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Plastic and Reconstructive Surgery.... Aug 2018Since BREAST-Q was developed in 2009, it has been widely used by clinicians and researchers to capture information regarding health-related quality of life (HRQoL) and...
BACKGROUND
Since BREAST-Q was developed in 2009, it has been widely used by clinicians and researchers to capture information regarding health-related quality of life (HRQoL) and patient satisfaction related to breast surgery. Yet clinical guidelines regarding the use of BREAST-Q for assessment of success of surgery in women with breast cancer remain limited. To maximize the benefits of using BREAST-Q to inform clinical decision making, this systematic review aimed to identify and appraise current evidence on patient-reported outcomes (PROs) assessed by BREAST-Q associated with breast oncoplastic surgery.
METHODS
A detailed search strategy was implemented and electronic databases searched include PubMed, MEDLINE, CINAHL, and PsycINFO. Review was limited to peer-reviewed studies published in English from 2009 to January 2018. Any interventional and observational studies that used BREAST-Q to assess PROs in the assessment of breast oncoplastic surgery were included.
RESULTS
Fifty-four peer-reviewed articles met inclusion criteria. Fifty-three studies were observational, 1 study was interventional. Current comparative studies using BREAST-Q indicated that abdominal flap, buttock flap, or thigh flap reconstruction offered highest satisfaction with breast; contralateral prophylactic mastectomy with immediate reconstruction offered higher levels of satisfaction with breast, but poor postsurgical physical well-being. Silicone implant and no radiation therapy offered higher level satisfaction and HRQoL.
CONCLUSIONS
Current evidence showed that BREAST-Q can effectively measure patient's satisfaction and HRQoL in relation to different type of breast oncoplastic surgeries. BREAST-Q captured meaningful and reliable information from the patients' perspective and may be useful for clinical decision making.
PubMed: 30254830
DOI: 10.1097/GOX.0000000000001904 -
Breast Cancer (Tokyo, Japan) Sep 2018Prophylactic mastectomy is used to reduce the incidence of breast cancer in women with genetic predisposition and family history of breast cancer, and the rate of... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Prophylactic mastectomy is used to reduce the incidence of breast cancer in women with genetic predisposition and family history of breast cancer, and the rate of application is increased nowadays. Chronic pain, body image, and sexuality may negatively affect quality of life, while patients generally have increased quality of life and satisfaction after prophylactic mastectomy. The aim of this study is the evaluation of the results of the studies about quality of life of patients who underwent breast reconstruction after prophylactic mastectomy.
METHODS
For the 1996-2016 literature, we searched the databases of Scopus, Science Direct, PubMed, EBSCO, Cochrane, Medline Complete, Ovid, Springer Link, Google Academic, Taylor & Francis, PsychINFO databases. For the gray literature, National Thesis Center and ULAKBIM databases were searched. Seven studies complying with the criteria were included in the review.
RESULTS
Seven studies included in this study aimed to investigate the effect of prophylactic mastectomy on breast pain, numbness, sexuality and quality of life. When the studies were reviewed, we were found that the majority of the patients were satisfied with the results of the procedure, although the body image perception and pain/ movement/ perception and sexual problems were experienced after the breast surgery.
CONCLUSIONS
While overall satisfaction with cosmetic results was high, most women were not satisfied with the softness of the reconstructed breasts, and had problems with breast hardness, numbness and sex. Therefore, it is very important to inform the patients about the complications that may develop after the operation, while there is not enough data about the importance of informing the patients before the operation.
Topics: Breast Implants; Breast Neoplasms; Female; Humans; Mammaplasty; Prophylactic Mastectomy; Quality of Life
PubMed: 29721811
DOI: 10.1007/s12282-018-0862-8 -
The Cochrane Database of Systematic... Apr 2018Recent progress in understanding the genetic basis of breast cancer and widely publicized reports of celebrities undergoing risk-reducing mastectomy (RRM) have increased... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Recent progress in understanding the genetic basis of breast cancer and widely publicized reports of celebrities undergoing risk-reducing mastectomy (RRM) have increased interest in RRM as a method of preventing breast cancer. This is an update of a Cochrane Review first published in 2004 and previously updated in 2006 and 2010.
OBJECTIVES
(i) To determine whether risk-reducing mastectomy reduces death rates from any cause in women who have never had breast cancer and in women who have a history of breast cancer in one breast, and (ii) to examine the effect of risk-reducing mastectomy on other endpoints, including breast cancer incidence, breast cancer mortality, disease-free survival, physical morbidity, and psychosocial outcomes.
SEARCH METHODS
For this Review update, we searched Cochrane Breast Cancer's Specialized Register, MEDLINE, Embase and the WHO International Clinical Trials Registry Platform (ICTRP) on 9 July 2016. We included studies in English.
SELECTION CRITERIA
Participants included women at risk for breast cancer in at least one breast. Interventions included all types of mastectomy performed for the purpose of preventing breast cancer.
DATA COLLECTION AND ANALYSIS
At least two review authors independently abstracted data from each report. We summarized data descriptively; quantitative meta-analysis was not feasible due to heterogeneity of study designs and insufficient reporting. We analyzed data separately for bilateral risk-reducing mastectomy (BRRM) and contralateral risk-reducing mastectomy (CRRM). Four review authors assessed the methodological quality to determine whether or not the methods used sufficiently minimized selection bias, performance bias, detection bias, and attrition bias.
MAIN RESULTS
All 61 included studies were observational studies with some methodological limitations; randomized trials were absent. The studies presented data on 15,077 women with a wide range of risk factors for breast cancer, who underwent RRM.Twenty-one BRRM studies looking at the incidence of breast cancer or disease-specific mortality, or both, reported reductions after BRRM, particularly for those women with BRCA1/2 mutations. Twenty-six CRRM studies consistently reported reductions in incidence of contralateral breast cancer but were inconsistent about improvements in disease-specific survival. Seven studies attempted to control for multiple differences between intervention groups and showed no overall survival advantage for CRRM. Another study showed significantly improved survival following CRRM, but after adjusting for bilateral risk-reducing salpingo-oophorectomy (BRRSO), the CRRM effect on all-cause mortality was no longer significant.Twenty studies assessed psychosocial measures; most reported high levels of satisfaction with the decision to have RRM but greater variation in satisfaction with cosmetic results. Worry over breast cancer was significantly reduced after BRRM when compared both to baseline worry levels and to the groups who opted for surveillance rather than BRRM, but there was diminished satisfaction with body image and sexual feelings.Seventeen case series reporting on adverse events from RRM with or without reconstruction reported rates of unanticipated reoperations from 4% in those without reconstruction to 64% in participants with reconstruction.In women who have had cancer in one breast, removing the other breast may reduce the incidence of cancer in that other breast, but there is insufficient evidence that this improves survival because of the continuing risk of recurrence or metastases from the original cancer. Additionally, thought should be given to other options to reduce breast cancer risk, such as BRRSO and chemoprevention, when considering RRM.
AUTHORS' CONCLUSIONS
While published observational studies demonstrated that BRRM was effective in reducing both the incidence of, and death from, breast cancer, more rigorous prospective studies are suggested. BRRM should be considered only among those at high risk of disease, for example, BRCA1/2 carriers. CRRM was shown to reduce the incidence of contralateral breast cancer, but there is insufficient evidence that CRRM improves survival, and studies that control for multiple confounding variables are recommended. It is possible that selection bias in terms of healthier, younger women being recommended for or choosing CRRM produces better overall survival numbers for CRRM. Given the number of women who may be over-treated with BRRM/CRRM, it is critical that women and clinicians understand the true risk for each individual woman before considering surgery. Additionally, thought should be given to other options to reduce breast cancer risk, such as BRRSO and chemoprevention when considering RRM.
Topics: Breast Neoplasms; Female; Genes, BRCA1; Genes, BRCA2; Genetic Predisposition to Disease; Humans; Observational Studies as Topic; Patient Satisfaction; Postoperative Complications; Prophylactic Mastectomy; Risk Assessment; Unilateral Breast Neoplasms
PubMed: 29620792
DOI: 10.1002/14651858.CD002748.pub4 -
Genetics in Medicine : Official Journal... Oct 2018To review the evidence for the effectiveness and cost-effectiveness of cancer risk management interventions for BRCA carriers.
PURPOSE
To review the evidence for the effectiveness and cost-effectiveness of cancer risk management interventions for BRCA carriers.
METHODS
Comparative effectiveness and cost-effectiveness analyses were identified by searching scientific and health economic databases. Eligible studies modeled the impact of a cancer risk management intervention in BRCA carriers on life expectancy (LE), cancer incidence, or quality-adjusted life years (QALYs), with or without costs.
RESULTS
Twenty-six economic evaluations and eight comparative effectiveness analyses were included. Combined risk-reducing salpingo-oophorectomy and prophylactic mastectomy resulted in the greatest LE and was cost-effective in most analyses. Despite leading to increased LE and QALYs, combined mammography and breast magnetic resonance imaging (MRI) was less likely to be cost-effective than either mammography or MRI alone, particularly for women over 50 and BRCA2 carriers. Variation in patient compliance to risk management interventions was incorporated in 11/34 studies with the remaining analyses assuming 100% adherence.
CONCLUSION
Prophylactic surgery and intensive breast screening are effective and cost-effective in models of BRCA carrier risk management. Findings were based predominantly on assuming perfect adherence to recommendations without assessment of the health-care resource use and costs related to engaging patients and maximizing compliance, meaning the real-world impact on clinical outcomes and resource use remains unclear.
Topics: BRCA1 Protein; BRCA2 Protein; Breast Neoplasms; Cost-Benefit Analysis; Female; Humans; Mass Screening; Risk Management
PubMed: 29323669
DOI: 10.1038/gim.2017.255 -
Breast Cancer Research and Treatment Sep 2017Although there is no consensus on whether pre-operative MRI in women with breast cancer (BC) benefits surgical treatment, MRI continues to be used pre-operatively in... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Although there is no consensus on whether pre-operative MRI in women with breast cancer (BC) benefits surgical treatment, MRI continues to be used pre-operatively in practice. This meta-analysis examines the association between pre-operative MRI and surgical outcomes in BC.
METHODS
A systematic review was performed to identify studies reporting quantitative data on pre-operative MRI and surgical outcomes (without restriction by type of surgery received or type of BC) and using a controlled design. Random-effects logistic regression calculated the pooled odds ratio (OR) for each surgical outcome (MRI vs. no-MRI groups), and estimated ORs stratified by study-level age. Subgroup analysis was performed for invasive lobular cancer (ILC).
RESULTS
Nineteen studies met eligibility criteria: 3 RCTs and 16 comparative studies that included newly diagnosed BC of any type except for three studies restricted to ILC. Primary analysis (85,975 subjects) showed that pre-operative MRI was associated with increased odds of receiving mastectomy [OR 1.39 (1.23, 1.57); p < 0.001]; similar findings were shown in analyses stratified by study-level median age. Secondary analyses did not find statistical evidence of an effect of MRI on the rates of re-excision, re-operation, or positive margins; however, MRI was significantly associated with increased odds of receiving contralateral prophylactic mastectomy [OR 1.91 (1.25, 2.91); p = 0.003]. Subgroup analysis for ILC did not find any association between MRI and the odds of receiving mastectomy [OR 1.00 (0.75, 1.33); p = 0.988] or the odds of re-excision [OR 0.65 (0.35, 1.24); p = 0.192].
CONCLUSIONS
Pre-operative MRI is associated with increased odds of receiving ipsilateral mastectomy and contralateral prophylactic mastectomy as surgical treatment in newly diagnosed BC patients.
Topics: Breast Neoplasms; Female; Humans; Magnetic Resonance Imaging; Mastectomy; Mastectomy, Segmental; Odds Ratio; Preoperative Care; Prognosis; Reoperation; Treatment Outcome
PubMed: 28589366
DOI: 10.1007/s10549-017-4324-3 -
The Cochrane Database of Systematic... Apr 2017Decision aids are interventions that support patients by making their decisions explicit, providing information about options and associated benefits/harms, and helping... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Decision aids are interventions that support patients by making their decisions explicit, providing information about options and associated benefits/harms, and helping clarify congruence between decisions and personal values.
OBJECTIVES
To assess the effects of decision aids in people facing treatment or screening decisions.
SEARCH METHODS
Updated search (2012 to April 2015) in CENTRAL; MEDLINE; Embase; PsycINFO; and grey literature; includes CINAHL to September 2008.
SELECTION CRITERIA
We included published randomized controlled trials comparing decision aids to usual care and/or alternative interventions. For this update, we excluded studies comparing detailed versus simple decision aids.
DATA COLLECTION AND ANALYSIS
Two reviewers independently screened citations for inclusion, extracted data, and assessed risk of bias. Primary outcomes, based on the International Patient Decision Aid Standards (IPDAS), were attributes related to the choice made and the decision-making process.Secondary outcomes were behavioural, health, and health system effects.We pooled results using mean differences (MDs) and risk ratios (RRs), applying a random-effects model. We conducted a subgroup analysis of studies that used the patient decision aid to prepare for the consultation and of those that used it in the consultation. We used GRADE to assess the strength of the evidence.
MAIN RESULTS
We included 105 studies involving 31,043 participants. This update added 18 studies and removed 28 previously included studies comparing detailed versus simple decision aids. During the 'Risk of bias' assessment, we rated two items (selective reporting and blinding of participants/personnel) as mostly unclear due to inadequate reporting. Twelve of 105 studies were at high risk of bias.With regard to the attributes of the choice made, decision aids increased participants' knowledge (MD 13.27/100; 95% confidence interval (CI) 11.32 to 15.23; 52 studies; N = 13,316; high-quality evidence), accuracy of risk perceptions (RR 2.10; 95% CI 1.66 to 2.66; 17 studies; N = 5096; moderate-quality evidence), and congruency between informed values and care choices (RR 2.06; 95% CI 1.46 to 2.91; 10 studies; N = 4626; low-quality evidence) compared to usual care.Regarding attributes related to the decision-making process and compared to usual care, decision aids decreased decisional conflict related to feeling uninformed (MD -9.28/100; 95% CI -12.20 to -6.36; 27 studies; N = 5707; high-quality evidence), indecision about personal values (MD -8.81/100; 95% CI -11.99 to -5.63; 23 studies; N = 5068; high-quality evidence), and the proportion of people who were passive in decision making (RR 0.68; 95% CI 0.55 to 0.83; 16 studies; N = 3180; moderate-quality evidence).Decision aids reduced the proportion of undecided participants and appeared to have a positive effect on patient-clinician communication. Moreover, those exposed to a decision aid were either equally or more satisfied with their decision, the decision-making process, and/or the preparation for decision making compared to usual care.Decision aids also reduced the number of people choosing major elective invasive surgery in favour of more conservative options (RR 0.86; 95% CI 0.75 to 1.00; 18 studies; N = 3844), but this reduction reached statistical significance only after removing the study on prophylactic mastectomy for breast cancer gene carriers (RR 0.84; 95% CI 0.73 to 0.97; 17 studies; N = 3108). Compared to usual care, decision aids reduced the number of people choosing prostate-specific antigen screening (RR 0.88; 95% CI 0.80 to 0.98; 10 studies; N = 3996) and increased those choosing to start new medications for diabetes (RR 1.65; 95% CI 1.06 to 2.56; 4 studies; N = 447). For other testing and screening choices, mostly there were no differences between decision aids and usual care.The median effect of decision aids on length of consultation was 2.6 minutes longer (24 versus 21; 7.5% increase). The costs of the decision aid group were lower in two studies and similar to usual care in four studies. People receiving decision aids do not appear to differ from those receiving usual care in terms of anxiety, general health outcomes, and condition-specific health outcomes. Studies did not report adverse events associated with the use of decision aids.In subgroup analysis, we compared results for decision aids used in preparation for the consultation versus during the consultation, finding similar improvements in pooled analysis for knowledge and accurate risk perception. For other outcomes, we could not conduct formal subgroup analyses because there were too few studies in each subgroup.
AUTHORS' CONCLUSIONS
Compared to usual care across a wide variety of decision contexts, people exposed to decision aids feel more knowledgeable, better informed, and clearer about their values, and they probably have a more active role in decision making and more accurate risk perceptions. There is growing evidence that decision aids may improve values-congruent choices. There are no adverse effects on health outcomes or satisfaction. New for this updated is evidence indicating improved knowledge and accurate risk perceptions when decision aids are used either within or in preparation for the consultation. Further research is needed on the effects on adherence with the chosen option, cost-effectiveness, and use with lower literacy populations.
Topics: Communication; Conservative Treatment; Decision Support Techniques; Elective Surgical Procedures; Health Knowledge, Attitudes, Practice; Humans; Patient Education as Topic; Patient Participation; Physician-Patient Relations; Publication Bias; Randomized Controlled Trials as Topic
PubMed: 28402085
DOI: 10.1002/14651858.CD001431.pub5 -
American Journal of Surgery Oct 2016Mutations in BRCA1 or BRCA2 genes results in an elevated risk for developing both breast and ovarian cancers over the lifetime of affected carriers. General surgeons may... (Review)
Review
BACKGROUND
Mutations in BRCA1 or BRCA2 genes results in an elevated risk for developing both breast and ovarian cancers over the lifetime of affected carriers. General surgeons may be faced with questions about surgical risk reduction and survival benefit of prophylactic surgery.
METHODS
A systematic literature review was performed using the electronic databases PubMed, OVID MEDLINE, and Scopus comparing prophylactic surgery vs observation with respect to breast and ovarian cancer risk reduction and mortality in BRCA mutation carriers.
RESULTS
Bilateral risk-reducing mastectomy provides a 90% to 95% risk reduction in BRCA mutation carriers, although the data do not demonstrate improved mortality. The reduction in ovarian and breast cancer risks using risk-reducing bilateral salpingo-oophorectomy has translated to improvement in survival.
CONCLUSIONS
Clinical management of patients at increased risk for breast cancer requires consideration of risk, patient preference, and quality of life.
Topics: Breast Neoplasms; Female; Genes, BRCA1; Genes, BRCA2; Heterozygote; Humans; Mutation; Ovarian Neoplasms; Ovariectomy; Prophylactic Mastectomy; Prophylactic Surgical Procedures; Salpingectomy
PubMed: 27649974
DOI: 10.1016/j.amjsurg.2016.06.010 -
Archives of Plastic Surgery Jul 2016Nipple-sparing mastectomy (NSM) is increasingly popular as a procedure for the treatment of breast cancer and as a prophylactic procedure for those at high risk of... (Review)
Review
Nipple-sparing mastectomy (NSM) is increasingly popular as a procedure for the treatment of breast cancer and as a prophylactic procedure for those at high risk of developing the disease. However, it remains a controversial option due to questions regarding its oncological safety and concerns regarding locoregional recurrence. This systematic review with a pooled analysis examines the current literature regarding NSM, including locoregional recurrence and complication rates. Systematic electronic searches were conducted using the PubMed database and the Ovid database for studies reporting the indications for NSM and the subsequent outcomes. Studies between January 1970 and January 2015 (inclusive) were analysed if they met the inclusion criteria. Pooled descriptive statistics were performed. Seventy-three studies that met the inclusion criteria were included in the analysis, yielding 12,358 procedures. After a mean follow up of 38 months (range, 7.4-156 months), the overall pooled locoregional recurrence rate was 2.38%, the overall complication rate was 22.3%, and the overall incidence of nipple necrosis, either partial or total, was 5.9%. Significant heterogeneity was found among the published studies and patient selection was affected by tumour characteristics. We concluded that NSM appears to be an oncologically safe option for appropriately selected patients, with low rates of locoregional recurrence. For NSM to be performed, tumours should be peripherally located, smaller than 5 cm in diameter, located more than 2 cm away from the nipple margin, and human epidermal growth factor 2-negative. A separate histopathological examination of the subareolar tissue and exclusion of malignancy at this site is essential for safe oncological practice. Long-term follow-up studies and prospective cohort studies are required in order to determine the best reconstructive methods.
PubMed: 27462565
DOI: 10.5999/aps.2016.43.4.328 -
Breast (Edinburgh, Scotland) Aug 2016Conduct a systematic review of quantitative and qualitative studies exploring patient reported factors and psychological variables influencing the decision to have... (Review)
Review
OBJECTIVE
Conduct a systematic review of quantitative and qualitative studies exploring patient reported factors and psychological variables influencing the decision to have contralateral prophylactic mastectomy (CPM), and satisfaction with CPM, in women with early stage breast cancer.
METHODS
Studies were identified via databases: Medline, CINAHL, Embase and PsycINFO. Data were extracted by one author and crosschecked by two additional authors for accuracy. The quality of included articles was assessed using standardised criteria by three authors.
RESULTS
Of the 1346 unique citations identified, 17 were studies that met the inclusion criteria. Studies included were primarily cross-sectional and retrospective. No study utilised a theoretical framework to guide research and few studies considered psychological predictors of CPM. Fear of breast cancer was the most commonly cited reason for CPM, followed by cosmetic reasons such as desire for symmetry. Overall, women appeared satisfied with CPM, however, adverse/diminished body image, poor cosmetic result, complications, diminished sense of sexuality, emotional issues and perceived lack of education regarding alternative surveillance/CPM efficacy were cited as reasons for dissatisfaction.
CONCLUSION
Current literature has begun to identify patient-reported reasons for CPM; however, the relative importance of different factors and how these factors relate to the process underlying the decision to have CPM are unknown. Of women who considered CPM, limited information is available regarding differences between those who proceed with or ultimately decline CPM.
Topics: Body Image; Breast Neoplasms; Choice Behavior; Emotions; Fear; Female; Humans; Patient Education as Topic; Patient Satisfaction; Prophylactic Mastectomy; Sexuality
PubMed: 27290619
DOI: 10.1016/j.breast.2016.04.005 -
The Cochrane Database of Systematic... May 2016Breast cancer is the most common cancer in women worldwide, and is a leading cause of cancer death among women. Prophylactic or curative mastectomy is often followed by... (Review)
Review
BACKGROUND
Breast cancer is the most common cancer in women worldwide, and is a leading cause of cancer death among women. Prophylactic or curative mastectomy is often followed by breast reconstruction for which there are several surgical approaches that use breast implants with which surgeons can restore the natural feel, size and shape of the breast.
OBJECTIVES
To assess the effects of different types of breast implants on capsular contracture, surgical short- and long-term complications, postoperative satisfaction level and quality of life in women who have undergone reconstructive breast surgery after mastectomy.
SEARCH METHODS
We searched the Cochrane Breast Cancer Group's Specialised Register on 20 July 2015, MEDLINE (1985 to 20 July 2015), EMBASE (1985 to 20 July 2015) and the Cochrane Central Register of Controlled Trials (CENTRAL; Issue 8, 2015). We also searched the World Health Organization's International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov on 16 July 2015.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) and quasi-RCTs that compared different types of breast implants for reconstructive surgery. We considered the following types of intervention: implant envelope surfaces - texturised versus smooth; implant filler material - silicone versus saline, PVP-Hydrogel versus saline; implant shape - anatomical versus round; implant volume - variable versus fixed; brands - different implant manufacturing companies and implant generation (fifth versus previous generations).
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed methodological quality and extracted data. We used standard Cochrane methodological procedures. The quality of the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system.
MAIN RESULTS
Five RCTs with 202 participants met the inclusion criteria. The women participants were typically in their 50s, and the majority of them (about 82%) received reconstructive surgery following breast cancer, while the others had reconstructive surgery after prophylactic mastectomy. The studies were heterogenous in terms of implant comparisons, which prevented us from pooling the data.The studies were judged as being at an unclear risk of bias for most risk of bias items owing to poor quality of reporting in the trial publications. Three of the five RCTs were judged to be at high risk of attrition bias, and one at high risk of detection bias.Textured silicone versus smooth silicone implants: textured implants were associated with worse outcomes when compared to smooth implants (capsular contracture: risk ratio (RR) 0.82, 95% CI 0.14 to 4.71; 1 study, 20 participants; very low quality evidence; reintervention: RR 0.82, 95% CI 0.14 to 4.71; 1 study, 20 participants; very low quality evidence). No results in this comparison were statistically significant.Silicone versus saline implants: saline-filled implants performed better than silicone-filled implants for some outcomes; specifically, they produced less severe capsular contracture (RR 3.25, 95% CI 1.24 to 8.51; 1 study, 60 participants; very low quality evidence) and increased patient satisfaction (RR 0.60, 95% CI 0.41 to 0.88; 1 study, 58 participants; very low quality evidence). However reintervention was significantly more frequent in the saline-filled implant group than in the silicone-filled group (OR 0.08, 95% CI 0.01 to 0.43; 1 study, 60 participants; very low quality evidence).Poly(N-vinyl-2-pyrrolidone) hydrogel-filled (PVP-hydrogel) versus saline-filled implants: PVP-hydrogel-filled implants were associated with worse outcomes when compared to saline-filled implants (capsular contracture: RR 3.50, 95% CI 0.83 to 14.83; 1 study, 40 participants; very low quality evidence; short-term complications: RR 2.10, 95% CI 0.21 to 21.39; 1 study, 41 participants; very low quality evidence).Anatomical versus round implants: anatomical implants were associated with worse outcomes than round implants (capsular contracture: RR 2.00, 95% CI 0.20 to 20.15; 1 study, 36 participants; very low quality evidence; short-term complications: RR 2.00, 95% CI 0.42 to 9.58; 1 study, 36 participants; very low quality evidence; reintervention: RR 1.50, 95% CI 0.51 to 4.43; 1 study, 36 participants; very low quality evidence). No results in this comparison were statistically significant.Variable-volume versus fixed-volume implants: data about one-stage reconstruction using variable-volume implants were compared with data about fixed-volume implants positioned during the second surgical procedure of two-stage reconstructions. Fixed-volume implant reconstructions were possibly associated with a greater number of women reporting that their reconstruction corresponded with expected results (RR 0.25, 95% CI 0.10 to 0.62; 1 study, 40 participants; very low quality evidence) and fewer reinterventions (RR 7.00, 95% CI 1.82 to 26.89; 1 study, 40 participants; very low quality evidence) when compared to variable-volume implants. A higher patient satisfaction level (rated from 1 to 6, with 1 being very bad and 6 being very good) was found with the fixed-volume implants for overall aesthetic result (mean difference (MD) -1.10, 95% CI -1.59 to -0.61; 1 study, 40 participants; very low quality evidence).There were no studies that examined the effects of recent (fifth) generation silicone implants versus previous generations or different implant manufacturing companies.
AUTHORS' CONCLUSIONS
Despite the central role of breast reconstruction in women with breast cancer, the best implants to use in reconstructive surgery have been studied rarely in the context of RCTs. Furthermore the quality of these studies and the overall evidence they provide is largely unsatisfactory. Some of our results can be interpreted as early evidence of potentially large differences between different surgical approaches, which should be confirmed in new high-quality RCTs that include a larger number of women. These days - even after a few million women have had breasts reconstructed - surgeons cannot inform women about the risks and complications of different implant-based breast reconstructive options on the basis of results derived from RCTs.
Topics: Breast Implants; Breast Neoplasms; Female; Humans; Hydrogels; Mammaplasty; Mastectomy; Middle Aged; Patient Satisfaction; Prophylactic Surgical Procedures; Prosthesis Failure; Randomized Controlled Trials as Topic; Silicone Gels; Sodium Chloride
PubMed: 27182693
DOI: 10.1002/14651858.CD010895.pub2