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Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) and the Textured Breast Implant Crisis

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A Correction to this article was published on 05 May 2020

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Abstract

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an uncommon T-cell, CD-30+/ALK lymphoma. Late (9 years) periprosthetic fluid (seroma) is the most common presentation (90% of the cases). A combination of textured breast implant, bacterial contamination, and genetic predisposition seems to be necessary for BIA-ALCL to occur. There are 35 million patients with implants in the world, and at the present moment, 573 cases of BIA-ALCL have been reported. The risk of developing BIA-ALCL in Australia varies from 1:2832 to 1:86,029, with texture grades 3 and 4 seeming to pose a higher risk than grades 2 and 1. NCCN has established guidelines for diagnosis and treatment, and early diagnosis is the key to cure. At an early stage and for the vast majority of patients, the treatment consists of capsulectomy and implant removal. However, at stages II to IV, a systemic treatment is warranted, including chemotherapy, radiotherapy (residual disease), and brentuximab vedotin. The majority of patients can be cured, and complete capsular removal is the most important factor. So far, 33 patients have died from BIA-ALCL worldwide, with deaths related to delay in diagnosis and treatment. Textured implants have been in the midst of the current implant crisis, and Biocell was recalled worldwide after the latest FDA update on the disease. At the present moment, no medical society or regulatory agency has recommended implant removal. It is about time that we start robust breast implant registries to determine risks. Besides, based on scientific criteria, we must consider all the benefits and risks associated with the available breast devices.

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From Clemens et al. [44]. Reprinted with permission. © (2016) American Society of Clinical Oncology. All rights reserved

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  • 05 May 2020

    Anne K. Groth���s name was wrongly tagged in the original publication of this article. It has been corrected here.

References

  1. Clemens MW, Horwitz SM (2017) NCCN consensus guidelines for the diagnosis and management of breast implant-associated anaplastic large cell lymphoma. Aesthet Surg J 37:285–289

    Google Scholar 

  2. Aladily TN, Nathwani BN, Miranda RN et al (2012) Extranodal NK/T-cell lymphoma, nasal type, arising in association with saline breast implant: expanding the spectrum of breast implant-associated lymphomas. Am J Surg Pathol 36:1729–1734

    PubMed  Google Scholar 

  3. Keech JA Jr, Creech BJ (1997) Anaplastic T-cell lymphoma in proximity to a saline-filled breast implant. Plast Reconstr Surg 100:554–555

    PubMed  Google Scholar 

  4. Swerdlow SH, Campo E, Pileri SA et al (2016) The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood 127:2375–2390

    CAS  PubMed  PubMed Central  Google Scholar 

  5. Rastogi P, Deva AK, Prince HM (2018) Breast implant-associated anaplastic large cell lymphoma. Curr Hematol Malig Rep 13:516–524

    CAS  PubMed  Google Scholar 

  6. Calobrace MB, Capizzi PJ (2014) The biology and evolution of cohesive gel and shaped implants. Plast Reconstr Surg 134:6S–11S

    PubMed  Google Scholar 

  7. Calobrace MB, Schwartz MR, Zeidler KR et al (2017) Long-term safety of textured and smooth breast implants. Aesthet Surg J 38:38–48

    PubMed  Google Scholar 

  8. Randquist C, Gribbe O (2010) Highly cohesive textured form stable gel implants: principles and techniques. In: Hall-Findlay EEG (ed) Aesthetic and reconstructive surgery of the breast. Elsevier, Philadelphia, pp 339–365

    Google Scholar 

  9. Adams WP Jr, Culbertson EJ, Deva AK et al (2017) Macrotextured breast implants with defined steps to minimize bacterial contamination around the device: experience in 42,000 implants. Plast Reconstr Surg 140:427–431

    CAS  Google Scholar 

  10. McGuire P, Reisman NR, Murphy DK (2017) Risk factor analysis for capsular contracture, malposition, and late seroma in subjects receiving Natrelle 410 form-stable silicone breast implants. Plast Reconstr Surg 139:1–9

    CAS  PubMed  Google Scholar 

  11. Hall-Findlay EJ (2011) Breast implant complication review: double capsules and late seromas. Plast Reconstr Surg 127:56–66

    CAS  PubMed  Google Scholar 

  12. Zingaretti N, Galvano F, Vittorini P et al (2019) Smooth prosthesis: our experience and current state of art in the use of smooth sub-muscular silicone gel breast implants. Aesthetic Plast Surg. https://doi.org/10.1007/s00266-019-01464-9

  13. Namnoum JD, Largent J, Kaplan HM et al (2013) Primary breast augmentation clinical trial outcomes stratified by surgical incision, anatomical placement and implant device type. J Plast Reconstr Aesthet Surg 66:1165–1172

    Google Scholar 

  14. Jones P, Mempin M, Hu H et al (2018) The functional influence of breast implant outer shell morphology on bacterial attachment and growth. Plast Reconstr Surg 142:837–849

    CAS  PubMed  Google Scholar 

  15. Collett DJ, Rakhorst H, Lennox P et al (2019) Current risk estimate of breast implant-associated anaplastic large cell lymphoma in textured breast implants. Plast Reconstr Surg 143:30S–40S

    CAS  Google Scholar 

  16. Hu H, Jacombs A, Vickery K et al (2015) Chronic biofilm infection in breast implants is associated with an increased T-cell lymphocytic infiltrate: implications for breast implant-associated lymphoma. Plast Reconstr Surg 135:319–329

    CAS  PubMed  Google Scholar 

  17. Hu H, Johani K, Almatroudi A et al (2016) Bacterial biofilm infection detected in breast implant-associated anaplastic large-cell lymphoma. Plast Reconstr Surg 137:1659–1669

    CAS  Google Scholar 

  18. Deva AK, Adams WP Jr, Vickery K (2013) The role of bacterial biofilms in device-associated infection. Plast Reconstr Surg 132:1319–1328

    CAS  PubMed  Google Scholar 

  19. Loch-Wilkinson A, Beath KJ, Knight RJW et al (2017) Breast implant-associated anaplastic large cell lymphoma in Australia and New Zealand: high-surface-area textured implants are associated with increased risk. Plast Reconstr Surg 140:645–654

    CAS  Google Scholar 

  20. Leberfinger AN, Behar BJ, Williams NC et al (2017) Breast implant-associated anaplastic large cell lymphoma: a systematic review. JAMA Surg 152:1161–1168

    PubMed  Google Scholar 

  21. Bizjak M, Selmi C, Praprotnik S et al (2015) Silicone implants and lymphoma: the role of inflammation. J Autoimmun 65:64–73

    CAS  PubMed  Google Scholar 

  22. Adams WP Jr, Conner WC, Barton FE Jr et al (2000) Optimizing breast pocket irrigation: an in vitro study and clinical implications. Plast Reconstr Surg 105:334–338 discussion 339-343

    PubMed  Google Scholar 

  23. Jewell ML, Adams WP Jr (2018) Betadine and breast implants. Aesthet Surg J 38:623–626

    PubMed  Google Scholar 

  24. Blombery P, Thompson E, Ryland GL et al (2018) Frequent activating STAT3 mutations and novel recurrent genomic abnormalities detected in breast implant-associated anaplastic large cell lymphoma. Oncotarget 9:36126–36136

    PubMed  PubMed Central  Google Scholar 

  25. Adams WP Jr (2017) Discussion: breast implant-associated anaplastic large cell lymphoma in Australia and New Zealand: high-surface-area textured implants are associated with increased risk. Plast Reconstr Surg 140:663–665

    CAS  PubMed  Google Scholar 

  26. American Society of Plastic Surgeons BIA-ALCL Physician Resources. https://www.plasticsurgery.org/for-medical-professionals/health-policy/bia-alcl-physician-resources/by-the-numbers. Accessed 5 Aug 2019

  27. Therapeutic Goods Administration (TGA). Breast implants and anaplastic large cell lymphoma. https://www.tga.gov.au/alert/breast-implants-and-anaplastic-large-cell-lymphoma. Accessed 24 Jan 2019

  28. Brody GS, Deapen D, Taylor CR et al (2015) Anaplastic large cell lymphoma occurring in women with breast implants: analysis of 173 cases. Plast Reconstr Surg 135:695–705

    CAS  PubMed  Google Scholar 

  29. Doren EL, Miranda RN, Selber JC et al (2017) U.S. epidemiology of breast implant-associated anaplastic large cell lymphoma. Plast Reconstr Surg 139:1042–1050

    CAS  PubMed  Google Scholar 

  30. Magnusson M, Beath K, Cooter R et al (2019) The epidemiology of breast implant-associated anaplastic large cell lymphoma in Australia and New Zealand confirms the highest risk for grade 4 surface breast implants. Plast Reconstr Surg 143:1285–1292

    CAS  PubMed  Google Scholar 

  31. Ruffenach L, Bruant-Rodier C, Goldammer F et al (2019) Thirty-six (36) French cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL): What do we know about their prosthetic histories, and what conclusions may be drawn? Ann Chir Plast Esthet 64:285–292

    CAS  PubMed  Google Scholar 

  32. Clemens MW, Brody GS, Mahabir RC et al (2018) How to diagnose and treat breast implant-associated anaplastic large cell lymphoma. Plast Reconstr Surg 141:586e–599e

    CAS  PubMed  Google Scholar 

  33. Di Napoli A, Pepe G, Giarnieri E et al (2017) Cytological diagnostic features of late breast implant seromas: from reactive to anaplastic large cell lymphoma. PLoS ONE 12:e0181097

    PubMed  PubMed Central  Google Scholar 

  34. Elswick SM, Nguyen MT (2018) Breast erythema in a patient with breast implant-associated anaplastic large cell lymphoma: a Case Report Discussing Cutaneous Manifestations. Aesthet Surg J 38:NP47–NP52

    PubMed  Google Scholar 

  35. Deva AK (2018) Commentary on: Breast erythema in a patient with breast implant-associated anaplastic large cell lymphoma: a case report discussing cutaneous manifestations. Aesthet Surg J 38:NP53–NP55

    PubMed  Google Scholar 

  36. U.S. Food and Drug Administration (FDA) FDA. Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) Available at: www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/breastimplants/ucm239995.htm. Aug 5th 2019

  37. Clemens MW, Jacobsen ED, Horwitz SM (2019) 2019 NCCN consensus guidelines on the diagnosis and treatment of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Aesthet Surg J 39:S3–S13

    PubMed  Google Scholar 

  38. Ramos-Gallardo G, Cuenca-Pardo J, Cardenas-Camarena L et al (2018) Is Latin America ready to identify anaplastic large cell lymphoma in breast implants patients? Regional encounter during the national plastic surgery meeting in Cancun, Mexico. Aesthetic Plast Surg 42:1421–1428

    PubMed  Google Scholar 

  39. Nava MB, Adams WP Jr, Botti G et al (2018) MBN 2016 aesthetic breast meeting BIA-ALCL consensus conference report. Plast Reconstr Surg 141:40–48

    CAS  PubMed  Google Scholar 

  40. Santanelli di Pompeo F, Laporta R, Sorotos M et al (2015) Breast implant-associated anaplastic large cell lymphoma: proposal for a monitoring protocol. Plast Reconstr Surg 136:144e–151e

    CAS  PubMed  Google Scholar 

  41. Alderuccio JP, Desai A, Yepes MM et al (2018) Frontline brentuximab vedotin in breast implant-associated anaplastic large-cell lymphoma. Clin Case Rep 6:634–637

    PubMed  PubMed Central  Google Scholar 

  42. Pro B, Advani R, Brice P et al (2012) Brentuximab vedotin (SGN-35) in patients with relapsed or refractory systemic anaplastic large-cell lymphoma: results of a phase II study. J Clin Oncol 30:2190–2196

    CAS  PubMed  Google Scholar 

  43. Mehta-Shah N, Clemens MW, Horwitz SM (2018) How I treat breast implant-associated anaplastic large cell lymphoma. Blood 132:1889–1898

    CAS  PubMed  PubMed Central  Google Scholar 

  44. Clemens MW, Medeiros LJ, Butler CE et al (2016) Complete surgical excision is essential for the management of patients with breast implant-associated anaplastic large-cell lymphoma. J Clin Oncol 34:160–168

    CAS  PubMed  Google Scholar 

  45. Clemens MW, Miranda RN, Butler CE (2016) Breast implant informed consent should include the risk of anaplastic large cell lymphoma. Plast Reconstr Surg 137:1117–1122

    CAS  PubMed  Google Scholar 

  46. Joint ASPS & ASAPS Statement on Breast Implant-Associated ALCL. https://www.surgery.org/sites/default/files/BEST%20PRACTICES_1.pdf. Accessed 23 Jan 2017

  47. Giordano S, Peltoniemi H, Lilius P et al (2013) Povidone–iodine combined with antibiotic topical irrigation to reduce capsular contracture in cosmetic breast augmentation: a comparative study. Aesthet Surg J 33:675–680

    PubMed  Google Scholar 

  48. Swanson E (2019) The textured breast implant crisis: a call for action. Ann Plast Surg 82:593–594

    CAS  PubMed  PubMed Central  Google Scholar 

  49. Swanson E (2017) Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL): why the search for an infectious etiology may be irrelevant. Aesthet Surg J 37:NP118–NP121

    PubMed  Google Scholar 

  50. (ANSM) Andsdmedpds Le marquage CE des implants mammaires texturés de la marque Allergan (Microcell et Biocell) n’a pas été renouvelé par l’organisme notifié GMED - Point d’information. https://ansm.sante.fr/S-informer/Points-d-information-Points-d-information/Le-marquage-CE-des-implants-mammaires-textures-de-la-marque-Allergan-Microcell-et-Biocell-n-a-pas-ete-renouvele-par-l-organisme-notifie-GMED-Point-d-information. Accessed 5 Aug 2018

  51. (FDA) USFaDA Statement from FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health on FDA’s new efforts to protect women’s health and help to ensure the safety of breast implants. https://www.fda.gov/news-events/press-announcements/statement-fda-principal-deputy-commissioner-amy-abernethy-md-phd-and-jeff-shuren-md-jd-director-fdas. Accessed 5 Aug 2019

  52. (FDA) USFaDA FDA. Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). https://www.fda.gov/medical-devices/safety-communications/fda-requests-allergan-voluntarily-recall-natrelle-biocell-textured-breast-implants-and-tissue. Accessed 5 Aug 2019

  53. Deva AK, Cuss A, Magnusson M et al (2019) The “Game of Implants”: a perspective on the crisis-prone history of breast implants. Aesthet Surg J 39:S55–S65

    PubMed  Google Scholar 

  54. Deva AK (2019) A perspective on the never-ending cycle of breast implant crises. Aesthet Surg J 39:NP85–NP86

    PubMed  Google Scholar 

  55. Hopper I, Ahern S, Nguyen TQ et al (2018) Breast implant registries: a call to action. Aesthet Surg J 38:807–810

    PubMed  Google Scholar 

  56. Australian Breast Device Registry. https://dica.nl. https://www.abdr.org.au. Accessed 20 Jan 2019

  57. Campanale A, Boldrini R, Marletta M (2018) 22 cases of breast implant-associated ALCL: awareness and outcome tracking from the Italian Ministry of Health. Plast Reconstr Surg 141:11e–19e

    CAS  PubMed  Google Scholar 

  58. Teixeira BN (2018) Anaplasic large cells lymphoma associated with breast implants. Mastology 28:67–68

    Google Scholar 

  59. Young-Afat DA (2018) Risk of breast implant-associated anaplastic large cell lymphoma. JAMA Oncol 4:1434–1435

    PubMed  Google Scholar 

  60. Deva AK (2017) Discussion: U.S. Epidemiology of Breast Implant-associated anaplastic large-cell lymphoma. Plast Reconstr Surg 139:1051–1052

    CAS  PubMed  Google Scholar 

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Correspondence to Anne K Groth.

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Dr. Groth has received a speaker honorarium from Allergan. The authors received no financial support for the research, authorship, and publication of this article.

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K Groth, A., Graf, R. Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) and the Textured Breast Implant Crisis. Aesth Plast Surg 44, 1–12 (2020). https://doi.org/10.1007/s00266-019-01521-3

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