Textured versus Smooth Tissue Expanders: A Comparison of Complications in 3526 Breast Reconstructions.

BACKGROUND: Increased understanding of breast implant-associated anaplastic large-cell lymphoma has led to a shift away from textured breast devices. A few small studies have compared the complication rates of textured and smooth tissue expanders (TEs). The aim of this study was to compare complication profiles in patients undergoing two-stage postmastectomy breast reconstruction with either textured or smooth TEs. METHODS: The authors performed a retrospective review of female patients who underwent immediate breast reconstruction with textured or smooth TEs from 2018 to 2020 at their institution. Rates of seroma, infection/cellulitis, malposition/rotation, exposure, and TE loss were analyzed in the overall cohort and subgroups undergoing prepectoral and subpectoral TE placement. A propensity score-matched analysis was used to decrease the effects of confounders comparing textured and smooth TEs. RESULTS: The authors analyzed 3526 TEs (1456 textured and 2070 smooth). More frequent use of acellular dermal matrix, SPY angiography, and prepectoral TE placement was noted in the smooth TE cohort ( P < 0.001). Univariate analysis suggested higher rates of infection/cellulitis, malposition/rotation, and exposure in smooth TEs (all P < 0.01). Rates of TE loss did not differ. After propensity matching, no differences were noted in infection or TE loss. Prepectoral smooth expanders had increased rates of malposition/rotation. CONCLUSIONS: TE surface type did not affect rates of TE loss, although increased rates of expander malposition were noted in the smooth prepectoral cohort. Further research is needed to examine breast implant-associated anaplastic large-cell lymphoma risk with temporary textured TE exposure to improve decision-making. CLINICAL QUESTION/LEVEL OF EVIDENCW: Therapeutic, III.

Financial Toxicity in Breast Implant-Associated Anaplastic Large Cell Lymphoma.

BACKGROUND: Financial toxicity is a growing concern due to its considerable effects on medical adherence, quality of life, and mortality. The cost associated with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is substantial from diagnosis to treatment, including adjuvant therapy and surgery. This study aims to assess the prevalence of financial toxicity in BIA-ALCL patients. METHODS: We performed a cross-sectional, survey-based study on women with confirmed cases of BIA-ALCL from December 2019 to March 2023. The primary study outcomes were financial toxicity measured by Comprehensive Score for Financial Toxicity (COST) score and patient-reported financial burden measured by the responses to the Evaluation of the Financial Impact of BIA-ALCL survey. Lower COST scores signify higher financial toxicity. Responses were linked to patient data extracted from the medical records. RESULTS: Thirty-two women treated for confirmed BIA-ALCL were included. Patients were all White and were diagnosed at a median age of 51 years (range, 41-65 years). The mean COST score was 27.9 ± 2.23. Lower COST scores were associated with receipt of radiotherapy ( P = 0.033), exceeding credit card limits ( P = 0.036), living paycheck to paycheck ( P = 0.00027), requiring financial support from friends and family ( P = 0.00044), and instability in household finances ( P = 0.034). CONCLUSIONS: Financial toxicity is prevalent in BIA-ALCL patients and has a substantial impact on patient reported burden. Insurance denial is frequent for patients with a prior history of cosmetic augmentation. Risk assessments and cost discussions should occur throughout the care continuum to minimize financial burden.

Breast Implant-Associated Anaplastic Large Cell Lymphoma Awareness: An Analysis of the Responses to an Institutional Campaign and Global Recall.

BACKGROUND: We performed an assessment of patient response rates and clinical outcomes to the global recall for textured breast implants and to our institution's letters informing them of their risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). METHODS: A retrospective review of patients who had textured implants placed at our institution was completed. Outcome measures included patient response rates to either the global recall or our institution's letters, rate of textured implant removal, and type of subsequent revision surgery. RESULTS: A total of 1176 patients with textured implants were reviewed for this study. In total, 374 patients (31.8%) reached out to discuss their risk of BIA-ALCL, and 297 (25.3%) eventually presented to the clinic. One hundred twenty eight patients (34.2%) responded after the letter but before the US Food and Drug Administration (FDA) ban of macrotextured BIOCELL implants, 186 (49.7%) after the FDA ban, and 48 (12.8%) after the manufacturer's multichannel campaign. One hundred eighteen patients with textured implants (11.6%) proceeded with surgery. Most underwent exchange with smooth implants (76 patients [64.4%]) after textured implant removal. CONCLUSIONS: A significant portion of patients (31.8%) responded to our letters, the FDA ban, and the manufacturer's campaign. Despite the low incidence of BIA-ALCL and the ongoing recommendation for observation in the setting of no symptoms, 11.6% of our patients still elected to proceed with implant removal. Exchange to smooth implants was the most popular surgical option at 64.4%.

Zwitterionic polymer on silicone implants inhibits the bacteria-driven pathogenic mechanism and progress of breast implant-associated anaplastic large cell lymphoma.

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) occurs in the capsule surrounding breast implants. Malignant transformation of T cells by bacteria-driven chronic inflammation may be underlying BIA-ALCL mechanism. Here, we covalently grafted 2-methacryloyloxyethyl phosphorylcholine (MPC)-based polymers on a silicone surface and examined its effects against BIA-ALCL pathogenesis. MPC grafting strongly inhibited the adhesion of bacteria and bacteria-causing inflammation. Additionally, cancer T cell proliferation and capsule-derived fibroblast-cancer cell communication were effectively inhibited by MPC grafting. We further demonstrated the effect of MPC against the immune responses causing BIA-ALCL around human silicone implants in micro-pigs. Finally, we generated a xenograft anaplastic T cell lymphoma mouse model around the silicone implants and demonstrated that MPC grafting could effectively inhibit the lymphoma progression. This study is the first to show that bacteria-driven induction and progression of BIA-ALCL can be effectively inhibited by surface modification of implants. STATEMENT OF SIGNIFICANCE: Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a major concern in the field of plastic and reconstructive surgery. In this study, we demonstrate strong inhibitory effect of zwitterionic polymer grafting on BIA-ALCL pathogenesis and progression, induced by bacterial infection and inflammation, both in vitro and in vivo. This study provides a molecular basis for the development of novel breast implants that can prevent various potential complications such as excessive capsular contracture, breast implant illness, and BIA-ALCL incidence, as well as for expanding the biomedical applications of zwitterionic polymers.

Epidemiology of Breast Implant-Associated Anaplastic Large Cell Lymphoma in the United States: A Systematic Review.

BACKGROUND: Although textured implants represent fewer than 10% of implants used in the United States, the country reports the highest incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). OBJECTIVES: The aim of this study was to perform a systematic literature review on US-based epidemiology to update knowledge on BIA-ALCL in the United States. METHODS: Publications on US BIA-ALCL epidemiology were searched between September 2022 and March 2023 on MEDLINE (National Institutes of Health; Bethesda, MD), Embase (Elsevier, Amsterdam, the Netherlands), Web of Science (Clarivate, London, UK), and SCOPUS (Elsevier, Amsterdam, the Netherlands). The US numerator was obtained by averaging the FDA MAUDE database and the PSF PROFILE registry, while the denominator was estimated from chest X-rays, and included female transgender individuals. Prevalence and risk were assessed accordingly, but the incidence rate (IR) could not be updated due to the lack of available follow-up data. RESULTS: Out of 987 identified manuscripts, 10 were included. The US prevalence of BIA-ALCL in the literature ranged from 1:300 to 1:500,000 and the IR from 4.5 per 10,000 to 31.1 per 100 million persons per year. A mean value of 453.5 BIA-ALCL cases was calculated. From a denominator of 4,264,618 individuals, which includes all breast implant surfaces, we calculated 414,521 individuals with textured implants, indicating a textured prevalence of 109.4 cases per 100,000 individuals and a risk of 1:913. CONCLUSIONS: BIA-ALCL IR, prevalence, and risk has increased when calculated exclusively for patients with textured devices. Although US macrotextured implants were recalled by the FDA, these findings may influence the surveillance of existing patients and the use of macrotextured implants in other parts of the world where they remain widespread.

Separating Myth from Reality in Breast Implants: An Overview of 30 Years of Experience.

SUMMARY: The purpose of this article is to review the pivotal events in the history of breast implants in the United States, including the events leading to the U.S. Food and Drug Administration moratorium on the use of silicone gel implants and subsequent approval; the emergence of breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL); and persistent concerns about an association between breast implants, autoimmune disease, and systemic symptoms. This article reviews the medical literature to outline our current knowledge on BIA-ALCL; offers recommendations for diagnosis and management of symptomatic and asymptomatic patients with textured implants; and reviews the science of potential associations of implants with autoimmune and systemic symptoms. The authors hope to help patients separate myths from reality and make educated decisions on having breast implants placed or removed.

The Influence of BIA-ALCL on the Use of Textured Breast Implant and its Placement: A Survey of Dutch Plastic Surgeons.

BACKGROUND: Breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) and its association with macrotextured breast implants may have induced plastic surgeons to change their breast augmentation and breast reconstruction practice. OBJECTIVES: The aim of this study was to survey Dutch plastic surgeons about the effects of BIA-ALCL on their choice of breast implant texture and placement technique. METHODS: An online questionnaire was distributed to all members of the Dutch Association of Plastic Surgeons. Descriptive data were presented as frequencies and percentages. Technique alterations were analyzed by the marginal homogeneity test for paired nominal data. RESULTS: A total of 63 plastic surgeons completed the questionnaire. The majority of respondents altered their use of textured implants due to BIA-ALCL concerns for both breast augmentation and reconstruction (75.4% and 69.8%, respectively; both being statistically significant, P < .001). Microtextured and smooth/nanotextured breast implants are now most frequently used. BIA-ALCL did not influence the placement technique in breast augmentation and reconstruction (87.7% and 94.3%, respectively). Dual-plane breast implant placement is still the most favored technique for breast augmentation, and submuscular placement is still most favored for breast reconstruction. CONCLUSIONS: BIA-ALCL has had a significant impact on the use of macrotextured breast implants by Dutch plastic surgeons in both aesthetic and reconstructive breast surgery. Breast implant placement technique has not been affected.

Breast Implant Surgery: An Overview of the Risks and Health Complications.

We present an overview of the risks and health complications associated with breast implant surgery with a focus on breast implant illness (BII), breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and breast implant-associated squamous cell carcinoma (BIA-SCC). BII is a constellation of systemic symptoms that can occur after breast implant devices are surgically implanted into the human body. BIA-ALCL is a T-cell lymphoma associated with the implantation of textured breast implant devices. BIA-SCC is a potentially aggressive epithelial-based tumor that can occur following implantation with smooth or textured breast implant devices. Nurses may lack awareness and knowledge regarding BII, BIA-ALCL, and BIA-SCC, and this can negatively affect patient safety. Therefore, it is essential that all nurses, especially members of the plastic and aesthetic nursing community, understand these disease processes. Currently, it is not standard practice to screen every patient for the presence of an implantable device at every health care encounter. However, by not doing so, health care professionals may miss the opportunity to identify illness, disease, or cancer that could be related to an implanted device; therefore, practice changes to increase patient safety are both necessary and warranted. To identify those individuals at greatest risk for implant-related illness, disease, or cancer, we propose implementing universal screening of all individuals for implantable devices. We define universal screening for implantable devices as assessing all patients for the presence or absence of an implantable device at every health care encounter. We recommend using the IOWA model to guide our proposed evidence-based practice update.

Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE): Updated Report 2012-2020.

BACKGROUND: In January of 2011, the U.S. Food and Drug Administration released a safety communication regarding the potential association between breast implants and anaplastic large-cell lymphoma (ALCL). In 2012, the American Society of Plastic Surgeons, The Plastic Surgery Foundation, and the Food and Drug Administration signed a cooperative research and development agreement to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large-Cell Lymphoma Etiology and Epidemiology (PROFILE) patient registry. METHOD: This is an updated report of registry findings. From August of 2012 to August of 2020, 330 unique, suspected, or confirmed cases of breast implant-associated (BIA) ALCL in the United States were reported to PROFILE, including 144 cases newly reported since the 2018 publication. RESULTS: Median time from implantation of any device to BIA-ALCL diagnosis was 11 years (range, 2 to 44 years). At the time of presentation, 91% of cases had local symptoms and 9% had concurrent systemic symptoms. The most common local symptom was seroma, seen in 79% of patients. All patients had a history of a textured device; there were no patients who had a confirmed smooth-only device history. Approximately 11% of the reported cases were diagnosed with stage 1A disease (tumor-node-metastasis staging classification). CONCLUSIONS: The PROFILE registry continues to be an essential tool in unifying the collection of granular-level data pertaining to BIA-ALCL. These data emphasize the critical importance of detailed tracking of BIA-ALCL cases, and will contribute significantly to our understanding of the relationship between breast implants and ALCL.

Risk of Breast Implant-Associated Anaplastic Large Cell Lymphoma in Patients with Textured Tissue Expanders.

BACKGROUND: The association between textured implants and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is well established, but the risk of BIA-ALCL in patients with transient exposure to a textured tissue expander (TE) is not as well documented. The aim of this study was to assess the incidence and risk of BIA-ALCL in patients with temporary exposure to a textured TE with subsequent smooth implant placement. METHODS: This single-institution retrospective cohort study included all female patients who underwent two-stage breast reconstruction with placement of a textured TE from 1995 to 2016 with subsequent exchange to a smooth permanent implant. Primary outcome of interest was development of BIA-ALCL. Patients with exposure to textured implants were excluded. Follow-up was determined by last documented visit. The authors calculated summary statistics for exposure time and follow-up intervals. RESULTS: Overall, 3310 patients had temporary exposure to a textured TE with exchange to a smooth implant, totaling 5201 textured TEs. Average textured TE exposure time was 6.7 months (median, 5.8 months). Average follow-up was 6.8 years (median, 6.3 years), ranging from 3.7 months to 18 years. No cases of BIA-ALCL were identified. CONCLUSIONS: As no cases of BIA-ALCL were identified, the risk of BIA-ALCL with short exposure to textured TEs is likely lower than the risk from exposure to permanent textured implants. Although longer follow-up is needed, these results can help counsel patients with previous exposure to textured TEs who are concerned about their risk of BIA-ALCL and can contribute to discussions on potential continued utility of textured TEs. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, IV.

BIA-ALCL Epidemiological Findings From a Retrospective Study of 248 Cases Extracted From Relevant Case Reports and Series: A Systematic Review.

BACKGROUND: The epidemiologic picture of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is unclear, with no high-level evidence, because only case reports and series are available. OBJECTIVES: The aim of this study was to update knowledge on BIA-ALCL epidemiology by utilizing all available data through a systematic review of scientific literature. METHODS: A search on PubMed, Scopus, and Web of Science was conducted between October 2021 and April 2022. Out of the 2799 available records, 114 pertinent articles were selected, featuring 248 BIA-ALCL cases which were retrospectively analyzed by means of descriptive statistics, incidence rate (IR), Kaplan-Meier survival curves, and Pearson correlation coefficients. RESULTS: The United States, the Netherlands, Italy, and Australia were the countries reporting the most cases. The mean age at first implantation was 42 years, and the mean age at diagnosis was 53 years. Aesthetic indications were the reason for 52% of cases, and reconstruction for 48%; macrotextured surface was linked to 73.8% of cases, and seroma to 83%. Total follow-up was 492 months, and mean event-free time (EFT) to BIA-ALCL development was 129 months. The IR was 96 new cases/1,000 women per year after first implantation, and was directly correlated to the number of replacements. EFT was directly correlated to the number of replacements, implant rupture, and capsule contracture, and was inversely associated with patients' age at first implantation and to BRACA1/2 and TP53 mutations. CONCLUSIONS: Macrotextured implant use in older patients and in patients with BRCA1/2 and TP53 mutations should be reconsidered, because this is associated with earlier disease onset. Implant replacement of asymptomatic, risk-stratified patients can be indicated due to its protective role against BIA-ALCL, reducing IR and risk, while increasing the EFT.

Outcomes Analysis of Textured Versus Smooth Tissue Expanders in Breast Reconstruction.

INTRODUCTION: Because of concerns related to the correlation of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and textured implants, the use of smooth devices in breast reconstruction has been increasing. Currently, there is a paucity of literature evaluating the safety of smooth tissue expanders (STEs), which are now being used more frequently in first-stage breast reconstruction. This study sought to compare the safety and outcomes associated with STEs compared with textured tissue expanders in prosthesis-based breast reconstruction. METHODS: A single-institution retrospective review of 394 patients undergoing tissue expander-based breast reconstruction (147 smooth and 247 textured) between 2015 and 2019 was conducted. Patient demographics, comorbidities, treatment characteristics, complications, and surgical outcomes were evaluated. Data analysis was performed using Fisher exact and t tests. RESULTS: No significant difference in demographics or complication rates were identified, including rates of hematoma, seroma, wound dehiscence, delayed wound healing, infection, tissue expander malposition, nipple necrosis, mastectomy flap necrosis, reoperation, readmission, and explantation. Average follow-up was 19 and 22 months for the smooth and textured groups, respectively. No cases of BIA-ALCL were identified in either group. CONCLUSIONS: With equivocal safety profiles and no demonstrated risk in BIA-ALCL associated with STEs, this study supports the safety of using STEs compared with textured tissue expanders in prosthesis-based breast reconstruction with the advantage in preventing BIA-ALCL and concludes that there is no role for textured breast expanders.

Breast Implant-Associated Anaplastic Large-Cell Lymphoma in Brazil: What Are We Missing?

BACKGROUND: Breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) has been diagnosed in more than 1000 patients in more than 30 countries, although only a few cases have been reported in Latin America and the Caribbean to date. As the second-largest global market for breast implants with a predominance of textured-surface implants, Brazil is a major global market for cosmetic augmentations, making it unlikely that cases of BIA-ALCL are actually scarce. METHODS: A local and voluntary registry of patients with BIA-ALCL was initiated in 2018. All patients diagnosed with BIA-ALCL were confirmed by the World Health Organization criteria. Implant characteristics, disease symptoms, treatment, and oncologic outcomes were assessed. RESULTS: Fourteen cases of BIA-ALCL in a Brazilian population were identified in the Paraná state. Disease-specific diagnostic tests were omitted before surgical intervention in 50 percent of patients. With additional cases from a literature review, the treatment and outcomes of 29 cases of BIA-ALCL in Brazil were assessed. CONCLUSIONS: Compared with other populations, these initial observations suggest that awareness of the disease by the local breast surgery community remains low and that a number of cases may remain undiagnosed. Lack of preoperative diagnostic testing compromises disease treatment, oncologic outcomes, and both short- and long-term surveillance.

The Macrotextured Implant Recall: Breast Implant-Associated-Anaplastic Large Cell Lymphoma Risk Aversion in Cosmetic and Reconstructive Plastic Surgery Practices.

BACKGROUND: The recall of Allergan Biocell (Irvine, CA) devices due to the association between anaplastic large cell lymphoma (ALCL) and macrotextured breast implants means that plastic surgeons are faced with the challenge of caring for patients with these implants in situ. Cosmetic and reconstructive surgeons have been contacting affected patients to encourage them to follow up and discuss the most appropriate risk-reduction strategies. OBJECTIVES: The aim of this study was to evaluate patient concerns about the risk of breast implant-associated ALCL (BIA-ALCL) and to compare management differences between cosmetic and reconstructive patients. METHODS: A retrospective review was performed of 432 patients with macrotextured implants who presented to clinic after being contacted (121 reconstructive and 311 cosmetic). These records were analyzed for their presenting concerns, surgery wait times, and management plans. Statistical analysis was performed to compare the cohorts, and odds ratios (ORs) were computed to determine the association between patient concerns and their choice of management. RESULTS: After consultation, 59.5% of the reconstructive cohort and 49.5% of the cosmetic cohort scheduled implant removal or exchange. The reconstructive population had a higher rate of ALCL concern (62.7%); however, both cohorts had a significant OR, demonstrating an expressed fear of ALCL likely contributed to their subsequent clinical management (OR cosmetic, 1.66; OR reconstructive, 2.17). CONCLUSIONS: Although the risk of ALCL appears to be more concerning to the reconstructive population, both cohorts were equally motivated to have their implants removed. Informing patients about their ALCL risk is crucial to ensure a patient-supported risk reduction plan.

Smooth Versus Textured Tissue Expander Breast Reconstruction: Complications and Efficacy.

INTRODUCTION: Ongoing recognition of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and its link with textured devices has brought a paradigm shift in prosthetic-based breast reconstruction. Many institutions no longer offer textured expansion devices for staged reconstruction. However, there is a paucity of data regarding the efficacy of smooth tissue expanders (TE). We hypothesized that the time to final reconstruction and complication profile between smooth and textured TEs would be similar in breast reconstruction patients. METHODS: A retrospective chart review was performed of all patients who underwent TE breast reconstruction during a 6-year period at the Penn State Hershey Medical Center. Rates of complications treated nonoperatively and those requiring reoperation were assessed. Mechanical complications, including expander malposition and rupture, were evaluated. Time to final breast reconstruction was quantified. Mixed-effects logistic regression and linear regression models, as appropriate, were used to compare textured to smooth TEs. Patient characteristics and anatomic plane placement were adjusted for in all analyses of outcomes. RESULTS: Data were collected on 389 patients, encompassing 140 smooth and 604 textured TEs. Textured devices had an increased incidence of complications treated nonsurgically (16.7% vs 10.7%; P = 0.14). However, smooth TEs had an increased incidence of reoperation (12.1% vs 7.6%; P = 0.06). Most noteworthy was that although smooth TEs had a 40-fold increase in malposition (13.6% vs 0.3%; P < 0.001), no reoperation for this complication was warranted. Further, the time to final reconstruction was comparable between the 2 devices (textured expanders: 221 days and smooth expanders: 234 days; P = 0.15). CONCLUSIONS: Staged, implant-based reconstruction is the most common surgical approach to recreate the breast mound following mastectomy. Textured TEs were the cornerstone to this approach. Unfortunately, the association between textured devices and BIA-ALCL now mandates an alternative. We postulated that smooth expanders would compare favorably for breast reconstruction. Although our study suggests that smooth TEs suffer more malposition, this has a negligible impact on the reconstructive timeline. Thus, smooth TEs may prove beneficial when considering the risk of BIA-ALCL associated with textured devices.

[Silicone breast implants: the importance of nuanced reporting]. / Siliconen borstimplantaten.

Silicone breast implants (SBIs) are frequently discussed in the media. Reporting on this topic is commonly characterised by sensationalism and a lack of nuance. SBIs have been linked to autoimmune disease and the controversial disease entity 'breast implant illness'. However, convincing evidence for this association is lacking because nearly all studies examining this association suffer from methodological weaknesses. Among the well-described long-term adverse effects of SBIs are implant ruptures, capsular contractures and the exceptionally rare breast implant-associated large cell lymphoma of the breast (BIA-ALCL). SBIs contribute significantly to the quality of life of many breast cancer patients and women with cosmetic implants. Any potential adverse effect of SBIs must therefore always be carefully weighed against the benefits of SBI-based procedures. In this consideration, evidence based on sound methodology is of vital importance. Oversimplified reporting based on deficient research leads to undue alarm among women with breast implants.

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

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 3rd World Consensus Conference on BIA-ALCL. OBJECTIVES: The authors sought 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 with 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 employing the Delphi process, gathering 18 experts panelists and utilizing 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 employed to accept, reject, or revise each statement. RESULTS: The literature search initially yielded 764 manuscripts, of which 405 were discarded. From the remaining 359, only 218 were included in the review and utilized to prepare 36 statements subdivided into 5 sections. After 1 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.