The Prevalence and Histological Characteristics of the Double Capsule Phenomenon in Breast Augmentation With Implants.

BACKGROUND: Double capsule formation around breast implants is associated with implant rotation and seroma. However, the prevalence and histological characteristics remain unclear. OBJECTIVES: To quantify the prevalence of double capsule formation between different implant surface textures and to explore the histological differences between the inner- and outer capsules from breast implant capsule biopsies. METHODS: The study was performed on data from the Copenhagen Breast Implant (COBI) Biobank comparing the prevalence of double capsule formation around Allergan Biocell implants (Allergan, Dublin, Ireland), Eurosilicone Cristalline implants (GC Aesthetics, Dublin, Ireland), and Mentor Siltex implants (Mentor, Irvine, CA). The histological characteristics of the inner and outer capsules was analyzed using a validated assessment tool. RESULTS: The study included data from 588 patients and 1128 implants. Double capsule formation was found around 25 implants resulting in an overall prevalence of 2.5% for textured implants. Mentor implants with a Siltex surface had a double capsule prevalence of 0.72%, which was significantly lower than the prevalence for Allergan implants with a Biocell surface (7.8%), (P<.001), and Eurosilicone implants with a Cristalline surface (3.4%), (P=.03). Histological analysis showed that inner capsules had lower cellular density (P=.04) and were more calcified (P=.03) compared with outer capsules. CONCLUSIONS: The risk of double capsule formation was highly correlated with the roughness of the breast implant texture, with the risk of double capsule formation around Mentor Siltex implants being significantly lower than that of macrotextured implants. The histological analysis implies that loss of vascularization to the inner capsule results in a lower cellular density and more frequently calcification.

A Histological Assessment Tool for Breast Implant Capsules Validated in 480 Patients with and Without Capsular Contracture.

BACKGROUND: Understanding the impact of breast implants on the histological response in the surrounding fibrous capsule is important; however, consensus is lacking on how to analyze implant capsules histologically. We aimed to develop a standardized histological assessment tool to be used in research potentially improving diagnostic accuracy and treatment strategies for capsular contracture. METHODS: Biopsies of breast implant capsules from 480 patients who had undergone breast augmentation or reconstruction were collected and stained with hematoxylin and eosin. Initially, biopsies from 100 patients were analyzed to select histological parameters demonstrating the highest relevance and reproducibility. Then, biopsies from the remaining 380 patients were used to determine intra- and interobserver agreements of two blinded observers and agreement with a pathologist. Finally, we tested the association between the parameters and capsular contracture. RESULTS: The histological assessment tool included ten parameters assessing the inflammatory, fibrotic, and foreign-body reaction to breast implants, each graded on two-, three-, or four-point scales. Intra- and interobserver agreements were almost perfect (0.83 and 0.80), and agreement with the pathologist was substantial (0.67). Four parameters were significantly correlated with capsular contracture, namely chronic inflammation with lymphocyte infiltration (p < 0.01), thickness of the collagen layer (p < 0.0001), fiber organization (p < 0.01), and calcification (p < 0.001). CONCLUSIONS: This is the first validated histological assessment tool for breast implant capsules. The validated tool not only advances our understanding of capsular contracture but also sets a new standard for histological evaluation in breast implant research and clinical diagnostics. NO LEVEL ASSIGNED: This journal requires that authors assign a level of evidence to each submission to which Evidence-Based Medicine rankings are applicable. This excludes Review Articles, Book Reviews, and manuscripts that concern Basic Science, Animal Studies, Cadaver Studies, and Experimental Studies. 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 .

Development and Validation of a Diagnostic Histopathological Scoring System for Capsular Contracture Based on 720 Breast Implant Capsules.

BACKGROUND: Capsular contracture is traditionally evaluated with the Baker classification, but this has notable limitations regarding reproducibility and objectivity. OBJECTIVES: The aim of this study was to develop and validate procedure-specific histopathological scoring systems to assess capsular contracture severity. METHODS: Biopsies of breast implant capsules were used to develop histopathological scoring systems for patients following breast augmentation and breast reconstruction. Ten histological parameters were evaluated by multivariable logistic regression to identify those most associated with capsular contracture. Significant parameters (P < .05) were selected for the scoring systems and assigned weighted scores (1-10). Validation was assessed from the area under the curve (AUC) and the mean absolute error (MAE). RESULTS: A total of 720 biopsies from 542 patients were included. Four parameters were selected for the augmentation scoring system, namely, collagen layer thickness, fiber organization, inflammatory infiltration, and calcification, providing a combined maximum score of 26. The AUC and MAE for the augmentation scoring system were 81% and 0.8%, which is considered strong. Three parameters were selected for the reconstruction scoring system, namely, fiber organization, collagen layer cellularity, and inflammatory infiltration, providing a combined maximum score of 19. The AUC and MAE of the reconstruction scoring system were 72% and 7.1%, which is considered good. CONCLUSIONS: The new histopathological scoring systems provide an objective, reproducible, and accurate assessment of capsular contracture severity. We propose these novel scoring systems as a valuable tool for confirming capsular contracture diagnosis in the clinical setting, for research, and for implant manufacturers and insurance providers in need of a confirmed capsular contracture diagnosis.

[Treatment of mechanically induced nerve injuries].

Peripheral nerve injury can result in significant morbidity. The gold-standard treatment is currently end-to-end suture and is possible by mobilisation of nerve ends in cases with segmental nerve loss up to 1 cm. In cases of defects above 1 cm nerve autograft is the gold-standard treatment. To avoid donor site morbidity alternative procedures can be used, including conduits, nerve transfers and end-to-side suture. The purpose of this review is to create an overview of the currently available treatments of peripheral nerve injury and the clinical management of patients.

[Spontaneous regeneration of facial nerve paresis caused by surgery].

Facial nerve paresis is a known complication to surgery in the facial region. Spontaneous regeneration of such injuries has been described, but little is known about the prognosis and optimal management. This is a case report of two patients with partial facial nerve paresis following surgery. The patients were treated conservatively. Both experienced a regeneration over ten months post-operatively. This suggests a favourable prognosis with conservative treatment in selected cases, which is reassuring for both doctors and patients.