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Complications in breast augmentation with textured versus smooth breast implants: a systematic review protocol.

ABSTRACT: INTRODUCTION:Breast augmentation is one of the most popular aesthetic plastic surgeries worldwide. There are various types of breast implants, and these can be categorised into different broad groups based on their content, shape or surface, to name a few. When looking at the surface of the shell, they can be categorised into two main kinds: textured and smooth implants. To our knowledge, a literature review and meta-analysis of the complications of these two types of implants when used for aesthetic breast augmentation has yet to be written. METHODS AND ANALYSIS:The PubMed, EMBASE and Cochrane electronic databases will be searched from their inception to 1 October 2017. Only cohort studies, case series, case-control studies and randomised controlled trials will be included. Identification of the articles for inclusion will be carried out by two independent researchers, and data will be extracted from these studies for analysis. This protocol defines the inclusion and exclusion criteria, as well as the primary and secondary outcomes. Statistical data analysis will be conducted in Review Manager V.5.3 from Cochrane Collaboration. The methodological quality of the included studies will also be assessed. ETHICS AND DISSEMINATION:This review will analyse secondary data collected from studies which are not linked to any specific individual. Once completed, the conclusions of the review could prove to be a valuable resource for plastic surgeons to conduct aesthetic implant procedures. The review will be submitted for publication in a peer-reviewed journal and presented at various national and international conferences. PROSPERO REGISTRATION NUMBER:CRD42017078727.

SUBMITTER: Wang C

PROVIDER: S-EPMC5898288 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Complications in breast augmentation with textured versus smooth breast implants: a systematic review protocol.

Wang Chenglong C Luan Jie J Panayi Adriana C AC Orgill Dennis P DP Xin Minqiang M

BMJ open 20180410 4

<h4>Introduction</h4>Breast augmentation is one of the most popular aesthetic plastic surgeries worldwide. There are various types of breast implants, and these can be categorised into different broad groups based on their content, shape or surface, to name a few. When looking at the surface of the shell, they can be categorised into two main kinds: textured and smooth implants. To our knowledge, a literature review and meta-analysis of the complications of these two types of implants when used ...[more]

PMID: 29643164

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Project description:IntroductionTwo-stage implant-based breast reconstruction is the most commonly performed postmastectomy reconstructive technique. During the first stage, a tissue expander creates a sufficiently large pocket for the definite breast implant placed in the second stage. Capsular contracture is a common long-term complication associated with implant-based breast reconstruction, causing functional complaints and often requiring reoperation. The exact aetiology is still unknown, but a relationship between the outer surface of the implant and the probability of developing capsular contracture has been suggested. The purpose of this study is to determine whether polyurethane-covered implants result in a different capsular contracture rate than textured implants.Methods and analysisThe Textured Implants versus Polyurethane-covered Implants (TIPI) trial is a multicentre randomised controlled trial with a 1:1 allocation rate and a follow-up of 10 years. A total of 321 breasts of female adults undergoing a two-stage breast reconstruction will be enrolled. The primary outcome is capsular contracture at 10-year follow-up which is graded with the modified Baker classification. It is analysed with survival analysis using a frailty model for clustered interval-censored data, with both an intention-to-treat and per-protocol approach. Secondary outcomes are other complication rates, surgical revision rate, patient satisfaction and quality of life and user-friendliness. Outcomes are measured 2 weeks, 6 months, 1, 2, 3, 5 and 10 years postoperatively. Interim analysis is performed when 1-year, 3-year and 5-year follow-up is completed.Ethics and disseminationThe trial has been reviewed and approved by the Medical Research Ethics Committee of the Erasmus MC, University Medical Centre Rotterdam (MEC-2018-126) and locally by each participating centre. Written informed consent will be obtained from each study participant. The results will be disseminated by publication in peer-reviewed journals.Trial registrationNTR7265.

Project description:IntroductionAnatomical total shoulder arthroplasty (TSA) is an effective treatment adopted for patients with glenohumeral osteoarthritis (OA). The glenoid component failure is the main risk that occurs in this therapeutic choice; however, doubts remain regarding the selection of the best implant for avoiding complication. This systematic review aims to evaluate the glenoid component in TSA by comparing the complications of different types of implants.Methods and analysisA systematic review of randomised clinical trials or quasi-randomised trials will be performed by applying the Preferred Reporting Items for Systematic Review and Meta-Analysis protocols and comparing polyethylene (keeled and pegged) versus metal-backed implants in adult patients with glenohumeral OA. Our search strategy will be performed using MEDLINE, PubMed, Cochrane Central Register of Controlled Trials, EMBASE and Web of Science. Data management and extraction will be performed using a data withdrawal form and by analysing study method characteristics, participant characteristics, intervention characteristics, results and methodological domains. The database search will be performed by February 2021. The Grading of Recommendations Assessment, Development and Evaluation will be used for assessing the quality of evidence of each study selected; however, some critical and important outcomes were determined such as the shoulder function through functional scores (Constant-Murley and American Shoulder and Elbow Surgeons), complications represented by pain (Visual Analogue Scale), surgical revision, radiograph radiolucency and loosening. The confidence in estimated effects for these outcomes will be applied as the overall confidence. The outcomes will be defined as early or late, according to the postoperative follow-up of less than or greater than 1 year, respectively, for complications and radiographs. For the shoulder function, follow-ups will be divided into 6, 12 and 24 months. Heterogeneity is expected in systematic reviews; therefore, the selection of outcomes, as well as the sample size, and specific statistical analysis can lead to meta-analysis; however, if it fails, narrative evidence synthesis will be conducted. Other analyses such as descriptive, subgroup and sensitivity analyses will be performed whenever possible. This systematic review will, therefore, provide evidence concerning the best clinical practice for avoiding complications.Ethics and disseminationThis study has been approved by the Institutional Review Board of Universidade Federal de São Paulo (protocols 0725/2017, 2.157.415 and 70473017.5.0000.5505), and the findings will be disseminated through peer-reviewed publication and conference presentations.Prospero registration numberCRD42018079537.

Project description:INTRODUCTION:Despite multiple scandals in the medical implant sector, premarket testing has been the attention of little published research. Complications related to new devices, such as the DePuy Articular Surface Replacement (ASR, DePuy Synthes, USA), have raised the issue of how designs are tested and whether engineering standards remain up to date with our understanding of implant biomechanics. Despite much work setting up national joint registries to improve implant monitoring, there have been few academic studies examining the premarket engineering standards new implants must meet. Emerging global economies mean that the markets have changed, and it is unknown to what degree engineering standards vary around the world. Governments, industry and independent regulatory bodies all produce engineering standards; therefore, the comparison of surgical implants across different manufacturers and jurisdictions is difficult. In this review, we will systematically collate and compare engineering standards for trauma and orthopaedic implants around the world. This will help inform patient, hospital and surgeon choice and provide an evidence base for future research in this area. METHODS AND ANALYSIS:This protocol is based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol (PRISMA-P) guidelines. We will conduct a systematic review of trauma and orthopaedic engineering standards from four main sources of information as identified in our preliminary scoping searches: governments, industry, independent regulatory bodies and engineering and medical publications. Any current standard relevant to trauma and orthopaedic implants will be included. We will use a predefined search strategy and follow the recommendations of the Cochrane handbook where applicable. We will undertake a narrative synthesis with qualitative evaluation of homogeneity between engineering standards. ETHICS AND DISSEMINATION:No ethics approval is required as no primary data are being collected. The results will be made available by peer-reviewed publication and reported according to PRISMA-P guidelines.

Project description:BackgroundThe posttreatment pain associated with breast augmentation is a top concern of most patients and can affect the decision concerning surgery.ObjectivesThis study aimed to compare the posttreatment pain and recovery times of patients undergoing primary breast augmentation with lightweight vs full-mass implants of similar volumes. The authors hypothesized that the reduced mechanical strain applied by lightweight implants elicits less pain.MethodsIn this retrospective, observational study, 100 women who had undergone primary breast augmentation with either a lightweight breast implant or a traditional full-mass silicone implant (n = 50), were contacted by phone and asked about their posttreatment experiences and overall satisfaction with the outcome. All women were treated by the same surgical team, and the two groups were matched by date of surgery.ResultsMost patients in the two cohorts had a self-reported preoperative B cup size and relatively high tolerance to pain. On average, LWBI patients were 6 years older than those undergoing full-mass implantation (32.4 ± 8.7 vs 26.2 ± 8.0; P = .0004) and more had experienced at least one pregnancy (61.2% vs 24%, P = .0002). LWBI patients opted for implants 39 ± 28.4 cc larger than patients in the control group. Subglandular placement was selected in most cases (LWBI: 83.7% and full-mass: 90.0%). Mean posttreatment pain was lower in the LWBI cohort (5.5 ± 2.4 vs 6.5 ± 2.4) and required a shorter duration of analgesics (3.87 ± 1.77 days vs 5.26 ± 2.94 days; P = .009). Age- and parity-adjusted measures demonstrated a respective 2-day and 5-day shorter recovery period and return to normal activities interval in the LWBI versus full-mass implant cohorts (P = .04 and P = .002, respectively).ConclusionsAs compared to traditional silicone filled full-mass implants, breast augmentations with B-Lite lightweight breast implants (G&G Biotechnology Ltd., Haifa, Israel) elicit less posttreatment pain and require less down-time, ultimately, meeting patients' quest for desired breast shape at minimal discomfort.Level of evidence 3

Dataset Information

Complications in breast augmentation with textured versus smooth breast implants: a systematic review protocol.

Publications

Complications in breast augmentation with textured versus smooth breast implants: a systematic review protocol.

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