BIA-SCC is a rare but potentially aggressive epithelial-based tumor that appears to be associated with breast implants and emanates from the breast implant capsule. At this time, ASPS/PSF is aware of so few reported cases of BIA-SCC (in its update, the FDA notes it is aware of 19 cases of SCC in the capsule around the breast implant from published literature) that it is not possible to determine what factors increase patient risk. All information provided by plasticsurgery.org.
Available information and recommendations are listed below, but the FDA did provide the following updated recommendations for healthcare providers in Wednesday’s communication:
Include information about SCC and various lymphomas in the capsule around the breast implant in your discussions with people who have or are considering breast implants.
For patients who have been diagnosed with SCC or various lymphomas in the capsule around the breast implant, develop an individualized treatment plan in coordination with a multidisciplinary team of experts including surgical oncology, plastic surgery, breast surgery, radiology, oncology, and pathology.
Report all cases of SCC, lymphomas, and any other cancers in the capsule around the breast implant to the FDA. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
Please include the following information in the report, if known:
Clinical presentation and breast implant history
Imaging studies performed
Pathology of the capsule tissue
Treatment therapy
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Outcomes
Overview
Breast implant-associated squamous cell carcinoma (BIA-SCC) is a very rare but potentially aggressive, epithelial-based tumor that appears to emanate from the breast implant capsule. Pathology shows sheets of squamous cells lining the capsule in nests and bundles. BIA-SCC can exhibit highly invasive properties including spread to lymph nodes, local tissues and distant sites, such as muscle and bone.
BIA-SCC is not a cancer of the breast tissue itself.
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an uncommon and treatable type of T-cell lymphoma that can develop around breast implants. BIA-ALCL can exhibit highly invasive properties, including spread to lymph nodes, local tissues and distant sites.
BIA-ALCL is not a cancer of the breast tissue itself.
Number of Known Cases: To the best of our knowledge, there are 19 cases reported in the literature.ASPS recognizes approximately 411 both suspected and confirmed cases in the United States and nearly 1,400 cases worldwide as of March 2023.
Lifetime Risk: Unknown
Current lifetime risk of BIA-ALCL varies widely (e.g., estimates of 1:2,207-1:86,029 based upon variable risk with different manufacturer types of textured implants. More recently, cumulative risk over 20 years in breast reconstruction patients implanted with Biocell devices was estimated at 1:100 (Cordeiro et al, 2020).
Age at presentation 55.8 years (range 40-81), 55.3 years (range 28-84)
Average length since initial implantation 22.74 years (range 11-40 years),10.32 years (range 0.08-41 years)
Implant Surface
In case reports, BIA-SCC has been reported in patients who have had smooth and/or textured implants.No cases of BIA-ALCL have been confirmed in patients who have only had smooth implants in case series, case reports or registries. However, it is not possible to exclude the appearance of BIA-ALCL in association with smooth implants at this time. The FDA states that all confirmed cases worldwide either have a history of a textured device or an incomplete clinical history available for review.
Implant Type
BIA-SCC has been associated with both silicone and saline implants in aesthetic as well as reconstructive patients.BIA-ALCL has been associated with both silicone and saline implants in aesthetic as well as reconstructive patients.
Presentation
• both can present with delayed seroma, pain, and unilateral swelling
Extracapsular spread at presentation 80% at presentation for squamous and 28% at presentation for
Imaging
Ultrasound to evaluate for peri-prosthetic fluid +/- aspiration; MRI with and without contrast to evaluate capsule to rule out mass; PET-CT for extent of disease, if present.Ultrasound to evaluate for peri-prosthetic fluid +/- aspiration; PET‐CT is performed following a positive diagnosis. Mammograms are not helpful for evaluating lymphoma but are important for the evaluation of breast cancer.
Treatment:
Official treatment recommendations will need to be based on emerging data. At present, it appears that explantation with complete (en bloc) capsulectomy will provide the best outcomes.
Based on existing case reports, it appears that incomplete resection of BIA-SCC can result in early and/or aggressive recurrence.In the majority of cases, explantation with complete (en bloc) capsulectomy is curative. Incomplete capsular resection has been associated with both recurrence and significantly lower survival. Rare patients will present with more advanced disease and may require radiotherapy and chemotherapy. Current treatment recommendation is for bilateral complete capsulectomy and implant removal, as a small number of women have had contralateral disease found incidentally.
Reporting:
The FDA recommends that any suspected or confirmed cases of SCC, lymphomas, or any other cancers around the breast implant be reported to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database and the device manufacturer.
Patient Counseling and Informed Consent
BIA‐SCC should be discussed with any patient considering breast implants as part of the informed-consent process. BIA‐ALCL should continue to be discussed with any patient considering breast implants as part of the informed-consent process.
ASPS/PSF Recommendations
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Prior to implantation of any breast implant, plastic surgeons should provide patients with the manufacturer’s patient labeling, the FDA-required patient decision checklist and any other educational material to best discuss the benefits and risks of breast implants.
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Preoperative workup is essential. All patients presenting with a late seroma should have fine needle aspiration (FNA) and cytology testing.
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All patients presenting with a late seroma should undergo a breast ultrasound and MRI with and without contrast. If disease is confirmed, a PET-CT should be considered prior to surgical intervention. A thorough preoperative work-up allows for potentially the most appropriately planned, single-stage surgery with the greatest chance of success for cure.
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Consider the possibility of BIA-ALCL, BIA-SCC and other lymphomas when treating a patient with late onset, peri-implant changes. If you have a patient with suspected BIA-ALCL or BIA-SCC, refer them to experts familiar with the diagnosis and treatment of BIA-ALCL and BIA-SCC.
References
on plasticsurgery.org website