scholarly journals BellaGel breast implant: 6-Year results of a prospective cohort study

2020 ◽  
Vol 47 (3) ◽  
pp. 235-241
Author(s):  
Joon Seok Oh ◽  
Jae Hoon Jeong ◽  
Yujin Myung ◽  
Jeongseok Oh ◽  
Shin Hyeok Kang ◽  
...  
Keyword(s):  
Cohort Study ◽  
Clinical Study ◽  
Breast Reconstruction ◽  
Breast Implant ◽  
Capsular Contracture ◽  
Breast Implants ◽  
Asian Women ◽  
Safety And Efficacy ◽  
Implant Rupture ◽  
Cohesive Silicone Gel

Background This is the first clinical study conducted among Asian women using breast implants manufactured by an Asian company. Four-year data regarding the safety and efficacy of BellaGel breast implants have already been published, and we now report 6-year data.Methods This study was designed to take place over 10 years. It included 103 patients who underwent breast reconstruction or augmentation using BellaGel breast implants. The rates of implant rupture and capsular contracture were measured and analyzed to evaluate the effectiveness of the breast implant.Results At patients’ 6-year postoperative visits, the implant rupture and capsular contracture rates were 1.15% and 2.30%, respectively. The implant rupture rate was 3.77% among reconstruction cases and 0% among augmentation cases. The capsular contracture rate was 5.66% among reconstruction cases and 0.83% among augmentation cases.Conclusions The 6-year data from this planned 10-year study suggest that the BellaGel cohesive silicone gel-filled breast implant is an effective and safe medical device that can be used in breast reconstruction and augmentation.

scholarly journals Thoracic migration of silicone gel after breast implant rupture: a case report and literature review

2021 ◽  
Author(s):  
Benedetta Fanelli ◽  
Marco Marcasciano ◽  
Stefano Lovero ◽  
Luca Codolini ◽  
Donato Casella ◽  
...  
Keyword(s):  
Breast Reconstruction ◽  
Biological Membrane ◽  
Breast Implant ◽  
Granulomatous Inflammation ◽  
Breast Implants ◽  
Silicone Implants ◽  
Axillary Lymph ◽  
Implant Rupture ◽  
Silicone Gel ◽  
Breast Implant Rupture

AbstractNowadays silicone is a widespread material for medical devices. In particular, it is commonly used for implants manufacturing, for that patients undergoing breast augmentation or breast reconstruction after mastectomy. However, the use of silicone implants is not free from risks. Ruptures of silicone breast implants are uncommon, in general post-traumatic or iatrogenic, and usually related to implant’s wall weakness of unknown origin but probably due to biochemical reactions that cause wall rupture. As a consequence of a rupture, silicone gel from damaged implants may have a continuity migration to the chest wall, axillae, and upper extremities, resulting in granulomatous inflammation or siliconoma, or a lymphatic migration to axillary lymph nodes. In this regard, silicone thoracic migration is extremely rare, and nowadays a leakage is unlikely to happen with more modern cohesive silicone gel implants. Nevertheless, procedures such as thoracic surgery and thoracotomies may be responsible for accidental breast implant rupture, capsular discontinuity, and eventually intrathoracic silicone migration, especially when dealing with older generations of breast implants. We report a rare case of a 75-year-old woman presenting with pleural silicone effusion, 18 years after a right breast reconstruction for breast cancer, followed by right upper lobe resection for a lung carcinoma. A combination of muscular flap and DTI pre-pectoral breast reconstruction with biological membrane (ADM) has been used for treatment. Literature was reviewed for cases of breast implants free silicone localization in the chest cavity, focusing on previous surgeries, anamnestic relevances, and surgical management.Level of Evidence: Level V, risk/prognostic study.

scholarly journals Self-Reported Health Complaints In Women Undergoing Explantation of Breast Implants

2020 ◽  
Author(s):  
Renée M L Miseré ◽  
René R W J van der Hulst
Keyword(s):  
Breast Reconstruction ◽  
Medical Center ◽  
Breast Implant ◽  
Tissue Expander ◽  
Retrospective Chart Review ◽  
Breast Implants ◽  
Good Alternative ◽  
Health Complaints ◽  
Implant Rupture ◽  
Patient Reported

Abstract Background Concerns about the safety of silicone breast implants have existed for years, but a causal relationship between systemic complaints and SBI has not been proven. Nevertheless, women are worried and even request explantation. Objectives This study aimed to review the explantation procedures performed, focusing on patient-reported symptoms preoperatively, the effect of explantation, and the effect of breast reconstruction on these symptoms. Methods A retrospective chart review was performed for patients who had undergone explantation between 2010 and 2020 at Maastricht University Medical Center. Patients excluded were those who had undergone tissue expander (TE) removal, TE to implant exchange, and direct implant exchange. Results More than half of the patients undergoing explantation reported complaints, mostly pain. Some 15% reported suggested implant-related systemic complaints. Breast implant illness (BII) was found to be the fifth most common indication for explantation (11.2%). A history of either allergies or implant rupture resulted in higher odds ratios of having BII (OR=2.1 and 2.1, respectively). Subjective improvement of BII after explantation was reported in about 60%. Conclusions A relatively low prevalence of suggested BII exists among women undergoing explantation; one in nine procedures was performed for this reason. Allergy and implant rupture may increase the likelihood of having BII. About 60% of BII patients experienced an improvement in their complaints after implant removal. Autologous breast reconstruction appears a good alternative. Prospective studies into health complaints and quality of life should be performed to confirm the effectiveness of explantation as a therapy for BII.

scholarly journals Punctual Breast Implant Rupture following Lipofilling: Only a Myth?

Breast Care ◽  
2020 ◽  
pp. 1-4
Author(s):  
Andres Rivera ◽  
Carlota González-Pozega ◽  
Gorka Ibarra ◽  
Borja Fernandez-Ibarburu ◽  
Ángela García-Ruano ◽  
...  
Keyword(s):  
Breast Reconstruction ◽  
Breast Implant ◽  
Capsular Contracture ◽  
Clinical Signs ◽  
Fat Graft ◽  
Implant Rupture ◽  
Fat Deposits ◽  
Autologous Fat Graft ◽  
Clinical Chart ◽  
Breast Implant Rupture

<b><i>Background:</i></b> Lipofilling techniques are widespread in clinical practice as a complement to breast reconstruction, despite posing some risk. Punctual implant rupture following a fat transfer is one of the possible complications, which has not been properly reported yet and is probably being underdiagnosed. The aim of this paper is to report key facts for appropriate diagnosis of this clinical chart.<i></i><b><i>Case Report:</i></b><i></i>We present the case of a 47-year-old woman with a bilateral prosthetic breast reconstruction who was treated with autologous fat graft for upper pole enhancing and scar improvement. The patient developed an early unilateral breast capsular contracture after the fat graft procedure, with normal radiological exploration. Surgical findings showed intraprosthetic fat deposits and a punctual implant rupture. <b><i>Conclusions:</i></b> Punctual breast implant rupture is a possible complication of lipofilling that is usually not suspected at first consultation and might be underdiagnosed based on radiological findings, so investigating clinical signs should necessarily be a prerequisite to diagnosis.

scholarly journals The A, B and C’s of Silicone Breast Implants: Anaplastic Large Cell Lymphoma, Biofilm and Capsular Contracture

Materials ◽  
2018 ◽  
Vol 11 (12) ◽  
pp. 2393 ◽  
Author(s):  
Maria Mempin ◽  
Honghua Hu ◽  
Durdana Chowdhury ◽  
Anand Deva ◽  
Karen Vickery
Keyword(s):  
Anaplastic Large Cell Lymphoma ◽  
Biofilm Formation ◽  
Cell Lymphoma ◽  
Breast Implant ◽  
Capsular Contracture ◽  
Breast Implants ◽  
Surface Characteristics ◽  
Large Cell ◽  
Breast Implantation ◽  
Large Cell Lymphoma

Breast implantation either for cosmetic or reconstructive e purposes is one of the most common procedures performed in plastic surgery. Biofilm infection is hypothesised to be involved in the development of both capsular contracture and anaplastic large cell lymphoma (ALCL). Capsular contracture is one of the principal reasons for breast revision surgery and is characterised by the tightening and hardening of the capsule surrounding the implant, and ALCL is an indolent lymphoma found only in women with textured implants. We describe the types of breast implants available with regard to their surface characteristics of surface area and roughness and how this might contribute to capsular contracture and/or biofilm formation. The pathogenesis of capsular contracture is thought to be due to biofilm formation on the implant, which results in on-going inflammation. We describe the current research into breast implant associated ALCL and how implant properties may affect its pathogenesis, with ALCL only occurring in women with textured implants.

scholarly journals Experimental model of capsular contracture in silicone implants

2003 ◽  
Vol 18 (spe) ◽  
pp. 22-28 ◽  
Author(s):  
Érika Malheiros Bastos ◽  
Miguel Sabino Neto ◽  
Lydia Masako Ferreira ◽  
Élvio Bueno Garcia ◽  
Richard Eloin Liebano ◽  
...  
Keyword(s):  
Plastic Surgery ◽  
Experimental Model ◽  
Breast Implant ◽  
Capsular Contracture ◽  
Breast Implants ◽  
Silicone Implants ◽  
Frequent Complication

The breast implant procedure is one of the most performed into Plastic Surgery and the contracture that occurs the capsule formed around the breast implants one of most frequent complication. We describe here one experimental model of capsule contracture in rats.

scholarly journals Ten-Year Safety Data for Eurosilicone’s Round and Anatomical Silicone Gel Breast Implants

2019 ◽  
Vol 1 (2) ◽  
Author(s):  
Franck Duteille ◽  
Pierre Perrot ◽  
Marie-Hélène Bacheley ◽  
Erin Bell ◽  
Sharon Stewart
Keyword(s):  
Capsular Contracture ◽  
Safety Data ◽  
Cumulative Risk ◽  
Breast Implants ◽  
Complication Rates ◽  
Primary Reconstruction ◽  
Safety And Efficacy ◽  
Silicone Gel ◽  
Kaplan Meier

Abstract Background Although silicone breast implants have been available for over 60 years, their safety and efficacy continue to be assessed via long-term clinical and vigilance studies. Complications often associated with breast implant surgery include but are not limited to capsular contracture and rupture. Objective The authors investigate and evaluate the safety and performance of Eurosilicone’s (Eurosilicone S.A.S, Apt Cedex, France) Cristalline Paragel breast implants at least 10 years postimplantation. Methods Nine hundred and ninety-five of Eurosilicone’s textured mammary implants were implanted in 526 women undergoing primary (423 patients) and revision surgery (103 patients) at 17 centers throughout France. Complications were recorded at 3 months and annually thereafter for 10 years. Descriptive statistics were used and the Kaplan-Meier method was utilized to analyze key complications. Results Seventy-four women (98 implants) experienced capsular contracture across all cohorts. The Kaplan-Meier 10-year cumulative risk of capsular contracture (Baker Grade III/IV) per implant was 11.5% in the primary augmentation cohort and 25.2% in the primary reconstruction cohort. Sixteen implant ruptures were observed by surgeon examination giving a Kaplan-Meier risk of 3.8% per patient and 3.5% per implant. Surgical re-intervention (explantation/exchange) was reported 80 times resulting in a Kaplan-Meier cumulative risk of 13.3% and 31.6% for primary augmentation and primary reconstruction, respectively, per patient. Local complication rates including infection and seroma were low with risk rates of 0.6% and 0.2% by subject. Conclusions This multicenter clinical study demonstrates the long-term safety and efficacy profile through 10 years for Eurosilicone round and anatomical silicone gel breast implants. Level of Evidence: 3

scholarly journals Comprehensive Comparison Between Shaped Versus Round Implants for Breast Reconstruction: A Systematic Review and Meta-Analysis

2020 ◽  
Vol 41 (1) ◽  
pp. 34-44 ◽  
Author(s):  
So-Eun Han ◽  
Kyeong-Tae Lee ◽  
Saik Bang
Keyword(s):  
Breast Reconstruction ◽  
Meta Analysis ◽  
Breast Implant ◽  
Capsular Contracture ◽  
Complication Rates ◽  
Level Of Evidence ◽  
Relative Risks ◽  
Patient Reported ◽  
Aesthetic Results ◽  
Retrospective Cohort Studies

Abstract Background Prosthetic breast reconstruction has been gaining popularity and a variety of implant options are currently available. Therefore, it is important to evaluate the safety and efficacy of newly developed shaped implants compared with those of conventional round implants. To date, few studies have investigated the outcomes of breast reconstruction with shaped versus round implants. Objectives The present study aimed to comprehensively compare, via meta-analytic methodology, shaped and round breast implant reconstruction in terms of complication profiles and aesthetic satisfaction. Methods PubMed/MEDLINE, Ovid, and Cochrane databases were searched to identify relevant studies presenting the complication rates for shaped and round implant groups. The relative risks of the following complications between the groups were calculated: infection, seroma, capsular contracture, rupture, rippling, reconstruction failure, and implant exchange or removal. Outcomes of aesthetic satisfaction included aesthetic results and patient-reported outcomes. Results Meta-analysis of 8 retrospective cohort studies, representing 2490 cases of implant-based breast reconstruction, was performed. There were no significant differences in the risks of infection, seroma, capsular contracture, and reconstruction failure between the 2 groups. The risks of implant rupture and rippling were significantly reduced with shaped implants. In a subgroup analysis of shaped/textured and round/smooth implants, the risk of infection was significantly enhanced in the former, whereas incidences of other complications, including capsular contracture and reconstruction failure, were similar. Aesthetic satisfaction analysis of the 2 groups demonstrated similar outcome scores with favorable overall results. Conclusions Our results suggest that both shaped and round implants might provide favorable breast reconstruction outcomes with similarly low complication rates and aesthetic results. Level of Evidence: 4

scholarly journals Device-Specific Findings of Imprinted-Texture Breast Implants: Characteristics, Risks, and Benefits

2019 ◽  
Author(s):  
Roger N Wixtrom ◽  
Vikram Garadi ◽  
John Leopold ◽  
John W Canady
Keyword(s):  
Risk Reduction ◽  
Breast Implant ◽  
Capsular Contracture ◽  
Breast Implants ◽  
Surface Metrology ◽  
Textured Surface ◽  
Primary Reconstruction ◽  
Implant Surface ◽  
Risks And Benefits ◽  
Core Study

Abstract Background The relative risks and benefits of various textured breast implants are the focus of considerable discussion. Studies have suggested different risk-benefit profiles for different implant surface topographies. Objectives The study aim was to provide device-specific, quantitative information on Mentor’s imprinted Siltex Textured breast implants with respect to textured surface characteristics and ISO 14607 classification, risk of breast implant–associated anaplastic large cell lymphoma (BIA-ALCL), and risk-reduction benefits relative to smooth implants. Methods Surface metrology was performed. Data for smooth and Siltex implants from the prospective MemoryGel Core Study were evaluated by Kaplan-Meier analysis for the most frequently occurring postoperative complications in augmentation and reconstruction leading to subsequent reoperation. Results The overall average surface roughness for Siltex MemoryGel and MemoryShape implants was 29.5 and 36.1 µm, respectively. A statistically significantly lower rate of reoperation in patients with Siltex compared with smooth devices over 10 years was observed for both capsular contracture in subglandular primary augmentation patients (2.02% vs 19.84%) and for asymmetry in primary reconstruction patients (3.88% vs 11.1%). Conclusions Surface analysis demonstrated that Siltex implants fall within the ISO 14607 category of “microtexture” breast implants. These devices exhibited a rare risk of BIA-ALCL (0.0012%) based on the most extensive data available. Relative to smooth implants, these Siltex devices provided risk-reduction benefits for the most common reason of reoperation in patients who underwent primary augmentation (capsular contracture) or primary reconstruction (asymmetry) in the Core Study. These findings provide valuable risk-benefit information for surgeons and their patients. Level of Evidence: 2

Clinical Experience with the Fifth-Generation of a Breast Implant with a Smooth, Fine Surface from a Korean Manufacturer in Asian Women

2021 ◽  
Author(s):  
Dong Yeon Hwang ◽  
Sang Wha Kim ◽  
Joon Yong Jung
Keyword(s):  
Clinical Experience ◽  
Safety Assessment ◽  
Breast Implant ◽  
Capsular Contracture ◽  
Asian Women ◽  
Hypertrophic Scars ◽  
Fifth Generation ◽  
Skin Excess ◽  
Fine Surface

Background In this study, we describe our clinical experience with the fifth-generation of a breast implant with a smooth, fine surface from a Korean manufacturer (BellaGel&Ograve; SmoothFine; HansBiomed Co. Ltd., Seoul, Korea) in Asian women. Methods We analyzed 223 women (mean age=35.28&plusmn;9.45 years and mean follow-up period=12.03&plusmn;2.48 months), comprising 118 bilateral cases and 109 unilateral ones, who received breast augmentation using the BellaGel&Ograve; SmoothFine at our hospital between June 4, 2018 and February 28, 2019. For safety assessment, we analyzed frequencies of postoperative complications and overall survival of the BellaGel&Ograve; SmoothFine. Results Postoperatively, complications (12 cases, 5.38%) include asymmetry (3 cases, 1.35%), hematoma (2 cases, 0.90%), hypertrophic scars (2 cases, 0.90%), wound disruption (2 cases, 0.90%), rippling (1 case, 0.45%), capsular contracture (1 case, 0.45%), stretch deformities with skin excess (1 case, 0.45%). In addition, time-to-events were calculated as 10.94&plusmn;0.64 months (95% CI 9.69-12.19). Conclusions Here, we describe our clinical experience with the BellaGel&Ograve; SmoothFine. Our results are of significance in that this is the first report about the fifth-generation of a breast implant with a smooth, fine surface from a Korean manufacturer in Asian women.

Sign in / Sign up

Export Citation Format

Share Document