2022 Practice Recommendation Updates From the World Consensus Conference on BIA-ALCL

Abstract

Background Laboratory and clinical research on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is rapidly evolving. Changes in standard of care and insights into best practice were recently presented at the 3 rd World Consensus Conference on BIA-ALCL. Objectives The aim of this manuscript is to provide practice recommendations from a consensus of experts, supplemented with a literature review regarding epidemiology, etiology, pathogenesis, diagnosis, treatment, socio-psychological aspects and international authority guidance. Methods A literature search of all manuscripts between 1997 and August 2021 for the above areas of BIA-ALCL was conducted using the PubMed database. Manuscripts in different languages, on non-human subjects, and/or discussing conditions separate from BIA-ALCL were excluded. The study was conducted using the Delphi process gathering 18 expert panelists, and employing email-based questionnaires to record the level of agreement with each statement, by applying a 5-point Likert Scale. Median response, interquartile range and comments were used to accept, reject or revise each statement. Results The literature search initially yielded 764 manuscripts out of which 405 were discarded. From the remaining 359, only 218 were included in the review and used to prepare 36 statements subdivided into 5 sections. After one round, panelists agreed on all criteria. Conclusions BIA-ALCL is uncommon and still largely underreported. Mandatory implant registries and actions by regulatory authorities are needed to better understand disease epidemiology and address initial lymphomagenesis and progression. Deviation from current diagnosis and treatment protocols can lead to disease recurrence, and research on breast implant risk factors provide insight to etiology.

Mortality Rate in Breast Implant Surgery: Is an Additional Procedure Worthwhile to Mitigate BIA-ALCL Risk?

“…The World Consensus Conferences on Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), held in 2019, 2020 and 2021, aimed to raise disease awareness and to create a forum for research on treatment and pathogenesis. As of May 2021, data from the American Society of Plastic Surgery (ASPS) BIA-ALCL Global Network and the European Association of Plastic Surgeons Scientific Committee on Device Safety and Development, report 1,148 confirmed cases worldwide, of which 489 presented in Europe [1]. The Scientific Committee on Health, Emerging and Environmental Risks (SCHEER) of the European Commission on 2021 issued a final opinion claiming a causal relationship with a moderate weight of evidence between all textured breast implants (BIs) and BIA-ALCL, and a higher risk in individuals with intermediate-to-high surface roughness implants (according to ISO-14607:2018) [2].…”

The Case Against Betadine Irrigation of Breast Implant Pockets

“…No reference to such recent revelations is provided. On the contrary, a recent publication summarizing the findings of the 2021 Consensus Conference on BIA-ALCL reported no evidence of a microbiological etiology for BIA-ALCL [14]. At one time, Ralstonia pickettii was thought to be the culprit [15].…”

“…The microbiome of a capsule affected by BIA-ALCL is not microbiologically distinct from the normal capsule [17]. Chronic inflammation and particles are now thought to be implicated, not infection [14].…”

“…At one time, Ralstonia pickettii was thought to be the culprit [15]. However, this association has not been reproduced [16] and any possible link is now regarded as either fictitious or the result of laboratory contamination [14,16]. The microbiome of a capsule affected by BIA-ALCL is not microbiologically distinct from the normal capsule [17].…”

“…The authors recognize that textured implants carry more bacteria, which they seek to minimize using antimicrobial irrigation [1]. Moreover, textured implants are now considered causative in the etiology of BIA-ALCL [14]. For years, industry has supported an infectious etiology for BIA-ALCL as opposed to a device-related etiology, including support for the 14 points [26,31].…”