Breast Implant-associated Anaplastic Large Cell Lymphoma Research Articles

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, bothin vitroandin 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.

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

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). 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. 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. 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%.

CD30 Lateral Flow and Enzyme-Linked Immunosorbent Assays for Detection of BIA-ALCL: A Pilot Study

Introduction: Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) commonly presents as a peri-implant effusion (seroma). CD30 (TNFRSF8) is a consistent marker of tumor cells but also can be expressed by activated lymphocytes in benign seromas. Diagnosis of BIA-ALCL currently includes cytology and detection of CD30 by immunohistochemistry or flow cytometry, but these studies require specialized equipment and pathologists’ interpretation. We hypothesized that a CD30 lateral flow assay (LFA) could provide a less costly rapid test for soluble CD30 that eventually could be used by non-specialized personnel for point-of-care diagnosis of BIA-ALCL. Methods: We performed LFA for CD30 and enzyme-linked immunosorbent assay (ELISA) for 15 patients with pathologically confirmed BIA-ALCL and 10 patients with benign seromas. To determine the dynamic range of CD30 detection by LFA, we added recombinant CD30 protein to universal buffer at seven different concentrations ranging from 125 pg/mL to 10,000 pg/mL. We then performed LFA for CD30 on cryopreserved seromas of 10 patients with pathologically confirmed BIA-ALCL and 10 patients with benign seromas. Results: Recombinant CD30 protein added to universal buffer produced a distinct test line at concentrations higher than 1000 pg/mL and faint test lines at 250–500 pg/mL. LFA produced a positive test line for all BIA-ALCL seromas undiluted and for 8 of 10 malignant seromas at 1:10 dilution, whereas 3 of 10 benign seromas were positive undiluted but all were negative at 1:10 dilution. Undiluted CD30 LFA had a sensitivity of 100.00%, specificity of 70.00%, positive predictive value of 76.92%, and negative predictive value of 100.00% for BIA-ALCL. When specimens were diluted 1:10, sensitivity was reduced to 80.00% but specificity and positive predictive values increased to 100.00%, while negative predictive value was reduced to 88.33%. When measured by ELISA, CD30 was below 1200 pg/mL in each of six benign seromas, whereas seven BIA-ALCL seromas contained CD30 levels > 2300 pg/mL, in all but one case calculated from dilutions of 1:10 or 1:50. Conclusions: BIA-ALCL seromas can be distinguished from benign seromas by CD30 ELISA and LFA, but LFA requires less time (<20 min) and can be performed without special equipment by non-specialized personnel, suggesting future point-of-care testing for BIA-ALCL may be feasible.

Huge Fibrin Accumulation after Augmentation mammoplasty with similar clinical features Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

Huge Fibrin Accumulation after Augmentation mammoplasty with similar clinical features Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

Smooth vs Textured Expanders: Patient Factors and Anatomic Plane Are Greater Factors in Determining First-Stage Breast Reconstruction Outcomes.

Textured implants and expanders are associated with an increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). As a result, plastic surgeons are utilizing smooth expanders, but many perceive these produce undesirable outcomes including infection, seroma, and lateral displacement. The aim of this study was to compare clinical outcomes of smooth and textured expanders. Breast reconstruction patients from January 2018 to May 2021 were retrospectively reviewed. Included patients underwent placement of tissue expanders at the time of mastectomy. Primary outcomes included postoperative seroma, infection, malposition, days to final reconstruction, explantation, and the need for capsulorrhaphy. In total, 233 patients were reviewed, of whom 167 met both inclusion and exclusion criteria. There was no statistically significant difference in poor outcomes comparing smooth and textured expanders. Days to final reconstruction was lower with smooth expanders per breast (P = .0424). The subpectoral group was associated with an increased likelihood of undergoing capsulorrhaphy (P = .004). Prepectoral placement was associated with more seromas (P = .0176) and infections (P = .0245). Demographic factors included older age as a protective factor for undergoing capsulorrhaphy (odds ratio [OR] = 0.962, P = .038), obesity increased the risk of infection (OR = 5.683, P = .0279) and malposition (OR = 6.208, P = .0222), and radiation was associated with malposition (OR = 3.408, P = .0246). There was no significant difference in poor outcomes between smooth and textured expanders. Patient demographics and anatomical plane placement had greater effects on infection, seroma, and the need for capsulorrhaphy compared with tissue expander texturing.

Breast Implant-Associated Anaplastic Large-Cell Lymphoma: Finding Fault Comes Full Circle.

Breast Implant-Associated Anaplastic Large-Cell Lymphoma: Finding Fault Comes Full Circle.

PI3K/AKT inhibitor BEZ-235 targets CCND2 and induces G1 arrest in breast implant-associated anaplastic large cell lymphoma

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a mature, CD30-positive T-cell lymphoma lacking expression of the anaplastic lymphoma kinase (ALK). In contrast to ALK-positive ALCL, BIA-ALCL cells express cyclin D2 (CCND2) which controls cyclin dependent kinases 4 and 6 (CDK4/6). DNA methylation and expression analyses performed with cell lines and primary cells suggest that the expression of CCND2 in BIA-ALCL cell lines conforms to the physiological status of differentiated T-cells, and that it is not the consequence of genomic alterations as observed in other hematopoietic tumors. Using cell line model systems we show that treatment with the CDK4/6 inhibitor palbociclib effects dephosphorylation of the retinoblastoma protein (RB) and causes cell cycle arrest in G1 in BIA-ALCL. Moreover, we show that the PI3K/AKT inhibitor BEZ-235 induces dephosphorylation of the mTORC1 target S6 and of GSK3β, indicators for translational inhibition and proteasomal degradation. Consequently, CCND2 protein levels declined after stimulation with BEZ-235, RB was dephosphorylated and the cell cycle was arrested in G1. Taken together, our data imply potential application of CDK4/6 inhibitors and PI3K/AKT inhibitors for the therapy of BIA-ALCL.

Replacement of Shaped Textured Implants with Round Smooth Implants in Breast Reconstruction: Long-Term Outcomes.

The number of patients undergoing exchange of textured implants for smooth devices has greatly increased because of concern over breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL). The authors examined long-term patient- and surgeon-reported outcomes in terms of aesthetics, comfort, and complications. Patients who underwent reconstruction with shaped, textured implants replaced with round, smooth implants between 1994 and 2022 and who had a minimum follow-up of 1 year were included. Patient-reported outcomes were collected using the BREAST-Q Reconstruction module and a survey evaluating aesthetics and comfort. Surgeon-reported outcomes included evaluation of aesthetics and capsular contracture. A total of 530 patients were reviewed, and 307 patients were included. Pairwise comparison of BREAST-Q data demonstrated that psychosocial well-being (72.68 to 76.45; P = 0.0075) and physical well-being (78.79 to 81.88; P = 0.0078) increased significantly. Overall breast satisfaction (61.94 to 67.27; P = 0.0082) and sexual well-being (53.89 to 57.98; P = 0.0002) were also significantly higher in parallel with a clinically meaningful increase in BREAST-Q score of 5.33 and 4.09 points, respectively. Most patients felt they appeared better (56.4%) or similar (27.3%) and were more comfortable (54.4%) or similar (39.4%) after the exchange procedure. The senior surgeon (P.G.C.) rated 40.1% of patients as having a better aesthetic grade after replacement and 50.3% as the same; 36.8% of patients were rated as having a decrease in Baker capsular contracture grade; 2.9% of patients experienced a perioperative complication; and there were no reconstructive failures. Exchange of textured to smooth implants is safe, does not sacrifice aesthetic outcome, and provides a more comfortable and satisfactory outcome for patients with minimal complications. Therapeutic, IV.

Cavity-based lymphomas: challenges and novel concepts. A report of the 2022 EA4HP/SH lymphoma workshop

The 2022 European Association for Haematopathology/Society for Hematopathology lymphoma workshop session on cavity-based lymphomas included sixty-eight cases in seven sections. The disease entities discussed include primary effusion lymphomas (PEL), extracavitary primary effusion lymphomas and confounding entities (ECPEL), HHV8-negative B-lineage lymphomas-effusion based (EBV-negative, EBV-positive, and plasmablastic types), diffuse large B-cell lymphoma associated with chronic inflammation, fibrin-associated diffuse large B-cell lymphoma (FA-DLBCL), breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and other lymphomas presenting as an effusion. All entities above are discussed; however, three are delved into greater detail given the challenges with classification: ECPEL, HHV8-negative effusion-based lymphomas, and FA-DLBCL. Cases exemplifying the diagnostic difficulty in differentiating ECPEL from HHV8-positive diffuse large B-cell lymphoma and germinotropic lymphoproliferative disorder were discussed. The more recently recognized effusion-based HHV8-negative large B-cell lymphoma is explored, with several cases submitted raising the question if this subset should be carved out as a specific entity, and if so, what should be the refining diagnostic criteria. Case submissions to the FA-DLBCL section yielded one of the largest case series to date, including classic cases, cases furthering the discussion on disease sites and prognosis, as well as novel concepts to be considered in this entity. The 2022 EA4HP/SH workshop cases allowed for further confirmation of the characteristics of some of the more historically accepted cavity-based lymphomas, as well as further inquiry and debate on relatively new or evolving entities.

Surgical Management of Textured Breast Implants: Assessing Risk and Analyzing Patient-Reported Outcomes.

Textured implants have been linked to breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL). Patients who undergo explantation have options for reconstruction, but data on safety and patient-reported outcomes (PROs) are limited. The purpose of this study was to classify complications and PROs in patients opting for surgical management of textured implants. Complication rates and BREAST-Q scores were compared between (1) asymptomatic patients who underwent conversion from textured to smooth implants ( n = 224), (2) symptomatic patients who underwent conversion from textured to smooth implants ( n = 83), (3) patients who underwent explantation without replacement ( n = 44), and (4) patients who underwent replacement with autologous reconstruction ( n = 33). Linear regression examined PROs controlling for clinical and surgical variables. Overall complication rates in 384 patients (637 implants) differed across groups ( P = 0.034), with the highest rate (25%) in patients who underwent explantation without replacement. These patients were specifically more impacted by minor complications, notably seroma. Capsulectomy extent did not significantly impact complications. Asymptomatic and symptomatic smooth implant patients had improvements in Satisfaction with Breasts ( P < 0.05). Autologous reconstruction patients had significant improvements in Satisfaction with Breasts sustained after 3 months postoperatively ( P < 0.01) and Sexual Well-being sustained after 6-months postoperatively ( P < 0.05). Patients who underwent removal without replacement had lower Physical Well-being of the Chest scores at 1 year or more than the other groups. Replacement of textured implants with smooth implants or flaps is safe and is associated with improved satisfaction with breasts and quality of life. The degree of capsulectomy does not appear to impact the incidence of perioperative complications. Therapeutic, III.

Oncological Outcomes After Multidisciplinary Management of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an uncommon type of non-Hodgkin lymphoma, associated with breast implant capsules. Despite improvements in our understanding of BIA-ALCL, communicating the prognosis to patients remains challenging due to limited long-term follow-up data. This has important implications for decision-making, including recommendations for subsequent reconstructive procedures. The aim of this study was to assess the longer-term oncological outcomes of patients receiving multidisciplinary treatment for BIA-ALCL. This was a retrospective cohort study of BIA-ALCL patients treated at a tertiary referral unit. The data are presented using simple descriptive statistics. Between 2015 and 2022, 18 BIA-ALCL patients were treated at our institution. The median age at diagnosis was 48.5 (IQR 41-55) years. Ten patients developed BIA-ALCL after cosmetic breast augmentation, and 8 after breast reconstruction following mastectomy for cancer. All patients had a history of textured implant insertion. The median time from first implant surgery to diagnosis was 8.5 (IQR 7-12) years. All patients underwent en-bloc total capsulectomy with implant removal, and 2 received systemic therapy. Fifteen patients had Stage I (IA-IC) disease, 2 had Stage IIA and 1 Stage III BIA-ALCL, based on the TNM classification system. At a median follow-up of 45 (IQR 15-71) months, there were no episodes of local or systemic relapse or death. Surgical management for BIA-ALCL is sufficient in early-stage disease, and associated with excellent oncological outcomes. This information is reassuring for patients when discussing recurrence risk.

The evaluation of the delayed swollen breast in patients with a history of breast implants.

Breast implants, whether placed for reconstructive or cosmetic purposes, are rarely lifetime devices. Rupture, resulting from compromised implant shell integrity, and capsular contracture caused by constriction of the specialized scar tissue that normally forms around breast implants, have long been recognized, and remain the leading causes of implant failure. It is apparent, however, that women with breast implants may also experience delayed breast swelling due to a range of etiologic factors. While a majority of delayed seromas associated with breast implants have a benign etiology, this presentation cannot be ignored without an adequate workup as malignancies such as breast implant associated anaplastic large cell lymphoma (BIA-ALCL), breast implant associated diffuse large B-cell lymphoma (BIA-DLBCL), and breast implant associated squamous cell carcinoma (BIA-SCC) can have a similar clinical presentation. Since these malignancies occur with sufficient frequency, and with sometimes lethal consequences, their existence must be recognized, and an appropriate diagnostic approach implemented. A multidisciplinary team that involves a plastic surgeon, radiologist, pathologist, and, as required, surgical and medical oncologists can expedite judicious care. Herein we review and further characterize conditions that can lead to delayed swelling around breast implants.

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

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. 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. 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. 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. Risk, IV.

Establishment and characterization of a novel breast implant-associated anaplastic large cell lymphoma cell line and PDX model (BIA-XR1) with a unique KRAS mutation

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an uncommon T-cell lymphoma type with distinct clinical, molecular and genetic features. Establishment of BIA-ALCL cell lines and patient-derived xenograft (PDX) models are essential experimental tools to investigate the molecular pathogenesis of the disease. We characterized a novel BIA-ALCL cell line and PDX model, named BIA-XR1, derived from a patient with textured breast implant who developed lymphoma. Next-generation sequencing revealed a STAT3 mutation, commonly detected in BIA-ALCL, and a unique KRAS mutation reported for the first time in this lymphoma type. Both JAK/STAT3 and RAS/MEK/ERK oncogenic pathways were activated in BIA-XR1, which are targetable with clinically available agents.

BIA-ALCL Epidemiology in an Aesthetic Breast Surgery Cohort of 1,501 Patients.

Epidemiologic studies on Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) currently estimate the risk between 1:300 and 1:30,000, assessed mainly in large breast reconstruction populations. Aims of the study was to assess BIA-ALCL epidemiology in a cohort of patients who have received textured implants for cosmetic indications. In a prospective cohort observational study, 1,501 patients who received a cosmetic breast augmentation, between 2006 and 2016, were monitored recording any implant-related complication, including BIA-ALCL. Cross-checking clinical, pathology and external records data was used to identify cases. Prevalence, Implant-Specific Prevalence (I-SP), Incidence Rate (IR), Event Free Time (EFT) and Kaplan Meier survival estimate were calculated. All but 2 patients received macrotextured or microtextured devices bilaterally. Mean follow-up was 3.2 years (1 months to 16.4 years). Five BIA-ALCL cases were investigated, prevalence was 1:300 patients, I-SP was 6.9 cases/1000 individuals/BIOCELL and 1.3 cases/1000 individuals/Siltex devices, IR was 1.07 cases/1,000 women/year. Mean (SD) EFT was of 9.2 years. When using a denominator based on a cohort of cosmetic patients, BIA-ALCL occurrence is higher than previously reported, particularly with macrotextured devices. Given the similar IR between reconstructive and cosmetic cohorts, their even distribution can be consequent to underreporting due to poorer follow up and lower awareness in the latter group. The genetic predisposition in oncologic cohort reasonably affects the early onset more than the IR. Importance of accurate follow-up is confirmed. Stratification risks analysis can guide surgeons during patient's counseling in the decision for prophylactic explantation.

Use of High-Resolution Ultrasound in Characterizing the Surface Topography of a Breast Implant.

Background and Objectives: With the emergence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), it has become necessary to identify the implant shell type patients have received. Therefore, an immediate, reliable method for identifying a breast implant shell type is essential. Evidence-based research and applying a real-world technique that identifies the surface topographic information of the inserted breast implants, without surgery, has become of paramount importance for breast implant physicians. Methods and Materials: A review of the medical records of 1901 patients who received 3802 breast implants and subsequently received an ultrasound-assisted examination was performed. All patients received not only a breast cancer examination but also a high-resolution ultrasonography (HRUS) assisted examination of the device at a single center between 31 August 2017 and 31 December 2022. Results: Most patients had breast implants within 10 years (77.7%) of the examination. Of the 3802 implants screened, 2034 (53.5%) were identified with macro-textured shell topography in ultrasonography. A macrotextured shell type implant was used in 53.5% of cases and a smooth type in 42.7% of cases. Seventy-three (1.9%) breast implant shell types could not be identified due to ruptures. However, 250 breast implant shell types could be identified despite rupture cases (6.5%). Conclusions: HRUS was found to be a useful and reliable image modality for identifying various surface shell types of breast implants. The shell type information would be helpful to patients who lack information about their breast implants and are concerned about BIA-ALCL.

BRCA1/2 MUTATIONS IMPACT ON THE DEVELOPMENT OF BREAST IMPLANT‐ASSOCIATED LYMPHOMA (BIA‐ALCL) IN WOMEN WITH BREAST CANCER RECONSTRUCTED WITH TEXTURED BREAST IMPLANTS

Introduction: Breast Implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a subtype of T-cell lymphoma arising as a seroma and/or mass in relation to the capsule of textured breast implants. Previous research in a Dutch population suggests a higher-than-expected prevalence of BRCA1/2 carriers in women with BIA-ALCL. Here we analyze the risk of BIA-ALCL occurrence related to BRCA in a large population of women with implants followed long term after breast cancer (BC) mastectomy. Methods: We compared the prevalence of BRCA1/2 pathogenic variants (pv) between women from a large cohort of BC patients treated at Memorial Sloan Kettering Cancer Center (MSKCC) who did and did not develop BIA-ALCL after reconstruction with textured implants. Hazard ratios (HRs) of developing BIA-ALCL were estimated using Cox regression. To best control for age at BC diagnosis and length of follow up, we conducted a nested case-control within the cohort, matching 1:3, analyzed with conditional logistic regression. Results: Among 3312 women with BC assessed for pv in the context of MSK-IMPACT tumor and normal study at MSKCC the prevalence of BRCA mutations was 5.3%. Among 526 patients with textured implants post BC mastectomy, followed long term at MSKCC (median FU 82 mo, range 12, 316) and clinically assessed for BRCA1/2, the prevalence of pv of BRCA1/2 was 7.8%. Of 31 BIA-ALCL post-BC cases seen at MSKCC, 16 received capsulectomy at MSKCC and 5/13 (38.4%) were BRCA1–2 positive. Within the cohort of 526 patients with BC tested for BRCA, reconstructed with textured implants and followed long-term, the age-adjusted rate of developing BIA-ALCL for women with BRCA mutations was 11.0 times the rate of BIA-ALCL among women without BRCA (HR 95% CI 3.6, 33.9, p < .0001). Carrying bilateral versus unilateral implants (HR 6.9, 95% CI 0.9, 53.2), prior chemotherapy exposure (HR 0.7, 95% CI 0.2, 2.05), prior radiation therapy exposure (HR 0.5, 95% CI 0.1, 2.5) were not significantly associated with the rate of BIA-ALCL. Within this cohort, 13 BIA-ALCL cases were matched 1:3 with 39 controls. Median ages at BC mastectomy were 47.2 (37, 66) and 46.8 (35, 65) in cases and controls, respectively. The median time between reconstruction for BC and BIA-ALCL was 130 (80, 190) months. The odds ratio of BIA-ALCL associated with carriership of a BRCA1/2 pathogenic variant was 12.4 (Wald 95% CI 1.4, 109.5 p = 0.0074). Conclusions: In this study, we define the role of BRCA1/2 mutations as a significant risk factor in the development of BIA-ALCL in patients with BC reconstructed with textured implants. These results will help decision making for women with BRCA1/2 mutations undergoing breast reconstruction, or with textured implants in place. Analysis of pathogenic variants in other DNA repair genes in this cohort potentially affecting lymphomagenesis is ongoing. The research was funded by: NIH R03 grant number R03CA267435 Keywords: aggressive T-cell non-Hodgkin lymphoma, prevention and cancer interception No conflicts of interests pertinent to the abstract.

OPTIMISING HOLISTIC CARE OF WOMEN AT RISK OF OR LIVING WITH BIA‐ALCL: A SURVEY OF UK HEALTH CARE PROFESSIONALS

Introduction: Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) was classified by the World Health Organisation in 2016. As of December 2021 there have been 86 reported cases within the UK. Raising awareness amongst clinicians of this novel entity is crucial in order to provide effective clinical care. Psycho-social support forms a vital arm of care, both for affected women but also for the now millions at risk or those considering new implants. This survey aims to assess the current awareness and experiences of health care providers potentially involved in the care of patients with BIA-ALCL with a particular focus on psycho-social support requirements. Methods: We performed an online survey using categorical and open-ended questions. The questionnaire was distributed amongst professional associations that have an interest in the topic researched, e.g., The Association of Breast Surgeons (ABS), British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS). In addition the survey was distributed amongst multidisciplinary teams that are likely to encounter these patients, e.g. Breast and Lymphoma. The survey was designed in Qualtrics and sent via a link. Data has been collated and analysed within SPSS. Research approval was obtained from Leeds Beckett University. Results: There were a total of 78 respondents who completed the survey. Breast surgeons made up the largest proportion of respondents (36%, 28/78) with over half of respondents having cared for a patient with BIA-ALCL (58% 42/78). The largest proportion of respondents reporting using ABS/BAPRAS joint guidelines in their clinical practice (46%, 36/78). High median confidence scores were reported in both diagnosing/managing, 7/10 (3) and having conversations with patients regarding BIA-ALCL, 7/10 (5) although a large range in responses was noted. The most frequently selected test to work up a case of suspected BIA-ALCL was ‘core biopsy of any associated peri-implant mass’ (82%, 64/78) with mammography the least selected (42%, 33/78). 45% (35/78) reported seeing women requesting reassurance or implant removal despite an absence of symptoms or signs of BIA-ALCL. The average degree of distress upon receiving a diagnosis was reported as 7/10 (2). 70% (54/77) of respondents felt patients diagnosed with BIA-ALCL or those awaiting test results would benefit from psychological support. Only 38 (29/76) % of respondents however, confirmed that breast implant patients have access to any psychological support as part of routine care. Conclusion: This survey demonstrates that although there is relatively high confidence in managing and conducting discussions with patients regarding BIA-ALCL, there is a large variability amongst healthcare providers. The findings suggest there is urgent need for psycho-social support for both patients diagnosed with BIA-ALCL and asymptomatic women seeking reassurance. Keyword: Aggressive T-cell non-Hodgkin lymphoma Conflicts of interests pertinent to the abstract D. Cunningham Consultant or advisory role Ovibio on scientific advisory board Research funding: Medimmune/AZ, Clovis, Eli Lilly, 4SC, Bayer, Celgene, Roche - institution recipient

Impact of Tissue Expander Surface Texture on Two-Stage Breast Reconstruction Outcomes: A Combined Analysis.

With ongoing investigations of the impact of device texturing on breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL), studies have begun comparing complication profiles of tissue expanders. However, there is a paucity of timing and severity data of complications. The aim of this study was to provide a comparative survival analysis of postoperative complications between smooth (STEs) and textured tissue expanders (TTEs) in breast reconstruction. A single-institution experience with tissue expander breast reconstruction was reviewed for complications up to 1 year after second-stage reconstruction from 2014 to 2020. Demographics, comorbidities, operation-related variables, and complications were evaluated. Kaplan-Meier curves, Cox proportional hazard models, and a consensus-based ordinal logistic regression model were used to compare complication profiles. Of 919 total patients, 600 (65.3%) received TTEs and 319 (34.7%) received STEs. There was increased risk of infection ( P < 0.0001), seroma ( P = 0.046), expander malposition ( P < 0.0001), and wound dehiscence ( P = 0.019) in STEs compared with TTEs. However, there was also a decreased risk of capsular contracture ( P = 0.005) in STEs compared with TTEs. Failure of breast reconstruction ( P < 0.001) and wound dehiscence ( P = 0.018) occurred significantly earlier in STEs compared with TTEs. Predictors for significantly higher severity complications included the following: smooth tissue expander use ( P = 0.007), shorter time to complication ( P < 0.0001), higher body mass index ( P = 0.005), smoking history ( P = 0.025), and nipple-sparing mastectomy ( P = 0.012). Differences in the timing and severity of complications contribute to the safety profiles of tissue expanders. STEs are associated with increased odds of higher severity and earlier complications. Therefore, tissue expander selection may depend on underlying risk factors and severity predictors. Therapeutic, III.

Textured vs. Smooth Breast Implants Using the Jones Criteria-What Is the Currently Available Evidence for BIA-ALCL?: A Systematic Review.

A literature search in PubMed in April 2023 and the article reference list of the French National Agency of Medicine and Health Products decision from 2019 were screened for applicable studies. Only clinical studies where the Jones surface classification could be applied (required information: breast implant manufacturer) for comparison of smooth and textured breast implants were considered. From a total of 224 studies, no articles were included due to the lack of fit to the strict inclusion criteria. Based on the scanned and included literature, implant surface types in relation to the incidence of BIA-ALCL were not evaluated in clinical studies and data from evidence-based clinical sources plays a minor to no role in this context. An international database that combines breast implant-related data from (national, opt-out) medical device registries is, therefore, the best available option to obtain relevant long-term breast implant surveillance data on BIA-ALCL.