Immediate Breast Reconstruction With Latissimus Dorsi Myocutaneous Flap and Silicone Implant Followed by Adjuvant Radiotherapy for Breast Cancer.

BACKGROUND: About 30% to 50% of women with breast cancer undergo mastectomy, and approximately 50% of them will receive adjuvant radiotherapy (ART). This study evaluates the medium- and long-term impact of ART after immediate breast reconstruction (IBR) with latissimus dorsi myocutaneous (LDM) flap and silicone implants. METHODS: Clinical, surgical, and oncological data were retrospectively collected and analyzed based on the medical records of 176 patients who had undergone IBR with LDM flap and silicone implants. RESULTS: The data showed that 7.4% of patients had a history of previous radiotherapy, 56.3% received ART, 31.8% developed capsular contracture with a mean follow-up of 58.1 months, and 14.2% of surgeries were categorized as procedures with a prolonged operating time, lasting above 1 SD of the observed mean. Those who experienced prolonged operating time (odds ratio, 4.72; 95% confidence interval, 1.72-12.93; P = 0.003) and those who received ART (odds ratio, 7.38; 95% confidence interval, 3.18-17.10; P < 0.001) were more likely to develop capsular contracture. Thirty-two patients (18%) underwent capsulectomy with implant replacement, and 7 patients (4%) had the implant removed. The mean time between IBR and reoperation was 29.1 months. Patients who received ART were 2.84 times more likely to experience reconstruction failure or undergo implant-related reoperation ( P = 0.002). CONCLUSIONS: The results indicated that IBR with LDM flap and silicone implant followed by ART is a safe procedure, resulting in low rates of reconstruction failure. However, ART increased the likelihood of capsular contracture development and implant-related reoperation, having a negative effect on reconstructed breasts.

Is Immediate Breast Reconstruction With a Latissimus Dorsi Myocutaneous Flap Safe for Starting Adjuvant Chemotherapy in Patients With Breast Cancer?

INTRODUCTION: Immediate breast reconstruction following mastectomy reduces perceptions of mutilation and femininity issues in oncological patients, but surgical complications should not delay chemotherapy. This study evaluated postsurgical complications in patients who underwent radical breast surgery followed by immediate reconstruction with latissimus dorsi myocutaneous flaps and silicone implants, along with resulting impacts in delaying chemotherapy. MATERIALS AND METHODS: This retrospective study utilized a prospectively maintained database. Clinical, surgical, and oncological data from 196 women were collected according to the operated side. Patients were grouped according to the time elapsed between surgery and the first cycle of adjuvant chemotherapy: ≤ 60 days (group 1), 61 to 90 days (group 2), or > 90 days (group 3). RESULTS: A total of 198 immediate reconstructions were performed on 196 patients between August 1, 2010 and March 31, 2020; after surgery, 47.4% had minor complications and 7.1% had major complications. Ninety-six patients (48.5%) received adjuvant chemotherapy. The mean time elapsed between surgery and the first chemotherapy cycle was 65.4 days (median: 59), with 52.7% of the patients assigned to group 1, 37.4% to group 2, and 9.9% to group 3. The occurrence of major postoperative complications significantly affected the start of chemotherapy (64.0 vs. 94.5 days; P = .044). Additionally, patients with 2 or more comorbidities were more likely to experience major complications (OR: 3.35; 95% CI: 1.03-10.95; P = .045) than those with 1 or 0. CONCLUSION: Major postoperative complications significantly delayed initiation of adjuvant chemotherapy in oncological patients who underwent radical breast surgery followed by immediate reconstruction with a latissimus dorsi myocutaneous flap and silicone implants.

Outcome analysis and assessment of the lower pole expansion following breast augmentation with ergonomic implants: Optimizing results with patient selection based on 5-year data.

BACKGROUND: Silicone implants have gone through adaptations to improve esthetic outcomes. With the progress of technology, including gel rheology, different properties have been introduced. Ergonomic style implants (ESI) feature enhanced rheological properties and provide a shaped contour with a round base. OBJECTIVES: This study investigated outcomes for ESI in breast augmentation concerning lower pole stretching (LPS) and implant stability and describes an algorithm to assist in decision-making. METHODS: A total of 148 patients (296 breasts) underwent breast augmentation with ESI; this procedure was indicated in patients with good skin quality and <6 cm between the nipple-areola complex and the inframammary fold. RESULTS: The mean patient age was 29.6 years (range: 19-39), and 93 patients (62.8%) underwent primary breast augmentation with demi/full projection (average volume of 245 cc [175-375 cc]). Axillary incision and subfascial pocket were indicated in 115 (77.7%) and 72 (48%) cases, respectively. Average LPS values were 32.2% (24.91 mm) and 10.86% (9.42 mm) at up to 10 days and 10 days to 12 months postprocedure, respectively. Patients were followed for a mean of 29.9 ± 26.4 months (range: 6-66). Complication rates per breast and per patient were 5% and 10%, respectively, and included subcutaneous banding in the axilla (1.6%), implant displacement (1.2%), and wound dehiscence (0.8%). No cases of infection, seroma, or rippling complications were observed. CONCLUSIONS: The present decision-making algorithm summarizes the process involved in breast augmentation using ESI and is intended to help standardize decisions. With correct planning, long-lasting outcomes can be achieved due to favorable interactions between ESI and the patient's tissues.

Neoadjuvant chemotherapy impact on outcomes in immediate breast reconstruction with latissimus dorsi flap and silicone implant.

BACKGROUND AND OBJECTIVES: Neoadjuvant chemotherapy (NCH) has demonstrated efficacy in downsizing tumors and facilitating less extensive surgery. However, immediate breast reconstruction (IBR) after NCH has raised concerns regarding higher complication rates. This study evaluates the impact of NCH on outcomes following IBR with a latissimus dorsi flap and implant (LDI) after mastectomy. METHODS: Cases from a prospective maintained database were reviewed, and patients classified according to whether or not they received NCH. Risk factors and major and minor complications in both groups were then analyzed. RESULTS: Among the 196 patients who underwent 198 IBR procedures, 38.4% received NCH and 66.1% did not. The overall complication rate was 46.7% in the non-NCH group and 53.3% in the NCH group (p = 0.650). The presence of comorbidities increased the likelihood of any complication (odds ratio [OR]: 3.46; 95% confidence interval [CI]: 1.38-8.66; p = 0.008) as well as major complications (OR: 3.35; 95% CI: 1.03-10.95; p = 0.045). Although patients in the NCH group experienced more major complications (10.5% vs. 4.9%; p = 0.134) and early loss of breast reconstruction (3.9% vs. 0.8%; p = 0.128), these findings were not statistically significant. CONCLUSION: This study found no statistically significant association between NCH and higher risk of complications or loss of IBR with LDI after mastectomy.

Determining Degree of Hypertrophy and Extent of Resection in Aesthetic Labia Minora Reduction: Technical Highlights and Step-by-Step Video Guide.

SUMMARY: Advances in aesthetic labia minora (LM) procedures have led to better results and fewer complications. Edge trim or wedge approaches are utilized, both of which use hidden incisions and preserve the edges of the LM. Since 1998 we have been performing a simple and reliable technique based on inferior wedge LM resection and superior pedicle flap reconstruction. While aesthetic LM reduction has been amply published, previous technical videos have not presented a detailed step-by-step description, and few studies specifically address how to estimate the amount of tissue to resect according to the degree of hypertrophy. This article and the accompanying videos provide a detailed guide that clearly outlines the senior author's technique for aesthetic LM reduction. Our experience demonstrates that superior pedicle flap reconstruction is a reliable and reproducible technique. The success of the procedure depends on patient selection, careful preoperative planning, and adequate intraoperative management.

The Influence of the Superficial Venous System on DIEP Flap Drainage in Breast Reconstruction.

BACKGROUND: Autologous tissue has become the gold standard in breast reconstruction. The use of a deep inferior epigastric perforator (DIEP) flap has the advantages of giving a natural appearance to the reconstructed breast and being associated with lower morbidity at the donor site when compared with the transverse rectus abdominis myocutaneous flap. Venous complications such as venous thrombosis and insufficiency remain the main causes of flap loss and surgical revisions. The aim of this study was to evaluate the influence of superficial venous drainage of the DIEP flap and the addition of a second venous anastomosis have on flap survival. METHODS: This was a retrospective cohort study collected from a prospective database maintained by our institution. Data was obtained from the medical records of female patients who underwent mastectomy and breast reconstruction with a DIEP flap between March 2010 and March 2017. We evaluated 137 DIEP patients with unilateral breast reconstructions. In 64 (46.7%) the deep venous system was chosen and 73 (53.3%) had an additional superficial vein anastomosed. RESULTS: Out of the 137 patients evaluated, there were 16 (11.67%) cases of revision, 14 (10.21%) were due to venous thrombosis. Twelve cases (8.75%) of flap loss were reported. Reoperation rate was lower in the dual venous drainage group when compared with the single venous drainage group (p = 0.005), as was the rate of flap loss (p = 0.006) and reoperation due to venous thrombosis (p = 0.002). Out of the 125 DIEP flaps, fat necrosis was clinically identified in 7 (5.1%) cases, and the rate was lower in the dual venous drainage system group (p = 0.01). CONCLUSION: Dual venous drainage of a DIEP flap appears to reduce the rates of venous thrombosis, reoperation, total flap loss, and fat necrosis.

Reoperative Transaxillary Subfascial Breast Augmentation and Fat Grafting: Technical Highlights and a Step-by-Step Video Guide.

SUMMARY: Reoperative procedures after breast augmentation are frequently more complex than primary cases because of local complications and insufficient soft-tissue coverage. Although the transaxillary incision is often indicated in primary breast augmentation, limitations of this approach include secondary surgery and correcting complications after using this approach via the same incision. Combining the transaxillary technique with a subfascial pocket has been suggested to avoid breast scarring and the limitations of submuscular pockets represented by breast animation. With advances in autogenous fat grafting (AFG) techniques, implant coverage alternatives and more natural outcomes have been reported from more superficial implant pockets. Simultaneous AFG with silicone implants (defined as hybrid breast augmentation) has been evaluated recently as an attractive procedure. These two techniques combine to provide breast projection and natural cleavage while camouflaging implant edges. AFG is also important to reduce the intermammary distance and achieve a smoother transition between the breasts. The transaxillary approach can be useful in reoperative breast augmentation and avoids additional scarring on the breast. This article and the accompanying videos provide a detailed, step-by-step guide to reoperative hybrid breast augmentation using a subfascial transaxillary approach, with a predictable and optimized surgical outcome.

Subfascial Axillary Hybrid Breast Augmentation: Technical Highlights and Step-by-Step Video Guide.

SUMMARY: Advances in breast augmentation techniques have led to safety improvements and better aesthetic results. The concurrent combination of the axillary approach with a subfascial pocket has been suggested for augmentation procedures, because it avoids breast scarring and the limitations of submuscular positioning represented by breast animation when the pectoral muscle is contracted. With the improvement of autogenous fat grafting techniques, new implant coverage options and more natural results have been proposed with more superficial implant pockets; simultaneous autogenous fat grafting with silicone implants (defined as hybrid breast augmentation) has recently been evaluated as a promising technique. Combining these two procedures allows core volume projection and natural cleavage while camouflaging implant edges. Fat grafting is also useful in reducing intermammary distance and achieving a smaller and smoother transition between the breasts. This article and the accompanying videos provide a detailed, step-by-step guide to hybrid breast augmentation using a subfascial axillary approach, with a predictable and optimized surgical outcome.

Hybrid Augmentation Mastopexy with New Generation of Smooth Surface Implants: Combining the Benefits of Fat Grafting, Inferior Muscle Support, and an L-Shaped Scar.

BACKGROUND: Augmentation mastopexy (AM) is a challenging procedure. Complications include implant displacement and visibility, which can be addressed, but the stability of the smooth implant surface and poor soft-tissue coverage may present limitations. This article describes a surgical technique for AM using a composite reverse inferior muscle sling associated with autogenous fat grafting. METHODS: Forty-five patients (90 breasts; mean age, 37.7 ± 7.2 years) underwent hybrid composite reverse inferior muscular sling AM. An upper/medial pole area between the implant and the clavicle region and parasternal area was marked to receive fat grafting and divided into three zones. Three-dimensional imaging was used to evaluate lower pole stretch and intermammary distance. RESULTS: The average implant volume was 265 cc (range, 175 to 335 cc). The average fat volumes in zones I/II and III were 80.1 (range, 61.6 to 95.2 cc) and 39.3 (range, 25.2 to 47.3 cc), respectively. Five complications were observed in three patients (6.6%)-minor dehiscence in two (4.4%) and nipple-areola asymmetry in one (2.2%). The lower pole stretched 11.51% (9.9 mm) and 9.8% (8.5 mm) on the right and left sides, respectively ( P < 0.0001), between 10 days and 1 year postoperatively. The intermammary distance was reduced, on average, 49.9% (25.1 mm) ( P < 0.001) between the preoperative value and 1 year postoperatively. CONCLUSIONS: Hybrid composite reverse inferior muscular sling has led to improved aesthetic results for patients with breast ptosis and poor tissue coverage. Fat grafting and recognizing cleavage zones are still important to obtain satisfactory results. This procedure offers a good alternative for AM candidates, providing an adequate smooth surface for implant stabilization.

Zones for Fat Grafting in Hybrid Breast Augmentation: Standardization for Planning of Fat Grafting Based on Breast Cleavage Units.

BACKGROUND: Autologous fat grafting is a procedure indicated for breast augmentation to improve coverage of silicone implants and redesign breast shape. Different techniques are based on parameters that have not been systematically standardized. The authors present a method using breast zone standardization based on breast anatomy to achieve an anatomical composite breast. METHODS: The authors performed this zone standardization in 76 breasts (38 patients) undergoing primary/secondary augmentation. The area between the implant and the clavicle and parasternal area was marked to receive fat grafting and divided into three zones. A mathematical formula [ volume of autologous fat graft = (π × r 2 × p)/4.8] was used to estimate the fat graft volume according to implant volume in the respective zones. RESULTS: Implant volumes ranged from 205 to 375 cc (mean, 265 cc), and patients received an average fat graft volume of 105.3 cc per breast (range, 36 to 135 cc); the average fat volume in zones I/II and III was 78.28 cc (range, 0 to 100 cc) and 27.03 cc (range, 15 to 60 cc), respectively. Three minor complications were observed (5.2 percent) during a mean follow-up of 12.8 months. A high correlation was observed between the fat grafting performed in the cohort and predictions obtained from the formula ( p < 0.001). CONCLUSIONS: Recognizing risky cleavage breast zones between the implant pocket and the upper and medial quadrants remains essential to attain satisfactory outcomes. Although experience and proper judgment are still important in the fat grafting technique, the data presented here offer plastic surgeons an additional standardized framework to help deliver predictable hybrid breast augmentation. . CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

The oncological safety of autologous fat grafting: a systematic review and meta-analysis.

OBJECTIVE: To present a systematic review of the literature and a meta-analysis evaluating the oncological safety of autologous fat grafting (AFG). SUMMARY BACKGROUND DATA: AFG for breast reconstruction presents difficulties during follow-up radiological exams, and the oncological potential of grafted fat is uncertain. Previous studies confirmed that the fatty tissue could be transferred under a good condition suitable would not interfere with mammographic follow-up, although the issue of oncological safety remains. METHODS: We reviewed the literature published until 01/18/2021. The outcomes were overall survival (OS), disease-free survival (DFS), and local recurrence (LR). We included studies that evaluated women with breast cancer who undergone surgery followed by reconstruction with AFG. We synthesized data using the inverse variance method on the log-HR (log of the hazard ratio) scale for time-to-event outcomes using RevMan. We assessed heterogeneity using the Chi2 and I2 statistics. RESULTS: Fifteen studies evaluating 8541 participants were included. The hazard ratios (HR) could be extracted from four studies, and there was no difference in OS between the AFG group and control (HR 0.9, 95% CI 0.53 to 1.54, p = 0.71, I2 = 58%, moderate certainty evidence), and publication bias was not detected. The HR for DFS could be extracted from six studies, and there was no difference between the AFG group and control (HR 1.01, 95% CI 0.73 to 1.38, p = 0.96, I2 = 0%, moderate certainty evidence). The HR for LR could be extracted from ten studies, and there was no difference between the AFG group and control (HR 0.86, 95% CI 0.66 to 1.12, p = 0.43, I2 = 1%, moderate certainty evidence). CONCLUSION: According to the current evidence, AFG is a safe technique of breast reconstruction for patients that have undergone BC surgery and did not affect OS, DFS, or LR.

Reoperative Augmentation Mammoplasty: An Algorithm to Optimize Soft-Tissue Support, Pocket Control, and Smooth Implant Stability with Composite Reverse Inferior Muscle Sling (CRIMS) and its Technical Variations.

BACKGROUND: Reoperative augmentation mammoplasty (RAM) is a challenging procedure, with the highest rates of complications and revision. Complications include implant malposition, lateral displacement, bottoming out, and rotation. These deformities can be addressed with various procedures, but the pocket control and stability of the new smooth implant surface may present limitations. OBJECTIVES: This study revisits a previously described predictable approach in primary breast augmentation and defines a surgical treatment algorithm for RAM technique selection. METHODS: Between 2017 and 2021, 72 patients (144 breasts) underwent RAM with composite reverse inferior muscle sling (CRIMS) technique and its technical variations (types I-IV). CRIMS technique involves placing a silicone gel implant into the submuscular (SM) pocket with an inferior sling of the pectoralis major muscle based on the dimensions of the implant, in combination with support points/dermal bridge sutures to stabilize the implant and glandular tissue at the lower breast pole (LBP). Reasons for surgery were ptosis (92%), implant and malposition (59.6%). Patients were followed for at least 6 months in 5 cases (6.9%), at least 12 months in 50 cases (69.4%), for at least 36 months in 10 cases (13.8%), and more than 36 months in 7 cases (9.7%) (mean 34 months; range 6-48 months). Patients were evaluated in terms of resolution of symptoms, satisfaction, and complications. Three-dimensional imaging (3DI) obtained from the Divina scanner system was used and followed up for 1 year to evaluate breast position, lower pole stretch (LPS), and intermammary distance (IMD). RESULTS: Eleven cases of minor complications were observed in 9 patients (12.5%): hypertrophic scarring in 4 (5.5%), wound dehiscence in 4 (5.5%), Baker II/III capsular contracture in 1 (1.3%). SmoothSilk surface silicone implants were used in all cases, with an average volume decrease of 120 cc. Sixty-eight patients (94.4%) were either very satisfied/satisfied with their aesthetic result. Breast images were performed in a group of 65 patients (90.2%), and in 7 breasts (10.7%), localized oil cysts were observed. The value for LPS was 7.87% (p <0.0001) between 10 days and 1 year, with the majority occurring early in the first 3 months, indicating that the LBP/implant remains steady during the last months of follow-up. No cases of fat necrosis/seroma were observed. There were no signs of intra/extracapsular ruptures, capsular contracture. There were 2 cases (3%) of minimal implant displacement and no cases of rotation. CONCLUSIONS: CRIMS and its variations can be performed successfully in RAM. An algorithmic approach can facilitate the pre- and intraoperative decision-making process and provide the new pocket control and implant stability with acceptable complication rates. Further accurate evaluation is recommended to understand the benefits or disadvantages of CRIMS compared to other RAM techniques. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Optimizing Surgical Outcomes with Small-Volume Silicone Implants Associated with Autogenous Fat Grafting in Primary and Revision Breast Augmentation Surgery: Soft Weight Hybrid (SWEH) Concept.

BACKGROUND: Simultaneous association of autologous fat grafting (AFG) with silicone implants, defined as a hybrid procedure, has been proposed for breast augmentation (BA). In some patients, larger-volume implants may result in larger incisions, with long-term effects including implant palpability, soft tissue atrophy, and secondary ptosis. Some patients do not want large volume implants, or have insufficient soft tissue coverage. Recent improvements in AFG have led to new surgical options in BA for addressing these cases. OBJECTIVES: This study combines AFG in BA using small-volume implants, known as the SWEH (soft weight hybrid) approach, and evaluates aesthetic advantages and outcomes following primary/secondary BA. METHODS: 25 patients (50 breasts) underwent SWEH procedures; this approach was indicated when the overlying tissue was insufficient to adequately cover the implant and patients refused large-volume implants. Three-dimensional images were obtained using a Divina 3D scanner system (AX3 Technologies, Miami, USA) to assess breast volume (BV) and intermammary distance (IMD) during follow-up. RESULTS: Mean patient age was 29.3 years (range: 21-42) and mean body mass index was 19.3 kg/m2 (15.3-27.2). The most common implant (SmoothSilk surface Round/Ergonomix style) volume was 180 cc (175-215), and patients received a mean volume of 125 cc of fat (89-168)/breast in the subcutaneous tissue. Preoperative average BV measurements were 236.85 cc (170-335). At 3 and 12 months post-procedure, the average BV values were 488.82 and 478.73cc, respectively (p=0.475). The average preoperative IMD was 31.76 mm (range, 22-43); at 3 and 12 months post-procedure, the average IMD was 20.47 and 20.94 mm, respectively (p=0.61). Postoperative complications included subcutaneous banding in the axilla (n = 1; 4%) and hypertrophic scarring (n = 1; 4%). Breast imaging exams were performed; in 2 breasts (8%) localized oil cysts were observed; no cases of suspicious calcifications, fat necrosis, or lumps were seen. Fat retention rate (1 year) was calculated by the difference between the BV expected with 100% fat intake and the real BV observed. In our sample we observed an average of 72.7 (range: 69.2-77.3, SD: 2.63) and 76.7 (range: 72.3-79.9, SD: 2.18) percent of fat intake on the right and the left breast respectively. No rippling, implant malposition, or infection was observed during a mean follow-up of 22 months (6-40). CONCLUSIONS: SWEH is a useful surgical alternative that combines the benefits of AFG and implant-based augmentation, particularly with regard to soft tissue coverage, and avoids the limitations of larger-volume implants. The association of small-volume gel implants and smaller scars can yield satisfactory aesthetic outcomes. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors http://www.springer.com/00266 .

Complications after breast reconstruction with alloplastic material in breast cancer patients submitted or not to post mastectomy radiotherapy.

BACKGROUND AND PURPOSE: Breast reconstruction following mastectomy is a relevant element of breast cancer treatment. The purpose of this study was to evaluate the influence of radiotherapy (RT) on local complications in patients with breast cancer that had undergone breast reconstruction with alloplastic material. MATERIALS AND METHODS: Retrospective study of breast cancer patients submitted to mastectomy and breast reconstruction from 2009 to 2013. Clinical and treatment variables were correlated with early and late complications. RESULTS: 251 patients were included; mean age was 49.7 (25 to 78) years. Reconstruction was immediate in 94% of the patients, with 88% performed with a temporary tissue expander. Postoperative radiotherapy (RT) was delivered to 167 patients (66.5%). Early complications were present in 26.3% of the patients. Irradiated patients presented 5.4% incidence of late complications versus 2.4% for non-irradiated patients (p = 0.327). Diabetes (OR = 3.41 95% CI: 1.23-9.45, p = 0.018) and high body mass index (BMI) (OR = 2.65; 95% CI: 1.60-4.37, p < 0.0001) were the main risk factors. The overall incidence of late complications was 4.4%, with predominance of severe capsular contracture (8/11). Arterial hypertension (OR = 4.78; 95% CI: 1.97-11.63, p = 0.001), BMI (OR = 0.170; 95% CI: 0.048-0.607, p = 0.006) and implant placement (OR = 3.55; 95% CI: 1.26-9.99, p = 0.016) were related to late complications. CONCLUSIONS: The overall rate of complications was low in this population. Radiotherapy delivery translated into a higher but not statistically significant risk of late complications when compared with the non-irradiated patients. Already well-known clinical risk factors for complications after breast reconstruction were identified.

The surface topography of silicone breast implants mediates the foreign body response in mice, rabbits and humans.

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.

Clinical and MRI Evaluation of Silicone Gel Implants with RFID-M Traceability System: A Prospective Controlled Cohort Study Related to Safety and Image Quality in MRI Follow-Up.

BACKGROUND: SmoothSilk implants (SSI) are the first generation of implants to incorporate a radio-frequency identification device (RFID-M), a non-invasive traceability system. Although the RFID-M is considered compatible with magnetic resonance imaging (MRI), the size of the artifact and its influence on breast tissue vary. This prospective study assessed safety and MRI issues in a cohort of breast reconstruction patients. METHODS: Forty-four SSI were used for breast reconstruction in patients undergoing treatment for breast cancer. All patients were evaluated for magnetic field interactions, MRI-related heating and artifacts in a 1.5-T MRI unit using standard T1/T2-weighted sequences utilized in clinical assessment of breast tissue/implants. RESULTS: Mean patient age was 41.5 years (27-53ys) and body mass index was 28+-6.44 kg/m2. In 18/22 patients (81.8%), mastectomies were unilateral. No patients reported local heat/discomfort. All implants showed RFID-M-related artifacts with an estimated mean volume in T1 of 42.9cm3 (26.2-63.6cm3; SD±8.6 and 95% CI, 40.37-45.45) and in T2 of 60.5cm3 (35.4-97.2cm3; SD±14.7 and 95% CI, 56.29-65.01). Artifact volume was smaller in T1 than in T2, to a statistically significant degree (p <0.001). There were no statistically significant differences in artifact volume according to surgical indication, breast side or implant volume. There were 4/44 (9%) cases of minor rotation (<45°). In all cases, adequate analysis of the breast tissue was performed. CONCLUSIONS: The results demonstrate that SSI with RFID-M technology presented an artifact volume of 42.9cm3 and 60.5cm3 in T1 and T2 images, respectively. Our findings provide detailed information on the quality and location of MRI artifacts in a reconstructed cohort which can help guide clinical decision-making for patients. To our knowledge, this is the first time RFID-M breast implants have been prospectively evaluated for clinical and MRI issues in a cohort of reconstructive patients. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .