Biocompatibility refers to a medical device’s ability to perform its intended function without provoking adverse biological responses. Although global regulatory agencies have introduced measures to improve risk communication about breast implants, there remains a lack of published preclinical data evaluating their biocompatibility. To enhance transparency and patient education regarding implant safety, this study aims to characterize the biocompatibility profile of a silicone breast implant with a 4-micron surface roughness shell by evaluating its performance across ISO 10993 biological endpoints relevant to current safety concerns and to make this data publicly available. Launched in 2010, it is now available in over 90 countries, including a recent approval by the U.S. Food and Drug Administration for breast augmentation. Genotoxicity testing revealed no mutagenic effects. A 26-week in vivo carcinogenicity study in Tg.rasH2 mice showed no evidence of carcinogenic potential. Immunophenotyping of peripheral blood and spleen indicated no signs of immunotoxicity. The device was also found to be non-cytotoxic, non-sensitizing, non-irritating, and non-toxic following acute, subacute, and chronic exposure. Furthermore, it demonstrated no pyrogenic or hemolytic activity and no evidence of reproductive or developmental toxicity. This is, to our knowledge, the first report of detailed results of ISO 10993-1 biocompatibility tests for a silicone breast implant. Collectively, these findings provide robust scientific support for the biocompatibility of 4-micron average roughness shell surface silicone implants. Ongoing research and transparent reporting will continue to inform patients and clinicians, support clinical decision-making, and strengthen public confidence in the safety of these devices.
BACKGROUND:Postoperative acute and chronic pain following breast surgery is a common complication that needs resolving to allow for improved patient outcomes. Previously, thoracic epidurals and paravertebral blocks have been the accepted standard administered intraoperatively. However, more recently the introduction of the pectoral nerve block (PECS and PECS-2 blocks) has appeared promising to control the pain more effectively, but further robust analysis is required to prove its efficacy. The authors aim to study the efficacy of a new block, S-PECS, that combines a serratus anterior and a PECS-2 block. METHODS:In this study, the authors performed a single-center, randomized, controlled, double-blind group trial in 30 female patients undergoing breast augmentation surgery with silicone breast implants and the S-PECS block. Divided into two groups of 15, the PECS group received local anesthetics and the no-PECS control group received a saline injection. All participants were followed up at recovery and at 4, 6, and 12 hours postoperatively. RESULTS:The authors' results showed that the pain score in the PECS group was significantly less than in the no-PECS group across all time points: recovery, and at 4, 6, and 12 hours. Furthermore, the patients who received the S-PEC block were 74% less likely to request pain medications compared with the no-PECS group ( P < 0.05). CONCLUSION:Overall, the modified S-PECS block is an effective, efficient, and safe method of controlling pain in patients undergoing breast augmentation surgery, with additional applications yet to be explored.
Silicone is widely used in chronic implants and is generally perceived to be safe. However, textured breast implants have been associated with immune-related complications, including malignancies. Here, by examining for up to one year the foreign body response and capsular fibrosis triggered by miniaturized or full-scale clinically approved breast implants with different surface topography (average roughness, 0–90 μm) placed in the mammary fat pads of mice or rabbits, respectively, we show that surface topography mediates immune responses to the implants. We also show that the surface surrounding human breast implants collected during revision surgeries also differentially alters the individual’s immune responses to the implant. Moreover, miniaturized implants with an average roughness of 4 μm can largely suppress the foreign body response and fibrosis (but not in T-cell-deficient mice), and that tissue surrounding these implants displayed higher levels of immunosuppressive FOXP3 + regulatory T cells. Our findings suggest that, amongst the topographies investigated, implants with an average roughness of 4 μm provoke the least amount of inflammation and foreign body response.
Background Fat grafting in breast augmentation surgery is becoming increasingly popular, allowing surgeons to fill the gaps that implant augmentation alone cannot. However, one of the current issues surrounding fat grafting is the lack of standardization. Objectives The objective of this study was to validate and summarize expert-based advice to help plastic surgeons better understand the benefits of utilizing fat grating to reduce implant size in their surgical planning. Methods This was a prospective study of fat grafting in 56 patients who underwent fat transfer together with silicone breast implants. A 3-dimensional planning system was used to plan the procedure and also to analyze the fat retention and resorption rates. Pictures served as a basis for a questionnaire in which both patients and physicians were asked to rate their satisfaction. Results Patients reported a satisfaction rate of “excellent” in 83.3% of cases and “good” in 16.7%. Physician satisfaction was rated as “excellent” in 84.5% of cases, “good” in 13.3%, and “fair” in 4.2% of cases. The mean fat volume grafted per breast was 113.63 mL. The mean absorption rate was 4.53%. Conclusions The procedure presented consistent and reproducible results. Hybrid breast augmentation can help design a pathway for a future with breasts free of silicone. This information is particularly relevant for women who have their first breast augmentation at an early age and will probably have 2 to 5 additional surgeries in their lifetime due to the nature of current silicone breast technology. Level of Evidence: 4
Renal Autotransplantation (RAT) is the surgical procedure in which the kidney is initially removed and subsequently re-implanted in a different position, allowing for improved outcomes in conditions involving ureteral pathology, renovascular and neoplastic disease primarily.In this paper, we aim to build upon the understanding of RAT and especially its effectiveness in treating patients with hypertension secondary to renal artery disease, intolerant to previous treatment approaches.In particular, the ex-vivo technique will be focused upon as introduced by Ota et al. in 1967 whereby the use of the workbench is frequently applied for patients requiring in excess of 45 minutes of ischaemic time.We, therefore, put forth two cases managed in co-operation by the University of Arkansas vascular and urology departments.The first of which was a 52-year-old woman with an aneurysmal Lesion reaching the renal artery at the hilum.The second was an 18-year-old woman with Takayasu arteritis.The use of vasopressin had preserved some renal function however at the time of the diagnosis, they were experiencing difficulty in controlling their hypertension, and thus RAT was performed, and the subsequent patient postoperative outcomes and effectiveness have been recorded and analysed as part of this study.
