September 13, 2022
Dear Members,
As you may be aware, the FDA recently posted a Safety Communication on their website informing healthcare practitioners and consumers about a number of reports received of squamous cell carcinoma (SCC) and various lymphomas (not including BIA-ALCL) detected in the capsule surrounding breast implants. While the FDA is making the public aware of these reports, their current understanding is these occurrences are rare but increasing. We are doing everything in our power to work with the FDA on this evolving matter in a coordinated fashion so that you and your patients may stay informed.
BIA-SCC is known to occur with both type of surfaces (textured and smooth) and filler (silicone and saline), whereby BIA-ALCL has only been associated with textured implants. Based on the literature there appears to be a bias to implants in place for many years (15-42). The literature links chronic inflammation (associated with device-associated infection in this instance) as the driver of the process, like in a Marjolin Ulcer. Current cases reported patients were diagnosed after years of having breast implants placed and have all presented with abnormal signs and symptoms including swelling, pain, lumps, or skin changes. Awareness by breast implant patients and physicians is paramount as well as emphasis on the need for long-term patient follow-up with their surgeon.
The Aesthetic Society developed the following talking points:
- The FDA advisory is not new information nor is it unique to breast implants where multiple rare malignancies have been reported around all types of implants including orthopedic implants, dental implants, pacemakers, and breast implants. The incidence of these malignancies including BIA-SCC is rare.
- Awareness for physicians and patients is key. Any abnormalities and deviation from the normal course for implant patients should be evaluated by a board-certified plastic surgeon.
- Strongly continue to recommend that breast implant patients have yearly follow-up and report any changes to their surgeon.
- Asymptomatic implant patients should have their first breast ultrasound or MRI about 5-6 years postoperatively, then every 2-3 years thereafter.
- BIA-SCC official treatment recommendations will need to be based on emerging data, and we will continue to update you. For this initial communication we recommend the following guidelines:
- The presentation of BIA-SCC has included breast/ axillary mass, unilateral swelling, pain, erythema.
- Surgeons should be aware of both BIA-ALCL, BIA-SCC or other possible malignancies when evaluating implant patients for changes in their breasts and should not operate on anyone with a seroma or mass without an appropriate pre-operative work up.
- For late seroma the diagnostic tool of choice is an ultrasound. Fluid should be aspirated and sent requesting the pathologist to rule out malignancy.
- If you have a patient that has a late seroma, preoperatively fluid should be sent for cytospin or cellblock and CD 30 testing. Based on this evaluation the pathologist will be able to decide if any further testing is warranted. The majority of these cases will have a negative evaluation as most late seromas are non-malignant. Despite, this, these are typically treated with surgical therapy. The capsule should be inspected and any suspicious areas submitted for histologic, and when appropriate, immunohistochemical evaluation, e.g. Cd5/6, p65 for suspicion of squamous cell carcinoma.
The FDA also has the following recommendations for people who have or are considering breast implants:
- If you are considering breast implants or if you have them, learn more about the risks and benefits of breast implants.
- If you have breast implants, you do not need to change your routine medical care or follow-up.
- Be aware that cases of SCC and various lymphomas in the capsule around the breast implant have been reported.
- Monitor your breast implants for as long as you have them. If you notice any abnormal changes in your breasts or implants, promptly talk to your surgeon or health care provider.
- If you do not have symptoms, the FDA does not recommend the removal of breast implants because of this safety communication.
- If you have breast implants and experience a problem, the FDA encourages you to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Your report, along with information from other sources, can provide information that helps improve patient safety.
Recommendations for Health Care Providers from the FDA:
Continue to provide routine care and support to your patients with breast implants.
- Be aware that cases of SCC and various lymphomas in the capsule around the breast implant have been reported.
- When examining breast implant specimens (for example, seroma, capsule, devices) for diagnostic evaluation, characterize all findings and potential diagnoses.
- Report 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.
Currently, these recommendations do not change or affect the recommendations previously provided by FDA on BIA-ALCL.
Sincerely,
Jennifer Walden, MD, FACS
President, The Aesthetic Society
Bruce W. Van Natta, MD
President, ASERF
References:
- Primary Squamous Cell Carcinoma Arising From a Breast Implant Capsule: A Case Report and Review of the Literature; Patrick J Buchanan, MD, Vinod K Chopra, MD, Kristen L Walker, MD, Ray Rudolph, MD, Richard J Greco, MD; Aesthetic Surgery Journal, Volume 38, Issue 7, July 2018, Pages NP 97–NP 102, https://doi.org/10.1093/asj/sjy092
- Macrotextured Breast Implants with Defined Steps to Minimize Bacterial Contamination around the Device: Experience in 42,000 Implants; September 2017; Plastic and Reconstructive Surgery 140(3): 427-431, Adams, WP, EJ Culbertson, AP Deva, Magnussun, C Layt, M Jewell, P Malucci, P Heden.
- Breast Implants: Reports of Squamous Cell Carcinoma and Various Lymphomas in Capsule Around Implants: FDA Safety Communication; accessed September 8, 2022, https://www.fda.gov/medical-devices/safety-communications/breast-implants-reports-squamous-cell-carcinoma-and-various-lymphomas-capsule-around-implants-fda?mkt_tok=MTAxLUJTTy05OTMAAAGGvabdQEZXAZ0B6MmGXXr1tXUK6XLuqIaD_XzFQAbqTBMX01LS9IU-obeX395jJdKeCBw_SNHi86OW-ViNfpkZgp-2FTaqjTjSRICcb50x-C0
- Kitchen SB, Paletta CE, Shehadi SI, Bauer WC. Epithelialization of the lining of a breast implant capsule. Possible origins of squamous cell carcinoma associated with a breast implant capsule. Cancer. 1994 Mar 1;73(5):1449-52.
- Liu Z, Liu, C, Chengglong, Z, Yu, Q, Zhang G, Wang X, Yu Z. Breast prosthetic implant-associated Squamous Cell Carcinoma: A case report and Literature Review. Research Square. 2021 Jan. doi.org/10.21203/rs.3.rs-141167/v1
- Paletta C, Paletta FX Jr, Paletta FX Sr. Squamous cell carcinoma following breast augmentation. Ann Plast Surg. 1992 Nov;29(5):425-9; discussion 429-32.
- Satgunaseelan L, Cheung D, Reddy, J. Breast Implant-Associated Squamous Cell Carcinoma – A Rare Long Term Complication. Pathology. Volume 47, Supplement 1, S72-S73, JANUARY 01, 2015. Alikhan MB, Nassar A, Mansoor I. Squamous metaplasia on the breast implant capsule. Int J Surg Pathol. 2010 Dec;18(6):570-4.
- Soni SE, Laun JC, Beard AS, Kuykendall LV. "Breast Implant Capsule-Associated Squamous Cell Carcinoma During Pregnancy: A Mimicker of Breast Implant-Associated Anaplastic Large Cell Lymphoma". Plast Reconstr Surg. 2022 Aug 12.