Cohesive Silicone Gel Implants Research Articles

Feminizing Gender Affirming Breast Surgery: Procedural Outcomes at a Single Academic Institution.

Implant-based breast augmentation is a gold standard procedure for transfeminine patients to create a more feminine-appearing chest. In many cases, ancillary procedures are performed simultaneously to achieve an optimal aesthetic result. To determine the clinical outcomes of patients undergoing feminizing gender-affirming breast surgery in a single academic institution. A retrospective electronic chart review of feminizing gender-affirming breast surgery patients at Mayo Clinic, Rochester, from 2017 to 2022 was conducted. Patients' demographics and surgical outcomes were gathered. A survival analysis was performed to obtain the time-to-event complication rate. Over 5 years, 46 patients (92 breasts) were included. The mean age was 39 years (standard deviation [SD] ±15), and most had an above-normal body mass index (BMI) (58.7%). Thirty (65%) had previous gender-affirming surgeries. The mean implant volume was 289 mL (SD ±95; 140-520). Most implants were placed in a subglandular plane (81%) with an inframammary fold incision (91.3%). All implants used were smooth, round cohesive silicone gel implants. Ancillary procedures were performed in 32 patients (69.57%). Eight patients presented complications (4 major vs 4 minor) in a median postoperative follow-up of 372 vs 392 days; at 1-month follow-up, the probability of a complication having occurred is 2.17% (95% CI: 0%-6.3%) vs 5% (95% CI: 0%-11.5%), and at 1 year, the probability is 10.21% (95% CI: 0%-20.9%) vs 12.5% (95% CI: 0%-23.4%), which remains the same up to 4 years. Breast augmentation with implants is a safe procedure to achieve feminization of the breast with a low rate of complications.

The Impact of Breast Implant Cohesivity on Rippling and Revision Procedures in 2-Stage Prepectoral Breast Reconstruction

Abstract Background Rippling remains one of the most common complications following prepectoral implant-based reconstruction (IBR). Objectives The purpose of this study was to assess how implant cohesivity, a measure of elasticity and form stability, affects the incidence of rippling in prepectoral IBR. Methods We performed a retrospective cohort study of 2-stage prepectoral IBR performed between January 2020 and June 2022 at the Brigham and Women's Hospital and Dana-Farber Cancer Institute, comparing outcomes in patients who received Allergan Natrelle least cohesive, moderately cohesive, and most cohesive silicone gel implants. Outcomes of interest were rippling and reoperation for fat grafting. Results A total of 129 patients were identified, of whom 52 had the least cohesive implants, 24 had the moderately cohesive implants, and 53 patients had the most cohesive implants. The mean follow-up time was 463 (±220) days. A decreased incidence of rippling was seen with moderately cohesive (odds ratio [OR] 0.30, P < .05) and most cohesive (OR 0.39, P < .05) implants. Third stage reoperation for fat grafting was less frequent in patients with the most cohesive implant (OR 0.07, P < .05). In subgroup analyses, the patients with the most cohesive implant, who did not receive fat grafting at the time of initial implant placement, did not require reoperation for fat grafting (0%). Conclusions The use of highly cohesive implants in prepectoral IBR is associated with decreased rippling and fewer reoperations for fat grafting. Level of Evidence: 3

Literature Review on the Different Types of Breast Implants: Advantages and Disadvantages

Breast implants are devices used in cosmetic and reconstructive surgery to increase the volume and improve the shape of the breasts. In this study, the different types of breast implants available in clinical practice were investigated. Four main types were identified: saline implants, silicone gel implants, highly cohesive silicone gel implants, and double lumen implants. Saline implants consist of a silicone shell filled with sterile saline. They have advantages such as the ability to adjust volume during surgery, easy rupture detection and lower cost. However, they may have a less natural feel and a higher risk of wrinkling and rippling. Silicone gel implants are widely used because of their more natural look and feel. Silicone gel is cohesive and offers a consistency similar to breast tissue. They have a lower incidence of wrinkling and rippling, greater durability and less sensitivity to cold. However, detection of ruptures can be more difficult and there is a potential risk of capsular contracture. Highly cohesive silicone gel implants, also known as anatomical implants, are designed to mimic the natural shape and projection of the breast. They have predictable aesthetic results, a lower incidence of capsular contracture and greater resistance to displacement. However, they may require longer incisions and have a higher cost. Double lumen implants have two separate shell layers, one internal with cohesive silicone gel and the other external with saline solution. They offer an additional layer of security in case of rupture of the inner shell and allow volume adjustment during surgery. However, they may have a less natural feel and greater technical complexity.

Prepectoral Breast Reconstruction: A Fad or Here to Stay?

Prepectoral breast reconstruction has rapidly gained attention as a new technique for implant-based breast reconstruction. It is essentially a modernization of an old technique made possible by the use of marketable products, primarily dermal matrices and cohesive silicone gel implants. The rapid dissemination of its benefits, not only to physicians, but also to the general public and referring physicians, leading to widespread adoption, is in part due to a combination of marketing and social media/Internet influences. This review will summarize the recent peer-reviewed literature to provide facts for the reconstructive surgeon to decide whether this technique is a fad or a useful option in implant-based breast reconstruction.

Tradeoffs in Implant Selection for Reconstructive Surgery and Adjuncts Utilized to Maximize Aesthetic Outcomes.

With many US Food and Drug Administration-approved cohesive gel implant styles currently available in the United States, surgeons and patients may feel overwhelmed by the implant-selection process. We discuss the relative merits of the most commonly used silicone cohesive gel implants and associated adjuncts, particularly in the reconstructive setting. A literature review was conducted in PubMed to identify articles that assessed the clinical impact of differing cohesive silicone gel implants and associated adjuncts on aesthetic outcomes and complications profile. First, we review how the shape, cohesivity, and texture of cohesive gel implants impact breast aesthetics and complications after implant-based breast reconstruction (IBBR). Second, we review common adjuncts used in IBBR, including fat grafting and acellular dermal matrix (ADM), and we explore their roles in prepectoral IBBR. Finally, we review future directions in IBBR, including nanoscale implant surface modifications. In the absence of data showing that shaped implants are aesthetically preferable over round implants, we turn to a risk-benefit analysis of the complication profile of each type of implant. In selecting a smooth, round cohesive silicone implant that offers a variety of cohesivity levels, the patient can enjoy the benefits of smooth shells and avoid the drawbacks of textured shells, all without sacrificing clinically significant visual aesthetics. In the era of the bioengineered breast, this remains even more true.

Clinical Results on Innovation in Breast Implant Design.

Breast implants have been shadowed in controversy since their introduction to the market; however, they represent a multi-million dollar industry and play a critical role both for cosmetic augmentation and enhancement and for reconstruction following treatment for cancer. With advancements in technology, breast implants have evolved tremendously over the years. Further, with the cessation of the FDA implemented moratorium on silicone, the use of silicone implants has grown exponentially over the years. Novel designs in the outer shell, breast implant fill particularly the cohesivity of the silicone gel, texturing of the outer shell, and the shape and projection of breast implants have produced a broad array of implants that can be employed by plastic and reconstructive surgeons to maximize outcomes for patients. However, despite the innovations in breast implant design and engineering, it is unclear whether these have had any influence on outcomes and patient satisfaction. The present article aims to provide a comprehensive review of the technological advancements in breast implant technology in optimizing patient outcomes and minimizing complications associated with placement of breast implants for aesthetic as well as reconstructive procedures. The article will provide a synopsis of round versus shaped breast implants, saline versus silicone especially the advent of cohesive silicone gel implants, and the texturing of the outer shell, and how each of these components should be considered when counseling patients and deciding which implants offer the optimal benefits for each individual patient.

Reply: Comparing Round and Anatomically Shaped Implants in Augmentation Mammaplasty: The Experts' Ability to Differentiate the Type of Implant.

BACKGROUND The purpose of this study was to determine whether the aesthetic results of subpectoral augmentation mammaplasty using anatomically shaped versus round prostheses are differentiable. METHODS Thirty observers (i.e., plastic surgeons and nurses) assessed preoperative and postoperative photographs (frontal and oblique views) of 30 patients who had undergone subpectoral augmentation mammaplasty with cohesive silicone gel implants, with an average implant volume of 295 cc (range, 220 to 340 cc). The observers classified each case as round or shaped on two different occasions with a 12-week time interval. A statistical concordance analysis was performed, calculating the overall concordance rate, the interobserver, the intraobserver, and the overall intraobserver kappa indexes, to evaluate the expert observers' capacity to differentiate the implant type. RESULTS Among the total of 1800 observations (30 observers assessed 30 cases on two occasions), the overall concordance rate was 50.33 percent (95 percent CI, 47.99 to 52.67). The interobserver kappa value was 0.010 (95 percent CI, 0.0025 to 0.04). The overall intraobserver kappa value was 0.0602 (95 percent CI, 0.0025 to 0.123). The observers were unable to recognize the type of implant used, nor was interobserver concordance noted. An agreement was not reached before the different observers, nor was an intraobserver concordance seen between the first and second classifications of the same cases by each observer. CONCLUSION The results obtained from subpectoral augmentation mammaplasty using anatomically shaped and round prostheses with a volume of 340 cc or less are indistinguishable, not justifying the systematic use of anatomically shaped implants in this patient. CLINICAL QUESTION/LEVEL OF EVIDENCE Therapeutic, III.

Cohesive silicone gel implants with smooth, textured or polyurethane-coated surface to restore volume in eviscerated sockets

ABSTRACTThe purpose of this article is to evaluate the three different surface coating on cohesive silicone gel implants in eviscerated rabbit eye sockets. Forty-five albino rabbits underwent right eye evisceration and received hemisphere-shaped cohesive silicone gel implants with smooth (Group 1), textured (Group 2), or polyurethane-coated surface (Group 3) in the socket. The animals were euthanized at 7, 30, and 90 days postoperatively. Computed tomography of the orbits was performed prior to euthanasia. Subsequently, the orbital contents were removed and underwent histologic and morphometric examination. Data were statistically analyzed. There were no adverse effects throughout the study. The majority of implants in the Group 1 exhibited 180° rotation. The Group 3 experienced an intense inflammatory reaction around the implant and implant deformation probably due to pseudocapsule contraction. Cohesive silicone gel implants had good integration into the scleral socket. Optimal results were obtained with cohesive silicone gel textured implants (Group 2). Smooth implants (Group 1) rotated significantly, whereas polyurethane (Group 3) coated implants precipitated an intense inflammatory reaction and were deformed postoperatively.

Commentary on: Implementation of an Integrated Biodimensional Method of Breast Augmentation with Anatomic, Highly Cohesive Silicone Gel Implants: Short-Term Results With the First 620 Consecutive Cases

Commentary on: Implementation of an Integrated Biodimensional Method of Breast Augmentation with Anatomic, Highly Cohesive Silicone Gel Implants: Short-Term Results With the First 620 Consecutive Cases

Implementation of an Integrated Biodimensional Method of Breast Augmentation with Anatomic, Highly Cohesive Silicone Gel Implants: Short-Term Results With the First 620 Consecutive Cases.

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. To evaluate outcomes of a surgeon newly adopting this method at the beginning of his career. 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. 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%). 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. 4.

Abstract: Implementation of the AkademiKliniken Method of Subpectoral Breast Augmentation with Anatomic, Highly Cohesive Silicone Gel Implants: The First 620 Consecutive Cases

DISCLOSURE/FINANCIAL SUPPORT: Dr. Montemurro is a consultant and speaker for Allergan, Dr. Hedén is a consultant and speaker for Allergan. BACKGROUND: Though only recently introduced in US, form stable implants have been available in Europe since 1993. The previously described AkademiKliniken (AK) method is a comprehensive approach to breast augmentation with form stable implants.! The purpose of this study was to evaluate outcomes of a single surgeon newly adopting this method at the beginning of his career. METHODS: A retrospective review of prospectively collected data on patients undergoing dual plane subpectoral augmentation between April 2009 and December 2014 was undertaken. The review was performed one year after the last operation. Only patients receiving textured, anatomic, cohesive silicone gel implants (Allergan Style 410) were included. The senior 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. The results were compared with previously published literature. RESULTS: A total of 620 consecutive patients met the inclusion criteria with a mean follow-up of 8 months. A minimum of one year elapsed since the last surgery with a range of 1 to 6 years. Complications occurred in 14.8% of the patients with request for larger size (3.3%), rotation (3%) and Baker III/IV capsular contracture (2.2%) being the most common ones. Average time to development of a complication was 286 (range, 0 to 1352) days. Of all the patient and implant characteristics tested for correlation low implant projection was determined to be a statistically significant risk factor (p<0.05) for the most common complication, request for a larger size. A body mass index higher than 25 km/m2 correlated with a significantly higher risk (p<0.05) for development of rotation, specifically. 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%). Average time to reoperation was 442 days (range, 0-1372). CONCLUSIONS: Breast augmentation with form stable anatomical implants requires a considerably different process. Novices in this new terrain can achieve optimum results with the implementation of a methodical approach to preoperative planning, surgical technique and postoperative care. The AK method is such a process that is efficient and independently reproducible. REFERENCES: 1. Hedén P, Jernbeck J, Hober M. Breast augmentation with anatomical cohesive gel implants: the world’s largest current experience. Clin Plast Surg 2001;28(3):531–552.

Augmentation mastopexy: maximal reduction and stable implant coverage using four flaps.

A single-stage operation to correct ptotic and hypoplastic breasts would appear to be a very appealing option for both surgeons and patients. However, this procedure is the most often litigated in aesthetic surgery because of its frequent complications. Our goal in this article is to report our experience with a four-flap technique for implant coverage in maximum reduction mastopexy with prosthesis. From January 2011 to March 2013, a total of 41 patients with Regnault grade II or grade III ptosis with no hypertrophy underwent primary bilateral augmentation mastopexy. Our technique includes an inverted-T mastopexy and a thin, well-vascularized, inferior dermoglandular flap to cover the inferior pole of the implant. Retrospective data collection revealed a mean patient age of 37.5 years. Thirty-nine patients were treated with round cohesive silicone gel implants and two with anatomical cohesive gel implants. The mean implant volume was 280 cc and mean follow-up time was 14 months. The following complications were observed in declining frequency: four suture dehiscences, two hematomas, one capsular contracture, one implant malposition, and one poor scarring. A satisfaction questionnaire revealed very high satisfaction in 23 patients (56.09 %), high satisfaction in 12 (29.26 %), moderate satisfaction in four (9.75 %), and low satisfaction in two (4.87 %). Our results demonstrated a low complication rate (21.9 %) and low reoperation rate (12.1 %) with our technique and make us confident in recommending this technique for grade II and grade III ptosis. 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 at www.springer.com/00266 .

Autologous fat transfer for breast augmentation: a systematic review

The role of autologous fat transfer (AFT) for cosmetic breast augmentation is uncertain due to ongoing concerns regarding its safety and efficacy compared with other breast augmentation techniques. The aim of this systematic review was to assess the safety and efficacy of AFT for cosmetic breast augmentation in comparison with saline and cohesive silicone gel implants. A systematic search of several electronic databases, including PubMed and EMBASE, was used to identify relevant studies for inclusion. The inclusion of studies was established through the application of a predetermined protocol by two independent reviewers. There were no comparative studies available, necessitating that all comparisons be indirect. Eighteen studies were included, 11 of which reported outcomes for AFT. Complications associated with AFT occurred in only a small proportion of patients, with fat necrosis, cysts and lumps most commonly reported. No data examining the effect of complications such as microcalcification on long-term mammographic and cancer-related outcomes were identified. Reabsorption of fat occurred to varying degrees, usually during the first 12 months following the procedure. Patient satisfaction following AFT was high. Limitation in breast volume increase was the main complaint associated with this procedure. Based on the limited evidence available, AFT was considered to be at least as safe as the nominated comparator procedures in regard to complications; however, its safety in regard to cancer detection could not be determined. The efficacy of AFT could not be determined.

Neck Lymphadenitis Due to Silicone Granuloma After Mammary Implants

Abstract Introduction A foreign body reaction due to silicone where it is infiltrated or at the places to which it can migrate is known as siliconoma. The use of silicone in breast augmentation procedures can provoke this reaction at the neck level in cases of leakage from mammary implants. Methods We reviewed the cases of patients with increased size neck lymph nodes who had previously undergone plastic surgery of the breast with highly cohesive silicone gel implants. Results In a 10-year period, we identified 12 cases with silicone-infiltrated neck lymphadenopathies, histologically confirmed by fine needle aspiration. They represented 3.5% of patients attended for neck lymph node study. We removed those detected by physical examination and CT in 5 cases, due to pathological characteristics of the node or a previous malignant history. In 2 of these nodes recurred, and node size also increased in 2 of the other 7 non-operated cases. After implant removal, silicone leakage was observed in only 7 cases. Conclusions Cohesive gel silicone used for mammary implants can generate increased neck lymphadenopathies as a secondary effect due to systemic reactions against the silicone when it migrates in cases of implant failure. Surgical options for involved nodes usually do not offer good long-term results.

Linfadenitis cervical debida a granuloma de silicona tras implantes mamarios

IntroductionA foreign body reaction due to silicone where it is infiltrated or at the places to which it can migrate is known as siliconoma. The use of silicone in breast augmentation procedures can provoke this reaction at the neck level in cases of leakage from mammary implants. MethodsWe reviewed the cases of patients with increased size neck lymph nodes who had previously undergone plastic surgery of the breast with highly cohesive silicone gel implants. ResultsIn a 10-year period, we identified 12 cases with silicone-infiltrated neck lymphadenopathies, histologically confirmed by fine needle aspiration. They represented 3.5% of patients attended for neck lymph node study. We removed those detected by physical examination and CT in 5 cases, due to pathological characteristics of the node or a previous malignant history. In 2 of these nodes recurred, and node size also increased in 2 of the other 7 non-operated cases. After implant removal, silicone leakage was observed in only 7 cases. ConclusionsCohesive gel silicone used for mammary implants can generate increased neck lymphadenopathies as a secondary effect due to systemic reactions against the silicone when it migrates in cases of implant failure. Surgical options for involved nodes usually do not offer good long-term results.

Aesthetic and Reconstructive Surgery of the Breast

Drs. Hall-Findlay and Evans' new Aesthetic and Reconstructive Surgery of the Breast is a unique work providing a purely surgical focus, covering the full scope of breast surgery. Coverage of hot topics includes new implant types, gel implants, fat injections to the breast for aesthetic enhancement, and fat injections for reconstruction. The book is organized into seven sections including reduction, mastopexy, augmentation, and more. Expert, international contributors deliver practical advice on the latest techniques, with a special emphasis on what can go wrong and how to avoid it. This full-color, templated reference comes with case studies and 16 video clips (both on web and on DVD) with approximately three hours of footage demonstrating key procedures. Video coverage includes form-stable high cohesive silicone gel implants, short scar with inferior pedicle, and sub-fascial breast augmentation. Expert Consult access enables you to search full text online and download images.

Silicone migration to the contralateral axillary lymph nodes and breast after highly cohesive silicone gel implant failure: a case report

Highly cohesive silicone gel implants are advertised for aesthetic and safety advantages. Our case is the fourth report describing early implant rupture and contralateral migration of siliconoma. Despite the greater degree of gel cohesiveness, a continued vigilance for signs and symptoms of migration is highly recommended.

Indications for Extra Full Projection Anatomical Cohesive Silicone Gel Implants in Cosmetic and Reconstructive Breast Surgery

In 2003, a new extra full projection (EFP) anatomic cohesive silicone gel breast implant was introduced onto the European market. This review presents the early experience of a single surgeon with this new implant over a 29-month period. Between 2003 and 2006, the McGhan Style 410 EFP breast implants were inserted for highly selected indications. Twenty-eight patients received a total of 47 EFP implants. Their age range was 23 to 66 years (mean: 46 years). The implant was used in 6 primary and 7 revisional cosmetic breast augmentation patients. The series included 9 postmastectomy breast reconstructions. In further, 6 patients the implant was used to revise existing breast reconstructions. After a mean follow-up period of 31 months, there were no infections, malrotations, or significant capsular contractures and no patients have required revisional implant surgery. The novel implant was successfully used to address specific challenges in cosmetic and reconstructive breast surgery. These included large skin envelopes in breast augmentation patients declining mastopexy, complicated implant exchanges, and suboptimal prosthetic breast reconstructions. This prosthesis may prove a useful addition to the range of breast implants available, especially when there is an overlap of challenging esthetic problems.

Clinical Experience With a Fourth-Generation Textured Silicone Gel Breast Implant: A Review of 1012 Mentor MemoryGel Breast Implants

Since the introduction of fourth- and fifth-generation silicone gel implants, manufacturers have conducted several prospective, multicenter trials to examine their safety and efficacy. However, these studies were not standardized with regard to surgeon skill, pocket placement, operative technique, adjunct therapies, or postoperative management. The purpose of this study was to examine the surgical outcomes of a single surgeon (WGS) in a consecutive series of breast augmentation cases using a fourth-generation cohesive silicone MemoryGel breast implant (Mentor, Santa Barbara, CA). A retrospective chart review was conducted to identify all patients who underwent silicone breast augmentation within the Mentor Adjunct Silicone MemoryGel breast implant by a single surgeon (WGS) within a single free-standing outpatient surgical center over a 13-year period (1992 to 2006). For each patient, demographic information, comorbidities, and surgical information (implant size and concomitant surgery) were recorded. In addition, outcomes were analyzed to identify complications and the need for surgical revision. A total of 1012 fourth-generation, textured, cohesive silicone gel implants were placed in 511 patients during the 13-year study period. The overall complication rate per implant was 5.5% (n=56 implants in 43 patients). The most common complication was capsular contracture (n=26; 2.6 %) followed by abnormal scarring (n=11; 1.1%). The overall revision rates per patient and per implant were 8.0% (n = 41 patients) and 6.8% (n = 69 implants), respectively. The average time interval between initial implantation and revision was 18.5 months (range, 2 weeks to 26 months). The most common indication for surgical revision was patient desire for implant size change (n=15 patients) followed by Baker class III or IV capsular contracture (n=13 patients). The presence of previous surgery for capsular contracture was not statistically correlated to the need for revision (P= .326). Age (P= .568), previous history of breast surgery (P= .704), and history of smoking (P= .138) were also not statistically correlated to revision. Placement of the implant in the subglandular position (n=30 implants), however, was statistically correlated with need for revision (P< .01). Mentor fourth-generation cohesive silicone gel implants possess a complication and revision profile that is superior to earlier-generation silicone gel implants. Implantation with MemoryGel implants, when standardized with regard to surgeon and operative technique, can have significantly reduced complication and revision rates compared to the Mentor Core Data.

Les prothèses mammaires anatomiques en chirurgie esthétique et reconstructrice : une étude de 135 cas

The aim of this work is to precise the indications to respect and the pitfalls to avoid in prosthesis setting using anatomical cohesive silicone gel implants.135 patients that undergone a reconstructive or cosmetic prosthesis setting were reviewed. Patients satisfaction has been assessed basing on the breast shape, consistency and symmetry. Complications (both usual and specific) were assessed and analysed. The results for mammary reconstruction after expansion or autologous flap and for cosmetic submuscular breast augmentation were good. Complications were unusual as far as the appropriate surgical procedure had been performed rigorously. These implants are an interesting alternative solution to round shape prosthesis in reconstruction indication. In breast augmentation border line indications, a beautiful result may be expected using these implants.