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Understanding Breast Implant Illness, Before and After Explantation: A Patient-Reported Outcomes Study.

ABSTRACT: BACKGROUND:Breast implant illness (BII) after aesthetic breast augmentation remains a poorly defined syndrome encompassing a wide spectrum of symptoms. While previously published series have observed overall symptomatic improvement after breast implant removal, there is a lack of studies evaluating changes in specific symptoms over time. The purpose of this study was to gain an understanding of symptoms associated with BII, and to evaluate how these symptoms change after removal of breast implants and total capsulectomy (explantation). We hypothesized that patients presenting with BII would experience both immediate and sustained improvement in constitutional symptoms after explantation. METHODS:A retrospective study of all patients who underwent explantation by a single surgeon over 2 years was conducted. Repeated-measures analysis of variance accounting for dependency was used to compare symptoms before and after surgery. Multivariate analyses and linear regression models were used to examine the impact of patient- and implant-related factors on changes in symptoms. RESULTS:Seven hundred fifty patients met inclusion criteria. Mean preoperative survey score (26.19 ± 11.24) was significantly different from mean postoperative survey score at less than 30 days (9.49 ± 7.56) and greater than 30 days (9.46 ± 7.82, P < 0.001). Patients with a BMI greater than 30 or those with clinically detectable contracture on examination showed greater improvement on their survey scores (P = 0.039, 0.034, respectively). CONCLUSIONS:Although BII encompasses a large range of symptoms, subjects in this study demonstrated significant and sustained improvement in 11 common symptom domains. This improvement was demonstrable within the first 30 days postoperatively and was maintained beyond 30 days. The study demonstrated a strong association of explantation and specific symptom improvement within the patient population studied. Future investigation will further elucidate possible biologic phenomena to better characterize the pathophysiology and mechanism of BII.

SUBMITTER: Wee CE

PROVIDER: S-EPMC7294749 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Understanding Breast Implant Illness, Before and After Explantation: A Patient-Reported Outcomes Study.

Wee Corinne E CE Younis Joseph J Isbester Kelsey K Smith Arvin A Wangler Brooke B Sarode Anuja L AL Patil Nirav N Grunzweig Katherine K Boas Samuel S Harvey Donald J DJ Kumar Anand R AR Feng Lu-Jean LJ

Annals of plastic surgery 20200701 S1 Suppl 1

<h4>Background</h4>Breast implant illness (BII) after aesthetic breast augmentation remains a poorly defined syndrome encompassing a wide spectrum of symptoms. While previously published series have observed overall symptomatic improvement after breast implant removal, there is a lack of studies evaluating changes in specific symptoms over time. The purpose of this study was to gain an understanding of symptoms associated with BII, and to evaluate how these symptoms change after removal of breas ...[more]

PMID: 32530850

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Project description:ImportancePrevious research suggests that clinicians view realistic patient expectations as the most important nonaudiological factor in the decision to proceed with a cochlear implant (CI). However, clinicians have few data to determine whether patients' outcome expectations are realistic.ObjectiveTo address this unmet clinical need through the development and psychometric analysis of a new patient-reported outcome measure, the CI Quality of Life (CIQOL) Expectations.Design, setting, and participantsThis cross-sectional study was conducted at a tertiary CI center from February 26, 2020, to August 31, 2021. First, a team comprising 2 CI audiologists, a CI surgeon, a hearing scientist, and 2 psychometricians with experience in instrument development converted all items from the CIQOL-35 Profile instrument into statements reflecting expected outcomes. Then, cognitive interviews with 20 potential CI users assessed the clarity and comprehensiveness of the new instrument. Next, responses to the CIQOL-Expectations instrument for 131 potential adult CI candidates were psychometrically analyzed using confirmatory factor analysis and item response theory. Finally, degree to which patient expectations changed from before to after and their CI evaluation appointments was measured.InterventionThe CIQOL-Expectations instrument.ResultsOf 178 participants, 85 (47.8%) were female, and there was 1 (0.6%) Asian, 26 (14.6%) Black or African American, 1 (0.6%) Latinx, and 150 (84.3%) White individuals. No major content or grammar changes were identified during the cognitive interviews. Overall, all CIQOL domains demonstrated adequate to strong psychometric properties. Several domains did not meet all a priori established indicators of model fit or ability to separate CI users based on response patterns, but all met most indicators. Potential CI users demonstrated the highest mean (SD) expectation scores for the environment (70.2 [20.8]) and social (68.4 [18.0]) domains. In addition, the entertainment (20 [15.3%]) and environment (31 [24.4%]) domains had the highest percentage of patients with expectation scores of 100. Yet, normative CIQOL-35 Profile data from experienced CI users suggested few patients obtain this high degree of functional benefit after implant.Conclusions and relevanceThe results of this cross-sectional study suggest that the CIQOL-Expectations instrument may provide an opportunity to assess potential CI users' expected outcomes using modification of an established CIQOL instrument and a patient-centered framework. The included items and domains reflect real-world functional abilities valued by CI users and may provide opportunities for an evidence-based shared decision-making approach to the CI evaluation process. With this instrument, clinicians can compare individual patients' pre-CI outcome expectations with established normative data and provide appropriate counseling.

Project description:BackgroundWith advancements in and the evolution of the medical field, several methods and surgical techniques have been developed for breast reconstruction after mastectomy. Generally, we can categorize these strategies into two broad groups: autologous reconstruction and implant-based reconstruction. This study aimed to analyze the satisfaction rate between these groups, considering age, timing of breast reconstruction, body mass index (BMI), major complications, and the need for radiotherapy or chemotherapy.Materials and methodsAll the patients who underwent a mastectomy and subsequent breast reconstruction surgery at our institution between August 1, 2013, and August 31, 2017, were invited to complete a BREAST-Q questionnaire. To compare the quality of life and complication rate between the autologous and implant-based reconstruction groups, data were collected from specific patients. All participants completed the Arabic version of the postoperative reconstruction module.ResultsAmong 61 patients, 43 (70.5%) completed the two domains of the BREAST-Q questionnaire, about the satisfaction with the implanted breast and satisfaction with the surgical outcome. These patients were divided into two groups: autologous (n = 21) and implant-based (n = 22) groups. The mean score of satisfaction with the implanted breast was 43.5 for the autologous group and 39.6 for the implant-based group. For the surgical outcome, the scores for the autologous and implant-based groups were 45.4 and 56.0, respectively. However, there was neither a statistical significance in the satisfaction with the implanted breast nor the surgical outcome between the two groups.ConclusionAlthough there are many different surgical techniques to reconstruct a breast after mastectomy, there is still no specific surgical method that is perfect or well-suited for all patients undergoing breast reconstruction surgery. In our study, we found that there was no significant difference in satisfaction between the ABR and IBR group.

Project description:BackgroundMore personalized implant designs for total knee arthroplasty might optimize the clinical outcome after surgery. One of these personalized implant designs is the Persona knee implant system (Zimmer Biomet, Warsaw, Indiana, USA). The primary objective of this study was to determine patient reported outcomes and implant survivorship of the Persona Knee system used in primary total knee arthroplasty, up to two years after surgery.MethodsFrom November 2013 to July 2016 consecutive patients undergoing primary total knee arthroplasty were enrolled in a prospective observational cohort study at three centers. Preoperatively, at 6 weeks, 6 months, 1 and 2 years after surgery, patients completed the Knee Injury and Osteoarthritis Outcome Score (KOOS), the Oxford Knee Score (OKS), the Knee Society Score (KSS, 2011, modified version) and the EQ-5D. Adverse Events were captured, assessed for relationship to device, and recorded in the study database. Furthermore, physical functioning was assessed by the orthopedic surgeon. Repeated measures analyses were performed on PROM scores. Kaplan Meier was used to calculate survivorship of the Persona Knee Implant System.ResultsA total of 146 total knee arthroplasties were performed. 61% (89/146) of the patients were female and mean age was 64.7 (± 6.9) years. Two years after surgery, one patient had a revision of the polyethylene insert because of a periprosthetic joint infection. Therefore, the Kaplan-Meier survival estimate at 2 years was 0.99 (0.95-1.00 95% CI). OKS increased from 22.1 (95% CI 20.9-23.3) to 41.8 (95% CI 40.6-43.1) two years after surgery. Furthermore, all other PROMs also increased from before surgery to 2 year postoperatively.ConclusionThe Persona Knee implant is safe and effective and the clinical results up to two years after surgery are promising. PROMs results are very good; pain, function and quality of life all improved greatly after TKA. Further studies are needed to determine the long term clinical performance of the Persona prosthesis.Trial registrationClinicaltrials.gov ( NCT02337244 ). Registered June 1st, 2015. Retrospectively registered.

Project description:Purpose The goals of immediate postmastectomy breast reconstruction are to minimize deformity and optimize quality of life as perceived by patients. We prospectively evaluated patient-reported outcomes (PROs) in women undergoing immediate implant-based or autologous reconstruction. Methods Women undergoing immediate postmastectomy reconstruction for invasive cancer and/or carcinoma in situ were enrolled at 11 sites. Women underwent implant-based or autologous tissue reconstruction. Patients completed the BREAST-Q, a condition-specific PRO measure for breast surgery patients, and Patient-Reported Outcomes Measurement Information System-29, a generic PRO measure, before and 1 year after surgery. Mean changes in PRO scores were summarized. Mixed-effects regression models were used to compare PRO scores across procedure types. Results In total, 1,632 patients (n = 1,139 implant, n = 493 autologous) were included; 1,183 (72.5%) responded to 1-year questionnaires. After analysis was controlled for baseline values, patients who underwent autologous reconstruction had greater satisfaction with their breasts than those who underwent implant-based reconstruction (difference, 6.3; P < .001), greater sexual well-being (difference, 4.5; P = .003), and greater psychosocial well-being (difference, 3.7; P = .02) at 1 year. Patients in the autologous reconstruction group had improved satisfaction with breasts (difference, 8.0; P = .002) and psychosocial well-being (difference, 4.6; P = .047) compared with preoperative baseline. Physical well-being of the chest was not fully restored in either the implant group (difference, -3.8; P = .001) or autologous group (-2.2; P = .04), nor was physical well-being of the abdomen in patients who underwent autologous reconstruction (-13.4; P < .001). Anxiety and depression were mitigated at 1 year in both groups. Compared with their baseline reports, patients who underwent implant reconstruction had decreased fatigue (difference, -1.4; P = .035), whereas patients who underwent autologous reconstruction had increased pain interference (difference, 2.0; P = .006). Conclusion At 1 year after mastectomy, patients who underwent autologous reconstruction were more satisfied with their breasts and had greater psychosocial and sexual well-being than those who underwent implant reconstruction. Although satisfaction with breasts was equal to or greater than baseline levels, physical well-being was not fully restored. This information can help patients better understand expected outcomes and may guide innovations to improve outcomes.

Dataset Information

Understanding Breast Implant Illness, Before and After Explantation: A Patient-Reported Outcomes Study.

Publications

Understanding Breast Implant Illness, Before and After Explantation: A Patient-Reported Outcomes Study.

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