Effects of general anesthesia on quality of recovery after transaxillary endoscopic breast augmentation: A randomized controlled trial.

BACKGROUND: Types of general anesthesia may affect the quality of recovery, but few studies have investigated the quality of postoperative recovery, and none has focused on patients undergoing breast augmentation. METHODS: This prospective, parallel, randomized controlled study enrolled 104 patients undergoing transaxillary endoscopic breast augmentation. Eligible patients were randomly assigned to receive inhalation anesthesia (IH, n = 52) or total intravenous anesthesia (TIVA, n = 52). Quality of recovery was assessed on the first and on the second postoperative days using the 15-item Quality of Recovery questionnaire (QoR-15). Baseline demographic, clinical characteristics, and operative data were also collected. RESULTS: The IH and TIVA groups had similar QoR-15 total scores on the first postoperative day (P = .921) and on the second postoperative day (P = .960), but the IH group had a significantly higher proportion of patients receiving antiemetics than the TIVA group (53.6% vs 23.1%, P = .002). Multivariate analysis revealed that the type of general anesthesia was not significantly associated with QoR-15 total scores on the first postoperative day (ß = 0.68, P = .874) and with QoR-15 total scores on the second postoperative day (ß = 0.56, P = .892), after adjusting for age, BMI, operation time, steroids use, and antiemetics use. CONCLUSION: For the patients undergoing transaxillary endoscopic breast augmentation, the type of general anesthesia did not significantly impact the quality of recovery. Both IH or TIVA could provide good quality of recovery demonstrated by high QoR-15 total scores. The results suggested that the type of general anesthesia may not be the most critical factors of quality of recovery in the patients undergoing transaxillary endoscopic breast augmentation.

Significantly reducing implant loss rates in immediate implant-based breast reconstruction: A protocol and completed audit of quality assurance.

INTRODUCTION: Immediate implant-based breast reconstruction (IBR) rates have increased considerably with the advent of acellular dermal matrices. Implant loss is a significant complication and is costly to patients and the NHS. National Mastectomy and Breast Reconstruction Audit and Implant-Based Breast Reconstruction Audit data have demonstrated national implant loss rate of 9% at 3 months. National Oncoplastic Guidelines for Best Practice cite a < 5% target. We aimed to reduce implant loss by introducing a protocol with pre-, intra- and post-operative interventions. METHODS: Audit of IBR at a single oncoplastic breast unit was commenced and implant loss at 3 months was recorded (May 2012-July 2014). Patients were identified from a prospectively maintained database, and case notes were examined by identifying factors associated with implant loss. A team involving microbiology, theatre staff, infection control and surgeons was established. A novel, evidence-based intervention bundle, including more than 25 protocol changes, was introduced. Prospective re-audit of IBR (April 2015-December 2017) was completed following introduction of the new protocol and implant loss was recorded at 3 months. RESULTS: The first retrospective audit of 77 reconstructions (54 patients) demonstrated 11 implant losses at 3 months (14%). Re-audit, post-intervention, comprised 129 reconstructions (106 patients) with no implant loss at 3 months. Fisher's exact analysis revealed statistically significant reduction in implant loss rate (P < 0.00001) following protocol introduction. CONCLUSIONS: Implant loss rate following IBR can be reduced to an exceptionally low level, well below national targets, by adhering to this evidence-based intervention bundle. Our protocol could improve outcomes nationally.

How to improve patient safety and quality of care in breast implant surgery? First outcomes from the Dutch Breast Implant Registry (2015-2017).

BACKGROUND: Although the use of breast implants is generally considered to be safe, breast implants are associated with short- and long-term complications. To evaluate and improve the quality of breast implant surgery, and increase our knowledge of implant performance, the national Dutch Breast Implant Registry (DBIR) was established in 2015. DBIR is one of the first up-and-running breast implant registries worldwide and follows an opt-out structure. OBJECTIVE: This article provides an overview of the first outcomes and experiences of the DBIR. METHODS: The national coverage of DBIR was studied using data from the Dutch Health and Youth Care Inspectorate. The incidence rate of breast implants was calculated for 2016 and 2017, and patient, device, and surgery characteristics were compared between cosmetic breast augmentations or reconstructive indications. Four infection control, measures were selected to demonstrate the variation in the Dutch clinical practice. RESULTS: In 2016, 95% of the hospitals and 78% of the private clinics participated in DBIR. Between 2015 and 2017, a total of 15,049 patients and 30,541 breast implants were included. A minimum breast implant incidence rate of 1 per 1,691 women could be determined for 2017. The majority of devices were inserted for a cosmetic indication (85.2%). In general, patient, device, and surgery characteristics differed per indication group. Substantial variation was seen in the use of infection control measures (range 0-100%). CONCLUSION: Preliminary results obtained from DBIR show high national participation rates and support further developments toward the improvement of breast implant surgery and patient safety.

Postmastectomy Radiation Therapy (PMRT) before and after 2-Stage Expander-Implant Breast Reconstruction: A Systematic Review.

Background: In those undergoing treatment for breast cancer, evidence has demonstrated a significant improvement in survival, and a reduction in the risk of local recurrence in patients who undergo postmastectomy radiation therapy (PMRT). There is uncertainty about the optimal timing of PMRT, whether it should be before or after tissue expander or permanent implant placement. This study aimed to summarize the data reported in the literature on the effect of the timing of PMRT, both preceding and following 2-stage expander-implant breast reconstruction (IBR), and to statistically analyze the impact of timing on infection rates and the need for explantation. Methods: A comprehensive systematic review of the literature was conducted using the PubMed/Medline, Ovid, and Cochrane databases without timeframe limitations. Articles included in the analysis were those reporting outcomes data of PMRT in IBR published from 2009 to 2017. Chi-square statistical analysis was performed to compare infection and explantation rates between the two subgroups at p < 0.05. Results: A total of 11 studies met the inclusion criteria for this study. These studies reported outcomes data for 1565 total 2-stage expander-IBR procedures, where PMRT was used (1145 before, and 420 after, implant placement). There was a statistically significant higher likelihood of infection following pre-implant placement PMRT (21.03%, p = 0.000079), compared to PMRT after implant placement (9.69%). There was no difference in the rate of explantation between pre-implant placement PMRT (12.93%) and postimplant placement PMRT (11.43%). Conclusion: This study suggests that patients receiving PMRT before implant placement in 2-stage expander-implant based reconstruction may have a higher risk of developing an infection.

A Comparison of Outcomes and Resource Utilization Between Plastic Surgeons and General Surgeons in Implant-Based Breast Reconstruction.

BACKGROUND: Because of lack of patient education on the importance of surgeon certification and barriers to access a plastic surgeon (PS), non-PSs are becoming more involved in providing implant-based breast reconstruction procedures. We aim to clarify differences in outcomes and resource utilization by surgical specialty for implant-based breast reconstruction. METHODS: Data were obtained from the American College of Surgeons National Surgical Quality Improvement Program database from 2012 to 2014. Patients undergoing immediate implant-based reconstruction or immediate/delayed tissue expander-based reconstruction were identified (Current Procedural Terminology codes 19340 and 19357, respectively). Outcomes studied were major and wound-based 30-day complications, operation time, unplanned readmission or reoperation, and length of hospital stay. RESULTS: We identified 9264 patients who underwent prosthesis or tissue expander-based breast reconstruction, 8362 (90.3%) by PSs and 902 (9.7%) by general surgeons (GSs). There were significant differences in major complications between specialty (1.2% PS vs 2.8% GS; P < 0.001). There were no significant differences in unplanned reoperation (5.3% PS vs 4.9% GS; P = 0.592), unplanned readmissions (4.3% PS vs 3.8% GS; P = 0.555), wound dehiscence (0.7% PS vs 0.6% GS; P = 0.602), or wound-based infection rates (2.9% PS vs 2.8% GS; P = 0.866). As it pertains to resource utilization, the GS patients had a significantly longer length of stay (1.02 ± 4.41 days PS vs 1.62 ± 4.07 days GS; P < 0.001) and operative time (164.3 ± 97.6 minutes PS vs 185.4 ± 126.5 minutes; P = 0.001) than PS patients. CONCLUSIONS: This current assessment demonstrates that patients who undergo breast implant reconstruction by a GS have significantly more major complications. It is beneficial for the health care system for PSs to be the primary providers of breast reconstruction services. Measures should be taken to ensure that PSs are available and encouraged to provide this service.

Evaluation of Modifications to Tissue-Expander Breast Reconstruction, a Quality Improvement Assessment Within a Private Practice.

BACKGROUND: As technology advances, surgical practice evolves over time. The author assesses a new approach to implant-based breast reconstruction and the impact of two changes implemented over several years. METHODS: A series of tissue-expander reconstructions performed early in the author's experience were retrospectively compared with a similar number of cases prospectively performed. Demographics, perioperative characteristics, and postoperative outcomes were assessed. RESULTS: Fifty-three patients (87 breasts) were analyzed, 29 treated earlier with one of the early acellular dermal matrices (ADMs) available and 24 current cases using a no-touch operative approach and pliable, perforated ADM. Demographics and perioperative characteristics between the cohorts were comparable. Mean age was 47.6 years, body mass index (BMI) of 25.8 and 18.9% had current or former nicotine use. Immediate reconstruction was performed in 75 (86.2%) breasts. Drains remained in situ 16 ± 8.9 days, with a significantly lower number of days required in latter patients. At a mean follow-up of 9.6 months, complications included early capsular thickening in 7 (13.2%) patients requiring capsulectomy at the second stage exchange surgery, prosthetic (expander) removal in 3 (3.4%) breasts, significant infection requiring intervention in 3 (5.7%) patients, seroma in 3 (5.7%) patients, 2 (3.8%) cases of wound dehiscence, and 1 (1.9%) case of flap necrosis and hematoma. Incomplete ADM incorporation was observed in 9 (10.3%) breasts. Three reconstructive failures occurred in the early cohort. Patients in the later cohort reported significantly improved BREAST-Q scores (P < 0.005) postoperatively with a high level of satisfaction. CONCLUSIONS: Using a no-touch technique and an ADM designed with functional characteristics advantageous to breast reconstructive surgery appears to have improved patient outcomes.

Adherence to best practice consensus guidelines for implant-based breast reconstruction: Results from the iBRA national practice questionnaire survey.

INTRODUCTION: The 2008 National Mastectomy and Breast Reconstruction Audit demonstrated marked variation in the practice and outcomes of breast reconstruction in the UK. To standardise practice and improve outcomes for patients, the British professional associations developed best-practice guidelines with specific guidance for newer mesh-assisted implant-based techniques. We explored the degree of uptake of best-practice guidelines within units performing implant-based reconstruction (IBBR) as the first phase of the implant Breast Reconstruction Evaluation (iBRA) study. METHODS: A questionnaire developed by the iBRA Steering Group was completed by trainee and consultant leads at breast and plastic surgical units across the UK. Simple summary statistics were calculated for each survey item to assess compliance with current best-practice guidelines. RESULTS: 81 units from 79 NHS Trusts completed the questionnaire. Marked variation was observed in adherence to guidelines, especially those relating to clinical governance and infection prevention strategies. Less than half (n = 28, 47%) of units obtained local clinical governance board approval prior to offering new mesh-based techniques and prospective audit of the clinical, cosmetic and patient-reported outcomes of surgery was infrequent. Most units screened for methicillin-resistant staphylococcus aureus prior to surgery but fewer than 1 in 3 screened for methicillin-sensitive strains. Laminar-flow theatres (recommended for IBBR) were not widely-available with less than 1 in 5 units having regular access. Peri-operative antibiotics were widely-used, but the type and duration were highly-variable. CONCLUSIONS: The iBRA national practice questionnaire has demonstrated variation in reported practice and adherence to IBBR guidelines. High-quality evidence is urgently required to inform best practice.

Current Trends in Breast Augmentation: An International Analysis.

BACKGROUND: Breast augmentation surgery remains the most frequently performed aesthetic surgical procedure worldwide. However, many variations exist regarding preoperative planning, surgical management, and postoperative care. OBJECTIVES: The goal was to evaluate current trends and practices in breast augmentation, with a focus on international variability. METHODS: A questionnaire was sent to over 5000 active breast surgeons in 44 countries worldwide. The survey inquired about current controversies, new technologies, common practices, secondary procedures, and surgeon demographics. The findings and variations were evaluated and correlated to evidence-based literature. RESULTS: There were a total 628 respondents equaling a response rate of approximately 18%. While certain approaches and common practices prevail also on an international basis, there exist several geographic controversies. For example, while almost fifty percent of surgeons in the United States and Latin America never use anatomically shaped implants, in Europe and Oceania most surgeons use them. Similarly, in Latin America, Europe, Asia, and Oceania, over 80% of surgeons use silicone implants only, whereas in the United States only 20% use them - meanwhile US surgeons use the largest implants (78% > 300 cc). Internationally dominant practice preferences include preoperative sizing with silicone implants, as well as the use of inframammary incisions and partial submuscular pockets. CONCLUSIONS: Significant differences exist when comparing most common surgical breast augmentation approaches on an international basis. While certain techniques seem to be universal standards, there still remain several controversies. Further standardizing this most common aesthetic surgical procedure according to evidence-based guidelines will help to improve outcomes.

Liability for providing a prognosis in surgical practice.

The common law's development of the doctrine of informed consent has progressively imposed broader obligations on surgeons to provide patients with information about the surgical and alternative treatment choices available. Prognosis is critical because the patient cannot provide informed consent without information about the likely evolution of the physiological or pathological processes involved in the surgery under consideration. But does the duty of care that a surgeon owes a patient require a precise prognosis to be given in every case? A recent decision of the Court of Appeal considers that question.

Comparing patient satisfaction in bilateral and unilateral breast reconstruction.

BACKGROUND: Current literature in breast reconstruction continues to provide answers to questions regarding patient satisfaction in the areas of autologous vs alloplastic reconstruction and silicone vs saline implants. There are no studies, however, that specifi cally address patient satisfaction with bilateral vs unilateral breast reconstruction. Our goal was to assess patient satisfaction with bilateral compared with unilateral breast reconstruction. METHODS: Over a 4-year period, 108 patients completed either unilateral or bilateral breast reconstruction from a single surgeon. Patient satisfaction in these patients was assessed using a questionnaire developed focusing on clinical outcome measures of aesthetic and functional satisfaction. RESULTS: A total of 72 anonymous surveys were returned. Statistically significant differences were seen with respect to overall symmetry, aesthetics without clothing, and overall satisfaction between unilateral and bilateral reconstructions. In each of these categories, the average patient satisfaction score was higher for bilateral reconstructions. Furthermore, when comparing unilateral vs bilateral reconstruction in the different reconstruction types, parallel differences in patient satisfaction were noted. CONCLUSION: The results of this study suggest that patients were more satisfied with bilateral reconstruction because of improved symmetry, superior aesthetic appearance without clothing, and overall satisfaction with the reconstructive process. Future studies with larger subsets of patients are needed.

Benefits and Limitations of Macrotextured Breast Implants and Consensus Recommendations for Optimizing Their Effectiveness.

Implant texture is an important factor influencing implant selection for breast augmentation. Natrelle Biocell implants are characterized by macrotextured shell surfaces containing irregularly arranged concavities with large open-pore diameters and depths. These properties facilitate adhesion of the implant to the surrounding tissue, thereby promoting implant immobilization. Relative to implants with other surfaces, macrotextured implants offer low rates of capsular contracture; low rates of malposition, rotation, and rippling; and high rates of patient satisfaction. However, macrotextured implants are associated with a slightly higher risk of double capsule and late seroma. The surgeon can minimize these risks with straightforward techniques that encourage tissue adhesion. This report presents experience-based recommendations to optimize the effectiveness of Biocell anatomic implants. The authors discuss the application of best practices to all aspects of the breast implantation process, from implant selection and surgical planning to operative technique and postoperative management. LEVEL OF EVIDENCE 3.

'If it ain't broke, don't fix it?': scandals, 'risk', and cosmetic surgery regulation in the UK and France.

The recent PIP scandal that affected patients worldwide, and received extensive media coverage, led to concerns being felt by patients about the 'risks' of cosmetic surgery. Theories about regulation and risk refer to societies such as those in the West becoming more risk averse. Regulation, in turn, has come to be seen as an instrument to solve a problem for a community seen to be or which perceives itself to be at risk. The political and electoral risk acknowledged by government if it ignores that concern, or at least media coverage of it, can lead to regulation, or the tightening up of regulation, as a response. This article looks at current proposals for legislation in the UK following the PIP silicone implant scandal as an example of the risk-regulation premise. Are cosmetic surgery patients in the UK now going to see stricter regulation of the cosmetic surgery industry? The article argues that the UK and France have both reacted to healthcare scandals and the ensuing societal conception of risk by drawing up more thorough legislation on cosmetic surgery than previously existed. France enacted the Kouchner law in 2002 and the UK government published the Keogh Report in April 2013. A comparison is made of these to establish whether the UK can learn from the French legislation when it comes to drafting actual regulation in the future, perhaps in 2014. Finally, some arguments are made about whether risk aversion may make better law.

The process of breast augmentation: four sequential steps for optimizing outcomes for patients.

BACKGROUND: Breast augmentation has been an integral part of plastic surgeons' practices for over 40 years. Although devices have evolved, patient outcomes are still not ideal, as documented in multiple premarket approval clinical trials. Unlike many other areas of surgery, the practice of breast augmentation has suffered from the lack of a defined process for patient management. The purpose of this study was to clinically define and evaluate the process of breast augmentation and analyze patient outcomes using these practices compared with existing premarket approval trial data. METHODS: Three hundred consecutive primary breast augmentations from 2001 to 2005 were followed prospectively. Each patient underwent a defined process of breast augmentation including structured patient education and informed consent; tissue-based preoperative planning consultation; refined surgical technique; and structured postoperative instructions, management, and follow-up. RESULTS: The mean follow-up was 2.1 years. The most common complications were rippling and palpability, soft-tissue stretch, and hypersensitivity. The overall reoperation rate was 3.7 percent for the entire group and 4.7 percent and 2.9 percent for saline and form-stable cohesive gel implants, respectively. CONCLUSIONS: Optimizing patient outcomes in breast augmentation requires defining the overall process to allow for enhanced patient outcomes. This is the first report that defines and integrates the entire process comprehensively that is validated by outcomes data. This process is transferable to other surgeons and, using this algorithm, patient outcomes in this study were superior to premarket approval clinical trial data. In summary, approaching this procedure with a global process produces superior patient outcomes in breast augmentation.

Achieving a predictable 24-hour return to normal activities after breast augmentation: part I. Refining practices by using motion and time study principles.

The purpose of this study was to develop techniques to predictably return patients receiving inframammary and axillary, subpectoral breast augmentation to full normal activities within 24 hours of their primary breast augmentation. This 5-year study applies motion and time study principles to refine practices in augmentation mammaplasty to reduce perioperative morbidity and shorten patient recovery. Retrospective data for operative times, medications administered, recovery times, times to discharge, and time to return to normal activities were collected from patient chart reviews and patient contacts from 1982 to 1984 (group 1, n = 16, axillary partial retropectoral augmentations) and 1990 (group 2, n = 16, inframammary partial retropectoral augmentations). Videotapes from operative procedures of groups 1 and 2 were analyzed with macromotion and micromotion study principles, and tables of events were formulated for all operating room personnel, detailing every step of each function they performed. The events tables were then refined into detailed scripts by using motion and time study principles. Scripts were used for surgeon and personnel training and for reference during operative procedures. Extensive changes in all aspects of patient care, including patient education, preparation, operative planning, implant selection, anesthesia techniques, surgical techniques, instrumentation, and postoperative care derived from data and videotape studies of patients in groups 1 and 2 were then applied to a third group of patients (group 3), collecting prospective data over a 3-year period (1998 to 2000). Group 3 (n = 627) data included timed events, medications, and time to return to normal activities. Patients in group 3 had substantially shorter anesthesia, operation, and postanesthesia care unit times and time to discharge and time to return to normal activities compared with groups 1 and 2. Of the patients in group 3, 96 percent were able to return to normal activities, lift their arms above their heads, lift normal-weight objects, and drive their car without any narcotic medications, drains, bandages, special bras, or other adjunctive treatments within 24 hours after their partial retropectoral breast augmentation. Applying motion and time study principles to analysis and refinement of surgeon and personnel actions and surgical techniques resulted in a substantial reduction in perioperative morbidity and a simpler, shorter 24-hour return to normal activities without intercostal blocks, narcotic pain medications, drains, bandages, or other adjunctive devices in 96 percent of 627 augmentation patients.