Textured Breast Implants Research Articles

Breast implant-associated anaplastic large cell lymphoma.

Breast implant-associated anaplastic large cell lymphoma is a subtype of non-Hodgkin's lymphoma that can occur around the surface of textured breast implants or in patients who have previously had textured breast implants. The condition should be suspected in cases of late-onset breast asymmetry and seroma formation around a breast implant. If the implant and surrounding connective tissue capsule is removed, the prognosis is usually very good. The purpose of this clinical review article is to provide a brief overview of the diagnosis and treatment of breast implant-associated anaplastic large cell lymphoma.

Breast implant-associated anaplastic large cell lymphoma in Romania: First case series of all documented cases

SummaryBreast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an uncommon malignancy linked to textured breast implants by moderate evidence in 2021. Documenting Romanian cases provides valuable insights into epidemiology, management, and outcomes, enhancing global understanding and informing clinical practices. Our objectives were to analyze BIA-ALCL cases in Romania, focusing on patient demographics, implant characteristics, clinical presentation, diagnostic methods, treatment, and outcomes.We conducted a retrospective review of all known BIA-ALCL cases in Romania, examining patient demographics, implant details, clinical presentation, diagnostic methods, and outcomes. Data sources included medical records, surgical reports, follow-up data, and implant characteristics like shape, texture, and manufacturer.The mean age at diagnosis was 44.4 years. All patients had textured implants and no replacements, 4 with aesthetic indication and 1 reconstruction. The mean time from implantation to diagnosis was 7.2 years. Clinical presentations were primarily late seromas, diagnosed through fine needle aspiration and immunohistochemistry. Treatments involved multidisciplinary teams, with bilateral en-bloc explantation and adjuvant therapies in two cases. One patient had immediate reconstruction with smooth implants and Acellular Dermal Matrix. No disease recurrence was observed post-treatment.The low BIA-ALCL prevalence in Romania estimated at 1:44,500 compared to the mean of 1:13,745 in Europe indicates the need for an increased awareness and tracking. Establishing mandatory national implant registries, pathology databases, and enhancing physician and patient education will help identify potential cases. All cases involved textured implants, highlighting the need for ongoing research to identify risk factors and guide surgeons consulting patients with these implants.

A comparison of textured vs smooth surfaced implants in sub fascial breast augmentation.

Subfascial placement of breast implants has the advantages of subglandular and submuscular placement without the adverse outcomes. This study examined the differences in outcomes between textured and smooth implants. A total of 385 patients underwent subfascial breast augmentation in two cohorts. The initial series (n=209) employed textured implants and the second (n=176) employed smooth implants. In all other respects, patient management was identical. Adverse outcomes, changes in breast morphometry, and patient satisfaction were compared between the two groups. The follow-up period ranged from to 74-272 weeks for smooth implants (mean 164 weeks, STD 50.6) and 78-279 weeks for textured implants (mean= 186 weeks, STD=54). The incidence of capsular contracture was the same for smooth and textured implants (4.7% and 6.2%, P=.64). Changes in breast shape at the lower pole, patient satisfaction, and the incidence of other adverse outcomes were the same in both groups. Subfascial placement of smooth and textured breast implants yielded similar outcomes.

The Risk of Breast Implant-Associated Anaplastic Large Cell Lymphoma; A Systematic Review and Meta-Analysis

Abstract Background Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an emerging disorder that has gained global attention throughout the past era. The present meta-analysis was performed to retrieve the risk of BIA-ALCL from population-based epidemiological studies. Factors associated with BIA-ALCL were evaluated to identify patients at higher risk of BIA-ALCL. Methods A systematic literature search was executed throughout 12 databases. All epidemiological studies encompassing patients with breast implants either for aesthetic or reconstructive purposes and reported the risk of BIA-ALCL were included. Studies reported the risk factors of BIA-ALCL were included. Results The present meta-analysis included 17 articles, encompassing 525,475 patients with breast implants. There were 254 patients with BIA-ALCL with a mean duration to the diagnosis of BIA-ALCL of 13.16 years (95% CI 11.7–14.6, P < 0.001). There were 44 patients with textured breast implants and two with smooth implants. Patients with breast implants were 28.86 times more at high risk of BI-ALCL (95% CI 3.123–266.681). The risk ranged from 0 to 1 per 1000 cases with breast implants, with a similar risk among patients seeking aesthetic and reconstructive surgeries. The risk was 0 to 1 case per 1000 cases among patients with textured breast implants. There was a significant association between the history of breast cancer and BIA-ALCL (P = 0.0016). Conclusion This meta-analysis confirmed the association between breast implants and ALCL. There was a similar risk of BIA-ALCL among patients with aesthetic or reconstructive surgeries. Patients with a history of breast cancer were at higher risk of BIA-ALCL. Level of Evidence III This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Patient factors associated with cancer worry post-breast reconstruction: A cross-sectional study

PurposeThe BREAST-Q Breast Cancer module is a patient-reported outcome measure for women with breast cancer diagnosis. Our research team developed and validated a novel BREAST-Q scale for this module that measures quality of life outcomes specific to cancer worry. The aim of this study was to investigate patient related breast reconstruction factors that are associated with worse scores on the new BREAST-Q Cancer Worry Scale. MethodsWomen with a history of breast cancer treated with mastectomy and reconstruction, aged ≥18 years, and English-speaking were recruited through the Love Research Army between October and November 2019. Participants completed demographic and clinical questions alongside the BREAST-Q Cancer Worry Scale. Univariable and multivariable regression analyses were used to identify participant characteristics associated with cancer worry scores. ResultsAmong the 554 potential respondents, 538 (97.1%) completed the Cancer Worry Scale. The average patient age was 58.4 (+9.8) years. Cancer Worry scores were normally distributed with a mean of 46.4 (+17.2). Cancer Worry scores were significantly associated (p < 0.01) with younger age, history of radiation therapy, complications associated with breast surgery since diagnosis, use of textured breast implants, and shorter duration since surgery. ConclusionsThis exploratory analysis provides evidence of patient characteristics that may be associated with cancer worry following postmastectomy breast reconstruction.

Biocompatibility of polyurethane-coated breast implants: A histological comparison of implant capsules.

Biocompatibility describes the influence of materials on their biological environment. Implant material in the human body can cause a foreign body reaction and the formation of a capsule around the foreign material. Since capsular formation is the most frequent issue after breast-implant insertion, knowledge and awareness of biocompatibility is crucial, especially since worldwide, breast augmentation continues to be the most popular plastic surgery, with over 1.6 million procedures performed in 2020, according to surveys by the International Society of Aesthetic Plastic Surgery (ISAPS). This study includes 80 capsular samples of female patients who underwent revision surgery after breast-implant insertion at the University Hospital Regensburg. Capsules of breast implants with different surface structures (smooth, textured and polyurethane-coated) and shapes (round-shaped, anatomically-shaped) were analyzed histologically after hematoxylin-eosin-staining in respect to capsular thickness and layer formation. Capsular thickness and layering showed a statistically significant difference between polyurethane-coated and smooth as well as polyurethane-coated and textured implants. Capsules around polyurethane-coated implants presented greater thickness. However, the difference between smooth and textured implants was not statistically significant. Furthermore, the shape of the implants also indicated a statistically significant difference in capsular thickness. Implants of anatomical shape resulted in a thinner capsule than round-shaped breast-implants. In conclusion, this study demonstrated a thicker capsule around polyurethane-coated breast implants and no difference in capsular thickness between smooth and textured breast implants. Anatomically shaped breast-implants presented a thinner capsule than round shaped breast-implants.

Incidental Bystander or Essential Culprit: A Systematic Review of Bacterial Significance in the Pathogenesis of Breast Implant-Associated Anaplastic Large Cell Lymphoma.

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a distinct subtype of T-cell non-Hodgkin lymphoma that arises in the context of prolonged exposure to textured breast implants. The intent of this manuscript is to explore whether the bacterial presence in biofilms on these implants is a mere incidental finding or plays a pivotal role in the pathogenesis of BIA-ALCL. Our goal is to delineate the extent of bacterial involvement, offering insights into potential underlying mechanisms, and establishing future research priorities aimed at resolving the remaining uncertainties surrounding this complex association. A comprehensive systematic review of several databases was performed. The search strategy was designed and conducted by an experienced librarian using controlled vocabulary with keywords. The electronic search identified 442 publications. After evaluation, six studies from 2015 to 2021 were included, encompassing 201 female patients aged 23 to 75. The diagnosis span post-implantation ranged from 53 to 135.6 months. Studies consistently found bacteria near breast implants in both BIA-ALCL cases and controls, with varied microbial findings. Both BIA-ALCL cases and controls exhibited the presence of specific bacteria, including Pseudomonas aeruginosa, Klebsiella oxytoca, Staphylococcus aureus, and Ralstonia spp., without any statistically significant differences between groups. The use of antiseptic and antimicrobial agents during implant insertion did not demonstrate any impact on reducing or altering the risk of developing BIA-ALCL. Our systematic review reveals that the current evidence is inadequate to link bacterial etiology as a central factor in the development of BIA-ALCL. The limitations in the existing data prevent a complete dismissal of the role of biofilms in its pathogenesis. The observed gap in knowledge underscores the need for more focused and comprehensive research, which should be structured in a multi-faceted approach. Initially, this involves the utilization of sophisticated genomic and proteomic methods. Following this, it is crucial to delve into the study of immunological reactions specifically induced by biofilms. Finally, this research should incorporate extended observational studies, meticulously tracking the evolution of biofilm development and its correlation with the emergence of BIA-ALCL. In light of the inconclusive nature of current findings, further investigation is not only justified but urgently needed to clarify these unresolved issues.

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%.

CARD9-Mediated Macrophage Responses and Collagen Fiber Capsule Formation Caused by Textured Breast Implants.

An increasing number of women are undergoing breast implantation for cosmetic purposes or for reconstructive purposes after breast excision. The surface morphology of the breast implant is a key factor associated with the induction of capsule contraction. The effect of surface morphology on the inflammatory response after implant insertion remains unclear, however. The authors conducted comparative analyses to determine the effect of the textured and smooth surface morphology of silicone sheets. Each type of silicone sheet was inserted into the subcutaneous pocket below the panniculus carnosus in C57BL/6 mice and mice with genetic disruption of CARD9 , Dectin-1 , Dectin-2 , or Mincle . The authors analyzed collagen fiber capsule thickness, histologic findings, and macrophage inflammatory response, including transforming growth factor (TGF)-β synthesis. The authors found that textured surface morphology contributed to the formation of collagen fiber capsules and the accumulation of fibroblasts and myofibroblasts, and was accompanied by the accumulation of TGF-β-expressing macrophages and foreign-body giant cells. CARD9 deficiency attenuated collagen fiber capsule formation, macrophage responses, and TGF-β synthesis, although the responsible C-type lectin receptors remain to be clarified. These results suggest that CARD9 may have a strong impact on silicone sheet morphology through the regulation of macrophage responses. Silicone breast implants have been widely used for postmastectomy and cosmetic augmentation mammaplasty breast reconstruction. The authors sought to elucidate the surface morphology of the breast implant as one of the key factors associated with the formation of collagen fiber capsules. Therapeutic, V.

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.

Breast Implant-Associated Tumors.

In addition to anaplastic large T-cell lymphomas (BIA-ALCL), other implant-related tumors have been described for some years. Squamous cell carcinoma (SSC) and B-cell lymphomas occurred in very rare cases. The unexplained pathogenesis as well as the unclear individual risk profile is an ongoing source of uncertainty for patients and physicians. The pathogenesis of the tumors is still largely not understood. While BIA-ALCL occurs more frequently with textured breast implants, other tumors were also observed with smooth implants and at other implant sites. Multiple potential mechanisms are discussed. It is suspected that the etiology of a chronic inflammatory response and subsequently immunostimulation is multifactorial and appears to play a key role in the malignant transformation. Since there are currently no sufficiently valid data for a specific risk assessment, this must be done with caution. This article presents the incidence, pathogenesis, as well as the level of evidence according to the current state of knowledge, and evaluates and discusses the current literature.

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.

Reviewing the risk of breast cancer recurrence following breast reconstruction.

It is widely accepted that both autologous and alloplastic reconstruction are safe. A recent publication reported a significant association between textured implants and metastatic recurrence of breast cancer. This study aims to assess if the published results are reproducible in our cohort and to review the safety of breast reconstruction. This is a retrospective cohort study of adult patients undergoing mastectomy and either alloplastic or autologous breast reconstruction at a single quaternary hospital. Outcomes include disease free survival (DFS), local and recurrence free survival (LRRFS) and BIA-ALCL. For time to event endpoints, unadjusted and multivariate adjusted hazard ratios (HRs) were estimated using Cox regression, and penalized Cox regression respectively. Four hundred and twenty-six patients of whom 187 underwent autologous reconstruction and 239 underwent alloplastic. There were 43 cancer recurrences (24 alloplastic and 19 autologous) and 14 local regional recurrences (8 alloplastic and 4 autologous). There were 26 deaths and no instances of BIA-ALCL. Median follow-up time was 4.7 years. No evidence of association was found between breast reconstruction method and DFS (HR 0.87 CI: 0.47-1.58). It is uncertain whether implant texture grade was associated with increased breast cancer recurrence (HR 2.17 CI: 0.65-7.52). Both autologous and alloplastic breast reconstruction have been carried out in our cohort and reconstructive modality was not associated with either reduced DFS or LRRFS. The results in this cohort show there is uncertainty between the use of textured breast implants and either local or distant breast cancer recurrence.

EBV-Positive Diffuse Large B-Cell Lymphoma in Association with Polyurethane Textured Breast Implants: Case Report and Literature Overview.

Lymphomas associated with breast implants are mostly of the T-cell type which typically present as a late-onset seroma or palpable mass adjacent to the implant. Primary lymphomas of the breast, in the absence of breast implants, are mostly of the B-cell type. However, we present a case of an Epstein-Barr virus-positive diffuse large B-cell lymphoma in a patient with polyurethane textured implants. A 75-year-old woman presented with a sudden onset of swelling in her right breast. Her medical history revealed a unilateral mastectomy at the age of 48 for an invasive ductal adenocarcinoma in her left breast. Reconstruction was performed using bilateral McGhan style 150 implants. Nine years later, she was diagnosed with Baker IV capsular contracture and bilateral rupture, as seen on magnetic resonance imaging. A complete capsulectomy with implant change (Polytech, Replicon® SL HP) and mastopexy on the right was performed. Given her history and the sudden onset of swelling, the situation was concerning. Ultrasound showed a large mass in contact with the implant and an effusion around it. After mastectomy withexplantation and capsulectomy, she was diagnosed with an Epstein-Barr virus-associated diffuse large B-cell lymphoma (DLBCL) of the capsule in association with textured breast implants. We report the first case of polyurethane textured implant association with the rare entity of EBV+ DLBCL. Our aim is to renew awareness of the clinical significance of late periprosthetic seroma and highlight the need for documenting all cases to advance our understanding of breast implant-associated lymphoma. This journal requires that authors assign a level of evidence to each article. For a full description of these evidence-based medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

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.

D33. Surgical Management of Textured Breast Implants: Assessing Risk and Analyzing Patient-Reported Outcomes

PURPOSE: Textured implants have been linked to breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL). Following explantation, patients have different reconstructive options, however data on safety and patient-reported outcomes (PROs) is limited. We aimed to 1) characterize the safety of surgical interventions for textured implant management and, 2) compare PROs across intervention groups using BREAST-Q scores. METHODS: We retrospectively reviewed patients who sought surgical intervention for textured implants between January 2018 and June 2021 and defined four management cohorts: 1) textured to smooth conversion in asymptomatic patients; 2) textured to smooth conversion in symptomatic patients, 3) explantation without replacement; and 4) textured to autologous conversion. RESULTS: We included 384 patients: 224 in the first cohort, 83 in the second, 44 in the third, and 33 in the fourth. We observed a difference in complication rates between management groups (p = 0.034), with patients undergoing explantation enduring the greatest complication rate, however we found no difference based on extent of capsulectomy. A subgroup PRO analysis, including 239 patients, showed patients converting to smooth implants or to autologous reconstruction had significantly higher satisfaction with their breasts postoperatively (p<0.05). The autologous group also had significantly improved sexual well-being 6 months and 1+ years postoperatively (p=0.005, p=0.043). CONCLUSION: Patients seeking surgical management for textured implants have acceptable rates of surgical complications. The data challenges the paradigm that complete capsulectomy is associated with increased complication rate and highlights postoperative satisfaction and well-being. This can guide patients considering surgical management and open a dialogue for shared decision making.

A Spectrum of Disease

Breast implant associated anaplastic large cell lymphoma (BIA-ALCL) is an uncommon and emerging malignancy caused by textured breast implants. The most common patient presentation is delayed seromas, other presentations include breast asymmetry, overlying skin rashes, palpable masses, lymphadenopathy, and capsular contracture. Confirmed diagnoses should receive lymphoma oncology consultation, multidisciplinary evaluation, and PET-CT or CT scan evaluation prior to surgical treatment. Disease confined to the capsule is curable in the majority of patients with complete surgical resection. BIA-ALCL is now recognized as one disease among a spectrum of inflammatory mediated malignancies which include implant-associated squamous cell carcinoma and B cell lymphoma.

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

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. 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. 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. 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. 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.

An Interesting Case of Breast Implant-Associated Anaplastic Large Cell Lymphoma

Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is a T-cell non-Hodgkins lymphoma that is a rare complication seen with textured breast implants. We describe the case of a 49-year-old woman with a past medical history of stage IIA infiltrating ductal carcinoma of the right breast status post bilateral mastectomy followed by chemotherapy and radiation therapy. The patient subsequently had textured implants bilaterally placed. Thirteen years later, she presented with right breast soreness with edema; pathology confirmed BIA-ALCL.

Abstract P2-15-10: Impact of the withdrawal of textured breast implants from the market on breast reconstruction practices

Abstract Background: In November 2018, the SOFCPRE (Société Française de chirurgie plastique, reconstructrice et esthétique) recommanded that textured Biocell© implants should no longer be used because of a potential risk of anaplastic large cell lymphoma (ALCL). This decision was confirmed in April 2019 by the French Medicines Agency (ANSM, Agence nationale de sécurité du médicament), and the French Medical Regulatory Authority. In the Georges-François Leclerc Cancer Center (Dijon, France), we suspended the use of textured Biocell© implants from November 2018 onwards, in favour of smooth surface, round implants. Objective: To assess the impact of textured implant withdrawal on surgical practices in breast reconstruction (BR) in a single French cancer center. Methods: This is a retrospective, single-centre study in the Georges-François Leclerc Cancer Center (Dijon, France). Surgical practices of BR and complications were compared between 2 periods: before the withdrawal of textured implants from the market (Period 1: September 2017-November 2017) and after (Period 2: December 2018-March 2020). Patients were included if they were operated on for the first time for immediate or secondary BR in either period. Univariate analysis was performed to compare before vs after groups, and to analyse surgical practices (rates of autologous techniques and breast implant) of BR and complications ((defined as any complication grade IIIB or higher according to the Clavien Dindo classification) between the 2 periods. Results: Data from 168 and 159 BR were collected from Periods 1 and 2 respectively. Characteristics were comparable between groups.The rate of BR with implants was significantly lower in period 2 compared with period 1 (23.9% vs 53.6%; p&amp;lt; 0.001). Similarly, autologous BR increased significantly in period 2 for muscle sparing latissimus dorsi (2.4% vs 12.6%; p&amp;lt; 0.001) and exclusive fat grafting (9.5% vs 21.5%; p&amp;lt; 0.01). Others autologous techniques was comparable between the two periods (DIEP and latissimus dorsi). The number of complications decreased in period 2 (10% vs 18.4% in period 1, p=0.04). Conclusion: After the withdrawal of textured implants, we observed a significant change in surgical practices for BR in our center. The rate of reconstruction with implants decreased in favour of autologous techniques. This change in practice was accompanied by a decrease in complications. Surgical techniques for breast reconstruction between the two periods Period 1: September 2017-November 2017;Period 2: December 2018-March 2020. DIEP, Deep Inferior Epigastric Perforator; SD, Standard deviation Citation Format: CLEMENTINE JANKOWSKI, Maxime Martinez, Vincent Laura, Pierre Burnier, CHARLES COUTANT. Impact of the withdrawal of textured breast implants from the market on breast reconstruction practices [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P2-15-10.