Anaplastic large-cell lymphoma was first reported in association with breast implants in a 1997 case report.1 In 2010, Thompson et al2 proposed the name “Effusion-associated anaplastic large cell lymphoma of the breast,” in view of the frequent presence of a seroma. In 2011, the US Food and Drug Administration (FDA) recognized this T-cell lymphoma in association with breast implants.3 That year, Carty et al4 published the first case report of a death from “implant-related primary anaplastic large cell lymphoma.” In 2013, Story et al5 proposed the name “breast implant-associated anaplastic large cell lymphoma.” Although this description took hold, the authors' label, “iALCL,” did not. Also in 2013, Thompson and Prince6 introduced the acronym BIA-ALCL. In 2015, Kim et al7 published a consensus statement, from 12 experts, labeling the disease “breast implant-associated anaplastic large-cell lymphoma,” or BIA-ALCL. This label was adopted by the World Health Organization in its new classification of this T-cell lymphoma in 2016.8

In a landmark contribution, Brody et al9 determined a link to textured implants in 2015. However, this important message was clouded by reports that some women with smooth implants were also affected. In 2017, the FDA published 28 adverse event reports of BIA-ALCL in women with smooth implants.10 At the 2019 FDA Hearing on breast implants and BIA-ALCL, Clemens11 clarified that no smooth implant-only cases of BIA-ALCL had been reported. The cases on the FDA Web site either had a mixed clinical history or no clinical history available for review.10,11

The news of a link to textured devices was not embraced by the plastic surgery community. Textured implants had been widely used since the late 1980s. Many surgeons remained unconvinced that texture could be the cause of this cancer.12,13 An alternative hypothesis attributed this T-cell lymphoma to infection acquired at the time of implantation. A 14-point plan was advocated to reduce bacterial contamination.14 If the infection theory were correct, cases should occur around smooth implants, which also become colonized by bacteria, although not as heavily as textured devices.15

Many plastic surgeons believed that it was just a matter of time before this disease would be reported in a woman whose implant history included only smooth implants. The eventuality has not come to pass.16 Advocates of textured implants continue to minimize the risk of BIA-ALCL in patients with textured devices17,18 and fail to acknowledge a categorical difference in risk.19 Santanelli di Pompeo et al20 refer to an “ongoing hunt for a BIA-ALCL smooth case” in an (unsuccessful) effort to dispel the notion that textured devices are uniquely affected. A BIA-ALCL case was recently reported in a woman with smooth implants, but she had textured expanders in place for 14 months before insertion of the smooth implants.21

In 2016, guidelines were proposed recommending that breast implants come with a warning regarding BIA-ALCL risk.22 It was deemed prudent to inform women that this could happen with any breast implant. Swanson,23 in 2017, disagreed with a blanket warning, opining that smooth implants should not come with such a warning in view of the lack of any documented cases of BIA-ALCL associated with smooth implants. Swanson24 cautioned that the search for an infectious etiology and efforts to improve sterility may be irrelevant. In hindsight, “textured breast implant-associated anaplastic large-cell lymphoma” would have been a more accurate label.25

In 2020, the FDA issued labeling guidelines that include a boxed warning.26 Patients are cautioned that breast implants are associated with BIA-ALCL and that this cancer “occurs more commonly in patients with textured implants than smooth implants.” The Allergan boxed warning contains the same language.27 Swanson28 argues that this language is misleading, akin to informing patients that pregnancy occurs more commonly in biological women than men. Ironically, these warnings are coming at the same time that the use of textured implants in the United States, estimated to be less than 3%, is approaching zero.28,29

According to the FDA, as of April 1, 2022, 1130 women worldwide have been diagnosed with BIA-ALCL and at least 59 women (5%) have died from this cancer.30 On March 30, 2023, in an update on this disease, Clemens29 confirmed no smooth implant cases to date. The Scientific Committee on Health, Emerging and Environmental Risks concluded that a causal relationship has now been established between textured implants and BIA-ALCL.31

The disease is believed to be caused by the textured surface, particulates, and genetic susceptibility.16,29 In a widely cited animal study, Doloff et al32 showed that surface topography mediates the immune response to breast implants. Smooth implants provoke the least amount of inflammation and foreign body response. A macrotextured implant creates an immunocompromised zone around the device.29,32 Gram-negative bacteria, including Ralstonia pickettii, and the discredited 14-point plan are now believed to be irrelevant to the etiology.16,29,33,34 Recently, Santanelli di Pompeo et al,35 for the first time, showed that explantation of macrotextured devices can reduce BIA-ALCL risk.

In view of evidence that has been collected by the FDA and multiple registries worldwide, the message is very clear. Textured implants are associated with BIA-ALCL; smooth implants are not. The difference is not quantitative, but rather categorical.28

Santanelli di Pompeo et al,36 in 2022, proposed changing the name to rough implant-associated ALCL (RIA-ALCL). The rationale was 2-fold. First, this change would clarify the link to implants with a textured surface. Second, by omitting the word “breast,” the public would understand that this disease has occasionally occurred in regions other than the breast and in association with other types of textured devices, such as a textured gluteal implant,37 orthopedic hardware, dental implants, and bariatric surgery devices.38 Indeed, “rough” and “textured” are both adjectives referring to the nonsmooth surface characteristic of breast implants implicated in BIA-ALCL.

When calling for a name change, there must be a reason that goes beyond semantics. Clarity is essential. The wrong language can affect patient and physician decision making and the advice plastic surgeons give to their patients.28 Although it may seem best to advise all breast implant patients that there is a risk of BIA-ALCL out of an abundance of caution, there is a substantial downside to not specifically limiting this warning to textured breast implants. A recent survey found that such warnings double the perception that implants are unsafe and make women much less likely to choose breast implants for augmentation or reconstruction.39 They may select nonimplant alternatives (eg, fat injection, autologous reconstruction) instead, which are often less successful, more costly, or impractical in lean women. These alternatives also introduce other risks.

There is also an important medicolegal consideration.29,34 Industry and its surrogates have attempted to find fault with the surgeon or the technique, as opposed to the device.13,14 Today, we are aware that there is no operative deficiency associated with this disease.29 The problem lies squarely with the device and its surface characteristic.24,25,28,29,31,33,34 A name change would help make this clear.

Breast implants are known to provide an improvement in self-esteem in 91% of women and an enhanced quality of life in 64% of women. Breast self-consciousness drops from 86% to 13%.40 Women who can benefit should not be discouraged by warning them of a nonexistent risk. The threshold for warning patients is a “foreseeable risk,” not any conceivable risk.23 For example, ALCL might occur in a patient without breast implants, or coincidentally in a patient with smooth implants (although not yet reported), but the risk is about 1 in 4 million,16 not rising to the level of a foreseeable complication.

It is not unusual for medical conditions to be renamed. Acquired immunodeficiency syndrome (AIDS) was originally named GRID, for Gay-Related Immune Deficiency.41 The name changed to AIDS when it was recognized that not only gay men were being infected, but other groups as well, including heterosexuals, transfusion recipients, and intravenous drug abusers. The virus, first known as human T-cell lymphotropic virus type 3, became human immunodeficiency virus. In the case of BIA-ALCL, the change would be in the other direction—recognition of a more specific population that is affected rather than a more general one. Acronyms can change. Our society names have also evolved. In 1999, the American Society of Plastic and Reconstructive Surgeons shortened its name,42 becoming ASPS, and the Plastic Surgery Educational Foundation has done so as well, known today as PSF.

Now that we have collected a large amount of data on this disease and its epidemiology,31 it is reasonable and advisable to update the name to reflect our improved knowledge base. The author proposes a name modification to “textured implant-associated anaplastic large-cell lymphoma (TIA-ALCL).” Such a change is expected to benefit patients and plastic surgeons by clarifying an essential distinction in risk profiles28 and improving patient care. Patients are intolerant of small risks that are entirely preventable.43 With accurate labeling, surgeons and patients are more likely to relegate textured implants to history28 and choose safe smooth implants instead.

1. Keech JA Jr., Creech BJ. Anaplastic T-cell lymphoma in proximity to a saline-filled breast implant. Plast Reconstr Surg. 1997;100:554–555. 2. Thompson PA, Lade S, Webster H, et al. Effusion-associated large cell lymphoma of the breast: time for it to be defined as a distinct clinic-pathological entity. Haematologica. 2010;95:1977–1979. 3. Center for Devices and Radiological Health, U.S. Food and Drug Administration. Anaplastic large cell lymphoma (ALCL) in women with breast implants: preliminary FDA findings and analysis. January 2011. Available at: https://www.plasticsurgery.org/documents/medical-professionals/health-policy/FDA-news-release-ALCL.pdf. Accessed May 6, 2023. 4. Carty MJ, Pribaz JJ, Antin JH, et al. A patient death attributable to implant-related primary anaplastic large cell lymphoma of the breast. Plast Reconstr Surg. 2011;128:112e–118e. 5. Story SK, Schowalter MK, Geskin LJ. Breast implant-associated ALCL: a unique entity in the spectrum of CD30+ lymphoproliferative disorders. Oncologist. 2013;18:301–307. 6. Thompson PA, Prince HM. Breast implant-associated anaplastic large cell lymphoma: a systematic review of the literature and mini-meta analysis. Curr Hematol Malig Rep. 2013;8:196–210. 7. Kim B, Predmore ZS, Mattke S, et al. Breast implant-associated anaplastic large cell lymphoma: updated results from a structured expert consultation process. Plast Reconstr Surg Glob Open. 2015;3:e296. 8. Swerdlow SH, Campo E, Pileri SA, et al. The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood. 2016;127:2375–2390. 9. Brody GS, Deapen D, Taylor CR, et al. Anaplastic large cell lymphoma occurring in women with breast implants: analysis of 173 cases. Plast Reconstr Surg. 2015;135:695–705. 10. Srinivasa DR, Miranda RN, Kaura A, et al. Global adverse event reports of breast implant-associated ALCL: an international review of 40 government authority databases. Plast Reconstr Surg. 2017;139:1029–1039. 11. Highlights from FDA hearing on breast implants and BIA-ALCL, March 25 and 26, 2019. Available at: https://www.youtube.com/watch?v=oWgjh0INJyQ Accessed May 6, 2023. 12. Adams WP Jr. Discussion: anaplastic large cell lymphoma occurring in women with breast implants: analysis of 173 cases. Plast Reconstr Surg. 2015;135:709–712. 13. Jewell ML. Letter to the editor regarding; risk of breast implant associated anaplastic large cell lymphoma in a cohort of 3546 women prospectively followed long term after reconstruction with macro-textured breast implants. J Plast Reconstr Aesthet Surg. 2020;S1748–6815:30423-X. 14. Adams WP Jr., Culbertson EJ, Deva AK, et al. Macrotextured breast implants with defined steps to minimize bacterial contamination around the device: experience in 42,000 implants. Plast Reconstr Surg. 2017;140:427–431. 15. Jacombs A, Tahir S, Hu H, et al. In vitro and in vivo investigation of the influence of implant surface on the formation of bacterial biofilm in mammary implants. Plast Reconstr Surg. 2014;133:471e–480e. 16. Fracol ME, Rodriguez MM, Clemens MW. A spectrum of disease: breast implant-associated anaplastic large cell lymphoma, atypicals, and other implant associations. Clin Plast Surg. 2023;50:249–257. 17. Rocco N, Andree C, Barnea Y, et al. Reply to: mortality rate in breast implant surgery: is an additional procedure worthwhile to mitigate BIA-ALCL risk? Aesthetic Plast Surg. 2023. doi:10.1007/s00266-023-03251-z. 18. Mercer N. What is missing from the 2022 practice recommendation updates from the world consensus conference on BIA-ALCL? Aesthet Surg J. 2023;43:NP136–NP137. 19. Longo B, Di Napoli A, Curigliano G, et al. Clinical recommendations for diagnosis and treatment according to current updated knowledge on BIA-ALCL. Breast. 2022;66:332–341. 20. Santanelli di Pompeo F, Clemens MW, Sorotos M, et al. The ongoing hunt for a BIA-ALCL smooth case. Aesthet Surg J. Published online March 23, 2023. doi:10.1093/asj/sjad074. 21. Akhavan AA, Wirtz EC, Ollila DW, et al. An unusual case of BIA-ALCL associated with prolonged/complicated Biocell-textured expander, followed by smooth round breast implant exposure, and concurrent use of adalimumab. Plast Reconstr Surg. 2021;148:299–303. 22. Clemens MW, Miranda RN, Butler CE. Breast implant informed consent should include the risk of anaplastic large cell lymphoma. Plast Reconstr Surg. 2016;137:1117–1122. 23. Swanson E. Textured breast implants, anaplastic large-cell lymphoma, and conflict of interest. Plast Reconstr Surg. 2017;139:558e–559e. 24. Swanson E. Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL): why the search for an infectious etiology may be irrelevant. Aesthet Surg J. 2017;37:NP118–NP121. 25. Swanson E. The Food and Drug Administration bans Biocell textured breast implants: lessons for plastic surgeons. Ann Plast Surg. 2020;84:343–345. 26. Food and Drug Administration. Breast implants–certain labeling recommendations to improve patient communication. Available at: https://www.fda.gov/media/131885/download. Accessed May 6, 2023. 28. Swanson E. BIA-ALCL: comparing the risk profiles of smooth and textured breast implants. Aesthetic Plast Surg. Published online March 30, 2023. doi: 10.1007/s00266-023-03329-8. 29. International Master Course on Aging Science. Beyond BIA-ALCL: global update on breast implant associated malignancies. Available at: https://www.imcas.com/en/academy/show/14093/beyond-bia-alcl-global-update-on-breast-implant-associated-malignancies. Accessed May 6, 2023. 30. Food and Drug Administration. Medical device reports of breast implant-associated anaplastic large cell lymphoma. Available at: https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implantassociated-anaplastic-large-cell-lymphoma. Accessed May 6, 2023. 31. De Jong WH, Panagiotakos D, Proykova A, et al. Final opinion on the safety of breast implants in relation to anaplastic large cell lymphoma: report of the scientific committee on health, emerging and environmental risks (SCHEER). Regul Toxicol Pharmacol. 2021;125:104982. 32. Doloff JC, Veiseh O, de Mezerville R, et al. The surface topography of silicone breast implants mediates the foreign body response in mice, rabbits and humans. Nat Biomed Eng. 2021;5:1115–1130. 33. Santanelli di Pompeo F, Clemens MW, Atlan M, et al. Practice recommendation updates from the world consensus conference on BIA-ALCL. Aesthet Surg J. 2022;42:1262–1278. 34. Swanson E. Concerns regarding dishonesty in reporting a large study of patients treated with Allergan Biocell breast implants. Ann Plast Surg. 2022;88:585–588. 35. Santanelli di Pompeo F, Panagiotakos D, Firmani G, et al. BIA-ALCL epidemiological findings from a retrospective study of 248 cases extracted from relevant case reports and series: a systematic review. Aesthet Surg J. 2023;43:545–555. 36. Santanelli di Pompeo F, Paolini G, Firmani G, et al. From breast implant to rough implant associated-anaplastic large cell lymphoma (RIA-ALCL). Aesthet Surg J. 2022;42:NP445–NP446. 37. Mendes J Jr., Mendes Maykey VA, Frascino LF, et al. Gluteal implant-associated anaplastic large cell lymphoma. Plast Reconstr Surg. 2019;144:610–613. 38. Bessonov AA, Clemens MW. Invited discussion on: “What is the evidence of lymphoma in patients with prostheses other than breast implants?”. Aesthetic Plast Surg. 2020;44:295–298. 39. Yesantharao PS, Lee E, Khavanin N, et al. Thinking outside the black box: current perceptions on breast implant safety and utility. Plast Reconstr Surg. 2021;147:593–603. 40. Swanson E. Prospective outcome study of 225 cases of breast augmentation. Plast Reconstr Surg. 2013;131:1158–1166. 41. A brief history of HIV. Available at: https://www.verywellhealth.com/the-history-of-hiv-49350. Accessed May 6, 2023. 43. Swanson E, Mackay DR. Why the micromort concept falls short in breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) risk analysis. Aesthet Surg J. 2018;38:NP68–NP70.