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Background: Silicone breast implant design has evolved over the last 50 years. Regulatory bodies including the FDA require data to support the modifications designed to improve the safety, efficacy, longevity, and biocompatibility of breast implants., Objectives: The authors reviewed the 3-year data on the safety and effectiveness of Motiva (Establishment Labs Holdings, Inc., Alajuela, Costa Rica) SmoothSilk silicone gel-filled breast implants submitted to the FDA. The current submitted data include the primary breast augmentation and revisional augmentation cohorts., Methods: The Motiva IDE is a prospective, single-arm, multicenter, 10-year pivotal study in which data are collected on breast augmentation, reconstruction, and revisional surgery. Three-year data were submitted to the FDA on adverse events, reoperations, patient and physician satisfaction, connective tissue diseases, and quality of life validated instruments. A subset of the patients underwent annual magnetic resonance imaging (MRI) at years 1, 2, and 3 to screen for implant rupture., Results: A total of 451 patients were implanted in the primary augmentation cohort and 109 patients in the revisional augmentation cohort. There were 218 patients enrolled in the MRI cohort. Reported rates for reoperation for any reason were 6.1% in the primary augmentation cohort (92.4% follow-up) and 25.8% in the revisional augmentation cohort (88.7% follow-up)., Discussion: Motiva implants were first introduced in 2010. The 3-year Motiva data suggests that the leading cause of revisional surgery has shifted from capsular contracture and rupture to more subjective indications for reoperation such as malposition and size change., Conclusions: Three-year data from the primary augmentation and revisional augmentation cohorts submitted to the FDA demonstrate the safety and efficacy of the Motiva implants. There were low complication rates for implant-related complications and high surgeon and patient satisfaction., (© The Author(s) 2024. Published by Oxford University Press on behalf of The Aesthetic Society.)

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., (© The Author(s) 2024. Published by Oxford University Press on behalf of The Aesthetic Society. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Breast augmentation procedures using silicone implants have become increasingly popular over the past six decades. This article addresses the concerns of patients regarding implant strength by providing clinicians with valuable information in addition to video and pictorial evidence to share, fostering reassurance. The article focuses on the structural integrity and stability of breast implants, which play a critical role in their long-term performance and patient satisfaction. Specifically, it examines the industry standards outlined by the International Organization for Standardization (ISO), with a particular emphasis on ISO14607-2018, which encompasses a range of mechanical and physio-mechanical tests, including the assessment of silicone gel-fill firmness, evaluation of shell integrity, and examination of the impact of environmental conditions on implant performance. Breast implants are not static devices and are subject to aging and fatigue-based degradation. This emphasizes the need for ongoing monitoring and evaluation to ensure the long-term safety and satisfaction of patients. By providing a comprehensive examination of breast implant structure and industry standards, this article equips clinicians with the necessary knowledge to address patient concerns and foster confidence in the safety and longevity of breast augmentation procedures using silicone implants.Level of Evidence III 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 ., (© 2024. Springer Science+Business Media, LLC, part of Springer Nature and International Society of Aesthetic Plastic Surgery.)

Background: Transumbilical breast augmentation (TUBA) with saline implants has been considered a safe and efficient technique for decades. However, because silicone implants are more popular than saline ones, TUBA with saline implants is not widely performed. In 2014, we published a report on transumbilical breast augmentation using silicone cohesive gel implants. As we have performed transumbilical silicone breast augmentation (TUSBA) for 13 years with slight modifications, this study aimed to describe this novel technique and present accompanying patient outcomes over 5 years., Methods: We enrolled patients desiring breast augmentation at a single center. The preoperative design was initially determined with the patients in standing positions before they underwent surgery under general anesthesia in a supine position., Results: Between January 2018 and December 2022, 69 women and one man underwent TUSBA at a single center. All patients underwent cohesive gel silicone implantation in the subpectoral pocket. The implant size varied from 225 to 300 mL (average 272 mL) because two patients underwent surgery with implants of different sizes due to breast asymmetry. All patients were satisfied with the surgery outcome except one who was dissatisfied because of abdominal bulging., Conclusions: TUSBA offers advantages such as minimal scarring and unrestricted arm movement; thus, it can be an alternative option for patients seeking breast augmentation., 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 https://www.springer.com/00266 ., (© 2024. Springer Science+Business Media, LLC, part of Springer Nature and International Society of Aesthetic Plastic Surgery.)

Background: After approval of Sientra silicone gel breast implants in March of 2012, the U.S. Food and Drug Administration required completion of a 10-year U.S. postapproval study. The authors present results from the first 6 years of this study., Methods: An ongoing, open-label, prospective, multicenter study is being conducted to evaluate the long-term clinical performance of Sientra implants in patients undergoing breast augmentation, reconstruction, and revision in the postmarket environment. Enrollment of 5197 patients (10,327 implants) was completed on March 6, 2015 (4046 primary augmentation, 895 revision-augmentation, 149 primary reconstruction, and 107 revision-reconstruction). Analyses were conducted at year 6 (database lock: January 24, 2022)., Results: Across all cohorts who received an implant, the Kaplan-Meier risk of investigator-reported Baker grade III/IV capsular contracture was 4.1% (3.9% with submuscular placement and 6.75%with subglandular placement), the risk of reoperation was 11.6%, and the risk of implant removal was 7.8% (5.9% with implant replacement and 2.0% without replacement). The primary reason (>50%) for reoperation was aesthetic (eg, style/size change). The Kaplan-Meier risk of rupture, calculated for patients who underwent explantation or MRI for rupture evaluation, was 5.8%. Overall, 82.6% of patients were highly satisfied/happy with their implant. No cases of breast implant-associated anaplastic large cell lymphoma were reported., Conclusion: Six-year results of the postapproval study were consistent with the 10-year core study and provide additional evidence in a large data set supporting the comprehensive safety and effectiveness profile of the Sientra implants., (Copyright © 2023 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the American Society of Plastic Surgeons.)

Introduction: Implant-based breast augmentations and reconstructions are one of the most common surgical procedures performed by plastic surgeons in the United States, which has rapidly increased in popularity since the 2000s. Silicone lymphadenopathy (SL) is a complication of breast implants that involves migration of silicone to nearby soft tissue/lymph nodes. Data on its clinical features and management is scarce., Methods: SL-related search terms were used to find articles in 3 databases. Of 598 articles, 101 studies met the inclusion criteria. Demographics, clinical presentation, workup, and management data were analyzed., Results: Of 279 cases of SL and 107 with information on initial diagnosis, 35 (33%) were incidental. The most common symptom was painless lymphadenopathy, followed by painful lymphadenopathy. 251 (95%) and 13 (5%) patients had silicone and saline implants, respectively. 149 (68%) patients had implant rupture. Axillary lymphadenopathy was the most affected region (136 cases, 72%), followed by internal mammary (40 cases, 21%), cervical/supraclavicular (36 cases, 19%), and mediastinal (24 cases, 13%) regions. 25% of patients underwent fine-needle aspiration, 12% core needle biopsy, and 59% excisional biopsy. 32% of cases underwent explantation and/or implant exchange. The most common indication for surgery was implant rupture. Histology showed multinucleated giant cells, large histiocytes, and silicone accumulation., Conclusions: SL is a complication associated with breast implants. The majority of patients are asymptomatic, and most cases are managed conservatively. Minority need a biopsy and surgical interventions due to abnormal imaging, persistent symptoms, and/or implant rupture. Workup and management should be tailored to the patient., Competing Interests: Declaration of Competing Interest For interpretation of the references to color in this figure legend , the reader is referred to the web version of this article. Dr. Devinder P. Singh is a consultant to 3M. Dr. Kristin Emilia Rojas has worked as a consultant for Roche Diagnostic Solutions, Merck. She has received honoraria from Pacira Pharmaceuticals. She has also received grant funding from Bristol Myers Squibb Foundation. Other authors have nothing to disclose., (Copyright © 2024 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.)

Background: Breast implant illness (BII) is a rising concern among many patients. Although not fully understood, a connection between silicone breast implants and systemic diseases may be present. This connection may influence the types of breast surgeries performed., Objectives: To evaluate changing trends in breast surgeries in Israel over time, with regard to implantation, explantation, and implant exchange surgeries., Methods: In this ecological study, we presented data from four private medical centers in Israel regarding the number of breast implant surgeries performed in the years 2018-2019. Data were collected bi-yearly. The types of surgeries included breast implantation, explantation, and breast implant exchange., Results: When we summed and compared the yearly data, we saw that the number of implantations in 2018 was 2267 (80.1% of breast implant procedures that year), and 1929 (68.9%) in 2019. The number of implant exchanges in 2018 and 2019 was 482 (17.0%) and 608 (21.7%), respectively. In 2018, 80 (2.8%) explantations were performed and 262 (9.4%) in 2019., Conclusions: There appears to be a trend in the rise of implant removal surgeries in addition to a decrease in breast implantations. One possible reason may be patient concerns of BII. Another reason may be the increased public interest and discussion about systemic effects of breast implants. More research is needed in this field to achieve better understanding of the phenomenon, the reasons behind it, and the possible solutions and ways of treatment.

This study aimed to assess the effectiveness and safety of BellaGel implants after implantation in Asian women and inform surgeons of another option for use in breast augmentation and reconstruction. This study was conducted in eight hospitals from November 27, 2015 to April 30, 2018. All patients underwent augmentation mammoplasty or implant-based breast reconstruction with BellaGel implants. Complication rates were compared between groups, and the cumulative hazard function was compared using the Kaplan-Meier survival analysis. Implants were grouped by surface type, and the cumulative hazard functions of total complication cases were compared. The biomechanical properties of the BellaGel implant and other company representative implants were tested using a mechanical testing machine, and surface topography was analyzed using a 3D laser scanning confocal microscope. There was a significant difference in the incidence of complications between the reconstruction (17.1%) and augmentation (4.7%) groups, but no significant difference in the complication rates of each group. There was no difference in the reoperation or revision rates between the groups. The log rank test showed a statistically significant difference in cumulative hazard function between the groups. Among the three types of implants (smooth, textured, and microtextured), the microtextured type had the lowest complication rate. The BellaGel microtexture implant had the highest maximal tensile load and displacement value. The BellaGel and Silksurface implants had the highest stored energy, although there was no significant difference. BellaGel implants can serve as a criterion for the selection of safe and effective implants among currently available implants., Competing Interests: Declaration of Competing Interest None declared., (Copyright © 2020 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.)

A 56-year-old woman with a 12-year history of recurrent triple-negative invasive carcinoma of the breast presented with progressive enlargement of lymph nodes in the setting of established rupture of the ipsilateral silicone breast implant. Although this was proven to be benign on cytology, its progressive nature led to repeated core biopsies for histology, which were necessary given the high-risk nature of triple-negative breast cancer and the multiple proven previous recurrences. The histology demonstrated features of silicone deposits without evidence of malignancy. This case demonstrates the dilemma in surveillance of high-risk patients with breast cancer who have had previous silicone lymphadenopathy., Competing Interests: Competing interests: None declared., (© BMJ Publishing Group Limited 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

A 69-year-old female developed subacute diplopia, right peripheral facial nerve palsy, bilateral upper and lower extremities dysesthesia and weakness 50 years after silicone injection for breast augmentation. Motor conduction study revealed prolonged distal latency and reduced amplitude in the median, ulnar, and peroneal nerves. Sensory conduction velocities were reduced in the median and ulnar nerves, and sensory potential in the sural nerve could not be recorded. While intravenous immunoglobulin therapy was ineffective, explantation of silicone breast implants improved her neurological symptoms. Histopathological study of axillary lymph node revealed foreign body granulomas and macrophages phagocyting silicone. The patient was diagnosed with human adjuvant disease presenting clinical features of Guillain-Barré syndrome. Human adjuvant disease should be considered in the patients with implants like silicone and neurological symptoms.

Background: In recent years, follow-up after breast reconstruction with silicone implants and the detection of complications have been relieved by the possibility of improved diagnostic methods., Methods: Between January 2015 and December 2019 a total of 40 patients (29-84 years) with silicone implants were included in this retrospective study. The implants were examined clinically and with modern imaging: general ultrasound imaging (US), magnetic resonance imaging (MRI), high resolution computed tomography (CT) and positron emission tomography -computed tomography (PET-CT). If necessary, a histological/cytological sample was taken. The breast implants were assessed by three radiologists specialized in breast imaging. The grade of capsular contracture was classified according to the Baker classification., Results: All 40 women obtained a clinical examination and an US diagnostic to identify early and more common complications such as implant folding and capsular fibrosis. Depending on the clinical examination and ultrasound findings additional MRI (n = 10), CT (n = 9) and/or PET-CT (n = 2) were performed. 16 patients had implants folding proven with US (n = 16), MRI (n = 6) and CT (n = 1). The grade of capsular fibrosis was determined according to the Baker classification. The following results were obtained in our study: 25 breast implants with Baker grade I and eleven breast implants with Baker grade II, both proven with US; one breast implants with Baker grade III and one breast implant with Baker grade IV, proven with US (n = 2), MRI (n = 1) and CT (n = 1). One patient had intracapsular rupture and one patient had extracapsular rupture, both detected on CT and surgically proven. No patient had a silicone accumulation in the lymph nodes. One patient had pathologically enlarged axillary lymph nodes, which were evaluated as inflammatory changes in PET-CT. Long-term complications such as the development of malignant breast tumors could not be observed., Conclusion: To detect early complications after breast implant surgery, a regular clinical examination is indispensable. Imaging methods complement each other and if they are used multimodal, it is easier to identify early complications. Modern diagnostic modalities like ultrasound and magnetic resonance imaging expand the spectrum and improve diagnostic safety.

Introduction: Pulse lavage (PL) irrigation of prosthesis pockets has prior been described for breast implant salvages. However, PL for removal of leaked silicone from prosthesis pockets after implant ruptures has not been studied yet. Since open capsulotomies are regarded as equal treatment of capsular contracture (CC) than capsulectomies, this study analyzed the clinical outcome of PL for silicone removal and subsequent capsulotomy in cases of concurrent CC and breast implant rupture., Methods: Between 2012 and 2017, 55 patients (75 breasts) with suspected silicone implant rupture and CC (Baker grade III/IV), after primary breast augmentation or implant-based breast reconstruction, were included in a retrospective, observational study. Mean patient follow-up was 12.2 ± 3.6 months., Results: In all preoperatively suspected ruptured silicone breast implants, around a quarter were intact. In contrast to previously published data, implant exchanges in cases of implant ruptures did not lead to significantly higher CC recurrence rates (27.6% vs. 22.2% in cases of intact implants, p = 0.682), if the prosthesis pockets were treated with PL irrigation followed by open capsulotomy. PL reduced the amount of encapsulated silicone remnants histologically. The age of patients with CC after failed implant-based reconstruction was significant lower for salvage surgeries with flap reconstruction than for implant exchanges, p < 0.05., Conclusions: PL irrigation of prosthesis pockets prior to open capsulotomy is a safe and effective treatment of CC with concurrent silicone leakage. Remaining silicone remnants in breast capsules may affect the development of a recurrent CC. To avoid CC recurrences, patients should consider conversion to autologous tissue., 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 .

Background: Silicone implant breast augmentation has been routinely performed since the 1960s. Emerging literature suggests the existence of a clinical syndrome, silicone implant incompatibility syndrome (SIIS) resulting from silicone implants. Autoimmune reactivity develops, with subsequent symptoms including myalgias, arthralgias, chronic fatigue, sleep disturbance and cognitive impairment. While the existence of a clinical entity is currently being established in the literature, there are currently no guidelines on management., Method: Literature review was conducted using Medline and PubMed databases with key terms searched for, prior to hand-searching and bibliographical review until February 2019. The relevant literature was reviewed to determine whether consensus exists on the most appropriate management strategy., Results: Forty-nine articles relevant to SIIS were identified with twenty-one of these specifically outlining treatment. Of these, only five provided data on larger cohorts, three provided conclusions from literature reviews, and the remainder were small case series or isolated case reports. Improvement in symptoms was obtained by medical management of their immune response, by explantation and by simply counselling on the condition itself., Conclusions: A new clinical condition is being described that appears to suggest a link between silicone implant use and various symptoms in a cohort of patients. The subsequent treatment of SIIS is yet to be agreed upon. Further research is required to establish guidelines for diagnosis and ensure evidence-based treatment, and that patients and clinicians have a more refined understanding of the potential risks of silicone breast implant use., Level of Evidence Iii: 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 .

Pulmonary fibrosis in a patient with history of ruptured silicone breast implants may present a therapeutic challenge to diagnose and treat. In this case report, we aim to discuss our experience in diagnosing a patient with chronic silicone embolism syndrome masquerading as refractory multifocal pneumonia that presented with respiratory failure. A young woman with no significant past exposure having recurrent admissions to the hospital due to fever and shortness of breath was found to have chronic silicone embolism with pneumonitis. This case report emphasis the prompt diagnosis and treatment of silicone induced fibrosis and approach to the most common side effects of breast implants., Competing Interests: Competing interests: None declared., (© BMJ Publishing Group Limited 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Breast implant-associated anaplastic large cell lymphoma is a malignancy of T lymphocytes that is associated with the use of textured breast implants in both esthetic and reconstructive surgeries. Patients typically present with a delayed seroma 8-10 years following implantation or-less commonly-with a capsular mass or systemic disease. Current theories on disease pathogenesis focus on the interplay among textured implants, Gram-negative bacteria, host genetics, and time. The possible roles of silicone leachables and particles have been less well substantiated. This review aims to synthesize the existing scientific evidence regarding breast implant-associated anaplastic large cell lymphoma etiopathogenesis.

The link between breast implants and systemic disease has been reported since the 1960s. Although many studies have looked at either supporting or refuting its existence, the issue still persists and has now been labeled "breast implant illness." The rise of patient advocacy and communication through social media has led to an increasing number of presentations to plastic surgeons. This article summarizes the history of breast implants and systemic disease, critically analyzes the literature (and any associated deficiencies), and suggests a way forward through systematic scientific study.

Background: One of the undesirable complications that might occur after breast augmentation with silicone implants is capsular contracture. In its etiology, the relations between mast cells and myofibroblasts play an important role in collagen synthesis. Mast cells are able to activate fibroblasts into myofibroblasts, through paracrine secretions, inducing collagen production. The objectives of this study were to analyze the myofibroblast concentration through the α-SMA immunomarker and evaluate the intensity of mast cell expression against the C-Kit immunomarker., Material and Method: Sixty-four Wistar rats were used, divided into two groups (polyurethane foam and textured surface) with 32 animals in each. The animals received silicone implants on the back, below the panniculus carnosus, and after the determined period, they were killed and the capsules formed around the implants were studied. The capsules were analyzed employing the immunohistochemical technique, with the α-SMA and C-Kit immunomarkers in subgroups of 30, 50, 70 and 90 days., Results: The myofibroblast concentration was higher in the polyurethane group when compared to the textured group (30 days p = 0.105; 50 days p = 0.247; 70 days p = 0.014 and 90 days p = 0.536). The intensity of mast cell expression was more pronounced in the polyurethane group when compared to the textured group (30 days p = 0.798; 50 days p = 0.537; 70 days p = 0.094 and 90 days p = 0.536)., Conclusions: Polyurethane-coated implants induced higher concentrations of myofibroblasts and higher expression of mast cells, when compared to the textured surface implants., No Level Assigned: 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 .

Background: Complications after silicone implantation, with silicone extravasation being the most severe, remain a safety issue in breast implantation surgery. The purpose of our study was to determine the incidence of medium- and long-term postoperative complaints and complications and indications for explantation in patients with a silicone breast implant., Methods: This is a retrospective cohort study consisting of patients who received silicone breast implants of the fourth or fifth generation between 2003 and 2015. Long-term outcomes (> 3 months after initial placement) were derived from medical records. The association with indication of breast surgery, method of placement, and type of reconstruction was determined., Results: In total, 448 patients (n = 738 silicone breast implants) met the inclusion criteria with a median follow-up of 330 days. Overall, 18% of the implants resulted in postoperative complaints, with discomfort or pain being the most common complaint (12%), significantly more frequent in reconstructive cases and significantly associated with subglandular placement in cosmetically augmented breasts. Physical examination revealed in 14% one or more postoperative complications, with capsular contracture being the most common complication. A total of 12% of the implants were eventually explanted within a median time of 568 days. Predominant reasons were cosmetic dissatisfaction, capsular contracture, and pain (in 37%, 21%, and 15%, respectively). Macroscopic leakage was demonstrated in 3% of the explanted prostheses., Conclusions: Explantation of breast implants occurred in 12%, within a median time of 1.6 years, wherein macroscopic leakage was rarely seen. Cosmetic dissatisfaction, capsular contracture, and pain were the most common indications., (Copyright © 2018 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.)

Background: The posttreatment pain associated with breast augmentation is a top concern of most patients and can affect the decision concerning surgery., Objectives: This study aimed to compare the posttreatment pain and recovery times of patients undergoing primary breast augmentation with lightweight vs full-mass implants of similar volumes. The authors hypothesized that the reduced mechanical strain applied by lightweight implants elicits less pain., Methods: In this retrospective, observational study, 100 women who had undergone primary breast augmentation with either a lightweight breast implant or a traditional full-mass silicone implant (n = 50), were contacted by phone and asked about their posttreatment experiences and overall satisfaction with the outcome. All women were treated by the same surgical team, and the two groups were matched by date of surgery., Results: Most patients in the two cohorts had a self-reported preoperative B cup size and relatively high tolerance to pain. On average, LWBI patients were 6 years older than those undergoing full-mass implantation (32.4 ± 8.7 vs 26.2 ± 8.0; P = .0004) and more had experienced at least one pregnancy (61.2% vs 24%, P = .0002). LWBI patients opted for implants 39 ± 28.4 cc larger than patients in the control group. Subglandular placement was selected in most cases (LWBI: 83.7% and full-mass: 90.0%). Mean posttreatment pain was lower in the LWBI cohort (5.5 ± 2.4 vs 6.5 ± 2.4) and required a shorter duration of analgesics (3.87 ± 1.77 days vs 5.26 ± 2.94 days; P = .009). Age- and parity-adjusted measures demonstrated a respective 2-day and 5-day shorter recovery period and return to normal activities interval in the LWBI versus full-mass implant cohorts (P = .04 and P = .002, respectively)., Conclusions: As compared to traditional silicone filled full-mass implants, breast augmentations with B-Lite lightweight breast implants (G&G Biotechnology Ltd., Haifa, Israel) elicit less posttreatment pain and require less down-time, ultimately, meeting patients' quest for desired breast shape at minimal discomfort.

Breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) is a rare peripheral T cell lymphoma. BIA-ALCL is a disease of the fibrous capsule surrounding the implant and occurs in patients after both breast reconstruction and augmentation. More than 300 cases have been reported so far, including two in a transgender patient. Here we describe BIA-ALCL presented with a mass in a transgender patient and the first case of BIA-ALCL in the Czech Republic. In 2007, a 33-year-old transgender male to female underwent bilateral breast augmentation as a part of his transformation to female. In June 2014, the patient developed a 5-cm tumorous mass in her left breast. Magnetic resonance imaging of the chest revealed a ruptured implant and a tumorous mass penetrating into the capsule and infiltrating the pectoral muscle. An R0 surgery was indicated-the implant, silicone gel and capsule were removed, and the tumorous mass was resected together with a part of the pectoral muscle. Histology revealed anaplastic large-cell lymphoma. The patient underwent standard staging procedures for lymphoma including a bone marrow trephine biopsy, which confirmed stage IE. The patient was treated with the standard chemotherapy for systemic ALCL-6 cycles of CHOP-21. The patient was tumor-free at the 2-year follow-up. BIA-ALCL has been reported mostly in women who received implants for either reconstructive or aesthetic augmentation. This is the third report of BIA-ALCL in a transgender person, the first in the Czech Republic. Level of Evidence V 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 .

Background: In March 2012, the United States Food and Drug Administration approved Sientra's application for premarket approval of its portfolio of round and shaped silicone gel breast implants based on data from the largest silicone gel breast implant study to date. This article presents the results of Sientra's Core Study at the conclusion of 10 years., Methods: The Sientra Core Study was a 10-year, open-label, prospective, multicenter clinical study designed to assess the safety and effectiveness of Sientra's breast implants in augmentation and reconstruction. A total of 1,788 patients (3,506 implants) were enrolled, including 1,116 primary augmentation, 363 revision-augmentation, 225 primary reconstruction, and 84 revision-reconstruction., Results: Across all cohorts, the rate of rupture by patient was 8.6%, the rate of Baker grade III/IV capsular contracture was 13.5%, and the rate of reoperation was 31.5%. The rate of capsular contracture was statistically significantly lower for textured devices [9.0%; 95% confidence interval (CI), 7.0-11.5%] compared with smooth devices (17.5%; 95% CI, 14.9-20.4%). There were no cases of breast implant-associated anaplastic large cell lymphoma. Primary reasons for reoperations included capsular contracture (18.8%), and style/size change (19.3%), with over 50% of the reoperations due to cosmetic reasons., Conclusion: The 10-year results of Sientra's Core Study support a comprehensive safety and effectiveness profile of Sientra's portfolio of round and shaped breast implants.

Background: Despite the increased understanding of surgical best practices, capsular contracture remains the most commonly reported complication and reason for reoperation following breast implant surgery. This study provides a long-term update to a previous investigation of potential contributing risk factors for capsular contracture in primary augmentation patients., Methods: The data used for this analysis include 5,122 implants in 2,565 primary augmentation patients implanted by 34 surgeons based on long-term results from Sientra's clinical study. Potential risk factors, including patient and implant attributes, surgery characteristics, pocket irrigation, and postsurgery characteristics, were analyzed using frequency and multivariate models., Results: A total of 333 capsular contracture events in 224 patients were reported. The overall Kaplan-Meier rate for capsular contracture was 10.8% by device through 10 years. Results from the multivariate analysis found 8 factors to be independently associated with capsular contracture (implant placement, implant surface, incision site, hematoma or seroma development, device size, surgical bra, steroid, and antibiotic pocket irrigation; all P values < 0.05). Results from correlation analysis found 2 of the 8 factors to be more strongly associated with early onset capsular contracture events, compared with those occurring after 2 and 5 years of implantation (implant surface and steroid pocket irrigation)., Conclusion: The results of this large-scale, multivariate analysis identified several significant risk factors for capsular contracture, including device features (smooth surface, smaller size), surgical factors (periareolar incision, subglandular placement, antibiotic irrigation), the development of hematoma/seroma, and the use of a surgical bra.

Background: Board-certified plastic surgeons utilizing the Sientra 207 Highly Cohesive Gel breast implants provided their initial satisfaction with usage and postoperative results on primary and revision augmentation patients, and study participants provided their satisfaction with surgical result., Methods: Up to 15 participating investigators at institutional review board-approved sites enrolled up to 180 women who received Sientra 207 implants for primary augmentation or revision augmentation procedures. Investigator and participant assessments were performed preoperatively and postoperatively at 3, 6, and 12 months., Results: All participating surgeons found the implants to be easy or very easy to implant, and 92 percentage reported satisfaction with surgical results. Patients receiving these implants reported similarly high rates of satisfaction (94%)., Conclusion: With this combination of high satisfaction and low complication rates, the Sientra 207 silicone breast implants now provide a welcome addition to plastic surgeons' breast implant options.

Background: The safety and efficacy of all medical devices, including breast implants, is important and consistent performance is best shown by undertaking long-term clinical and vigilance studies. Local complications such as capsular contracture and rupture are risks often associated with breast implant surgery., Objectives: The authors investigate and evaluate the safety and performance of Eurosilicone's (Eurosilicone S.A.S, Apt Cedex, France) Cristalline Paragel breast implants at 8 years postimplantation., Methods: In this prospective clinical study, 995 Eurosilicone textured cohesive Cristalline Paragel mammary implants were implanted in 526 women undergoing augmentation and reconstructive surgery at 17 centers across France. Complications were recorded at 3 months and annually thereafter for 8 years. Descriptive statistics were used and key complications were analysed using the Kaplan-Meier method., Results: Capsular contracture was reported in 8.5% of implants across all cohorts through 8 years. The Kaplan-Meier risk of capsular contracture (Baker Grade III/IV) per implant was 8.4% in the primary augmentation cohort and 18.0% in the primary reconstruction cohort. Eight implant ruptures were identified by surgeon examination during this follow-up period. The Kaplan-Meier risk of rupture occurring within 8 years postimplantation, across all cohorts, was 1.4% per patient and 0.9% per implant. Actual implant removal rate (explantation/exchange) was 6.0% and 13.8% for primary augmentation and primary reconstruction, respectively. Actual rates of local complications including infection and seroma were low with risk rates of 0.6% and 0.2% by subject., Conclusions: This multicenter clinical study involving Eurosilicone's silicone gel breast implants in both round and shaped profiles demonstrates an excellent safety and efficacy profile through 8 years., (© 2017 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com)

Since the 1960s, silicone implants have been used for breast augmentations, both cosmetically and in reconstructive surgery. Tissue exposed to silicone can react with multiple adverse advents. Autoimmune/inflammatory syndrome induced by adjuvants due to silicone exposure from ruptured silicone implants can lead to different interstitial lung manifestations predominantly with granuloma evolvement, leading to the so-called silicone implant incompatibility syndrome (SIIS). This case describes a 57-year-old woman with multiple lung infiltrations and a left-sided breast implant. The implant had been replaced twice, once due to implant rupture 36 years ago. The nodular infiltrates could not be related to infection, malignancy, interstitial lung disease, vasculitis or connective tissue disorder, and it was concluded that the nodular infiltrations were of inflammatory origin due to an autoimmune response secondary to the silicone implants (SIIS). After explantation, the patient's symptoms subsided and her physical condition has remarkably improved., Competing Interests: Competing interests: None declared., (© BMJ Publishing Group Ltd (unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Background: The previously described Akademikliniken (AK) method is a comprehensive approach to breast augmentation with form stable implants that has been shown to afford favorable outcomes when applied by experienced surgeons., Objectives: To evaluate outcomes of a surgeon newly adopting this method at the beginning of his career., Methods: A retrospective review of patients undergoing dual plane subpectoral augmentation with Style 410 implants between April 2009 and December 2014 was undertaken. The review was performed one year after the last operation. The first author (P.M.) performed all operations. Complications and reoperation rates were analyzed and correlated with patient and implant characteristics using the chi-square or Fisher's exact test, as appropriate., Results: A total of 620 consecutive patients met the inclusion criteria with a mean follow up of 8 months (range, 1 week-60 months). Complications occurred in 14.8% of the patients: request for larger size (3.3%), rotation (3%), and Baker III/IV capsular contracture (2.2%) were the most common ones. Low implant projection was a statistically significant risk factor (P < 0.05) for the most common complication - request for a larger size. The overall reoperation rate was 8.7%. The most common indication for reoperation was request for larger size (2.2%) followed by rotation (2.2%) and capsular contracture (2%)., Conclusions: Breast augmentation with form stable anatomical implants requires a considerably different process. By implementing a systematic approach such as the AK method, novices in this terrain can expect to achieve reasonable outcomes., Level of Evidence: 4., (© 2017 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com)

Background: There is societal concern regarding potential health problems associated with breast implants. Much of this distrust climate was a reaction to the Poly Implant Prosthesis (PIP) scandal. Studying the mechanisms of implant rupture is an important step for their improvement. The mechanical behaviour of breast implant shells was studied on explanted and virgin implants. Implants from both PIP and another brand (brand X), currently in the market, were considered., Methods: To study the mechanical behaviour of the shell, a total of 940 samples from 11 explants and 5 control implants were analysed. The experimental protocol follows the ISO standards for shell integrity and determination of tensile stress-strain properties. Pearson correlation analyses and the multi-factor ANOVA statistical tests were performed using mechanical test data., Results: Both PIP control and explants had significant variations of stress (P = 0.0001) and shell thickness (P = 0.000) throughout the implant. The stress was directly related to shell thickness. Shell thickness varied significantly for PIP implants, exceeding the manufacturer's specifications. Regarding the other brand, thickness variation was within manufacturer's specifications., Conclusions: The heterogeneous nature of PIP implants was confirmed. The implant shell thickness should be considered as a relevant parameter during the manufacturing process, for quality control purposes. These results may contribute to dispel mistrust and doubt surrounding breast implants, among the medical community and patients., Level of Evidence Iii: 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 .

Background: Clinical trials have demonstrated through core and independent studies that anatomical devices are safe and effective with low complication rates. The rotation rate of shaped breast implants in the literature is 0 to 8.2%. Currently there are no studies evaluating the efficacy of in office ultrasound or clinical rotation vs actual rotation rates seen on high-resolution ultrasound (HRUS)., Objectives: The purpose of the study is to demonstrate the ease and reliability of HRUS for evaluating the rotation rate of 2 different brands of anatomic implants and to correlate this with the presumed clinical rate, as well as independent evaluators assessments., Methods: A total of 69 patients were followed up at routine intervals and were evaluated for rotation. Any implant rotated past >30° off of midline (outside 5-7 o’clock) was considered to be rotated. To determine if radiographic rotation was clinically evident, 20 composite patient photos were blindly evaluated., Results: A random total of 69 patients underwent bilateral augmentation mammoplasty with form stable anatimic gel implants using 138 implants. Twenty-nine of the 69 (42%) patients and 37 of the 138 (27%) implants were found to be rotated-using HRUS. Eight of the 69 (12%) patients had bilateral rotations. Independent evaluators were able to identify two of 12 (17%) possible rotations, or 2 rotations in 40 (5%) total implants., Conclusions: Anatomic form stable gel implants are actually rotated up to 25 times more frequently than previously thought, but these rotations do not translate into clinically significant sequela. High-resolution ultrasound is a simple alternative for breast implant surveillance and is better accepted by patients than magnetic resonance imaging (MRI). The clinical value of HRUS is also discussed and recommendations for FDA implant labeling changes are provided in this article., Level of Evidence: 4, (© 2017 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com)

Background: Capsular contracture remains the most frequent long-term complication after augmentation mammoplasty with silicone implants. Thereby, the main part of the fibrotic capsule is collagen. The collagenase of the bacterium Clostridium histolyticum is approved for the treatment of fibrotic diseases and has been demonstrated to be effective for capsular fibrosis treatment in the short term. However, long-term effectiveness is currently unknown but mandatory for clinical utilization., Materials and Methods: Forty-eight rats received miniature silicone implants and an injection with either collagenase (treatment group) or plain solvent solution (control group) 120 days post insertion. Ten and 60 days after the injections, the rats underwent 7-Tesla magnetic resonance imaging (MRI) and high-resolution ultrasound (HR-US). Capsule tissue was harvested, and capsule thickness and collagen density were evaluated through histology. Furthermore, the expression levels of inflammatory (CD68, IL4, IL10, IL12, IL13), pro-, and anti-fibrotic (TGFb1, TGFb3, Smad3, Col1-4) genes were analyzed using qRT-PCR., Results: On days 10 and 60 after injection of collagenase, histology showed that capsule thickness was significantly reduced in the treatment group when compared with the control (p < 0.05). Thickness measurements were verified by MRI and HR-US analysis. Skin perforation occurred in two cases after collagenase injection. The initial up-regulation of pro-fibrotic and inflammatory genes 10 days after collagenase injection did not persist in the long term. Contrarily, on day 60, a slight trend towards lower expression levels with a significant down-regulation of TGFb3 was detected in the treatment group., Conclusion: The collagenase of the bacterium C. histolyticum effectively degrades capsular fibrosis around silicone implants with stable outcomes throughout 60 days post injection. Skin perforation and adequate and uniform drug distribution within the implant pocket are issues that need to be addressed. Further studies are warranted to clarify whether collagenase injections have the potential to become a viable treatment option for capsular contracture., No Level Assigned: This journal requires that authors 46 assign a level of evidence to each article. For a full 47 description of these Evidence-Based Medicine ratings, 48 please refer to the Table of Contents or the online 49 Instructions to Authors. www.springer.com/00266 .

Background: First-generation polyurethane foam-coated breast implants were associated with a low risk of capsular contracture (CC), but the risk of CC with modern polyurethane-coated silicone implants has not been established., Objectives: The authors sought to determine the long-term rates of CC after primary breast augmentation with Microthane, a polyurethane-coated silicone gel implant., Methods: A total of 131 patients (255 breasts) were evaluated in a retrospective study. Data were compiled from postoperative follow-up sessions at 2 weeks; 1, 3, 6, and 12 months; and annually thereafter. Rates of various complications, including CC, were determined., Results: CC developed in 3 of the 255 implanted breasts (1.2%; Baker grade III or IV), and postoperative hematoma occurred in 2 implanted breasts (0.8%). Spontaneous CC that was not associated with other complications was observed in 1 implanted breast (0.4%). All instances of CC occurred before the 31st postoperative month., Conclusions: For patients who undergo primary breast augmentation with modern polyurethane-coated implants, the long-term risk of CC is low., Level of Evidence: 3 Therapeutic., (© 2016 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.)

Background: Silicone implants have been successfully used for breast augmentation and reconstruction in millions of women worldwide. The reaction to the silicone implant is highly variable; it can lead to local inflammatory symptoms, and sometimes to systemic symptoms and disease. Over 80 cases of anaplastic lymphoma kinase-negative anaplastic large cell lymphoma have been reported in patients with silicone breast implants and have been accepted as a new clinical entity. To the best of our knowledge, an intravascular large B-cell lymphoma associated with a silicone breast implant has not been reported previously., Case Presentation: A 48-year-old Caucasian woman who presented with high fever was found to have splenomegaly on physical examination. A laboratory diagnosis revealed pancytopenia, hypertriglyceridemia, and hyperferritinemia. She developed signs of altered sensorium, hemiparesis, aphasia, and cauda equina syndrome. On further evaluation, she fulfilled the necessary five out of eight criteria for diagnosis of macrophage activation syndrome/hemophagocytic lymphohistiocytosis. Dexamethasone administration was followed by prompt improvement; however, 3 days later she again manifested high fever, which persisted despite administration of immunoglobulin and cyclosporine A. Her silicone breast implant was considered a possible contributor to her macrophage activation syndrome and was therefore removed. A histological examination of the capsule tissue showed an extensive lymphohistiocytic/giant cell foreign body reaction suggestive of autoimmune/inflammatory syndrome induced by adjuvants. However, the histological examination unexpectedly also revealed an intravascular large B-cell lymphoma., Conclusions: The genetic background of our patient with silicone breast implants might have predisposed her to three rare and difficult to diagnose syndromes/diseases: macrophage activation syndrome/hemophagocytic lymphohistiocytosis, autoimmune/inflammatory syndrome induced by adjuvants, and intravascular large B-cell lymphoma. The simultaneous manifestation of all three syndromes suggests causal interrelationships. Human leukocyte antigen testing in all women who undergo silicon breast implantation could in the future enable us to better evaluate the risk of potential side effects.

Background: Following a Europe-wide scandal, substandard breast implants containing silicone for industry purposes produced by Poly Implant Prothèse (PIP&Rofil) were explanted due to its potential health risks., Objective: We investigated whether these implants actually imposed a threat to patients' health., Methods: In this retrospective single-centre case-control study, we compared patients with breast augmentation receiving implant explantation (01/2011-01/2015). Data were collected retrospectively from the patients' records. Patients were split into two groups: PIP&Rofil and implants of other manufacturers., Results: A total of 307 patients with 495 breast implants met the inclusion criteria, 64 patients with 115 PIP&Rofil implants and 243 patients with 380 implants of other manufacturers. Comparison of descriptive statistics between the two groups revealed that for a variety of indicators (e.g. patient age, breast cancer, aesthetic vs. reconstructive indication, implant volume, submuscular vs. subglandular implant position) PIP implants differ from non-PIP implant patients. Raw mean comparison showed higher rupture rates for non-PIP implants, 28.42 % (PIP 23.48 %). However, when controlling for implant indwelling time, PIP implants had shown higher rupture rates. Both groups had similar rates of capsular contracture (PIP: 71.30 %, Others: 72.63 %) with different distribution of Baker Scores (Baker 2/3/4: PIP 5/8/13 and non-PIP 3/24/135)., Conclusion: Concerning patient symptoms, we did not find any objective reason to justify implant explantation of PIP&Rofil implants as a solely precautionary measure. As PIP&Rofil implants showed shorter retention periods until rupture and ruptured implants can cause symptoms or health problems, PIP&Rofil implants should be regularly monitored and explanted if there is evidence of rupture., Level of Evidence Iii: 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.

Background: Capsular contracture remains a common and dreaded complication of breast augmentation. The etiology of capsular contracture is believed to be multi-factorial, and its causes may include biofilm formation due to implant/pocket contamination with skin flora. It has been shown that insertion funnel use reduces skin contact and potential contamination by 27-fold in a cadaver model. After incorporating the funnel into our surgical protocols, we anecdotally believed we were experiencing fewer capsular contractures in our augmentation practices., Objectives: The purpose of this study was to test the hypothesis that capsular contracture related reoperation rates decreased after insertion funnel adoption using data from multiple practices., Methods: At seven participating centers, we retrospectively reviewed the surgical records from March 2006 to December 2012 for female patients who had undergone primary breast augmentation with silicone gel implants. Group 1 consisted of consecutive augmentations done without the insertion funnel, and Group 2 consisted of consecutive augmentations done with the insertion funnel. The primary outcome variable was development of grade III or IV capsular contracture that led to reoperation within 12 months., Results: A total of 1177 breast augmentations met inclusion criteria for Group 1 and 1620 breast augmentations for Group 2. The rate of reoperation due to capsular contracture was higher without use of the insertion funnel (1.49%), compared to Group 2 with funnel use (0.68%), a 54% reduction (P = 0.004)., Conclusions: The insertion funnel group experienced a statistically significant reduction in the incidence of reoperations performed due to capsular contracture within 12 months of primary breast augmentation., (© 2015 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.)

This paper presents a case of a patient with invasive ductal breast cancer following breast augmentation. Following breast implants rupture in March 2013 the breast implants have been removed - histopathological examination revealed leaked silicone with inflammatory infiltration, without evidence of cancerous lesions. Diagnostic imaging revealed multiple encapsulated silicone particles and clusters of post-inflammatory macrocalcifications in both breasts. In January 2014 the patient presented with symptoms of massive inflammation of the left breast. Following surgical consultation the patient had undergone radical left-sided mastectomy with lymphadenectomy. Postoperative histopathological examination revealed a multifocal advanced invasive ductal cancer G3 pT3pN3a (vascular invasion, metastases in 11 of 12 examined axillary lymph nodes). Following surgery the patient was qualified for further treatment - chemotherapy, radiotherapy, hormone therapy. The discussion includes a review of literature on the risk evaluation of co-occurrence of breast cancers in women with silicone breast implants and presents diagnostic challenges of breast cancer in this patient group.

Background: A large, multicenter, 10-year observational study is being conducted to compare the long-term safety and effectiveness of Natrelle silicone breast implants with saline implants or national norms. Study baseline data and surgical characteristics are reported here., Methods: Women seeking primary augmentation, revision-augmentation, primary reconstruction, or revision-reconstruction participated. Eligible subjects had completed surgery and received one implant or matching implants. Baseline demographics, health, lifestyle, and surgical characteristics were recorded. Data are presented here for subjects (≥22 years old) who underwent primary augmentation or revision-augmentation., Results: Of 50,979 subjects who underwent augmentation procedures, 35,756 received silicone implants and 15,223 received saline implants. Of these, 86.3 percent underwent primary augmentation, and 13.7 percent underwent revision-augmentation; nearly all subjects (99.3 percent) received bilateral implants. In the primary augmentation group, 67.6 percent of subjects received silicone implants versus 86.1 percent in the revision-augmentation group. Median age was lower in the primary augmentation group compared with the revision-augmentation group (33 versus 42 years old, respectively). Most subjects were white nonsmokers and had attended college. Hispanic subjects and subjects with a body mass index of 25 kg/m or greater were more likely to receive saline versus silicone implants. Across groups, the most common characteristics by procedure or implant type included inframammary incision site (54.6 percent), partial (58.2 percent) or complete (31.9 percent) submuscular placement, smooth surface implants (93.1 percent), and implant size of 300 to 399 cc. Incision size was larger for silicone versus saline implants., Conclusion: These data add to the body of knowledge on women undergoing augmentation procedures by providing an unprecedented look at a large number of subjects.

Breast implant surgery is one of the most commonly performed procedures in the field of plastic surgery. While silicone implants are now routinely used in breast surgery, they have previously been the subject of controversy. This was particularly true in the U.S., where there was a moratorium on their use from 1992 to 2006. Following subsequent scientific validation of their safety, silicone implants have re-gained widespread acceptance for clinical use. Modern implant design has aimed to optimize aesthetic outcomes while minimizing implant-related complications, such as capsular contracture and device rupture. One of the most significant advances has been the use of highly cohesive silicone which, through extensive cross-linking, maintains its shape within the body in the presence of physiologic forces. Overall, silicone breast implants are associated with a high degree of patient satisfaction and low rates of complications. Further independent research is necessary to better establish long-term outcomes.

Background: Contoured cohesive gel breast implants have been recently approved in the United States. These implants have been available for premarket approval studies for selected surgeons. The purpose of this study was to assess a single surgeon's outcomes in three specific clinical situations-breast augmentation, secondary augmentation, and breast reconstruction-using implants of all three contoured cohesive gel implant manufacturers (Allergan, Mentor, and Sientra) over a 10-year period., Methods: The authors performed a prospective study of contoured cohesive silicone gel breast implants. Demographic and outcomes data were recorded. Complication rates were compared among the three implant manufacturers., Results: From 2001 to 2013, 695 patients were included from U.S. Food and Drug Administration clinical trials. Mean age at implantation was 42.7 years (range, 18 to 82 years), and mean time enrolled was 5.3 years (range, <1 to 10 years). One hundred sixty-four patients (24 percent) received Allergan implants, 245 (35 percent) received Mentor implants, and 286 (41 percent) received Sientra implants. Three hundred eighty-four patients (55 percent) underwent primary augmentation, 198 (29 percent) underwent secondary augmentation, and 113 (16 percent) underwent breast reconstruction. The total complication rate was the lowest for primary augmentation of the Mentor group compared with the Allergan and Sientra groups (p < 0.05). There were no significant differences in complication rates when used for secondary augmentation and reconstruction. There was no statistically significant difference between implant group reoperation, explantation, or capsular contracture rates. Overall implant rupture and rotation rates were low (0.7 percent and 1.3 percent, respectively). Patient and surgeon satisfaction was high., Conclusions: Contoured cohesive gel breast implants overall have low complication rates and high patient and surgeon satisfaction. The authors believe these implants to be safe and effective in breast augmentation and reconstruction., Clinical Question/level of Evidence: Therapeutic, III.

Background: At its inception, transaxillary breast augmentation was a blind technique associated with complications and unpredictable outcomes. The transaxillary approach now involves electrocautery dissection with direct endoscopic visualization and yields excellent aesthetic outcomes with a concealed scar. Shaped implant devices can be combined with transaxillary augmentation for natural-appearing results that can be individualized to the patient., Objectives: The authors sought to improve the results of transaxillary endoscopic breast augmentation by placing shaped gel implants in patients with an indistinct or absent inframammary fold (IMF), who wished to avoid a breast scar., Methods: One hundred sixteen Asian women underwent transaxillary endoscopic breast augmentation with electrocautery dissection and were evaluated in a prospective study. A partial retropectoral plane pocket was created in 4 sequential dissection steps with direct endoscopic visualization and careful control of bleeding. Shaped cohesive gel implants were placed to produce smooth, natural-appearing breast mounds and well-defined IMFs., Results: Patients were monitored for 6 to 24 months after surgery (mean, 10 months; median, 12 months). There were no instances of pneumothorax, instrument-related skin burns, or severe implant deformation due to rotation or displacement of the implants postoperatively. Three of 116 patients (2.6%) experienced Baker 3 unilateral capsular contracture. One patient developed a unilateral hematoma at 3 weeks after surgery., Conclusions: Endoscopic breast surgery is associated with shortened recovery times, a reduced need for drainage, and excellent outcomes, including a well-defined and symmetric IMF. This approach, combined with shaped gel implants, can yield natural-appearing results of transaxillary breast augmentation., Level of Evidence: 4 Therapeutic., (© 2015 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.)

Background: Despite being the cosmetic procedure most performed worldwide, there are still few objective measurements of postoperative volumetric analysis of breast augmentation available in the literature., Objective: The aim of this study was to evaluate volumetric changes in the breast parenchyma after the placement of silicone implants in the subglandular plane., Methods: Thirty-four women were randomly allocated to the intervention group (n = 24), who underwent breast augmentation in the subglandular plane, or to the control group (n = 10), who received no intervention. Volumetric magnetic resonance imaging was performed at inclusion, and after 6 and 12 months in all participants. The non-parametric Friedman's test was used for statistical analysis., Results: There was a significant reduction in glandular volume (mean, 22%) at 12 months postoperatively in patients who underwent breast augmentation., Conclusions: Breast augmentation caused reduction in the volume of the breast parenchyma., Level of Evidence: 3 Therapeutic., (© 2015 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.)

Unlabelled: Polyurethane breast implants were first introduced by Ashley (Plast Reconstr Surg 45:421-424, 1970), with the intention of trying to reduce the high incidence of capsular contracture associated with smooth shelled, high gel bleed, silicone breast implants. The sterilization of the polyurethane foam in the early days was questionable. More recently, ethylene oxide (ETO)-sterilized polyurethane has been used in the manufacturing process and this has been shown to reduce the incidence of biofilm. The improved method of attachment of polyurethane onto the underlying high cohesive gel, barrier shell layered, silicone breast implants also encourages bio-integration. Polyurethane covered, cohesive gel, silicone implants have also been shown to reduce the incidence of other problems commonly associated with smooth or textured silicone implants, especially with reference to displacement, capsular contracture, seroma, reoperation, biofilm and implant rupture. Since the introduction of the conical polyurethane implant (Silimed, Brazil) into the United Kingdom in 2009 (Eurosurgical, UK), we have had the opportunity to review histology taken from the capsules of polyurethane implants in three women ranging from a few months to over 3 years after implantation. All implants had been inserted into virgin subfascial, extra-pectoral planes. The results add to the important previously described histological findings of Bassetto et al. (Aesthet Plast Surg 34:481-485, 2010). Five distinct layers are identified and reasons for the development of each layer are discussed. Breast capsule around polyurethane implants, in situ for fifteen and 20 years, has recently been obtained and analysed in Brazil, and the histology has been incorporated into this study. After 20 years, the polyurethane is almost undetectable and capsular contracture may appear. These findings contribute to our understanding of polyurethane implant safety, and give reasoning for a significant reduction in clinical capsular contracture rate, up to 10 years after implantation, compared to contemporary silicone implants. A more permanent matrix equivalent to polyurethane may be the solution for reducing long-term capsular contracture., Level of Evidence V: 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 .