RESUMO
For localized breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), surgical resection is crucial; however, radiation therapy (RT) can be utilized as local-regional therapy if surgery is incomplete or not recommended. We present the case of a woman with BIA-ALCL who received systemic therapy and consolidation RT.
RESUMO
Importance: Premastectomy radiotherapy (PreMRT) is a new treatment sequence to avoid the adverse effects of radiotherapy on the final breast reconstruction while achieving the benefits of immediate breast reconstruction (IMBR). Objective: To evaluate outcomes among patients who received PreMRT and regional nodal irradiation (RNI) followed by mastectomy and IMBR. Design, Setting, and Participants: This was a phase 2 single-center randomized clinical trial conducted between August 3, 2018, and August 2, 2022, evaluating the feasibility and safety of PreMRT and RNI (including internal mammary lymph nodes). Patients with cT0-T3, N0-N3b breast cancer and a recommendation for radiotherapy were eligible. Intervention: This trial evaluated outcomes after PreMRT followed by mastectomy and IMBR. Patients were randomized to receive either hypofractionated (40.05 Gy/15 fractions) or conventionally fractionated (50 Gy/25 fractions) RNI. Main Outcome and Measures: The primary outcome was reconstructive failure, defined as complete autologous flap loss. Demographic, treatment, and outcomes data were collected, and associations between multiple variables and outcomes were evaluated. Analysis was performed on an intent-to-treat basis. Results: Fifty patients were enrolled. Among 49 evaluable patients, the median age was 48 years (range, 31-72 years), and 46 patients (94%) received neoadjuvant systemic therapy. Twenty-five patients received 50 Gy in 25 fractions to the breast and 45 Gy in 25 fractions to regional nodes, and 24 patients received 40.05 Gy in 15 fractions to the breast and 37.5 Gy in 15 fractions to regional nodes, including internal mammary lymph nodes. Forty-eight patients underwent mastectomy with IMBR, at a median of 23 days (IQR, 20-28.5 days) after radiotherapy. Forty-one patients had microvascular autologous flap reconstruction, 5 underwent latissimus dorsi pedicled flap reconstruction, and 2 had tissue expander placement. There were no complete autologous flap losses, and 1 patient underwent tissue expander explantation. Eight of 48 patients (17%) had mastectomy skin flap necrosis of the treated breast, of whom 1 underwent reoperation. During follow-up (median, 29.7 months [range, 10.1-65.2 months]), there were no locoregional recurrences or distant metastasis. Conclusions and Relevance: This randomized clinical trial found PreMRT and RNI followed by mastectomy and microvascular autologous flap IMBR to be feasible and safe. Based on these results, a larger randomized clinical trial of hypofractionated vs conventionally fractionated PreMRT has been started (NCT05774678). Trial Registration: ClinicalTrials.gov Identifier: NCT02912312.
Assuntos
Neoplasias da Mama , Mamoplastia , Feminino , Humanos , Pessoa de Meia-Idade , Mama/patologia , Neoplasias da Mama/radioterapia , Neoplasias da Mama/cirurgia , Neoplasias da Mama/patologia , Mamoplastia/métodos , Mastectomia , Recidiva Local de Neoplasia/patologia , Adulto , IdosoRESUMO
Breast implant-associated anaplastic large cell lymphoma has been recognized as a distinct entity in the World Health Organization classification of hematolymphoid neoplasms. These neoplasms are causally related to textured implants that were used worldwide until recently. Consequently, there is an increased demand for processing periprosthetic capsules, adding new challenges for surgeons, clinicians, and pathologists. In the literature, the focus has been on breast implant-associated anaplastic large cell lymphoma; however, benign complications related to the placement of breast implants occur in up to 20% to 30% of patients. Imaging studies are helpful in assessing patients with breast implants for evidence of implant rupture, changes in tissues surrounding the implants, or regional lymphadenopathy related to breast implants, but pathologic examination is often required. In this review, we couple our experience with a review of the literature to describe a range of benign lesions associated with breast implants that can be associated with different clinical presentations or pathogenesis and that may require different diagnostic approaches. We illustrate the spectrum of the most common of these benign disorders, highlighting their clinical, imaging, gross, and microscopic features. Finally, we propose a systematic approach for the diagnosis and handling of breast implant specimens in general.
Assuntos
Implante Mamário , Implantes de Mama , Linfoma Anaplásico de Células Grandes , Humanos , Implantes de Mama/efeitos adversos , Feminino , Linfoma Anaplásico de Células Grandes/patologia , Linfoma Anaplásico de Células Grandes/etiologia , Implante Mamário/efeitos adversos , Implante Mamário/instrumentação , Valor Preditivo dos Testes , Neoplasias da Mama/patologia , Neoplasias da Mama/cirurgia , Relevância ClínicaRESUMO
BACKGROUND: In the absence of high-quality evidence, there is a need to provide guidelines and multidisciplinary consensus recommendations on Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). The purpose of this expert consensus conference was to evaluate the existing evidence regarding the diagnosis, and management of BIA-ALCL caused by textured implants. The aim is to provide evidence-based recommendations regarding the management and prevention of BIA-ALCL. METHODS: A comprehensive search was conducted in the MEDLINE, Cochrane Library, and Embase databases, supplemented by manual searches of relevant English language articles and "related articles" sections. Studies focusing on breast surgery and lymphoma associated with breast implants were included for analysis. Meta-analyses were performed and reviewed by experts selected by the American Association of Plastic Surgeons by a Delphi consensus method. RESULTS: 840 articles between January 2011 and January 2023 were initially identified and screened. Full-text of 188 articles were assessed. An additional 43 articles were excluded for focus, and 145 articles were included in the synthesis of results, with 105 of them being case reports or case series. The analysis encompassed a comprehensive examination of the selected articles to determine the incidence, risk factors, clinical presentation, diagnostic approaches, and treatment modalities related to BIA-ALCL. CONCLUSIONS: Plastic surgeons should be aware of the elevated risks by surface type, implement appropriate patient surveillance, and follow the recommendations outlined in this statement to ensure patient safety and optimize outcomes. Ongoing research on pathogenesis, genetic drivers, and preventative and prophylactic measures is crucial for improving patient care.
RESUMO
Squamous cell carcinoma may arise primarily from the breast parenchyma (PSCCB) or from the periprosthetic capsule in patients with breast implants (breast implant-associated squamous cell carcinoma [BIA-SCC]). A systematic literature review was performed to identify all PSCCB and BIA-SCC cases, and to estimate prevalence, incidence rate (IR), and risk. Studies up to November 2023 were searched on PubMed, Web of Science, Google Scholar, and Cochrane Library for predefined keywords. The numerator for PSCCB and BIA-SCC was the number of cases obtained from the literature; the denominator for PSCCB was the female population aged from 18 to 99, and the denominator for BIA-SCC was the population with breast implants. Overall, 219 papers were included, featuring 2250 PSCCB and 30 BIA-SCC cases. PSCCB prevalence was 2.0 per 100,000 (95% CI, 0.2:100,000 to 7.2:100,000) individuals, with a lifetime risk of 1:49,509 (95% CI, 0.2:10,000 to 5.6:10,000); and BIA-SCC prevalence was 0.61 per 100,000 (95% CI, 0.2:100,000 to 1.3:100,000), with a lifetime risk of 1:164,884 (95% CI, 0.2:100,000 to 5.6:100,000). The prevalence of BIA-SCC is 3.33 times lower than that of PSCCB, while the prevalence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is 3.84 times higher than that of primary breast ALCL. When comparing the BIA-SCC prevalence of 1:164,910 individuals with breast implants regardless of texture to the BIA-ALCL prevalence of 1:914 patients with textured implants, the BIA-SCC risk is 180 times lower than the BIA-ALCL risk. BIA-SCC occurs less frequently than PSCCB and considerably less than BIA-ALCL. The association between textured implants and BIA-SCC cases is relevant for patient education regarding uncommon and rare risks associated with breast implants, and ongoing vigilance, research, and strengthened reporting systems remain imperative.
Assuntos
Implante Mamário , Implantes de Mama , Neoplasias da Mama , Carcinoma de Células Escamosas , Humanos , Implantes de Mama/efeitos adversos , Feminino , Neoplasias da Mama/epidemiologia , Neoplasias da Mama/etiologia , Carcinoma de Células Escamosas/epidemiologia , Carcinoma de Células Escamosas/etiologia , Prevalência , Incidência , Implante Mamário/efeitos adversos , Implante Mamário/instrumentação , Fatores de Risco , Pessoa de Meia-Idade , Adulto , Idoso , Idoso de 80 Anos ou mais , Adulto Jovem , AdolescenteRESUMO
SUMMARY: The impact of clinical prediction models within Artificial Intelligence (AI) and machine learning (ML) is significant. With its ability to analyze vast amounts of data and identify complex patterns, machine learning has the potential to improve and implement evidence-based plastic, reconstructive, and hand surgery. Among others, it is capable of predicting the diagnosis, prognosis, and outcomes of individual patients. This modeling aids daily clinical decision making, most commonly at the moment, as decision-support.Therefore, the purpose of this paper is to provide a practice guideline to plastic surgeons implementing AI in clinical decision-making or setting up AI research to develop clinical prediction models using the 7-step approach and the ABCD validation steps of Steyerberg et al. Secondly, we describe two important protocols which are in the development stage for AI research: 1) the Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD) checklist, and 2) The PROBAST checklist to access potential biases.
RESUMO
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.
Assuntos
Implante Mamário , Implantes de Mama , Neoplasias da Mama , Linfoma Anaplásico de Células Grandes , Humanos , Feminino , Adulto , Pessoa de Meia-Idade , Idoso , Implantes de Mama/efeitos adversos , Estresse Financeiro , Linfoma Anaplásico de Células Grandes/epidemiologia , Linfoma Anaplásico de Células Grandes/etiologia , Linfoma Anaplásico de Células Grandes/terapia , Estudos Transversais , Qualidade de Vida , Implante Mamário/efeitos adversos , Neoplasias da Mama/etiologia , Neoplasias da Mama/cirurgiaRESUMO
BACKGROUND: Postmastectomy radiotherapy (PMRT) is associated with altered cosmetic outcomes and higher complication rates in implant-based breast reconstruction (IBR). Conventional wisdom suggests that muscle coverage is somewhat protective against PMRT-related complications. In this study, the authors compared surgical outcomes in patients who underwent two-stage prepectoral versus subpectoral IBR in the setting of PMRT. METHODS: The authors performed a retrospective cohort study of patients who underwent mastectomy and PMRT with two-stage IBR from 2016 to 2019. The primary outcome was breast-related complications, including device infection; the secondary outcome was device explantation. RESULTS: The authors identified 179 reconstructions (101 prepectoral and 78 subpectoral) in 172 patients with a mean follow-up time of 39.7 ± 14.4 months. There were no differences between the prepectoral and subpectoral reconstructions in rates of breast-related complications (26.7% and 21.8%, respectively; P = 0.274), device infection (18.8% and 15.4%, respectively; P = 0.307), skin flap necrosis (5.0% and 1.3%, respectively; P = 0.232), or device explantation (20.8% and 14.1%, respectively; P = 0.117). In adjusted models, compared with prepectoral device placement, subpectoral device placement was not associated with a lower risk of breast-related complications [hazard ratio (HR), 0.75; 95% confidence interval (CI), 0.41 to 1.36], device infection (HR, 0.73; 95% CI, 0.35 to 1.49), or device explantation (HR, 0.58; 95% CI, 0.28 to 1.19). CONCLUSIONS: Device placement plane was not predictive of complication rates in IBR in the setting of PMRT. Two-stage prepectoral IBR provides safe long-term outcomes with acceptable postoperative complication rates comparable to those with subpectoral IBR, even in the setting of PMRT. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.
Assuntos
Implante Mamário , Implantes de Mama , Neoplasias da Mama , Mamoplastia , Humanos , Feminino , Implante Mamário/efeitos adversos , Implantes de Mama/efeitos adversos , Mastectomia/efeitos adversos , Neoplasias da Mama/radioterapia , Neoplasias da Mama/cirurgia , Neoplasias da Mama/complicações , Estudos Retrospectivos , Mamoplastia/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/prevenção & controleRESUMO
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.
RESUMO
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.
Assuntos
Implante Mamário , Implantes de Mama , Neoplasias da Mama , Linfoma Anaplásico de Células Grandes , Humanos , Feminino , Estados Unidos/epidemiologia , Implantes de Mama/efeitos adversos , Linfoma Anaplásico de Células Grandes/epidemiologia , Linfoma Anaplásico de Células Grandes/etiologia , Linfoma Anaplásico de Células Grandes/patologia , Implante Mamário/efeitos adversos , Incidência , Países Baixos , Neoplasias da Mama/etiologiaRESUMO
BACKGROUND: Skin-preserving, staged, microvascular, breast reconstruction often is preferred in patients requiring postmastectomy radiotherapy (PMRT) but may lead to complications. We compared the long-term surgical and patient-reported outcomes between skin-preserving and delayed microvascular breast reconstruction with and without PMRT. METHODS: We conducted a retrospective, cohort study of consecutive patients who underwent mastectomy and microvascular breast reconstruction between January 2016 and April 2022. The primary outcome was any flap-related complication. The secondary outcomes were patient-reported outcomes and tissue-expander complications. RESULTS: We identified 1002 reconstructions (672 delayed; 330 skin-preserving) in 812 patients. Mean follow-up was 24.2 ± 19.3 months. PMRT was required in 564 reconstructions (56.3%). In the non-PMRT group, skin-preserving reconstruction was independently associated with shorter hospital stay (ß - 0.32, p = 0.045) and lower odds of 30-days readmission (odds ratio [OR] 0.44, p = 0.042), seroma (OR 0.42, p = 0.036), and hematoma (OR 0.24, p = 0.011) compared with delayed reconstruction. In the PMRT group, skin-preserving reconstruction was independently associated with shorter hospital stay (ß - 1.15, p < 0.001) and operative time (ß - 97.0, p < 0.001) and lower odds of 30-days readmission (OR 0.29, p = 0.005) and infection (OR 0.33, p = 0.023) compared with delayed reconstruction. Skin-preserving reconstruction had a 10.6% tissue expander loss rate and did not differ from delayed reconstruction in terms of patient-reported satisfaction with breast, psychosocial well-being, or sexual well-being. CONCLUSIONS: Skin-preserving, staged, microvascular, breast reconstruction is safe regardless of the need for PMRT, with an acceptable tissue expander loss rate, and is associated with improved flap outcomes and similar patient-reported quality of life to that of delayed reconstruction.
Assuntos
Neoplasias da Mama , Mamoplastia , Humanos , Feminino , Mastectomia/efeitos adversos , Neoplasias da Mama/cirurgia , Neoplasias da Mama/complicações , Estudos de Coortes , Estudos Retrospectivos , Qualidade de Vida , Complicações Pós-Operatórias/etiologia , Mamoplastia/efeitos adversos , Radioterapia Adjuvante/efeitos adversos , Medidas de Resultados Relatados pelo Paciente , Resultado do TratamentoRESUMO
BACKGROUND: Although obesity has previously been associated with poor outcomes after mastectomy and breast reconstruction, its impact across the WHO obesity classification spectrum and the differential effects of various optimization strategies on patient outcomes have yet to be delineated. We sought to examine the impact of WHO obesity classification on intraoperative surgical and medical complications, postoperative surgical and patient-reported outcomes of mastectomy and autologous breast reconstruction, and delineate outcomes optimization strategies for obese patients. STUDY DESIGN: This is a review of consecutive patients who underwent mastectomy and autologous breast reconstruction from 2016 to 2022. Primary outcomes were complication rates. Secondary outcomes were patient-reported outcomes and optimal management strategies. RESULTS: We identified 1,640 mastectomies and reconstructions in 1,240 patients with mean follow-up of 24.2 ± 19.2 months. Patients with class II/III obesity had higher adjusted risk of wound dehiscence (odds ratio [OR] 3.20; p < 0.001), skin flap necrosis (OR 2.60; p < 0.001), deep venous thrombosis (OR 3.90; p < 0.033), and pulmonary embolism (OR 15.3; p = 0.001) than nonobese patients. Obese patients demonstrated significantly lower satisfaction with breasts (67.3 ± 27.7 vs 73.7 ± 24.0; p = 0.043) and psychological well-being (72.4 ± 27.0 vs 82.0 ± 20.8; p = 0.001) than nonobese patients. Unilateral delayed reconstructions were associated with independently shorter hospital stay (ß -0.65; p = 0.002) and lower adjusted risk of 30-day readmission (OR 0.45; p = 0.031), skin flap necrosis (OR 0.14; p = 0.031), and pulmonary embolism (OR 0.07; p = 0.021). CONCLUSIONS: Obese women should be closely monitored for adverse events and lower quality of life, offered measures to optimize thromboembolic prophylaxis, and advised on the risks and benefits of unilateral delayed reconstruction.
Assuntos
Neoplasias da Mama , Mamoplastia , Embolia Pulmonar , Humanos , Feminino , Mastectomia/efeitos adversos , Qualidade de Vida , Beleza , Neoplasias da Mama/cirurgia , Neoplasias da Mama/complicações , Mamoplastia/efeitos adversos , Obesidade/complicações , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Embolia Pulmonar/etiologia , Necrose/complicações , Estudos RetrospectivosRESUMO
BACKGROUND: Opinion regarding the optimal plane for prosthetic device placement in breast reconstruction patients has evolved. The purpose of this study was to assess the differences in complication rates and patient satisfaction between patients who underwent prepectoral and subpectoral implant-based breast reconstruction (IBR). METHODS: The authors conducted a retrospective cohort study of patients who underwent two-stage IBR at their institution from 2018 to 2019. Surgical and patient-reported outcomes were compared between patients who received a prepectoral versus a subpectoral tissue expander. RESULTS: A total of 694 reconstructions in 481 patients were identified (83% prepectoral, 17% subpectoral). The mean body mass index was higher in the prepectoral group (27 versus 25 kg/m 2 , P = 0.001), whereas postoperative radiotherapy was more common in the subpectoral group (26% versus 14%, P = 0.001). The overall complication rate was very similar, with 29.3% in the prepectoral and 28.9% in the subpectoral group ( P = 0.887). Rates of individual complications were also similar between the two groups. A multiple-frailty model showed that device location was not associated with overall complications, infection, major complications, or device explantation. Mean scores for Satisfaction with the Breast, Psychosocial Well-Being, and Sexual Well-Being were similar between the two groups. Median time to permanent implant exchange was significantly longer in the subpectoral group (200 versus 150 days, P < 0.001). CONCLUSION: Prepectoral breast reconstruction results in similar surgical outcomes and patient satisfaction compared with subpectoral IBR. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.
Assuntos
Implante Mamário , Implantes de Mama , Neoplasias da Mama , Mamoplastia , Humanos , Feminino , Implante Mamário/métodos , Implantes de Mama/efeitos adversos , Estudos Retrospectivos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Mamoplastia/métodos , Medidas de Resultados Relatados pelo Paciente , Neoplasias da Mama/radioterapia , Neoplasias da Mama/cirurgia , Neoplasias da Mama/complicaçõesRESUMO
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.
Assuntos
Implante Mamário , Implantes de Mama , Neoplasias da Mama , Linfoma Anaplásico de Células Grandes , Humanos , Feminino , Implantes de Mama/efeitos adversos , Linfoma Anaplásico de Células Grandes/epidemiologia , Linfoma Anaplásico de Células Grandes/etiologia , Linfoma Anaplásico de Células Grandes/diagnóstico , Implante Mamário/efeitos adversos , Remoção de Dispositivo/efeitos adversos , Sistema de Registros , Neoplasias da Mama/epidemiologia , Neoplasias da Mama/etiologia , Neoplasias da Mama/cirurgiaRESUMO
BACKGROUND: Abdominal wall reconstruction (AWR) is one of the most commonly performed procedures, yet large comparative studies comparing outcomes of AWR using bovine acellular dermal matrix (BADM) and porcine acellular dermal matrix (PADM) are lacking. METHODS: In this retrospective cohort study of patients who underwent AWR from March of 2005 to June of 2019, the primary comparative outcome measure was hernia recurrence with BADM versus PADM. The secondary outcome was the incidence of surgical-site occurrence (SSO) and surgical-site infection. A propensity score matching approach was applied to compare the clinical outcomes between the two study groups. RESULTS: The authors identified 725 patients who underwent AWR using BADM (50.5%) or PADM (49.5%). Their mean ± SD age was 59.8 ± 11.5 years, mean body mass index was 31.4 ± 6.7 kg/m 2 , and mean follow-up time was 42 ± 29 months. With propensity score matching, 219 matched pairs were identified. Hernia recurrence rates in BADM (11.4%) and PADM (13.7%) groups did not differ significantly ( P = 0.793). SSO (26.5% versus 29.2%; P = 0.518) and SSI (13.2% versus 11%; P = 0.456) rates did not differ significantly in the PADM and BADM groups, respectively. Conditional logistic regression model and marginal Cox proportional hazards regression model determined that type of acellular dermal matrix was not significantly associated with SSOs (adjusted OR, 1.11; 95% CI, 0.74 to 1.70; P = 0.589) or hernia recurrence (adjusted hazard ratio, 0.85; 95% CI, 0.50 to 1.42; P = 0.52). CONCLUSIONS: Both BADMs and PADMs provide durable, long-term outcomes. The hernia recurrence and postoperative surgical complication rates were not significantly different between BADM and PADM. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.