallace said. She noted, however, that the FDA’s safety alert presents an opportunity to have an open dialogue about the risk of these cancers.
“All patients who are having implants placed should be educated about the potential risk of these rare cancers prior to device placement,” Dr Piper said.
Screening is also important for these patients, according to Dr Wallace. She recommends that her patients get regular mammograms after breast implant surgery. She also asks her patients to return for a checkup every other year after the surgery and suggests that patients undergo an MRI after 10 years.
The FDA recommends that patients monitor their breast implants and talk to their surgeon or health care provider if there are any abnormal changes in the breasts or the implants.1 The FDA does not recommend the removal of breast implants for patients who are not experiencing problems.
Dr Euhus said BIA-SCC and implant-associated lymphomas “should be considered when evaluating a patient with breast implants who has developed a change in the size of one of the breasts or a palpable lump.”
“Look for peri-implant fluid with sonography, and submit any aspirated fluid for cytology,” he said.
All patients with a late seroma should have fine needle aspiration and cytology testing, according to the American Society of Plastic Surgeons (ASPS) and the Plastic Surgery Foundation (PSF).4
Specimens should be sent for immunohistochemistry, including CD30 and ALK (for BIA-ALCL) and CK 5/6 and p63 (for BIA-SCC), as well as flow cytometry to look for T cells, squamous cells, and keratin, the ASPS and PSF recommend.
When considering non-BIA-ALCL lymphomas, stains for B-cell-associated antigens (including CD20, PAX5, and CD138), human herpesvirus-8, and in situ hybridization for EBV-encoded RNA are recommended.9
The ASPS and PSF recommend that all patients with a late seroma undergo a breast ultrasound and MRI, with and without contrast.4 If SCC or lymphoma is confirmed, a PET-CT should be considered before surgery.
“A thorough preoperative workup allows for potentially the most appropriately planned, single-stage surgery with the greatest chance of success for cure,” the ASPS and PSF wrote in a statement.4
Any suspected or confirmed cases of implant-associated cancers should be reported to the FDA’s Manufacturer and Use Facility Device Experience (MAUDE) database “so that we can track, study, and learn about them to better inform management,” Dr Piper said.10
The FDA plans to conduct an extensive literature review and continue collaboration with the ASPS to collect detailed data on these cases and further elucidate the risks to patients with breast implants.8
Disclosures: Dr Euhus and Dr Wallace reported having no disclosures. Dr Piper has consulted for Sientra.
1. US Food and Drug Administration. Breast implants: Reports of squamous cell carcinoma and various lymphomas in capsule around implants: FDA safety communication. September 8, 2022. Accessed October 29, 2022.
2. Goldberg MT, Llaneras J, Willson TD, et al. Squamous cell carcinoma arising in breast implant capsules. Ann Plast Surg. 2021;86(3):268-272. doi:10.1097/SAP.0000000000002524
3. Buchanan PJ, Chopra VK, Walker KL, Rudolph R, Greco RJ. Primary squamous cell carcinoma arising from a breast implant capsule: A case report and review of the literature. Aesthet Surg J. 2018;38(7). doi:10.1093/asj/sjy092
4. American Society of Plastic Surgeons. ASPS statement on breast implant associated-squamous cell carcinoma (BIA-SCC). September 8, 2022. Accessed October 29, 2022.
5. US Food and Drug Administration. Questions and answers about breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). October 23, 2019. Accessed October 29, 2022.
6. Bewtra C, Gharde P. Current understanding of breast implant-associated anaplastic large cell lymphoma. Cureus. 2022;14(10):e30516. doi:10.7759/cureus.30516
7. Medeiros LJ, Marques-Piubelli ML, Sangiorgio VFI, et al. Epstein-Barr-virus-positive large B-cell lymphoma associated with breast implants: An analysis of eight patients suggesting a possible pathogenetic relationship. Mod Pathol. 2021;34(12):2154-2167. doi:10.1038/s41379-021-00863-1
8. US Food and Drug Administration. FDA issues safety alert for squamous cell carcinoma and various lymphomas in scar tissue around breast implants. October 3, 2022. Accessed October 29, 2022.
9. Jaffe ES, Ashar BS, Clemens MW, et al. Best practices guideline for the pathologic diagnosis of breast implant–associated anaplastic large-cell lymphoma. J Clin Oncol. 2020; 38(10):1102–1111. doi:10.1200/JCO.19.02778
10. US Food and Drug Administration. About Manufacturer and User Facility Device Experience (MAUDE). September 8, 2022. Accessed October 29, 2022.