Sonication of removed breast implants for improved detection of subclinical infection.

BACKGROUND: Capsular fibrosis is a severe complication after breast implantation with an uncertain etiology. Microbial colonization of the prosthesis is hypothesized as a possible reason for the low-grade infection and subsequent capsular fibrosis. Current diagnostic tests consist of intraoperative swabs and tissue biopsies. Sonication of removed implants may improve the diagnosis of implant infection by detachment of biofilms from the implant surface. METHODS: Breast implants removed from patients with Baker grades 3 and 4 capsular contracture were analyzed by sonication, and the resulting sonication fluid was quantitatively cultured. RESULTS: This study investigated 22 breast implants (6 implants with Baker 3 and 16 implants with Baker 4 capsular fibrosis) from 13 patients. The mean age of the patients was 49 years (range, 31-76 years). The mean implant indwelling time was 10.4 years (range, 3 months to 30 years). Of the 22 implants, 12 were used for breast reconstruction and 10 for aesthetic procedures. The implants were located subglandularly (n = 12), submuscularly (n = 6), and subcutaneously (n = 4). Coagulase-negative staphylococci, Propionibacterium acnes, or both were detected in the sonication fluid cultures of nine implants (41%), eight of which grew significant numbers of microorganisms (>100 colonies/ml of sonication fluid). CONCLUSIONS: Sonication detected bacteria in 41% of removed breast implants. The identified bacteria belonged to normal skin flora. Further investigation is needed to determine any causal relation between biofilms and capsular fibrosis.

Breast Implants Information for women considering breast implants

Breast Implants Information for women considering breast implants The information in this booklet is being provided for women considering the option of breast implant surgery. The aim of the booklet is to assist women in making an informed choice about breast implants before opting for surgery. The information has been compiled by a subcommittee of the Advisory Committee for Medical Devices at the Irish Medicines Board and has included consultation with health professionals and representatives of interested organisations.  Download the PDF

Breast screening: what if I have breast implants?

This leaflet is used to support the Northern Ireland breast screening programme and explains the procedure for women with breast implants

Bacterial biofilms and capsular contracture in patients with breast implants.

BACKGROUND: It has been hypothesized that bacterial biofilms on breast implants may cause chronic inflammation leading to capsular contracture. The association between bacterial biofilms of removed implants and capsular contracture was investigated. METHODS: Breast implants explanted between 2006 and 2010 at five participating centres for plastic and reconstructive surgery were investigated by sonication. Bacterial cultures derived from sonication were correlated with patient, surgical and implant characteristics, and the degree of capsular contracture. RESULTS: The study included 121 breast implants from 84 patients, of which 119 originated from women and two from men undergoing gender reassignment. Some 50 breast prostheses were implanted for reconstruction, 48 for aesthetic reasons and 23 implants were used as temporary expander devices. The median indwelling time was 4·0 (range 0·1-32) years for permanent implants and 3 (range 1-6) months for temporary devices. Excluding nine implants with clinical signs of infection, sonication cultures were positive in 40 (45 per cent) of 89 permanent implants and in 12 (52 per cent) of 23 temporary devices. Analysis of permanent implants showed that a positive bacterial culture after sonication correlated with the degree of capsular contracture: Baker I, two of 11 implants; Baker II, two of ten; Baker III, nine of 23; and Baker IV, 27 of 45 (P < 0·001). The most frequent organisms were Propionibacterium acnes (25 implants) and coagulase-negative staphylococci (21). CONCLUSION: Sonication cultures correlated with the degree of capsular contracture, indicating the potential causative role of bacterial biofilms in the pathogenesis of capsular contracture. Registration number: NCT01138891 (http://www.clinicaltrials.gov).

Breast phantom with silicone implant for evaluation in conventional mammography

With the increased incidence of cancer and a similarly increased number of surgeries for insertion of silicone breast implants, it is necessary to assess the effect of such material within the breast tissue, particularly in mammography, because of the reduction in the power of breast cancer diagnosis. In this work, we introduce a breast phantom with silicone implants in order to evaluate the influence of the implant on the visibility of the main mammographic findings: fibers, microcalcifications and tumor masses. In this proposed phantom, the breast tissue was simulated using gel paraffin. In the optical density of phantom mammograms with implants, a reduction in breast tissue visibility was seen corresponding to 23% when compared to a phantom without silicone implants. This poor visibility was due to the X-ray beam scattering on silicone material; this effect produced a loss of visibility in the areas adjacent to the implant. It is expected that the proposed phantom model may be used as a device for the establishment of a technical standard for these types of procedures.

Is ultracision knife safe and efficient for breast capsulectomy? A preliminary study.

BACKGROUND: Silicone breast implants are used to a wide extent in the field of plastic surgery. However, capsular contracture remains a considerable concern. This study aimed to analyze the effectiveness and applicability of an ultracision knife for capsulectomy breast surgery. METHODS: A prospective, single-center, randomized study was performed in 2009. The inclusion criteria specified female patients 20-80 years of age with capsular contracture (Baker 3-4). Ventral capsulectomy was performed using an ultracision knife on one side and the conventional Metzenbaum-type scissors and surgical knife on the collateral side of the breast. Measurements of the resected capsular ventral fragment, operative time, remaining breast tissue, drainage time, seroma and hematoma formation, visual analog scale pain score, and sensory function of the nipple-areola complex were assessed. In addition, histologic analysis of the resected capsule was performed. RESULTS: Five patients (median age, 59.2 years) were included in this study with a mean follow-up period of 6 months. Three patients had Baker grade 3 capsular contracture, and two patients had Baker grade 4 capsular contracture. The ultracision knife was associated with a significantly lower pain score, shorter operative time, smaller drainage volume, and shorter drainage time and resulted in a larger amount of remaining breast tissue. Histologic analysis of the resected capsule showed no apoptotic cells in the study group or control group. CONCLUSIONS: The results suggest that ventral capsulectomy with Baker grade 3 or 4 contracture using the ultracision knife is feasible, safe, and more efficient than blunt dissection and monopolar cutting diathermy and has a short learning curve. LEVEL OF EVIDENCE II: 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 .

Aesthetic breast augmentation with hyaluronic acid: imaging findings and implications for radiological assessment

New injectable fillers such as hyaluronic acid have recently been employed as a non-surgical alternative to implants such as silicone for aesthetic breast enhancement. Although their utilization is not yet widespread in Brazil, radiologists should be aware of the imaging findings in this context and of the implications of the presence of this filler for the radiological evaluation in the screening for breast cancer.

Breast implant-associated anaplastic large cell lymphoma: two distinct clinicopathological variants with different outcomes.

BACKGROUND: ALK-negative anaplastic large cell lymphoma associated with breast implant (i-ALCL) has been recently recognized as a distinct entity. Among 43 830 lymphomas registered in the French Lymphopath network since 2010, 300 breast lymphomas comprising 25 peripheral T-cell lymphomas (PTCL) were reviewed. Among PTCL, ALK-negative ALCL was the most frequent and all of them were associated with breast implants. PATIENTS AND METHODS: Since 2010, all i-ALCL cases were collected from different institutions through Lymphopath. Immuno-morphologic features, molecular data and clinical outcome of 19 i-ALCLs have been retrospectively analyzed. RESULTS: The median age of the patients was 61 years and the median length between breast implant and i-ALCL was 9 years. Most implants were silicone-filled and textured. Implant removal was performed in 17 out of 19 patients with additional treatment based on mostly CHOP or CHOP-like chemotherapy regimens (n = 10/19) or irradiation (n = 1/19). CHOP alone or ABVD following radiation without implant removal have been given in two patients. The two clinical presentations, i.e. effusion and less frequently tumor mass correlated with distinct histopathologic features: in situ i-ALCL (anaplastic cell proliferation confined to the fibrous capsule) and infiltrative i-ALCL (pleomorphic cells massively infiltrating adjacent tissue with eosinophils and sometimes Reed-Sternberg-like cells mimicking Hodgkin lymphoma). Malignant cells were CD30-positive, showed a variable staining for EMA and were ALK negative. Most cases had a cytotoxic T-cell immunophenotype with variable T-cell antigen loss and pSTAT3 nuclear expression. T-cell receptor genes were clonally rearranged in 13 out of 13 tested cases. After 18 months of median follow-up, the 2-year overall survival for in situ and infiltrative i-ALCL was 100% and 52.5%, respectively. CONCLUSIONS: In situ i-ALCLs have an indolent clinical course and generally remain free of disease after implant removal. However, infiltrative i-ALCLs could have a more aggressive clinical course that might require additional therapy to implant removal.

Applying scanning electron microscopy for the ultrastructural and clinical analysis of periprosthetic capsules in implant-based breast reconstruction

La reconstruction en deux étapes par expanseur et implant est la technique la plus répandue pour la reconstruction mammmaire post mastectomie. La formation d’une capsule périprothétique est une réponse physiologique universelle à tout corps étranger présent dans le corps humain; par contre, la formation d’une capsule pathologique mène souvent à des complications et par conséquent à des résultats esthétiques sous-optimaux. Le microscope électronique à balayage (MEB) est un outil puissant qui permet d’effectuer une évaluation sans pareille de la topographie ultrastructurelle de spécimens. Le premier objectif de cette thèse est de comparer le MEB conventionnel (Hi-Vac) à une technologie plus récente, soit le MEB environnemental (ESEM), afin de déterminer si cette dernière mène à une évaluation supérieure des tissus capsulaires du sein. Le deuxième objectif est d‘appliquer la modalité de MEB supérieure et d’étudier les modifications ultrastructurelles des capsules périprothétiques chez les femmes subissant différents protocoles d’expansion de tissus dans le contexte de reconstruction mammaire prothétique. Deux études prospectives ont été réalisées afin de répondre à nos objectifs de recherche. Dix patientes ont été incluses dans la première, et 48 dans la seconde. La modalité Hi-Vac s’est avérée supérieure pour l’analyse compréhensive de tissus capsulaires mammaires. En employant le mode Hi-Vac dans notre protocole de recherche établi, un relief 3-D plus prononcé à été observé autour des expanseurs BIOCELL® dans le groupe d’approche d’intervention retardée (6 semaines). Des changements significatifs n’ont pas été observés au niveau des capsules SILTEX® dans les groupes d’approche d’intervention précoce (2 semaines) ni retardée.

Evaluation of the biocompatibility of silicone gel implants - histomorphometric study

Breast implants are medical devices that are used to augment breast size or to reconstruct the breast following mastectomy or to correct a congenital abnormality. Breast implants consist of a silicone outer shell and a filler (most commonly silicone gel or saline). Approximately 5 to 10 million women worldwide have breast implants. Histomorphometric study to evaluate the biological tissue compatibility of silicone implants suitable for plastic surgery and the adverse effects and risks of this material. Thirty Wistar white rats received subcutaneous implants and the revestiment of silicone gel Silimed ®®, and randomized into six groups of five animals each, according to the type of implanted material and the time of sacrifice. Eight areas of 60.11mm2 corresponding to the obtained surgical pieces were analyzed, counting mesenchymal cells, eosinophils, and foreign body giant cells, observing an acceptable biocompatibility in all implants, for subsequent statistical analysis by Tukey test. Silicone gel showed inflammation slightly greater than for other groups, with tissue reactions varying from light to moderate, whose result was the formation of a fibrous capsule around the material, recognized by the organism as a foreign body. Despite frequent local complications and adverse outcomes, this research showed that the silicone and top layer presented an acceptable chronic inflammatory reaction, which did not significantly differ from the control group. In general, it is possible to affirm that silicone gel had acceptable levels of biocompatibility, confirmed the rare presence of foreign body giant cells, and when of the rupture, formed a fibrous capsule around the material, separating the material of the organism. © AVICENA 2013.

MRI-based breast volumetry-evaluation of three different software solutions

As lipofilling of the female breast is becoming more popular in plastic surgery, the use of MRI to assess breast volume has been employed to control postoperative results. Therefore, we sought to evaluate the accuracy of magnetic resonance imaging (MRI)-based breast volumetry software tools by comparing the measurements of silicone implant augmented breasts with the actual implant volume specified by the manufacturer. MRI-based volume analysis was performed in eight bilaterally augmented patients (46 ± 9 years) with three different software programs (Brainlab© I plan 2.6 neuronavigation software; mass analysis, version 5.3, Medis©; and OsiriX© v.3.0.2. 32-bit). The implant volumes analysed by the BrainLab© software had a mean deviation of 2.2 ± 1.7% (r?=?0.99) relative to the implanted prosthesis. OsiriX© software analysis resulted in a mean deviation of 2.8 ± 3.0% (r?=?0.99) and the Medis© software had a mean deviation of 3.1 ± 3.0% (r?=?0.99). Overall, the volumes of all analysed breast implants correlated very well with the real implant volumes. Processing time was 10 min per breast with each system and 30 s (OsiriX©) to 5 min (BrainLab© and Medis©) per silicone implant. MRI-based volumetry is a powerful tool to calculate both native breast and silicone implant volume in situ. All software solutions performed well and the measurements were close to the actual implant sizes. The use of MRI breast volumetry may be helpful in: (1) planning reconstructive and aesthetic surgery of asymmetric breasts, (2) calculating implant size in patients with missing documentation of a previously implanted device and (3) assessing post-operative results objectively.

Applying scanning electron microscopy for the ultrastructural and clinical analysis of periprosthetic capsules in implant-based breast reconstruction

La reconstruction en deux étapes par expanseur et implant est la technique la plus répandue pour la reconstruction mammmaire post mastectomie. La formation d’une capsule périprothétique est une réponse physiologique universelle à tout corps étranger présent dans le corps humain; par contre, la formation d’une capsule pathologique mène souvent à des complications et par conséquent à des résultats esthétiques sous-optimaux. Le microscope électronique à balayage (MEB) est un outil puissant qui permet d’effectuer une évaluation sans pareille de la topographie ultrastructurelle de spécimens. Le premier objectif de cette thèse est de comparer le MEB conventionnel (Hi-Vac) à une technologie plus récente, soit le MEB environnemental (ESEM), afin de déterminer si cette dernière mène à une évaluation supérieure des tissus capsulaires du sein. Le deuxième objectif est d‘appliquer la modalité de MEB supérieure et d’étudier les modifications ultrastructurelles des capsules périprothétiques chez les femmes subissant différents protocoles d’expansion de tissus dans le contexte de reconstruction mammaire prothétique. Deux études prospectives ont été réalisées afin de répondre à nos objectifs de recherche. Dix patientes ont été incluses dans la première, et 48 dans la seconde. La modalité Hi-Vac s’est avérée supérieure pour l’analyse compréhensive de tissus capsulaires mammaires. En employant le mode Hi-Vac dans notre protocole de recherche établi, un relief 3-D plus prononcé à été observé autour des expanseurs BIOCELL® dans le groupe d’approche d’intervention retardée (6 semaines). Des changements significatifs n’ont pas été observés au niveau des capsules SILTEX® dans les groupes d’approche d’intervention précoce (2 semaines) ni retardée.