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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: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:BACKGROUND:More 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. METHODS:From 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. RESULTS:A 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. CONCLUSION:The 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 REGISTRATION:Clinicaltrials.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.

Project description:PURPOSE:For older women with breast cancer, local therapy options may include lumpectomy plus whole-breast irradiation (Lump + WBI), lumpectomy plus brachytherapy (Lump + Brachy), lumpectomy alone (Lump alone), mastectomy without radiation therapy (Mast alone), and mastectomy plus radiation therapy (Mast + RT). We surveyed a population-based cohort of older breast cancer survivors to assess the association of local therapy with long-term quality-of-life outcomes. METHODS AND MATERIALS:We used nationally comprehensive Medicare claims to identify women aged ?67 years in whom nonmetastatic breast cancer was diagnosed in 2009, who were treated with 1 of the 5 aforementioned treatment options, and who were still alive in 2015. From this cohort, 1650 patients (330 patients per treatment) were randomly selected. A survey that included the CanSORT (Cancer Surveillance and Outcomes Research Team) Satisfaction with Breast Cosmetic Outcome, BREAST-Q, Decisional Regret Scale, and EQ-5D-3L was mailed to potential participants. We used multivariable linear regression to assess associations between local therapy and outcomes after adjusting for patient, disease, and treatment covariates. RESULTS:Among the 489 women who returned the surveys (30% response rate), the median age at diagnosis was 72 years (range, 67-87 years). The interval from diagnosis to survey completion was approximately 6 years for all patients. Compared with Lump + WBI (adjusted score, 3.40), the CanSORT cosmetic satisfaction scores were higher for Lump + Brachy (score, 3.77; P = .007) and Lump alone (score, 3.80; P = .04) and lower for Mast + RT (score, 3.01; P = .006). Similar trends were seen for BREAST-Q cosmetic satisfaction. BREAST-Q psychosocial, sexual, and physical well-being and EQ-5D-3L global health status tended to be better in patients treated with less irradiation and less surgery. BREAST-Q adverse radiation effects were worse for Lump + WBI compared with Lump + Brachy. Decisional regret regarding surgery and radiation therapy did not differ across groups. Compared with patients treated with Lump + WBI, patients treated with Lump + Brachy and Lump alone reported slightly higher rates of in-breast recurrence (excess risk of 5.8% and 6.4%, respectively; P = .01). CONCLUSIONS:In this nationally diverse cohort, less irradiation and less surgery were associated with better long-term quality-of-life outcomes. However, patient regret regarding surgery and radiation therapy was similar across all groups.

Project description:IntroductionBreast reconstruction (BR) is offered to improve quality of life for women with breast cancer undergoing mastectomy. As most women will be long-term breast cancer survivors, high-quality information regarding the long-term outcomes of different BR procedures is essential to support informed decision-making. As different techniques vary considerably in cost, policymakers also require high-quality cost-effectiveness evidence to inform care. The Brighter study aims to explore the long-term clinical and patient-reported outcomes (PROs) of implant-based and autologous BR and use health economic modelling to compare the long-term cost-effectiveness of different reconstructive techniques.Methods and analysisWomen undergoing mastectomy and/or BR following a diagnosis of breast cancer between 1 January 2008 and 31 March 2009 will be identified from hospital episode statistics (HES). Surviving women will be contacted and invited to complete validated PRO measures including the BREAST-Q, EQ-5D-5L and ICECAP-A, or opt out of having their data included in the HES analysis. Long-term clinical outcomes will be explored using HES data. The primary outcome will be rates of revisional surgery between implant-based and autologous procedures. Secondary outcomes will include rates of secondary reconstruction and reconstruction failure. The long-term PROs of implant-based and autologous reconstruction will be compared using BREAST-Q, EQ-5D-5L and ICECAP-A scores. Multivariable regression will be used to examine the relationship between long-term outcomes, patient comorbidities, sociodemographic and treatment factors. A Markov model will be developed using HES and PRO data and published literature to compare the relative long-term cost-effectiveness of implant-based and autologous BR.Ethics and disseminationThe Brighter study has been approved by the South-West -Central Bristol Research Ethics Committee (20/SW/0020), and the Confidentiality Advisory Group (20/CAG/0021). Results will be published in peer-reviewed journals and presented at national meetings. We will work with the professional associations, charities and patient groups to disseminate the results.

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.

Similar Datasets

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