With the number of breast augmentations performed in Silicon Valley and throughout the United States, communication between plastic surgeons and the FDA is crucial to fully understand the safety issues of squamous cell carcinoma and various lymphomas in capsules surrounding breast implants. Information about these concerns is limited and evolving. Hence, the American Society of Plastic Surgeons and the Plastic Surgery Foundation openly communicate with the FDA on this emerging issue.

To ensure patient health and safety, Aesthetx continually monitors new data as it becomes available. Breast implant-associated squamous cell carcinoma is rare, but can be aggressive within the breast implant capsule. Currently, published literature monitored by the ASPS and PSF reports only 19 cases of this breast implant-related illness.

Information and Recommendations

Aesthetx follows all FDA recommendations for health providers from its most recent communications. These include:

• Discuss information about squamous cell carcinoma and lymphoma in capsules surrounding breast implants with women considering breast augmentation surgery or revision.
• For women diagnosed with squamous cell carcinoma or lymphoma, create an individualized treatment plan with a multidisciplinary team of experts, including plastic surgery, surgical oncology, radiology, breast surgery, pathology, and oncology.
• Report every case of breast implant-related cancer to the FDA. Rapid reporting of adverse effects helps the FDA better understand the risks associated with medical implants. Your report should include the following information:
  • Imaging studies performed
  • Breast implant history
  • Clinical presentation
  • Treatments used
  • Capsule tissue pathology
  • Results

Aesthetx prioritizes safety and informed decision-making through research and the persistent surveillance of breast implants. Women can find patient information on the ASPS website (Breast Implant Safety: What Patients Need to Know).

Overview

This overview helps our plastic surgeons at Aesthetx recognize breast implant-associated squamous cell carcinoma as a potential long-term complication of breast implants. In addition, to illuminate the specialty-wide understanding concerning breast implant-associated anaplastic large cell lymphoma, we’ll compare the two diseases below. The Plastic Surgery Foundation is preparing a manuscript summarizing the updated information for plastic and reconstructive surgery.

BIA-SCC

Breast implant-associated squamous cell carcinoma is a sporadic but potentially aggressive, epithelial-based tumor that appears to originate from the capsule created for silicone and saline breast implants. Pathology indicates sheets of squamous cells in bundles along the capsule. BIA-SCC can exhibit highly invasive properties, like spreading to local tissues, lymph nodes, and distant sites, such as muscle and bone. However, BIA-SCC is not a cancer of the breast tissue.

To the best of our knowledge, there have only been 19 reported BIA-SCC cases. This complication is so rare that the lifetime risk remains unknown. The average onset age is 55.8 years.

BIA-ALCL

BIA-ALCL is a treatable type of T-cell lymphoma that can develop around breast implants. BIA-ALCL is uncommon but can exhibit highly invasive properties such as spreading to local tissues, lymph nodes, and distant sites. BIA-ALCL is not breast tissue cancer.

Through March 2023, ASPS recognizes approximately 411 confirmed and suspected cases in the United States and almost 1,400 cases worldwide. The average onset age is 55.3 years.

Current lifetime BIA-ALCL risk varies widely with silicone and saline implants from different manufacturers, but all confirmed cases involve textured implants. Recent studies estimate the cumulative risk over 20 years with Biocell-implanted devices was 1:100 (Cordeiro 2020).

presentation

Delayed seroma BIA-SCC – Yes BIA-ALCL – Yes

Unilateral swelling BIA-SCC – Yes BIA-ALCL – Yes

Pain, erythema BIA-SCC – Yes BIA-ALCL – Yes

Capsular contracture BIA-SCC – Often BIA-ALCL – Sometimes

Extracapsular spread at presentation BIA-SCC – 80% at presentation BIA-ALCL – 28% at presentation

Typical Pathology

• BIA-SCC: Squamous cells in sheets with varying degrees of metaplasia and atypia and at least one focus of SCC.
• BIA-ALCL: Lymphoma with mass confined to a single area on the capsule.

imaging

• BIA-SCC: Ultrasound to evaluate for peri-prosthetic fluid +/- aspiration; MRI with and without contrast to evaluate capsule to rule out mass; PET-CT for the extent of disease, if present.
• BIA-ALCL: Ultrasound to assess for peri-prosthetic fluid +/- aspiration; PET‐CT is performed following a positive diagnosis. Mammograms do not help evaluate lymphoma but are essential in determining breast cancer.

treatment

• BIA-SCC: Official treatment recommendations must derive from emerging data. However, explantation with en bloc capsulectomy will provide the best outcomes.
• BIA-ALCL: Based on existing case reports, incomplete resection can result in early and aggressive recurrence.

Explantation with total complete capsulectomy is curative. Incomplete capsular resection links to significantly lower survival. Rarely patients with more advanced disease may require radiotherapy and chemotherapy. The treatment approach should follow international guidelines established by the National Comprehensive Cancer Network for BIA-ALCL. The current treatment recommendation is for bilateral en bloc and implant removal, as a few women have had contralateral disease found incidentally.

reporting

The FDA requests reporting any suspected or confirmed cases of lymphomas, BIA-SCC, BIA-ALCL, or any cancers around breast implants to the Manufacturer and User Facility Device Experience database and the device manufacturer. To submit a case to the database, visit accessdata.fda.gov.

Pending IRB approval, the Plastic Surgery Foundation will enable plastic surgeons to report suspected or confirmed implant-associated capsular pathologies, including BIA-SCC and BIA-ALCL cases, to profile.

Patient Counseling and Informed Consent

During the breast implant consultation process, plastic surgeons should inform patients about the risks of BIA‐SCC and BIA‐ALCL.

ASPS/PSF Recommendations

The ASPS and PSF have provided the following recommendations for breast implant surgeons.

• Before any breast implantation, plastic surgeons should provide their patients with the manufacturer’s patient labeling, FDA-required patient decision checklist, and any educational material to explain the possible risks and benefits of breast implants.
• Preoperative workup is crucial. All patients with a late seroma should have fine-needle aspiration and cytology testing. In addition, doctors should send specimens for immunohistochemistry to look for squamous cells, T-cells, and keratin.
• All patients with a late seroma should undergo an MRI and breast ultrasound with and without contrast. If screening confirms illness, consider a PET-CT before surgical intervention. A thorough preoperative workup allows for the most appropriately planned, single-stage surgery with the best chance for a successful cure.
• Consider the possibility of BIA-SCC, BIA-ALCL, and other lymphomas when treating a patient with late-onset, peri-implant changes. Refer patients with suspected BIA-SCC or BIA-ALCL to specialists familiar with diagnosing and treating these illnesses.
• During surgery, the surgeon should collect fresh seroma fluid, representative capsule portions, and specific pathology requests to rule out BIA-SCC and BIA-ALCL.
• Diagnostic evaluation should include cytological seroma assessment fluid or mass with Wright Giemsa stained smears and cell block immunohistochemistry/flow cytometry testing for a cluster of differentiation (CD30), Anaplastic Lymphoma Kinase markers, and Cytokeratin 5/6 (CK 5/6) and p63 .
• Flow cytometry should include instructions to look for squamous cells and keratin, at T-cells.
• Surgeons should enter confirmed or suspected BIA-SCC data into the PROFILE Registry.
• Surgeons should enter data on patients with seroma into the National Breast Implant Registry.

Your Safety and Comfort Are Our Priorities

Aesthetx commits to patient safety, advancing the quality of medical care, and practicing medicine based on the most recent scientific evidence. We will continue to monitor and review all new information and data as it becomes available to keep our community informed. If you have any questions, please don’t hesitate to contact us for more information.