Does the use of Acellular Dermal Matrices (ADM) in women undergoing pre-pectoral implant-based breast reconstruction increase operative success versus non-use of ADM in the same setting? A systematic review.

BACKGROUND: Breast cancer is the most common malignancy among women in the UK. Reconstruction - of which implant-based breast reconstruction (IBBR) is the most common - forms a core part of surgical management of breast cancer. More recently, pre-pectoral IBBR has become common as technology and operative techniques have evolved. Many surgeons use acellular dermal matrix (ADM) in reconstruction however there is little evidence in literature that this improves surgical outcomes. This review will assess available evidence for surgical outcomes for breast reconstructions using ADM versus non-use of ADM. METHODS: A database search was performed of Ovid Medline, Embase, Cochrane Central Register of Controlled Trials and Cochrane Database of Systematic Reviews (2012-2022). Studies were screened using inclusion and exclusion criteria. Risk of Bias was assessed using the Newcastle Ottawa scale and ROBIS tools. Analysis and meta-analysis were performed. RESULTS: This review included 22 studies (3822 breast reconstructions). No significant difference between overall complications and failure rates between ADM and non-ADM use was demonstrated. Capsular contracture, wound dehiscence and implant rippling had significant differences however these results demonstrated high heterogeneity thus wider generalisation may be inaccurate. Patient quality of life scores were not recorded consistently or comparably between papers. CONCLUSIONS: This review suggests a lack of significant differences in most complications between ADM use and non-use for pre-pectoral IBBR. If no increase in complications exists between groups, this has significant implications for surgical and legislative decision-making. There is, however, inadequate evidence available on the topic and further research is required.

Acellular Dermal Matrix without Basement Membrane in Immediate Prepectoral Breast Reconstruction: A Randomized Controlled Trial.

BACKGROUND: Acellular dermal matrix (ADM) has become popular in various reconstructive procedures of different anatomic regions. There are different needs depending on the clinical application, including breast, abdominal wall, and any other soft-tissue reconstruction. Removal of the basement membrane, which consists of collagen fibers, may help achieve natural and soft breast reconstruction, which requires highly elastic ADMs. Given the lack of knowledge of the effectiveness of ADM without the basement membrane, the authors compared the clinical outcomes of ADMs with and without basement membrane in breast reconstruction. METHODS: The authors conducted a single-blind randomized controlled trial to evaluate differences in clinical outcomes. The patients were randomized into 2 groups: ADM with or without basement membrane. Both groups underwent immediate prepectoral direct-to-implant breast reconstruction. Demographic characteristics, surgical outcomes, and breast shape change using nipple position were compared between the 2 groups. RESULTS: A total of 56 patients were divided into 2 groups: ADM with basement membrane (n = 30 [53.6%]) or ADM without basement membrane (n = 26 [46.4%]). Clinical and surgical characteristics were similar between the 2 groups. The authors detected no statistically significant differences in the overall rate of complications or breast shape change between the 2 groups. However, the rate of seromas was higher in the ADM with basement membrane group than in the ADM without basement membrane group (10% versus 0%; P = 0.09). CONCLUSIONS: The 2 groups showed similar surgical outcomes. ADM without basement membrane in implant-based breast reconstruction was safe, and had mechanical properties of lower tensile strength and higher elasticity. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Early post-operative outcome of pre-pectoral implant-based immediate total breast reconstruction with Polyglactin 910 (Vicryl™) mesh - low cost solution for a low-middle income country.

BACKGROUND: The incidence of breast cancer in Pakistan has been rising with approximately one third of these patients requiring mastectomy. Among breast reconstruction treatment options, the use of Acellular Dermal Matrix (ADM) for pre-pectoral breast implant surgery has proven effective with improved cosmetic outcome. However, due to high cost it cannot be regularly implemented in a developing country like Pakistan. An alternative to ADM, Polyglactin 910 (Vicryl™, Ethicon) mesh has been introduced in pre-pectoral breast reconstructive surgery which has shown to be almost 10 times lower in cost. We set out to determine the frequency of early postoperative complications when using Polyglactin 910 mesh for pre-pectoral implant-based breast reconstruction surgery. METHODS: A single centre, retrospective, chart review was conducted, and a total 28 women were included in the study. Thirty-two pre-pectoral implant-based mastectomies with Polyglactin 910 mesh were performed. Early post-operative outcomes (within 12 months of procedure) including duration of antibiotic use, post-operative infection, implant displacement, flap necrosis, seroma formation, wound dehiscence, hematoma formation, capsular contracture and reconstruction failure, were recorded. RESULTS: Only 4 (12.5%) women experienced early post-operative morbidity. One patient developed a wound dehiscence, which eventually led to reconstruction failure and removal of the implant. Another patient had seroma formation and flap necrosis. None of the patients developed postoperative implant displacement, hematoma formation or capsular contracture in the early post-operative period. CONCLUSION: This study reveals that early post-operative outcomes with Polyglactin 910 mesh in breast reconstructive surgery are few, thus making it a cost effective, reliable, and safe treatment option, especially in developing countries like Pakistan.

A Pericardium Bovine Matrix Pocket in DTI Prepectoral Breast Reconstruction.

Breast reconstructive surgery has evolved significantly over the years. One of the recent advancements is the use of prepectoral implants in combination with synthetic and biological material as a natural and effective coverage. To date, there is little published data on breast reconstruction using acellular bovine pericardium matrix and most concern submuscular breast reconstruction. This study aimed to describe the multicentric-multisurgeon experience in performing direct to implant (DTI) prepectoral breast reconstructions using acellular bovine pericardium matrix (ABPM) pocket. A retrospective multicentric data collection of the all the immediate prepectoral breast reconstructions using acellular bovine pericardium was carried out by the authors. Surgical data including type of mastectomy, axillary surgery, type and size of implant, size of ABPM, duration of surgery were collected for each patient. Postoperative data including adjuvant treatments, complications, necessity to perform other interventions, patient's satisfaction were collected. Cosmetic results were also evaluated by 7 different observers at minimum 1 year follow-up. A total of 65 breast reconstruction were included in the study. Mean follow up was 21.3 months. Average surgical time was 1,42 hours. Minor complications occurred in 4 breasts; major complications occurred in 2 breasts. After 6 months follow-up, 7 patients underwent fat grafting to correct any rippling and /or wrinkling. Breast aesthetic and patients reported outcomes were satisfactory. Not significant capsular contracture was noted at the follow up control. To date, this is the largest study about prepectoral breast reconstruction with ABPM. On the basis of our results, prepectoral breast reconstruction ABPM assisted is a reliable, safe and suitable option providing good patient satisfaction outcomes.

Quality of life in breast reconstruction: a comparison of lightweight and conventional breast implants.

BACKGROUND: Due to the declining mortality rates of breast carcinoma and the rising incidence of risk-reducing mastectomies, enhancing the quality of life after breast reconstructions has become an increasingly important goal. The advantages of lightweight breast implants (B-Lite®) may significantly contribute to achieving this objective. This study aims to investigate whether lightweight implants are suitable for patients undergoing breast reconstruction and could improve the quality of life in comparison to conventional implants. METHODS: In this study, we retrospectively analyzed 48 patients (38 implants in each group) who underwent implant-based breast reconstruction with either B-Lite® or conventional breast implants between 2019 and 2022 at the University Center for Plastic Surgery in Regensburg. As part of the postoperative follow-up, a clinical examination and a survey using the Breast-Q® questionnaire were conducted to evaluate the postoperative quality of life. RESULTS: The implants used were similar in weight and shape. On average, the B-Lite® implants had a higher implant volume and patients in this group had a slightly higher BMI. Patients who received B-Lite® implants showed a significantly better result regarding the sensation of sensitivity in the surgical area and the scar formation also appeared to be more favorable. However, patients with B-Lite® implants perceived their implants as more uncomfortable than those with conventional breast implants. In other terms concerning quality of life, both groups appeared similar. CONCLUSION: In summary, there are confounding factors that could influence the outcome of some aspects in this study, which could not be avoided due to the retrospective study design and the temporary suspension of B-Lite implants. Nevertheless, as the first of its kind, this study demonstrated that B-Lite implants could also be suitable for usage in breast reconstructions, thus providing an important foundation for further prospective studies to build upon.

Impact of Hematoma on Capsular Contracture: A Comparative Study of Smooth and Textured Implants in a Miniature Pig Model.

BACKGROUND: Capsular contracture is a significant complication following mammaplasty, with varying incidence rates and symptoms. The etiology of capsular contracture is multifactorial, with postoperative hematoma recognized as a potential contributing factor. OBJECTIVES: In this study we aimed to investigate the impact of postoperative hematoma on capsular contracture following mammaplasty, utilizing pig models and modified biomechanical testing. We sought to compare the severity of capsular contracture between smooth and textured implants in the presence of hematoma, assess the biomechanical properties of the capsules, and explore the histological and molecular changes associated with the condition. METHODS: The study involved 5 female miniature pigs, implanted with both smooth and textured implants. Hematoma models were established, and various methods were employed to evaluate the impact of the prosthesis surface and hematoma on capsular contracture, including ultrasound assessment, biomechanical tests, scanning electron microscopy, histological analysis, and transcriptome sequencing. RESULTS: Capsules in hematoma groups were classified as Baker III/IV, with significantly unfavorable thickness, elastic modulus, and relaxation and creep amounts compared to nonhematoma groups. Smooth implants under hematoma conditions exhibited increased muscle content and biomechanical strength of the capsule. Transcriptomic analysis highlighted differential gene expression related to muscle development and contraction in smooth implants with hematomas. CONCLUSIONS: Hematomas increase the risk of capsular contracture, with smooth implants exacerbating this effect by enhancing pathways related to muscle development and contraction. This underscores the importance of hematoma prevention and treatment strategies, particularly when placing smooth implants, to minimize the occurrence of capsular contracture. The study provides insights into the mechanisms underlying capsular contracture and offers evidence to guide surgical and postoperative management strategies.

Patient-Reported Outcomes and Complication Profiles of Implant-Based Breast Reconstruction in Patients With Postmastectomy Radiation Therapy.

OBJECTIVE: This study aims to investigate the patient-reported outcomes (PROs) and complications of distinct implant-based breast reconstruction modality for patients with postmastectomy radiation therapy (PMRT). METHODS: A retrospective review was conducted on breast cancer patients with stage II-III disease who performed implant-based breast reconstruction following with PMRT between September 2016 and April 2022. The patients were categorized into two matched groups: (1) patients receiving prepectoral breast reconstruction (PBR) or (2) subpectoral breast reconstruction (SBR) followed by PMRT. Following reconstruction, the patients were further compared for PMRT with the tissue expander (PMRT-TE) versus PMRT with permanent implant (PMRT-PI). PROs were measured with BREAST-Q questionnaire. Early and late complications were recorded and analyzed. RESULTS: A total of 55 eligible patients were recruited. Patients who underwent PBR reported significantly higher satisfaction with breasts scores (P = 0.003) compared with the SBR group. The PMRT-TE group had higher satisfaction with breasts (P = 0.001) but lower physical well-being (P = 0.029) scores compared with PMRT-PI group. Moreover, patients in SBR cohort had a higher risk of capsular contracture (Baker grade III or IV) (20.5% vs 6.3%) and implant dislocation (48.7% vs 12.5%) than patients in PBR cohort. Patients in PMRT-PI group had a slightly higher rate of capsular contracture (Baker grade III or IV) than PMRT-TE group (20.8% vs 12.9%). CONCLUSIONS: PBR was associated with lower rates of late complications, especially for implant dislocation, and higher satisfaction with breasts scores compared to SBR. In addition, compared to PMRT-TE with PMRT-PI, patients in PMRT-TE cohort reported superior PROs of satisfaction with breasts.

Outcomes in Subfascial Versus Subglandular Planes in Breast Augmentation: A Systematic Review and Meta-analysis.

Breast augmentation is the most commonly performed aesthetic surgery procedure in women worldwide. The use of the subfascial plane has been suggested to decrease the incidence of capsular contracture compared with the subglandular plane, while simultaneously avoiding the complication of animation deformity in the subpectoral plane. The aim of this systematic review and meta-analysis was to compare the adverse outcomes of subfascial vs subglandular planes in breast augmentation. This review was registered a priori on OSF (https://osf.io/pm92e/). A search from inception to June 2023 was performed on MEDLINE, Embase, and CENTRAL. A hand search was also performed. All randomized and comparative cohort studies that assessed the use of the subfascial plane for breast augmentation were included. Outcomes evaluated included the incidences of seroma, hematoma, infection, rippling, capsular contracture, and revision surgery. Ten studies were included in this systematic review. Three randomized controlled trials and 7 comparative cohort studies were used for quantitative synthesis. There was a significant difference favoring subfascial compared with subglandular planes in the incidence of hematoma, rippling, and capsular contracture. All included studies had a high risk of bias. The current evidence suggests that the subfascial plane for breast augmentation decreases the risk of capsular contracture, hematoma, and rippling compared with the subglandular plane. Further randomized evidence with high methodological rigor is still required to validate these findings.

Artificial Intelligence, Genuine Outcome: Analysis of 72 Consecutive Cases of Subfascial Augmentation Mastopexy With Smooth Round Implants Supported by P4HB Scaffold.

BACKGROUND: Ptosis recurrence often leads to unsatisfactory results after mastopexy, even more so when additional stress is provided by implants on compromised native tissue. The poly-4-hydroxybutyrate(P4HB) scaffold (GalaFLEX) with its favorable safety profile and proven long-term mechanical strength represents a preferred option for soft tissue support. OBJECTIVES: The primary endpoint was assessment of lower pole stretch from the early postoperative period up to 3 years. METHODS: Out of 151 patients who underwent surgery by G.B. from March 2020 to December 2023, a total of 72 with a 12-month-mininum follow-up who had primary (46) or secondary (26) augmentation mastopexy with subfascial round smooth implants and P4HB scaffold support were included in the study. Three-dimensional artificial intelligence software was utilized for all measurements. Further analysis included evaluation of ptosis recurrence and all complications. RESULTS: No recurrent ptosis, bottoming out, implant displacement, or capsular contracture was reported during follow-up (mean, 24.8 months). The lower pole arch's elongation was 8.04% and 9.44% at 1 and 3 years respectively, comparing favorably with previous reports. Statistically significant correlation (P < .05) between implant size and lower pole stretch was noted, this being greater for larger implants (> 400 cc; P = .0011) and primary cases (P = .1376). Progressive volume redistribution from upper to lower pole was observed in the first year, with substantial stability thereafter. CONCLUSIONS: This is the largest published series reporting long-term results (up to 45 months) in mastopexy augmentation with GalaFLEX, suggesting its supportive role in lower pole stability even in the setting of concurrent breast augmentation with smooth implants in a subfascial plane.

Silicone Lymphadenopathy Following Augmentation Mammoplasty With Silicone Implants.

BACKGROUND: Silicone implants are by far the most widely used implant globally for breast augmentation. Despite technological advancements, complications persist, with silicone lymphadenopathy (siliconoma) being a noteworthy concern. This phenomenon has been inadequately addressed in the existing literature. OBJECTIVES: The aim of this study was to characterize axillary siliconomas and identify potential risk factors to help reduce their occurrence. METHODS: The authors conducted a retrospective observational cross-sectional study spanning between 2011 and 2021 at the Shamir Assaf Harofeh Medical Center, Israel. Preoperative ultrasound examination was conducted, categorizing patients into those with siliconomas and those without. RESULTS: A total of 614 women (1209 breasts) met the inclusion criteria. The incidence of siliconomas was 13.6% (165 breasts). In univariate analysis, older age (47 years vs 43 years, P < .001), older implant age (12.2 years vs 11 years, P = .026), ruptured implants (59.4% vs 17.7%, P < .001), subpectoral placement (P = .019), severe capsular contracture, and the use of Mentor implants (Irvine, CA; P = .007) and Poly Implant Prothèse implants (PIP; La Seyne-sur-Mer, France; P = .001) correlated significantly with the presence of siliconomas. In a multivariate analysis, implant rupture (odds ratio [OR] = 6.342), and implant manufacturer-Mentor (OR = 3.047) and PIP (OR = 3.475)-were identified as independent risk factors associated with a higher incidence of siliconomas. Severe capsular contracture was also associated with a higher incidence of siliconomas (OR = 1.65). CONCLUSIONS: Surgeons should inform candidates about the potential risk of silicone migration. Patients with ruptured implants, significant capsular contracture, and Mentor and PIP implants face an increased risk for developing siliconomas. Closer monitoring for the detection of siliconomas in the axilla for these patients is advisable, and potential prophylactic replacement or removal of implants may be warranted to mitigate siliconoma risk.

Breast reconstruction with mentor anatomical implants and the risk of implant rotation: A retrospective study of 1134 women.

BACKGROUND: Implant rotation is a known complication to breast reconstruction using anatomical implants. However, there is a lack of large studies investigating the risk of implant rotation and potential predisposing risk factors. METHOD: We reviewed the medical records of all patients who underwent breast reconstruction with Mentor anatomical implants from 2010 to 2021 at two Danish hospitals. We compared the risk of implant rotation between one- and two-stage breast reconstruction using univariate logistic regression. We analyzed the effect of biological mesh, immediate versus delayed reconstruction, and use of a higher final expander volume than the permanent implant volume on the risk of implant rotation. Finally, we analyzed the success rate of revision surgery for implant rotation. RESULTS: In total, 1134 patients were enrolled. Patients who underwent two-stage breast reconstruction (n = 720) had a significantly higher risk of implant rotation than those who underwent one-stage breast reconstruction (n = 426; 11% vs. 5%, p < 0.01). There was no significant association between implant rotation and the use of biological mesh, immediate breast reconstruction, or use of a higher final expander volume than the permanent implant volume. The success rate of revision surgery after implant rotation was 73% (62/85 rotations). CONCLUSIONS: Two-stage breast reconstruction significantly increased the risk of implant rotation compared to one-stage breast reconstruction. The overall risk of implant rotation was low and success rate of revision surgery was high. These findings suggest that anatomical implants are safe to use for breast reconstruction. However, surgeons and patients should be aware of the increased risk of implant rotation after two-stage reconstruction.

Breast Reduction with Implants or Augmentation Reduction: Patient-Reported Outcomes from a Single-Centre Retrospective Cohort Analysis.

Background and Objectives: The correction of breast hypertrophy and ptosis with implant placement has always posed a challenge for plastic surgeons. Various methods have been devised, yielding conflicting results. The purpose of this study is to describe our surgical technique of breast reduction with silicone implants, present the safety profile of the procedure, and report patient-reported outcomes. Materials and Methods: A retrospective review was performed on our case series of cosmetic breast surgery performed by the senior author between October 2020 and November 2023. Only patients who had over 300 g of breast tissue removed were included. The surgery and demographic characteristics were recorded. Patients were asked to complete a questionnaire about satisfaction with their breasts pre-operatively and after the surgery. Results: Over 745 cases were performed, and 25 were included in the analysis. In total, 78.3% of the patients presented with a Grade 3 ptosis. The mean implant size was 352.39 cc (range 300-455 cc). The breast tissue removed ranged from 312 to 657 g. The mean follow-up was 14.17 months. Only one case required revision surgery after developing capsular contracture and a waterfall deformity. Patients reported a statistically significant improvement across all domains of the questionnaire (p < 0.001). Conclusions: Breast reduction plus implants is a safe and effective alternative for patients with large ptotic breasts who wish to attain a full upper pole. It carries a similar risk profile to augmentation mastopexy and maintains its functional benefits in alleviating back, neck, and shoulder pain.