Implant Shell Characteristics: The Science Behind the Surface.

Modern breast implant design emphasizes the host response at the surface. Implant surfaces are characterized by their roughness, surface area, and potential for bacterial attachment. The future of implant design may lie in the ability of bioengineers to transform both the structure and chemical properties of the device surface and therefore affect potential long-term outcomes.

Management of Asymptomatic Patients With Textured Surface Breast Implants.

With the recent voluntary recall by Allergan of their Biocell textured implants, many plastic surgeons are left with questions of how to best manage asymptomatic patients who have concerns about having these devices. We realized that there is no clear, published recommendations or scientific data to guide surgeons on how to discuss options with their patients and recommendations for surgical management in this uncharted territory. Using available literature and personal experience, we answer the most common questions we are hearing from our plastic surgery colleagues.

A Step Forward Toward the Understanding of the Long-Term Pathogenesis of Double Capsule Formation in Macrotextured Implants: A Prospective Histological Analysis.

BACKGROUND: Although increasingly reported in the literature, most plastic surgeons cannot define the etiology of double capsules. Often an incidental finding at implant exchange, double capsules are frequently associated with macrotextured devices. Several mechanisms have been proposed, including at the forefront that shearing causes a delamination of the periprosthetic capsule into a double capsule. OBJECTIVES: This study was designed to confirm the hypothesis that mechanical forces are involved in formation of double capsules by histological analysis. METHODS: A prospective analysis of consecutive implants with double capsules removed over 2 years was performed. Data collected at the time of surgery included Baker classification, reason for explant, implant manufacturer and style, and any presence of a seroma associated with the capsule. Specimens were sent for analysis by histology utilizing hematoxylin and eosin and alpha-smooth muscle actin staining techniques. RESULTS: Eight double capsules were collected for specimen analysis. All capsules demonstrated evidence of granulation tissue, alpha-smooth muscle actin positive myofibroblasts, and folds with embedded texture. Fibrosis surrounded weak areas with presence of layering and splitting, creating a potential space that is prone to separation. Tears and folds from granulomatous reaction are also present within the outer layer of the double capsule, which can only be explained by a mechanical shearing force as a pathogenic mechanism. CONCLUSIONS: Understanding the pathogenesis of double capsules may allow plastic surgeons to refine their indications for macrotextured implants while providing guidance to patients on avoidance of activities that produce shear-forces. The findings support the hypothesis that shearing forces delaminate the capsule into 2 separate distinct capsules.

CD30+ T Cells in Late Seroma May Not Be Diagnostic of Breast Implant-Associated Anaplastic Large Cell Lymphoma.

The objective was to analyze and discuss the implications of a nonmalignant CD30+ late seroma. Methods included collection of seroma fluid and peripheral blood from a patient with a late seroma 22 years after initial breast reconstruction. A panel of 24 monoclonal antibodies was used to detect T-cell receptor Vß regions present on ~70% of normal human peripheral blood T lymphocytes. Flow cytometry gated on CD3+ and CD30+ activated T lymphocytes. Cytospins were used to inspect the morphology of the T lymphocytes. Results from the seroma fluid cytology revealed a spectrum of activated T lymphocytes as seen in the blood of patients with immune disorders such as infectious mononucleosis. Cells were judged to be nonmalignant by routine pathology. Flow cytometry revealed >23% of CD3+ T lymphocytes belonged to an expanded T-cell family expressing TCRVß13.2. Most Vß13.2 cells expressed T-cell activation antigen CD30 indicating that CD30 is not restricted to anaplastic large cell lymphoma (ALCL) in seroma fluids. A smaller expanded population of CD30+ T lymphocytes expressing TCRVß 13.2 was detected in the blood. In conclusion, in this index case, an expanded population of CD30+ activated T lymphocytes was detected in seroma fluid surrounding a textured breast implant as well as in peripheral blood, consistent with a local and systemic immune response. The demonstration of an expanded CD30+ T-cell population in a polyclonal background suggests a possible role for bacterial superantigens as a pathogenic factor. These data further suggest that breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) may be the end stage of a CD30+ T-cell lymphoproliferative disorder. LEVEL OF EVIDENCE: 5.

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.

The Etiologies of Chest Wall and Breast Asymmetry and Improvement in Breast Augmentation.

Patients presenting for correction of breast and chest wall asymmetries may have undergone numerous thoracic procedures in early childhood and may have suffered profound psychosocial effects. Complex congenital syndromes as well as mild breast asymmetries should be carefully documented using objective measurements, photography, and 3-dimensional simulations when available. Shaped highly cohesive breast implants offer plastic surgeons more possibilities and precision by fine-tuning the gel distribution and specific volumes required to correct the hypoplastic elements. Long-lasting correction of asymmetry can be obtained when patients are not oversized, and care is taken to avoid visibility, palpability, and malposition problems.

Decision and management algorithms to address patient and food and drug administration concerns regarding breast augmentation and implants.

During the U.S. Food and Drug Administration's advisory panel hearings to evaluate the premarket approval for conventional silicone gel implants on October 14 and 15, 2003, panel members and patient advocate representatives focused on four specific areas of concern: reoperation rates in primary breast augmentation; levels, depth, and methods of patient education and informed consent; modes, frequency, and management of silicone gel implant device failures, including management of "silent" ruptures; and methods of monitoring and managing symptoms or symptom complexes that may or may not be associated with connective tissue disease or other undefined symptom complexes. These concerns, with a reported 20 percent reoperation rate for primary augmentation within just 3 years, and a lack of concise, definitive management protocols addressing these areas of concern may have contributed to the Food and Drug Administration's rejection of the premarket approval, despite the panel's recommendation for approval. This article presents decision and management algorithms that have been used successfully for 7 years in a busy breast augmentation practice (Tebbetts and Tebbetts). The algorithms have been further expanded and refined by a group of surgeons with diverse experiences and expertise to address the following clinical situations that coincide with concerns expressed by patients and the Food and Drug Administration: implant size exchange, grade III to IV capsular contracture, infection, stretch deformities (implant bottoming or displacement), silent rupture of gel implants, and undefined symptom complexes (connective tissue disease or other). In one practice (Tebbetts and Tebbetts) that uses the TEPID system (tissue characteristics of the envelope, parenchyma, and implant and the dimensions and fill distribution dynamics of the implant), implant selection is based on quantified patient tissue characteristics, pocket selection is based on quantified soft-tissue coverage, and anatomic saline implants have fill volumes that are designed to minimize shell collapse and fold fatigue; in this practice, the algorithms contributed to a 3 percent overall reoperation rate in 1662 reported cases with up to 7 years of follow-up, compared with a 20 percent reoperation rate at 3 years in the 2003 premarket approval study.