Why Do We Need Anatomical Implants? the Science and Rationale for Maintaining Their Availability and Use in Breast Surgery.

The choice between anatomical and round implants is an important decision in breast augmentation surgery; however, both have their place and the decision between them that should be made on a patient-by-patient basis, taking into account the patient's desires, anatomy, and surgical history. In some individuals, there are clear indications for using either anatomical or round devices, and there is good evidence that aesthetic outcomes are better with anatomical implants in some instances. When both types are an option, anatomical devices may offer increased flexibility and, despite a longer learning curve needed to properly manage them, they are associated with positive long-term outcomes and high levels of patient satisfaction. Concerns about implant rotation can be minimized with proper patient selection and surgical technique, and the overall complication rate may favor anatomical over round devices in appropriate patients. Breast implant-associated anaplastic large-cell lymphoma is an important issue, and while rare, it must be considered in the context of the entire patient risk profile. Both anatomical and round implants remain key elements of a complete surgical toolbox in 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 www.springer.com/00266.

Physical Properties of Silicone Gel Breast Implants.

BACKGROUND: Surgical applications using breast implants are individualized operations to fill and shape the breast. Physical properties beyond shape, size, and surface texture are important considerations during implant selection. OBJECTIVES: Compare form stability, gel material properties, and shell thickness of textured shaped, textured round, and smooth round breast implants from 4 manufacturers: Allergan, Mentor, Sientra, and Establishment Labs, through bench testing. METHODS: Using a mandrel height gauge, form stability was measured by retention of dimensions on device movement from a horizontal to vertical supported orientation. Dynamic response of the gel material (gel cohesivity, resistance to gel deformation, energy absorption) was measured using a synchronized target laser following application of graded negative pressure. Shell thickness was measured using digital thickness gauge calipers. RESULTS: Form stability, gel material properties, and shell thickness differed across breast implants. Of textured shaped devices, Allergan Natrelle 410 exhibited greater form stability than Mentor MemoryShape and Sientra Shaped implants. Allergan Inspira round implants containing TruForm 3 gel had greater form stability, higher gel cohesivity, greater resistance to gel deformation, and lower energy absorption than those containing TruForm 2 gel and in turn, implants containing TruForm 1 gel. Shell thickness was greater for textured vs smooth devices, and differed across styles. CONCLUSIONS: Gel cohesivity, resistance to gel deformation, and energy absorption are directly related to form stability, which in turn determines shape retention. These characteristics provide information to aid surgeons choosing an implant based on surgical application, patient tissue characteristics, and desired outcome.

Ten-year results from the Natrelle 410 anatomical form-stable silicone breast implant core study.

BACKGROUND: Silicone breast implants have long been used for breast augmentation and reconstruction. During this time, these medical devices have gone through a number of modifications to improve their safety, quality, and clinical outcome performance. OBJECTIVES: The authors conducted a 10-year study to determine the safety and effectiveness of Natrelle 410 silicone breast implants. METHODS: This prospective, multicenter study enrolled 941 subjects who were undergoing either augmentation, augmentation revision, reconstruction, or reconstruction revision. Data on complications, reoperations, explantations, and subject satisfaction were collected at annual clinic visits, and one-third of subjects underwent biennial magnetic resonance imaging (MRI) to screen for implant rupture. The authors used the Kaplan-Meier estimator to calculate risk rates for local complications, reoperations, and explantations. RESULTS: Capsular contracture rates increased approximately 1% per year from the previously reported 6-year rates. The rates were significantly lower than those from the Natrelle round gel core study. The overall rate of confirmed ruptured implants in subjects who underwent MRI was 5.7%. Eleven late seromas were reported. The most common reason for explantation was a subject requesting a size or style change. Satisfaction rates remained high through 10 years, with most subjects saying they were somewhat or definitely satisfied with their implants. CONCLUSIONS: This 10-year prospective trial demonstrated the long-term safety and effectiveness of Natrelle 410 anatomical form-stable implants. The complication rates were low and the satisfaction rates were high. LEVEL OF EVIDENCE 1: Therapeutic.

High-resolution ultrasound in the detection of silicone gel breast implant shell failure: background, in vitro studies, and early clinical results.

BACKGROUND: Magnetic resonance imaging (MRI) has historically been considered the "gold standard" for imaging silicone gel breast implants and is currently recommended by the US Food and Drug Administration for device surveillance. Recent studies, however, have questioned its accuracy as the best screening test for implant failure. In addition, the high cost of MRI is a significant deterrent to follow-up, especially among asymptomatic patients. Recent advancements in ultrasound technology have led to the development of high-resolution devices with the potential to accurately image breast implants and breast tissues. OBJECTIVES: The authors evaluate the feasibility of portable, high-resolution ultrasound (HRUS) for imaging of silicone gel breast implants and perform preliminary comparisons of HRUS to MRI in the assessment of both intact and failed implants in a clinical setting by both radiologists and plastic surgeons. METHODS: Phase 1 was composed of in vitro and ex vivo scanning model assessments in a variety of implant models utilizing multiple HRUS hardware platforms (GE LOGIQ-9, LOGIQ-e, LOGIQ-i, and Venue-40 devices) and transducer heads (range, 8-16 MHz, mainly GE12ML transducer). In Phase 2, these technologies were applied clinically to provide imaging experience in three patients previously diagnosed with unilateral implant failure. Phase 3 was a preliminary prospective evaluation of HRUS of 29 implants in 15 consecutive patients for whom MRI and independent surgeon-performed and radiologist-performed HRUS scans were compared to subsequent surgical findings. RESULTS: In Phase 1, all hardware models easily detected both intact and intentionally damaged shells in currently marketed fourth-generation responsive gel implants and in investigational, fifth-generation highly-cohesive gel devices. Although multiple transducers were able to detect shell failure, the 12-MHz head produced the best images at the normal clinical depth range. In Phase 2, confirmatory HRUS scans correctly identified the side of rupture and were consistent with MRI and surgical findings in all patients. In Phase 3, MRI, surgeon-performed HRUS, and radiologist-performed HRUS scans were all accurate in predicting implant shell integrity in 29 of 29 imaged breasts (100%) as confirmed at the time of surgery in both symptomatic and asymptomatic patients. CONCLUSIONS: Preliminary results with a variety of base and transducer systems demonstrated that HRUS provides excellent visualization of current fourth- and fifth-generation silicone gel implants both in the in vitro and ex vivo scanning models. In vivo surgeon-performed HRUS accurately identified implant status and correlated with radiologist-performed HRUS, MRI, and surgical findings. An ongoing Phase 4 prospective study is under way to help define the sensitivity and specificity of HRUS technologies in the evaluation of current implant designs. However, the relative affordability, accessibility, availability, and dynamic real-time visualization provided by HRUS represent significant potential advantages of HRUS over MRI in both the screening and future diagnosis of breast implant shell failure.

Natrelle style 410 form-stable silicone breast implants: core study results at 6 years.

BACKGROUND: The Natrelle Style 410 shaped, form-stable silicone gel implant (Allergan, Inc; Irvine, California) has been the subject of a pivotal study that supports potential US Food and Drug Administration approval of the device. The 3-year results of this study were reported previously. OBJECTIVES: The authors update the safety and effectiveness findings for the Natrelle Style 410 implants through 6 years of study. METHODS: This prospective, nonrandomized, multicenter study included 941 patients (492 primary augmentations, 156 revision-augmentations, 225 primary reconstructions, and 68 revision-reconstructions). Since the original 3-year report, follow-up visits have been conducted annually. Kaplan-Meier risk rates were calculated for local complications, reoperations, and explantations. One-third of the subjects were enrolled in the magnetic resonance imaging (MRI) cohort and underwent biannual MRI rupture screening. Effectiveness was measured by subject satisfaction on a 5-point scale. RESULTS: As expected after breast implantation, capsular contracture (CC) was one of the most common complications, with 6-year risk rates of 4.6% for augmentation, 6.9% for revision-augmentation, 10.7% for reconstruction, and 18.3% for revision-reconstruction. The rates for CC among augmentations and revision-augmentations were significantly lower with the Natrelle 410 implants than with other standard gel implants. The rupture rate (confirmed plus suspected) across all cohorts was 6.4% by subject and 3.8% by implant. The most common reasons for reoperation were style or size change (augmentation), implant malposition (revision-augmentation), scarring (reconstruction), and CC (revision-reconstruction). The satisfaction rate exceeded 80% in all cohorts. CONCLUSIONS: These fifth-generation, form-stable implants represent another option to achieve desired aesthetic outcomes with minimal complications.

Defining Internal Tissue Closure: High-Resolution Ultrasound Evaluation of Interi-A Novel Internal Tissue Closure System.

Background: Seroma remains a leading postsurgical complication in plastic surgery. Conventional drains are ineffective in clearing blood and fluid and closing down surgical spaces. The Interi (Internal Closure System, IC Surgical, Grand Rapids, MI) is comprised of a novel branching internal manifold attached to a self-contained portable pump with a higher, consistent, continuous negative pressure, may reduce this long-standing issue. In addition, high-resolution ultrasound (HRUS) has emerged as an ideal tool to visualize structures, fluid collections, and seromas internally. Objectives: This study evaluates Interi in full abdominoplasty patients utilizing HRUS to evaluate Interi's ability to evacuate blood and fluid, hold internal tissues together and document, for the first time, what internal tissue healing actually looks like radiographically. Methods: An IRB approved, Contract Research Organization reviewed retrospective study evaluated consecutive patients undergoing full abdominoplasty utilizing Interi from July 2020 through March 2021 by three plastic surgeons. HRUS visualized and confirmed the presence or absence of fluid collections and healing tissue planes during the postoperative process. Study data and all adverse events were recorded, with HRUS images reviewed by investigators and confirmed by an independent radiologist. Results: Seventy-one Interi patients were enrolled. Mean age was 43 (range: 21-74) and BMI was 28. Seroma was confirmed clinically and through HRUS in 3/71 patients, and was associated with either clot (2) or failure to activate system (1). Interi's ability to eliminate fluid and approximate/hold surgical tissue planes together was confirmed with HRUS. No other major complications, including abscess, hematomas, or flap necrosis were observed. Conclusions: This novel Internal Tissue Closure System effectively evacuated blood and fluid, approximated and maintained closure of internal tissue planes in abdominoplasty patients, allowing for primary tissue healing and internal wound closure to occur. Healing tissue planes and any fluid present are easily identified on HRUS visualizing actual internal tissue healing with a simple, widely available radiographic scan.

The Nomenclature, Terminology and Lexicon of Breast Surgery: Are We Really Saying the Same Thing?

This study investigated inconsistencies in the use of descriptors in breast surgery and recommends a novel nomenclature that will be adopted and standardized among plastic surgeons. The study used a modified Delphi methodology to first identify redundant descriptors or those with multiple interpretations, and then achieve consensus on ideal recommended nomenclature in breast surgery. The Delphi panel agreed that there was misuse of and lack of a clear definition for several terms, and recommended removal of these subjective terms. Replacement with more anatomic nomenclature was suggested. Stretch deformity, pectoral banding, and implant-gland mismatch were introduced as new terms.

Various Properties of Silicone Breast Implant Surfaces and Multimodal Techniques for the Functional Surface Modification.

"Silicone breast implants are the most widely used medical devices for breast reconstruction and augmentation, and revision, but even after more than 60 years of use they are associated with multiple continued complications. Using advancement in current technologies, researchers are attempting to create an optimal implant surface for patients. Through these efforts, plastic surgeons and material researchers have made great progress in the field of implant research. Multimodal techniques for the functional modification of implant surfaces will contribute to further the development of ideal biomaterials useful in breast implants.

Breast infections with atypical mycobacteria following reduction mammaplasty.

Reduction mammaplasty is one of the most common plastic surgery procedures performed in the US, with the goal of correcting symptomatic macromastia. More than 70,000 cases were performed in 2009, with few complications and low infection rates. The authors present two cases of breast infections with Mycobacterium fortuitum and one with Mycobacterium chelonei following bilateral reduction mammaplasty. Infection with these organisms is exceptionally rare following breast surgery in the absence of a prosthetic implant. All of the patients had a delayed presentation following complete wound healing and were refractory to first-line antibiotic therapy. All three required long-term antibiotics in consultation with an infectious disease specialist. The patients all required surgical drainage, and two patients also required formal operative debridement. All three patients eventually went on to complete wound healing.

The Standardization of Bra Cup Measurements: Redefining Bra Sizing Language.

There are many challenges in developing a standardized bra cup system, the most significant being that bra cup sizes are a continuum. Women's breasts occur as a fluid range of shapes, sizes, and volumes. Patients have specific expectations regarding bra cup size, and failure to achieve expectations remains the leading cause of patient dissatisfaction. Implant selection that determines eventual bra cup size is critical in patient education and management of patient expectations; however, this is not achievable until all speak the same bra cup language. Patient and surgeon perceptions may never be exact, but it is important to establish guidelines and standards to bridge this gap.

Clinical Applications of Barbed Suture in Aesthetic Breast Surgery.

The breadth of literature regarding barbed suture applications in plastic surgical procedures and of importance to this article, barbed suture applications in breast surgery, is growing dramatically as surgical practitioners are becoming more familiar with the advantages of this new suture technology. Barbed suture devices were first implemented by plastic surgeons for the use in various minimally invasive techniques for facial rejuvenation, but have now surpassed these applications and are now much more commonly used in Breast and Body closures.

The development of SERI® Surgical Scaffold, an engineered biological scaffold.

The primary goal of reconstructive and revision surgery is to restore, repair, rebuild, and support damaged, weakened, or absent tissue. There are numerous approaches for soft tissue support and repair, including the use of autologous tissue, human- or animal-derived acellular dermal matrices, absorbable or permanent synthetic mesh, and, now, a new class of bioresorbable protein scaffold. Although many factors influence the choice of surgical approach and the specific product used for soft tissue support and repair, the goal is to improve long-term outcomes while minimizing complications and recurrences requiring further revisional surgery. In this review, the basic science, clinical characteristics, and clinical applications of SERI(®) Surgical Scaffold, a novel, engineered, highly purified silk product for soft tissue support and repair will be presented.

The Laminated Nature of the Pectoralis Major Muscle and the Redefinition of the Inframammary Fold: Clinical Implications in Aesthetic and Reconstructive Breast Surgery.

The breast is appreciated aesthetically and clinically for its shape, projection, and volume. Surgical techniques have evolved to manipulate the breast skin envelope, soft tissues, and chest wall anatomy, with and without prosthetic devices. The pectoralis major specifically is altered for pocket dissection and implant coverage. Both the aesthetic and reconstructive surgeons are aware of its relationship to the chest wall and the breast soft tissues. Both are able to achieve outstanding outcomes; however, the authors present an alternative appreciation of the pectoralis and its relationship to the breast.