Experimental protocol for evaluation of biomaterials in an in-vivo silicone implant coverage.

PURPOSE: To describe an experimental surgical model in rats using a dual-plane technique for evaluation of biomaterials in an in-vivo silicone implant coverage. METHODS: This study was developed following the ISO 10993-6 standard. In this study, 40 male Wistar rats weighing between 250 and 350 g were used, distributed into two groups: experimental, biomaterial superimposed on the minimammary prosthesis (MP); and control, MP without implantation of the biomaterial, with eight animals at each biological point: 1, 2, 4, 12, and 26 weeks. Thus, at the end of biological points (1, 2, 4, 12, and 26 weeks; n = 8 animals per week), the tissue specimens achieved were fixed in buffered formalin and stained with hematoxylin-eosin. RESULTS: Macroscopically, throughout the study, no postoperative complications were apparent. In the histological analysis, it was possible to observe the evolution of the inflammatory response, tissue repair, and fibrous capsule during the biological points. CONCLUSIONS: The experimental model described in this study proved to be suitable for evaluating the biomaterial used in the coverage of breast silicone implants.

Fibrin associated large B-cell lymphoma accidentally identified in a breast implant capsule: a molecular report of a rare entity.

Breast implant-associated (BIA) lymphoma is a rare malignancy, typically originating from T-cells; however, few cases of diffuse large B-cell lymphoma (LBCL) have been recently described. These cases share major features: Epstein-Barr virus positivity and a favorable prognosis with surgical intervention alone, hinting at a potential link to fibrin-associated LBCL (FA-LBCL). This study presents the first case of BIA-FA-LBCL in Italy and one of the few assessed from a molecular standpoint so far. We identified two pathogenic mutations in DNMT3A and a variant of uncertain significance (VUS) in JAK2. These findings suggest that dysfunctional epigenetic mechanisms and constitutive activation of the JAK-STAT pathway may underpin BIA-FA-LBCL lymphomagenesis. Finally, we summarized all the previously reported cases in alignment with the updated WHO-HAEM5 classification, shedding further light on the nature of this new entity. This report highlights the rarity of BIA-FA-LBCL and underscores the importance of comprehensive capsule sampling and reporting to national databases for accurate characterization and management of these lymphomas. The study supports the classification of BIA-FA-LBCL within the spectrum of FA-LBCL, emphasizing the need for further research to elucidate its molecular underpinnings and improve clinical outcomes.

Immediate prepectoral versus submuscular breast reconstruction in nipple-sparing mastectomy: a retrospective cohort analysis.

Objective: To evaluate early complications in prepectoral breast reconstruction. Methods: A retrospective cohort study including 180 consecutive cases of nipple-sparing mastectomy, comparing immediate breast reconstruction with subpectoral to prepectoral mammary implants in 2012-2022. Clinical and demographic characteristics and complications in the first three months following surgery were compared between the two techniques. Results: The prepectoral technique was used in 22 cases (12.2%) and the subpectoral in 158 (87.8%). Median age was higher in the prepectoral group (47 versus 43.8 years; p=0.038), as was body mass index (25.1 versus 23.8; p=0.002) and implant volume (447.5 versus 409 cc; p=0.001). The prepectoral technique was more associated with an inframammary fold (IMF) incision (19 cases, 86.4% versus 85, 53.8%) than with periareolar incisions (3 cases, 13.6% versus 73, 46.2%); (p=0.004). All cases in the prepectoral group underwent direct-to-implant reconstruction compared to 54 cases (34.2%) in the subpectoral group. Thirty-eight complications were recorded: 36 (22.8%) in the subpectoral group and 2 (9.1%) in the prepectoral group (p=0.24). Necrosis of the nipple-areola complex/skin flap occurred in 27 patients (17.1%) in the subpectoral group (prepectoral group: no cases; p=0.04). The groups were comparable regarding dehiscence, seroma, infection, and hematoma. Reconstruction failed in one case per group (p=0.230). In the multivariate analysis, IMF incision was associated with the prepectoral group (aOR: 34.72; 95%CI: 2.84-424.63). Conclusion: The incidence of early complications was comparable between the two techniques and compatible with previous reports. The clinical and demographic characteristics differed between the techniques. Randomized clinical trials are required.

Surgical complications after immediate implant-based breast reconstruction for breast cancer in women over 65 years.

BACKGROUND: While immediate breast reconstruction rates in breast cancer are increasing, they remain low in women over 65 years old. The aim was to investigate surgical outcomes in women older than 65 years receiving implant-based immediate breast reconstruction. METHOD: The population-based Stockholm Breast Reconstruction Database includes all adult women with breast cancer receiving an implant-based immediate breast reconstruction in Stockholm, Sweden, 2005-2015. Primary outcomes within 30 days from immediate breast reconstruction were: infection requiring antibiotics and reoperation on. Implant removal was a secondary outcome. Women more than 65 years were compared with younger age groups. Chi-square tests and multivariable logistic regression were applied for the primary outcomes, and Kaplan-Meier analysis for the secondary outcome. RESULTS: Among 1749 cases of immediate breast reconstruction, 140 (8.0%) were in women more than 65 years. Median follow-up was 74 months (1-198). Postoperative infection was not more common in women older than 65 years old (22 of 140, 15.7%) than in women under 65 years old (303 of 1609, 18.8%; P = 0.221). Reoperation on was more frequent in women older than 65 years than in other age groups (more than 65: 8.6%; 50-64: 6.5%; 40-49: 3.5%; less than 40: 1.6%; P < 0.001), however, age older than 65 years was not an independent risk factor in the multivariable analysis (OR 1.00, 95% c.i. 0.44 to 2.28). Overall, 6-year probability of implant removal was 11.4%, (8.1% due to complications and 3.3% due to patient preference). There was no statistically significant difference between age groups for either reason (P = 0.085 and P = 0.794 respectively). CONCLUSION: Older age alone was not associated with worse surgical outcomes after implant-based immediate breast reconstruction in highly selected patients older than 65 years when compared with their younger counterparts.

Surgical treatment after augmentation mammoplasty with polyacrylamide hydrogel.

Polyacrylamide hydrogel mammoplasty is a simple and relatively affordable surgery. However, this procedure is associated with a significant frequency of late complications, prompting its suspension in 2006. Despite this, patients continue facing long-term consequences. These include hydrogel migration, changes in breast shape and volume, granulomas, fistulas, and abscess formation. The clinical case described here presents the surgical treatment after augmentation mammoplasty with polyacrylamide hydrogel performed 35 years ago.

Nanocarbon-Polymer Composites for Next-Generation Breast Implant Materials.

Most breast implants currently used in both reconstructive and cosmetic surgery have a silicone outer shell, which, despite much progress, remains susceptible to mechanical failure, infection, and foreign body response. This study shows that the durability and biocompatibility of breast implant-grade silicone can be enhanced by incorporating carbon nanomaterials of sp2 and sp3 hybridization into the polymer matrix and onto its surface. Plasma treatment of the implant surface can be used to modify platelet adhesion and activation to prevent thrombosis, postoperative infection, and inflammation disorders. The addition of 0.8% graphene flakes resulted in an increase in mechanical strength by 64% and rupture strength by around 77% when compared to pure silicone, whereas when nanodiamond (ND) was used as the additive, the mechanical strength was increased by 19.4% and rupture strength by 37.5%. Composites with a partially embedded surface layer of either graphene or ND showed superior antimicrobial activity and biocompatibility compared to pure silicone. All composite materials were able to sustain the attachment and growth of human dermal fibroblast, with the preferred growth noted on ND-coated surfaces when compared to graphene-coated surfaces. Exposure of these materials to hydrogen plasma for 5, 10, and 20 s led to substantially reduced platelet attachment on the surfaces. Hydrogen-treated pure silicone showed a decrease in platelet attachment for samples treated for 5-20 s, whereas silicone composite showed an almost threefold decrease in platelet attachment for the same plasma treatment times. The absence of platelet activation on the surface of composite materials suggests a significant improvement in hemocompatibility of the material.

Protective role of transforming growth factor-Β3 (TGF-Β3) in the formation of radiation-induced capsular contracture around a breast implant: In vivo experimental study.

Postmastectomy radiotherapy causes capsular contracture due to fibroproliferation of the capsular tissue around the implant. In fibrosis, unlike normal wound healing, structural and functional disorders are observed in the tissues caused by excessive/irregular accumulation of extracellular matrix proteins. It has been reported that transforming growth factor-ß3 (TGF-ß3) prevents and reverses fibrosis in various tissues or provides scarless healing with its antifibrotic effect. Additionally, TGF-ß3 has been shown to reduce fibrosis in radiotherapy-induced fibrosis syndrome. However, no study in the literature investigates the effects of exogenously applied TGF-ß3 on capsular contracture in aesthetic or reconstructive breast implant application. TGF-ß3, which has a very short half-life, has low bioavailability with parenteral administration. Within the scope of this study, free TGF-ß3 was loaded into the nanoparticles to increase its low bioavailability and extend its duration of action by providing controlled release. The aim of this study is to investigate the preventive/improving effects of radiation induced capsular contracture using chitosan film formulations containing TGF-ß3 loaded poly(lactic-co-glycolic acid)-b-poly(ethylene glycol) (PLGA-b-PEG) nanoparticles in implant-based breast reconstruction. In the characterization studies of nanoparticles, the particle size and zeta potential of the TGF-ß3-loaded PLGA-b-PEG nanoparticle formulation selected to be used in the treatment group were found to be 123.60 ± 2.09 nm and -34.87 ± 1.42 mV, respectively. The encapsulation efficiency of the formulation was calculated as 99.91 %. A controlled release profile was obtained in in vitro release studies. Chitosan film formulations containing free TGF-ß3 or TGF-ß3-loaded PLGA-b-PEG nanoparticles were used in in vivo studies. In animal studies, rats were randomly distributed into 6 groups (n = 8) as sham, implant, implant + radiotherapy, implant + radiotherapy + chitosan film containing unloaded nanoparticles, implant + radiotherapy + chitosan film containing free TGF-ß3, implant + radiotherapy + chitosan film containing TGF-ß3 loaded nanoparticle. In all study groups, a 2 cm incision was made along the posterior axillary line at the thoracic vertebral level in rats to reach the lateral edge of the latissimus dorsi. The fascial attachment to the chest wall was then bluntly dissected to create a pocket for the implants. In the treatment groups, the wound was closed after films were placed on the outer surface of the implants. After administering prophylactic antibiotics, rats were subjected to irradiation with 10 Gy photon beams targeted to each implant site. Each implant and the surrounding excised tissue were subjected to the necessary procedures for histological (capsule thickness, cell density), immunohistochemical, and biochemical (α-SMA, vimentin, collagen type I and type III, TGF-ß1 and TGF-ß3: expression level/protein level) examinations. It was determined that the levels of TGF-ß1 and TGF-ß3 collagen type III, which decreased as a result of radiotherapy, were brought to the control level with free TGF-ß3 film and TGF-ß3 nanoparticle film formulations. Histological analyses, consistent with biochemical analyses, showed that thick collagen and fibrosis, which increased with radiotherapy, were brought to the control level with free TGF-ß3 film and TGF-ß3 nanoparticle film treatments. In biochemical analyses, the decrease in thick collagen was compatible with the decrease in the collagen type I/type III ratio in the free TGF-ß3 film and TGF-ß3 nanoparticle film groups. Changes in protein expression show that TGF-ß3 loaded nanoparticles are more successful than free TGF-ß3 in wound healing. In line with these results and the literature, it is thought that the balance of TGF-ß1 and TGF-ß3 should be maintained to ensure scarless wound healing with no capsule contracture.

Timing and type of breast reconstruction in SweBRO 3: long-term outcomes.

BACKGROUND: Breast reconstruction after mastectomy helps women with breast cancer feel better about their bodies and lives. There is debate about the best time and type of reconstruction (immediate versus delayed, and using own tissue versus implants). Long-term studies are rare. AIM: This study looked at long-term results of different breast reconstruction methods and timings in Swedish women who had mastectomies in 2000, 2005 or 2010. It focused on how satisfied the women were with their surgeries and their quality of life. METHOD: The study included 5853 women from the Swedish National Breast Cancer Registry who had mastectomies in 2000, 2005 or 2010. Of these, 2904 women answered the survey, and 895 had breast reconstruction. Satisfaction and quality of life were measured using two surveys: EORTC QLQ-BRECON23 and BREAST-Q. RESULTS: Of the women who answered the survey, 895 (31%) had breast reconstruction. Of these, 176 (20%) had immediate reconstruction, and 719 (80%) had delayed reconstruction; 58% had implant-based reconstructions, 31% had reconstructions using their own tissue, 2% had both types and 9% did not report the type of reconstruction. There were no major differences in satisfaction between immediate and delayed reconstruction. Women who used their own tissue were more satisfied with their results and breast appearance than those with implants. CONCLUSION: Autologous reconstruction leads to better satisfaction and outcomes than implants. The timing of reconstruction (immediate versus delayed) was less of an influence on quality of life.

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.

Comparative study of muscle-sparing latissimus dorsi vs breast implants following total mastectomy.

INTRODUCTION: With 60,000 cases per year, breast cancer is the most frequent type of cancer in France, and a quarter of these cases require mastectomy. Following the surgery, breast reconstruction can be indicated. Two of the available techniques are breast implants (BIs) and muscle-sparing latissimus dorsi (MSLD). The aim of this study was to compare postoperative complications of each approach and thus help the surgeon and the patient in making an informed decision before surgery. MATERIALS AND METHODS: This descriptive, retrospective and single-centre study was conducted in the Croix Rousse hospital in Lyon (France) between 1 July 2018 and 1 July 2023. It included women aged ≥18 years who underwent mastectomy followed by (immediate or delayed) breast reconstruction with MSLD or BI. Complications were recorded and evaluated using the Clavien-Dindo classification. RESULTS: Over the course of the study, 92 patients were managed with MSLD reconstruction and 63 patients with BI. We observed a complication rate of 62% in the BI group and 39% in the MSLD group (odds ratio [OR]=0.16; p < 0.005). Body mass index (BMI) significantly impacted this rate (OR=1.11; p = 0.01), whereas smoking status and diabetes did not. No complication occurred more predominantly than others. A second surgery was required more often in the BI group (p < 0.005). There were no severe complications (>Grade 4). CONCLUSION: MSLD predicted fewer complications and was associated with a shorter hospital stay compared with implants, suggesting that it may be a preferable option for breast reconstruction.

Debate article: Management of breast cancer in patients with pre-existing bilateral breast augmentation-a snapshot of global practice and call for international guidelines.

Breast cancer (BC) is the most common female cancer, and as bilateral breast augmentation (BBA) increases, more women are presenting with BC within an augmented breast. No international guidelines exist on how to manage such a situation, so this group undertook a global survey to provide a snapshot of current surgical practice. The key finding was the variable oncoplastic management of BC after BBA: most surgeons responded that when oncologically safe, breast conservation with implant preservation was appropriate as radiotherapy was not a contra-indication to preserving implants. Immediate symmetrisation could be considered but was not always available. We propose a large multicenter observational study to support the development of international guidelines. This will help patients, healthcare funders, providers, and surgeons to optimize care and reduce inequity of access to appropriate oncoplastic surgery options for the increasing number of women with BBA and BC.

PET/CT Recognition of Costal Cartilage Infection After Breast Implant Surgery.

BACKGROUND: Postoperative infection of breast implants can lead to implant removal and other complications. This study aimed to investigate the presence of costal cartilage infection following breast implant surgery and the diagnostic role of PET/CT in identifying this rare complication. PATIENTS AND METHODS: A retrospective study included 16 patients with persistent infections after breast implant removal surgery. Patients underwent PET/CT scans before surgery, and surgical plans were made based on PET/CT findings. Surgical procedures were guided by PET/CT, and specimens were collected for pathological examination and microbiological culture. Follow-up assessments were performed at 1, 3, and 12 months postoperatively. RESULTS: Among the 16 patients, 11 were diagnosed with costal cartilage infection, whereas 5 had subcutaneous soft tissue infections. PET/CT accurately identified costal cartilage infection in all cases and localized the infected costal cartilage in the majority of cases. Microbiological culture results showed various pathogens. All patients were cured with one or staged surgery. CONCLUSION: Costal cartilage infection following breast implant surgery is a significant concern. PET/CT plays a crucial role in the accurate diagnosis and localization of infected costal cartilage, aiding in appropriate surgical management. Patients should be closely monitored for the possibility of costal cartilage infection when experiencing persistent symptoms after breast implant surgery.

Postoperative complications of hypofractionated and conventional fractionated radiation therapy in patients with implant-based breast reconstruction: A systematic review and meta-analysis.

INTRODUCTION: Post-mastectomy radiation therapy is an important component of adjuvant therapy for high-risk patients. However, radiation to reconstructed breasts can cause various complications. Recently, hypofractionated (HF) protocols have been adopted in several countries. Here, we aimed to assess the impact of HF protocols on implant-reconstructed breasts through a meta-analysis and systematic review of the currently available literature. METHODS: Records published until August 2023 were systematically searched in PubMed, Cochrane Library, and EMBASE databases. Keywords included hypofractionation radiotherapy, mastectomy, and breast reconstruction. Studies that utilized HF and conventional fractionation (CF) after prosthetic reconstruction were selected. Due to the rarity of events in outcomes, Mantel-Haenszel's odds ratios were calculated using a fixed-effect model to compare the complication rates between HF and CF groups. For analysis with high heterogeneity, a random effect model was used. RESULTS: Seven articles with 924 implant reconstructions, in which 506 (54.8 %) underwent HF were included. HF patients received 43.8 Gy on average, while CF patients received 51.2 Gy. Mean follow-up ranged from 10.6 to 35 months. Seven studies were included in the meta-analysis. HF groups had a significantly lower risk of capsular contracture (OR 0.25, 95 % CI 0.11-0.55), major revision surgery (OR 0.19, 95 % CI 0.05-0.80), and wound dehiscence (OR 0.24, 95 % CI 0.07-0.78) compared to CF groups. The risks of other complications were not statistically significant. CONCLUSION: This study indicates that HF protocols are associated with fewer complications than CF protocols in implant-reconstructed patients. These findings suggest that the application of HF PMRT in implant-reconstructed patients with breast cancer is plausible.

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.