Technical Refinements and Outcomes Assessment in Prepectoral Pocket Conversion After Postmastectomy Radiotherapy.

BACKGROUND: Several studies show how submuscular breast reconstruction is linked to animation deformity, shoulder dysfunction, and increased postoperative chest pain, when compared to prepectoral breast reconstruction. In solving all these life-impairing side effects, prepectoral implant pocket conversion has shown encouraging results. OBJECTIVES: The aim of this study was to propose a refinement of the prepectoral implant pocket conversion applied to previously irradiated patients. METHODS: We conducted a retrospective study on 42 patients who underwent previous nipple- or skin-sparing mastectomy and immediate submuscular reconstruction, followed by radiotherapy. We performed fat grafting sessions as regenerative pretreatment. Six months after the last fat graft, we performed the conversion, with prepectoral placement of micropolyurethane foam-coated implants. We investigated the preconversion and postconversion differences in upper limb range of motion, Upper Extremity Functional Index, and patient satisfaction with the breast and physical well-being of the chest. RESULTS: We reported a resolution of animation deformity in 100% of cases. The range of motion and the Upper Extremity Functional Index scores were statistically improved after prepectoral implant pocket conversion. BREAST-Q scores for satisfaction with the breast and physical well-being of the chest were also improved. CONCLUSIONS: The refined prepectoral implant pocket conversion is a reliable technique for solving animation deformity and improving quality of life in patients previously treated with submuscular reconstruction and radiotherapy.

Post-mastectomy Breast Reconstruction With Gas vs Saline Tissue Expanders: Does the Fill Type Matter?

The most common reconstruction technique following mastectomy is a 2-stage technique that involves tissue expansion followed by definitive implant-based reconstruction (IBR). Tissue expanders (TEs) have classically used saline for initial fill; however, TEs with an initial gas fill (GTE)-including the CO2-based AeroForm (AirXpanders, San Francisco, CA) TE and TEs initially filled with atmospheric air-have been increasingly used in the past decade. We aimed to compare the outcomes in breast reconstruction for tissue expanders initially filled with saline vs gas. PubMed was queried for studies comparing gas- and saline-filled tissue expanders (STEs) used in IBR. A meta-analysis was performed on major postoperative outcomes and the required expansion and definitive reconstruction time. Eleven studies were selected and included in the analysis. No significant differences existed between tissue expansion with GTEs vs STEs for 11 of the 13 postoperative outcomes investigated. Out of the complications investigated, only the risk of infection/cellulitis/abscess formation was significantly lower in the GTE cohort (odds ratio 0.62; 95% CI, 0.47 to 0.82; P = .0009). The time to definitive reconstruction was also significantly lower in the GTE cohort (mean difference [MD], 45.85 days; 95% CI, -57.80 to -33.90; P < .00001). The total time to full expansion approached significance in the GTE cohort (MD, -20.33 days; 95% CI, -41.71 to 1.04; P = .06). A cost analysis considering TE cost and infection risk determined that GTE use saved a predicted $2055.34 in overall healthcare costs. Surgical outcomes for both fill types were predominantly similar; however, GTEs were associated with a significantly decreased risk of postoperative infection compared to saline-filled TEs. GTEs could also reduce healthcare expenditures and require less time until definitive reconstruction after placement.

Postoperative pain assessment of robotic nipple-sparing mastectomy with immediate prepectoral prosthesis breast reconstruction: a comparison with conventional nipple-sparing mastectomy.

Aims: Nipple-sparing mastectomy (NSM) is a surgical procedure for patients with breast cancer without nipple-areolar complex (NAC) involvement. Robotic NSM (RNSM) with immediate breast reconstruction has been recently introduced; however, reports regarding RNSM are still lacking. Therefore, this study aimed to evaluate the postoperative assessment with a focus on postoperative pain of RNSM with prepectoral immediate prosthesis breast reconstruction (IPBR) compared with conventional NSM (CNSM) in patients with breast cancer without NAC invasion. Methods: This retrospective study included 81 patients who underwent RNSM (n = 40) or CNSM (n = 41) with prepectoral IPBR using direct-to-implant or tissue expander between January 2018 and June 2020. The primary endpoint was to compare postoperative pain intensity based on a numerical rating scale (NRS). The secondary endpoint was to evaluate the postoperative recovery profile, including postoperative nausea/vomiting (PONV) and complications. Results: A statistical difference was observed in the resting NRS scores at 0-6 postoperative hours between the RNSM and CNSM groups (3.2 ± 1.5 versus 4.2 ± 1.6, respectively; Bonferroni corrected P = 0.005), however, no difference was shown at other time periods. Also, no between-group difference was found in the NRS scores for acting pain within 48 postoperative hours and the number of patients requiring additional analgesics. Conclusions: Despite a statistical difference in the resting NRS scores during the early postoperative phase, the absence of any significant difference in the requirement of additional analgesics between the groups suggested that RNSM does not significantly attenuate postoperative pain intensity.

Splitting the Difference: Using Synthetic and Biologic Mesh to Decrease Cost in Prepectoral Immediate Implant Breast Reconstruction.

SUMMARY: Prepectoral breast reconstruction has minimized morbidity and dynamic deformities associated with submuscular implant-based breast reconstruction. However, reliance on implant coverage with acellular dermal matrix in immediate implant reconstruction remains limited by high material costs. The authors describe a technique in which anterior implant coverage in prepectoral reconstruction is split into acellular dermal matrix inferolaterally and synthetic, absorbable mesh superiorly. Use of acellular dermal matrix inferiorly provides coverage and reinforces the inframammary fold, whereas the absorbable mesh is trimmed and sutured to the acellular dermal matrix at the appropriate tension to support the implant and relieve pressure on mastectomy flaps. A retrospective review was performed on all consecutive prepectoral one-stage breast reconstructions using this technique at a single institution. Patient demographics, mastectomy and reconstruction characteristics, reconstructive outcomes, and cost of support materials were queried and analyzed. Eleven patients (21 breasts) underwent prepectoral immediate implant reconstruction with Vicryl and acellular dermal matrix anterior coverage. Average mastectomy weight was 775.8 g. Smooth, round cohesive implants were used in all cases and average implant size was 514.5 ml. Overall complication rates were low and included one minor infection (4.8 percent) and one case of minor mastectomy flap and partial nipple necrosis each (4.8 percent). Calculated cost savings of Vicryl and acellular dermal matrix anterior coverage was up to $3415 in unilateral and $6830 in bilateral cases. Prepectoral breast reconstruction using acellular dermal matrix inferiorly and Vicryl mesh superiorly is a safe technique that decreases material costs associated with support materials and allows the surgeon to precisely control the implant pocket and position. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

A controlled cost and outcomes analysis of acellular dermal matrix and implant-based reconstruction.

INTRODUCTION: The use of acellular dermal matrix (ADM) for breast reconstruction continues to change in both single- and two-stage reconstruction. Determining optimal outcomes clinically, aesthetically, financially as well as for the patient's quality of life has become a priority. METHODS: A retrospective review of implant-based reconstructions was performed at a single center from 2010 to 2016, with patients blindly matched 1:1:1 into three cohorts based on reconstruction type: 1) single stage direct to implant with ADM, 2) two-stage tissue expander to implant (TE/I) without ADM, and 3) two-stage TE/I with ADM. Relative cost between groups, esthetic outcomes, and quality of life within each group was analyzed. RESULTS: Group 1 was more likely to be older and use intraoperative angiography, but with fewer overall surgeries and postoperative visits (p<0.001). There was no statistically significant difference in reconstructive success among all three groups (p = 0.85). Cost was significantly higher for group 3 relative to groups 1 and 2. Overall appearance was higher in groups 1 and 3 relative to group 2, with radiation therapy the only independent factor. Group 1 had higher scores using Breast-Q for the physical well-being domain (p = 0.01). CONCLUSION: This is the first study to incorporate clinical outcomes, esthetic visual grading, and patient-reported quality within the same cohort of individuals, considering both use of ADM and staging. Despite the added ADM cost, it is proven safe, eliminates time and cost associated with tissue expanders, decreases post-operative visits and can lead to equally as functional and aesthetically pleasing outcomes in single- and two-stage breast reconstructions.

The Use of Absorbable Mesh in Implant-Based Breast Reconstruction: A 7-Year Review.

BACKGROUND: Breast reconstruction is most frequently performed using implants or expanders. Adjunctive materials such as acellular dermal matrix and synthetic meshes are used to support the implant or expander. A paucity of large studies exist on the use of synthetic mesh for breast reconstruction. METHODS: A retrospective chart review of all patients over the past 7 years who had implant reconstruction with synthetic absorbable mesh at the Massachusetts General Hospital was performed. Data were collected on demographic and surgical outcomes. Statistical analysis was performed. RESULTS: A total of 227 patients (376 mastectomies) were treated with direct-to-implant subpectoral reconstruction with absorbable mesh from 2011 to 2017. The infection rate was 2.1 percent. The rate of capsular contracture was 4.8 percent. Patients who had radiation therapy either preoperatively or postoperatively had a higher rate of complications, including capsular contracture. Cost savings for using mesh instead of acellular dermal matrix surpassed $1.2 million. CONCLUSION: Synthetic absorbable mesh is a safe alternative to acellular dermal matrix in prosthetic breast reconstruction and provides stable results along with significant cost savings. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Breast Implant Imaging Surveillance among U.S. Plastic Surgeons: U.S. Food and Drug Administration Recommendations versus Clinical Reality.

BACKGROUND: Device rupture is considered a major complication associated with breast implants. The U.S. Food and Drug Administration recommends magnetic resonance imaging (MRI) surveillance 3 years after implantation and then every 2 years, but adherence to these recommendations is poor. The authors identified current practice management for breast implant rupture surveillance by surveying practicing U.S. plastic surgeons. METHODS: An online survey of all active members of the American Society of Plastic Surgeons was performed. Questions analyzed imaging practice patterns related to breast implants. Logistic regression models were used to analyze determinants for radiographic imaging in breast implant patients. RESULTS: The survey had a response rate of 16.5 percent. For patients with breast implants, 37.7 percent of respondents recommended MRI at the recommended intervals. Fifty-five percent perform imaging only if there is a problem with the implant. Academic surgeons more frequently recommended MRI (56.3 percent and 39.3 percent; p = 0.0002). Surgeons with less than 5 years of experience are four times more likely to order MRI than surgeons with over 25 years' experience (60.8 percent and 28.1 percent; p < 0.0001). Furthermore, lower volume surgeons recommend significantly more MRI (45.2 percent and 27.3 percent; p = 0.001). Respondents are almost two times more likely to recommend MRI in reconstructive versus cosmetic patients (51.2 percent and 35.6 percent; p = 0.0004). CONCLUSIONS: MRI limitations include high costs, time commitments, and equipment constraints. Fewer than 40 percent of survey respondents suggest the recommended screening frequency to their patients; however, academic, low-volume, early-career surgeons are more likely to recommend MRI implant monitoring. Screening recommendations need to be evidence based and align with common practices to prevent undue system, provider, and patient burden.

Health outcomes in offspring of mother with breast implants: A protocol of systematic review and meta-analysis.

BACKGROUND: An increasing number of women undergo breast augmentation at their reproductive age. The most existing evidence focuses on the impact of breast implant on the index women's health and breastfeeding after they give birth to a child. No previous systematic review has investigated the association between breast implant in mother and health outcomes in offspring. In this study, we aimed to conduct a systematic review and meta-analysis to evaluate the influence of breast implant on offspring's health outcomes. METHODS: A comprehensive search strategy will be conducted including the following databases: MEDLINE (via PubMed), Embase, Cochrane Central Register of Controlled Trials, Chinese Biomedical Literature Database, China National Knowledge Infrastructure, Wan Fang Data. The World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) will be searched as well for retrieving the ongoing studies. The cohort study and case-control study will be considered as eligible study if investigating the impact of breast implant in mother on health outcomes in offspring. The risk of bias of included studies will be appraised by the Newcastle-Ottawa scale. RESULTS: The results of this study will be presented in the full-text of the systematic review. CONCLUSION: This systematic review and meta-analysis will infer a conclusion on the association between breast implant in mother and health outcomes in offspring, and the quality of existing evidence.PROSPERO registration number: CRD42019121221.

Acellular Dermal Matrix in Immediate Expander/Implant Breast Reconstruction: A Multicenter Assessment of Risks and Benefits.

BACKGROUND: Acellular dermal matrix has gained widespread acceptance in immediate expander/implant reconstruction because of perceived benefits, including improved expansion dynamics and superior aesthetic results. Although previous investigators have evaluated its risks, few studies have assessed the impact of acellular dermal matrix on other outcomes, including patient-reported measures. METHODS: The Mastectomy Reconstruction Outcomes Consortium Study used a prospective cohort design to evaluate patients undergoing postmastectomy reconstruction from 10 centers and 58 participating surgeons between 2012 and 2015. The analysis focused on women undergoing immediate tissue expander reconstruction following mastectomies for cancer treatment or prophylaxis. Medical records and patient-reported outcome data, using the BREAST-Q and Numeric Pain Rating Scale instruments, were reviewed. Bivariate analyses and mixed-effects regression models were applied. RESULTS: A total of 1297 patients were evaluated, including 655 (50.5 percent) with acellular dermal matrix and 642 (49.5 percent) without acellular dermal matrix. Controlling for demographic and clinical covariates, no significant differences were seen between acellular dermal matrix and non-acellular dermal matrix cohorts in overall complications (OR, 1.21; p = 0.263), major complications (OR, 1.43; p = 0.052), wound infections (OR, 1.49; p = 0.118), or reconstructive failures (OR, 1.55; p = 0.089) at 2 years after reconstruction. There were also no significant differences between the cohorts in the time to expander/implant exchange (p = 0.78). No significant differences were observed in patient-reported outcome scores, including satisfaction with breasts, psychosocial well-being, sexual well-being, physical well-being, and postoperative pain. CONCLUSIONS: In this multicenter, prospective analysis, the authors found no significant acellular dermal matrix effects on complications, time to exchange, or patient-reported outcome in immediate expander/implant breast reconstruction. Further studies are needed to develop criteria for more selective use of acellular dermal matrix in these patients. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

A Longitudinal Assessment of Outcomes and Healthcare Resource Utilization After Immediate Breast Reconstruction-Comparing Implant- and Autologous-based Breast Reconstruction.

OBJECTIVES: Immediate breast reconstruction (IBR) after mastectomy for cancer has increased in recent years, yet long-term, modality-specific comparative data are lacking. We performed this study to compare short- and long-term outcomes after expander, autologous (AT), and direct-to-implant (DI) breast reconstruction. METHODS: Using four state-level inpatient and ambulatory surgery databases, we conducted a retrospective cohort study of adult women who underwent mastectomy with immediate breast reconstruction from 2008 to 2009. Our primary outcomes were complications within 90 days of surgery, rate of secondary breast surgery within 3 years, and cumulative healthcare charges. RESULTS: The final cohort included 15,154 women who underwent mastectomy with tissue expander (TE: 70.5%), autologous (AT: 18.1%), or direct to implant (DI: 11.3%) reconstruction. Ninety-day complications were lowest after expander and highest after AT breast reconstruction (TE = 6.5% [reference] vs AT = 13.1% [2.09, 1.82-2.41] vs DI = 6.6% [1.03, 0.84-1.27], P < 0.001). However, adjusted rates of secondary breast procedures were most frequent after expander (2021/1000 discharges) and least frequent after AT (949.0/1000 discharges) reconstruction (P < 0.001). Specifically, unplanned revisions were highest among the tissue expander cohort (TE = 59.2% vs AT = 34.4% vs DI = 45.9%, P < 0.001). The cumulative, adjusted healthcare charges for secondary breast procedures differed slightly across groups (TE = $63,806 vs AT = $66,882 vs DI = $64,145, P < 0.001). CONCLUSIONS: Complications and secondary breast procedures, including unplanned revisions, after breast reconstruction are common and vary by reconstructive modality. The frequency of these secondary procedures adds substantial healthcare charges to the care of the breast reconstruction patient.

MemoryShape: impact of clinical trials, global medical economics, and the future.

The global breast implant business was invented and configured by American plastic surgeons. In 2012, the first shaped silicone implants were approved in the United States by the Food and Drug Administration. It is the peculiar historical course of implant usage in America that has deprived US plastic surgeons of the opportunity to become experts in the use of this device. Most studies indicate significant safety benefits to using shaped devices, despite the technical challenges involved in their use. Upon approval, adoption of the devices has been slow in the United States, running the risk that American plastic surgery may lose the intellectual and clinical practice hegemony it has enjoyed for over 50 years in this area of the specialty. To continue to maintain leadership in the field of breast surgery, US surgeons should evaluate this new modality and either join the global trend or present data to contradict it.

The Multi Centre Canadian Acellular Dermal Matrix Trial (MCCAT): study protocol for a randomized controlled trial in implant-based breast reconstruction.

BACKGROUND: The two-stage tissue expander/implant (TE/I) reconstruction is currently the gold standard method of implant-based immediate breast reconstruction in North America. Recently, however, there have been numerous case series describing the use of one-stage direct to implant reconstruction with the aid of acellular dermal matrix (ADM). In order to rigorously investigate the novel application of ADM in one-stage implant reconstruction, we are currently conducting a multicentre randomized controlled trial (RCT) designed to evaluate the impact on patient satisfaction and quality of life (QOL) compared to the two-stage TE/I technique. METHODS/DESIGNS: The MCCAT study is a multicenter Canadian ADM trial designed as a two-arm parallel superiority trial that will compare ADM-facilitated one-stage implant reconstruction compared to two-stage TE/I reconstruction following skin-sparing mastectomy (SSM) or nipple-sparing mastectomy (NSM) at 2 weeks, 6 months, and 12 months. The source population will be members of the mastectomy cohort with stage T0 to TII disease, proficient in English, over the age of 18 years, and planning to undergo SSM or NSM with immediate implant breast reconstruction. Stratified randomization will maintain a balanced distribution of important prognostic factors (study site and unilateral versus bilateral procedures). The primary outcome is patient satisfaction and QOL as measured by the validated and procedure-specific BREAST-Q. Secondary outcomes include short- and long-term complications, long-term aesthetic outcomes using five standardized photographs graded by three independent blinded observers, and a cost effectiveness analysis. DISCUSSION: There is tremendous interest in using ADM in implant breast reconstruction, particularly in the setting of one-stage direct to implant reconstruction where it was previously not possible without the intermediary use of a temporary tissue expander (TE). This unique advantage has led many patients and surgeons alike to believe that one-stage ADM-assisted implant reconstruction should be the procedure of choice and should be offered to patients as the first-line treatment. We argue that it is crucial that this technique be scientifically evaluated in terms of patient selection, surgical technique, complications, aesthetic outcomes, cost-effectiveness, and most importantly patient-reported outcomes before it is promoted as the new gold standard in implant-based breast reconstruction. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00956384.

Preoperative assessment preferences and reported reoperation rates for size change in primary breast augmentation: a survey of ASPS members.

BACKGROUND: The purpose of this study was to determine the current preferences of plastic surgeons regarding preoperative assessment and their effect on clinical outcome in primary breast augmentation. METHODS: An eight-question online survey was sent to members of the American Society of Plastic Surgeons. Data collected online were analyzed using Student's t test or Pearson's chi-square test. A value of p < 0.05 was considered statistically significant. RESULTS: The response rate was 20.1 percent (604 respondents). Breast base diameter [n = 286 (47.4 percent)] was ranked the most important consideration vital in choosing implants. Most surgeons chose to reeducate their patients to resolve a conflict between their patient's implant size request and the surgeon's clinical judgment [n = 385 (63.7 percent)], whereas 151 (25 percent) would proceed anyway. Those surgeons who chose reeducation ranked breast base diameter as a vital consideration significantly higher than those who would accommodate their patients (2.03 ± 1.41 versus 2.31 ± 1.41; p = 0.041). Similarly, surgeons who reeducated their patients ranked implant volume as the vital consideration significantly lower than those who accommodated their patients (2.90 ± 1.67 versus 2.44 ± 1.47; p = 0.002). Regarding size change, 332 surgeons (55 percent) reported their rate was 5 percent or less, whereas 272 (45 percent) reported it was greater than 5 percent. Surgeons who reported a 5 percent or less rate ranked implant volume significantly lower than those with reoperation rates greater than 5 percent (2.93 ± 1.71 versus 2.55 ± 1.53; p = 0.004). CONCLUSIONS: Breast base diameter and implant volume were the two most important considerations in choosing an implant for breast augmentation. Reported reoperation rates for size change were significantly lower for surgeons who regarded breast base diameter as more vital than those who valued implant volume more.