The role of angiogenesis, inflammation and estrogen receptors in breast implant capsules development and remodeling.

BACKGROUND: Capsular contracture is the most common complication following breast implant placement. The multiple factors unbalancing the physiological response to the foreign body have not been fully elucidated. The aim of this study was to investigate the role of neo-angiogenesis, inflammation and estrogen receptors in peri-prosthetic tissue development and remodeling. METHODS: The study enrolled 31 women who underwent expander substitution with definitive implant. Specimens were stained with hematoxylin/eosin, Masson trichrome, immunohistochemistry and immunofluorescence for alpha-smooth muscle actin, estrogen receptor-α (ER-α), estrogen receptor-ß (ER-ß), Collagen type I and III, CD31 (as a marker of neo-angiogenesis) and vascular endothelial growth factor (VEGF). Inflammatory infiltration was quantified and analyzed. Transmission electron microscopy was performed for ultrastructural evaluation. RESULTS: Myofibroblasts, mainly localized in the middle layer of capsular tissue, expressed VEGF, ER-α and ER-ß. ER-ß expression positively correlated with Collagen type I deposition (p= 0.025). Neo-angiogenesis was predominant in the middle layer. CD31 expression positively correlated with Collagen type I expression (p=0.009) and inflammatory infiltration grade (p= 0.004). The degree of inflammatory infiltration negatively correlated with the time from implantation (p = 0.022). DISCUSSION: The middle layer is key in the development and remodeling of capsular tissue. Myofibroblasts produce VEGF, that induces neo-angiogenesis. New vessels formation is also correlated to the inflammatory response. Collagen deposition is associated with ER-ß expression and neo-angiogenesis. These findings may prelude to targeted pharmacologic therapies able to control such interactions, thus hampering the self-sustaining loop promoting the progression of physiologic fibrosis toward pathologic contracture.

Breast Durometer (Mammometer): A Novel Device for Measuring Soft-Tissue Firmness and Its Application in Cosmetic Breast Surgery.

The measurement of soft-tissue firmness has many potential applications in medical practice. This study reports a user-friendly, novel device that is capable of measuring changes in soft-tissue firmness in a reproducible manner. The study reports the development of the equipment and how it has been applied to breast implant surgery. The device was tested for both intra- and inter-observer variability on an in vitro model, using a breast implant. Once reproducibility was confirmed, breast firmness was measured on a series of patients who underwent sub-fascial breast augmentation (n = 50) to examine how it varied post-operatively. Firmness in the upper half of the breast increased to a maximum level two weeks post-surgery (0.44-0.61 Pa), reducing to pre-operative levels by 6 weeks (0.37-0.54 Pa). There was no further significant change at 12 weeks. Firmness in the nipple areolar complex (NAC) and at the lower outer quadrant (LOQ) followed a similar pattern, but remained firmer at 12 weeks. We interpret these patterns as implying that measurements taken at the upper half of the breast are indicative of post-operative oedema, whereas those at the NAC and LOQ represent changes in firmness produced by the breast implant composite. We consider the potential for this novel device in the measurement of soft-tissue firmness in aesthetic breast surgery and would encourage other researchers to explore novel applications. 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 .

Comparison of Allergan, Mentor, and Sientra Contoured Cohesive Gel Breast Implants: A Single Surgeon's 10-Year Experience.

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.

Treatment of breast animation deformity in implant-based reconstruction with pocket change to the subcutaneous position.

UNLABELLED: Breast animation may be an unfortunate result of subpectoral implant-based reconstruction following mastectomy. This article reviews a novel approach to the treatment of animation deformity in cases of reconstruction, whereby the pectoralis major muscle is sutured down to the chest wall and the implant is transferred to the subcutaneous plane. A retrospective review was performed on 19 breasts undergoing pocket change. In selected cases, fat grafting was added to augment the soft-tissue framework around the implant. Demographics, operative details, outcomes, and complications were recorded. All 19 breasts had complete resolution of their animation deformity. Complications were seen in five breasts (26.3 percent). Four breasts (21.1 percent) developed Baker grade III or IV capsular contracture requiring capsulectomy that was curative. One seroma (5.3 percent) required in-office drainage. There were no visible implant deformities, infections, or implant removals. In appropriately selected patients, pocket change to a subcutaneous plane is a safe and effective technique for correction of severe animation deformity following implant-based breast reconstruction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Acellular dermal matrix for reoperative breast augmentation.

Revisionary breast surgery in previously augmented patients is complex, with many variables that have to be considered. Obtaining durable repairs is challenging because these patients often present with thinned breast tissue, inadequate local tissue, and/or scarred breast envelope from multiple procedures. Capsular contracture, ptosis, tissue atrophy, and wrinkling/rippling are some of the most frequent reasons for reoperation. Conventional repair techniques generally involve a combination of capsule modification (capsular flaps), site change, mastopexy, and implant exchange. Recently, acellular dermal matrices have been introduced into revision surgery to reinforce soft tissue, reinforce the implant pocket, and potentially mitigate capsular contracture. Clinical outcomes of acellular dermal matrix-assisted revision surgery are reviewed from the published literature to evaluate the efficacy and safety of acellular dermal matrices for this indication.

How texture-inducing contraction vectors affect the fibrous capsule shrinkage around breasts implants?

BACKGROUND: Breast augmentation was performed on nine female volunteer patients to determine the influence of three textured surfaces on fibrous capsule formation. The high degree of surface texture reduced the capsular fibrous tissue formation. METHODS: Patients were distributed according to the degree of texture created by the open-pore diameter and depth of the surface texture. Macroscopic and histological examinations were performed to evaluate the implant texture and fibrous capsule interface. Magnetic resonance imaging established a mutual correlation with breast firmness achieved by the Baker grade. RESULTS: The parallelogram law was applied to linear vectors arising from the same initial point into the concavities or undulations on the textured surface to achieve the resultant contraction vector. They were identical to resultant vectors created on the fibrous capsule except in the inverted direction. The adhesive effect or mirror-image tissue response to the implant texture on the fibrous capsule noticeably reduced capsular contracture but only with macrotextured implants. Increased capsular contracture resulted from implants showing micro- and medium surface texture with no significant difference between them. CONCLUSION: Biocell™ implants created resultant vectors on the capsular interface of small and similar lengths with divergent directions creating natural breast firmness. Biodegradation of Polyurethane™ foam disrupted the texture from creating resultant vectors of long and different lengths and in variable directions, increasing breast firmness from 12 months. Siltex™ implants created few and very long resultant vectors perpendicular to the fibrous capsule that developed fibrous capsule contraction after 9 months. We conclude that implants with macrotextured surfaces significantly reduced the risk of fibrous capsular contraction.

Microbiological evaluation of tissue expanders in patients who had first stage breast reconstruction.

Capsular contracture is one of the most common complications associated to the use of foreign materials in reconstruction after mastectomy and aesthetic breast augmentation. Many risk factors, causes, and conditions seldom associated with capsular contracture have been identified but none of these have been confirmed by published data. Among these, subclinical infections (particularly those caused by Staphylococcus epidermidis) seem to be one of the most likely. In the present study we analysed the correlation between capsular contracture and the incidence of periprosthetic subclinical infection in two groups of patients who had first-stage breast reconstruction: one group of patients who were not having adjuvant or neoadjuvant radiotherapy for breast cancer (n = 25) and a second group of patients who had had quadrantectomy and radiotherapy (QUART) and successive radical mastectomy for recurrent disease (n = 25). Patients who had radiotherapy had a significantly higher incidence of subclinical infection (n = 13) than patients who did not (n = 1), but there was no statistical correlation between subclinical infection and capsular contracture. Subclinical infections seemed to present at a later stage and under certain local and systemic circumstances that favoured bacterial growth, such as radiotherapy.