Retrospective multicenter cohort analysis of 621 cases of BellaGel silicone breast implants with study of physicochemical properties and surface topography.

This study aimed to assess the effectiveness and safety of BellaGel implants after implantation in Asian women and inform surgeons of another option for use in breast augmentation and reconstruction. This study was conducted in eight hospitals from November 27, 2015 to April 30, 2018. All patients underwent augmentation mammoplasty or implant-based breast reconstruction with BellaGel implants. Complication rates were compared between groups, and the cumulative hazard function was compared using the Kaplan-Meier survival analysis. Implants were grouped by surface type, and the cumulative hazard functions of total complication cases were compared. The biomechanical properties of the BellaGel implant and other company representative implants were tested using a mechanical testing machine, and surface topography was analyzed using a 3D laser scanning confocal microscope. There was a significant difference in the incidence of complications between the reconstruction (17.1%) and augmentation (4.7%) groups, but no significant difference in the complication rates of each group. There was no difference in the reoperation or revision rates between the groups. The log rank test showed a statistically significant difference in cumulative hazard function between the groups. Among the three types of implants (smooth, textured, and microtextured), the microtextured type had the lowest complication rate. The BellaGel microtexture implant had the highest maximal tensile load and displacement value. The BellaGel and Silksurface implants had the highest stored energy, although there was no significant difference. BellaGel implants can serve as a criterion for the selection of safe and effective implants among currently available implants.

Mechanical Performance of Poly Implant Prosthesis (PIP) Breast Implants: A Comparative Study.

BACKGROUND: There is societal concern regarding potential health problems associated with breast implants. Much of this distrust climate was a reaction to the Poly Implant Prosthesis (PIP) scandal. Studying the mechanisms of implant rupture is an important step for their improvement. The mechanical behaviour of breast implant shells was studied on explanted and virgin implants. Implants from both PIP and another brand (brand X), currently in the market, were considered. METHODS: To study the mechanical behaviour of the shell, a total of 940 samples from 11 explants and 5 control implants were analysed. The experimental protocol follows the ISO standards for shell integrity and determination of tensile stress-strain properties. Pearson correlation analyses and the multi-factor ANOVA statistical tests were performed using mechanical test data. RESULTS: Both PIP control and explants had significant variations of stress (P = 0.0001) and shell thickness (P = 0.000) throughout the implant. The stress was directly related to shell thickness. Shell thickness varied significantly for PIP implants, exceeding the manufacturer's specifications. Regarding the other brand, thickness variation was within manufacturer's specifications. CONCLUSIONS: The heterogeneous nature of PIP implants was confirmed. The implant shell thickness should be considered as a relevant parameter during the manufacturing process, for quality control purposes. These results may contribute to dispel mistrust and doubt surrounding breast implants, among the medical community and patients. 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 .

'If it ain't broke, don't fix it?': scandals, 'risk', and cosmetic surgery regulation in the UK and France.

The recent PIP scandal that affected patients worldwide, and received extensive media coverage, led to concerns being felt by patients about the 'risks' of cosmetic surgery. Theories about regulation and risk refer to societies such as those in the West becoming more risk averse. Regulation, in turn, has come to be seen as an instrument to solve a problem for a community seen to be or which perceives itself to be at risk. The political and electoral risk acknowledged by government if it ignores that concern, or at least media coverage of it, can lead to regulation, or the tightening up of regulation, as a response. This article looks at current proposals for legislation in the UK following the PIP silicone implant scandal as an example of the risk-regulation premise. Are cosmetic surgery patients in the UK now going to see stricter regulation of the cosmetic surgery industry? The article argues that the UK and France have both reacted to healthcare scandals and the ensuing societal conception of risk by drawing up more thorough legislation on cosmetic surgery than previously existed. France enacted the Kouchner law in 2002 and the UK government published the Keogh Report in April 2013. A comparison is made of these to establish whether the UK can learn from the French legislation when it comes to drafting actual regulation in the future, perhaps in 2014. Finally, some arguments are made about whether risk aversion may make better law.

Siliconomas tras rotura de implantes mamarios de gel de silicona de alta cohesividad y Poly Implant Prostheses. Revisión de indicaciones diagnósticas y terapéuticas / Siliconomas after high cohesive silicone gel implant rupture and Poly Implant Prostheses. Review of diagnostic and therapeutic indications

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Inclusion of calf implants for the correction of lower limb amyotrophy / Inclusão de implantes de panturrilha na correção das amiotrofias dos membros inferiores

BACKGROUND: Lower limb amyotrophy is a serious deformity that is often disabling and causes esthetic problems such as asymmetries and changes in the shape and contour of the legs. The present study evaluated the use of silicone implants for the correction of lower limb amyotrophy. METHODS: Women who underwent surgical correction of lower limb amyotrophy with silicone implants between 2002 and 2009 at the Plastic Surgery Service of Instituto Ivo Pitanguy at the 38th Nursing Service of Santa Casa da Misericórdia, Rio de Janeiro and at their associated services were retrospectively reviewed. RESULTS: Five cases were studied and the results were retrospectively assessed. Follow-up ranged from 3 months to 2 years after surgery until the last postoperative visit. In 4 of 5 patients, the desired result was obtained after a single surgical procedure, and no patient developed capsular contracture, compartment syndrome, circulatory disorders, neurological disorders, or infections. CONCLUSIONS: Calf augmentation in patients with lower limb amyotrophy did not correct the associated functional deficit, but resulted in a high level of satisfaction with regard to the esthetic improvement of the limb, thus improving the quality of life of these patients.

INTRODUÇÃO: As amiotrofias dos membros inferiores são deformidades por vezes incapacitantes, mas que trazem aos pacientes problemas estéticos, como assimetrias e alterações da forma e contorno das pernas. Este estudo teve como objetivo avaliar a aplicabilidade do uso de implantes de silicone para correção de amiotrofias de membros inferiores. MÉTODO: Estudo retrospectivo de pacientes, todas do sexo feminino, submetidas a correção cirúrgica de amiotrofia de pernas com a utilização de implantes de silicone, entre 2002 e 2009, no Serviço de Cirurgia Plástica do Instituto Ivo Pitanguy, na 38ª Enfermaria da Santa Casa da Misericórdia do Rio de Janeiro e em serviços associados. RESULTADOS: Foram analisados 5 casos. A maioria dos resultados foi avaliada de maneira retrospectiva. O tempo de acompanhamento variou de 3 meses a 2 anos, desde a cirurgia até a última consulta pós-operatória. Do total de pacientes, 4 apresentaram resultado desejado em apenas um procedimento cirúrgico e nenhuma paciente apresentou contratura capsular, síndrome compartimental, alterações circulatórias, alterações neurológicas ou infecção. CONCLUSÕES: O aumento das panturrilhas em pacientes portadoras de amiotrofias de membros inferiores não proporcionou modificações no tocante ao deficit funcional prévio. Todavia, essas pacientes, geralmente bastante castigadas pela doença de base, apresentam índice de satisfação muito elevado com a melhoria estética do membro, otimizando, dessa forma, a qualidade de vida dessas pacientes.

Assessment of silicone gel breast implant biodurability by NMR and EDS techniques.

In a study using explanted gel breast implants and appropriate nonimplanted controls, we examined silicone biodurability after long-term implantation. Using NMR spectroscopy, as well as NMR relaxometry measurements (T(2)), no evidence of hydrolysis or other chemical degradation of the cross-linked silicone matrix was observed in specimens from an early breast implant model (Cronin) explanted after 32 years in vivo or a more recent Silastic II model after 13 years in vivo. In addition, no appreciable differences were seen in T(2) relaxation times comparing explanted breast implants to suitably-matched nonimplanted controls, further underscoring the biostability of the cross-linked silicone shell and gel. Our T(2) data and resultant interpretations differ from a 2004 report by the NMR lab at the University of Münster, highlighting the importance of suitable nonimplanted controls and sample preparation. Energy dispersive spectroscopy (EDS) was also performed, confirming the persistence of a fluorosilicone layer inside the elastomer shells of Silastic II implants.

Early experience with an anatomical soft cohesive silicone gel prosthesis in cosmetic and reconstructive breast implant surgery.

Recently, an anatomic breast implant filled with soft cohesive silicone gel was introduced by Mentor Medical Systems onto the European market. This study reports the early experience of a single surgeon with this implant. All patients who received a Contour Profile Gel (CPG) implant from March 2001 to October 2002 were studied. Patient satisfaction with breast shape and consistency was assessed using linear analogue scales with a maximum score of 10. Thirty-five patients received CPG implants for cosmetic (10 patients, 20 breasts) and reconstructive (25 patients, 31 breasts) surgery purposes. Patients were satisfied with their breast shape (mean score: 8.3). Eighty-five percent of the breasts were rated as soft (score >/=6). No serious esthetic complications such as implant malposition or significant capsular contracture were observed. Anatomic soft cohesive gel implants provide excellent results in selected cases. They are well accepted by patients and not associated with an increased rate of complications.

Biodurability of retrieved silicone gel breast implants.

This study analyzed the shells of single-lumen silicone gel breast implants within the general context of device durability in vivo. The investigation included the major types of gel-filled implants that were manufactured in the United States in a 30-year period. The implants analyzed were Cronin seamed (two explants and one control), Silastic 0 and Silastic I (18 explants and seven controls), and Silastic II (22 explants and 43 controls). The biodurability of the explants was investigated with measurements of the mechanical and chemical properties of the various types of silicone gel control and explanted shells, with implantation times ranging from 3 months to 32 years. The shell properties measured for the controls and explants included the stress-strain relationships, tensile strength, elongation, tear resistance, moduli, cross-link density, and amount of extractable material in the shell. In addition, the mechanical properties of shells that had been extracted with hexane were analyzed for both explants and control implants. The silicone gel explants investigated in this study included some of the oldest explants of the various major types that have been tested to date. For assessment of long-term implantation effects, the data obtained in this study were combined with all known data from other institutions on the various major types of gel implants. The study also addressed the failure mechanisms associated with silicone gel breast implants. The results of the study demonstrated that silicone gel implants have remained intact for 32 years in vivo and that degradation of the shell mechanical and chemical properties is not a primary mechanism for silicone gel breast implant failure.

Variability in the properties of silicone gel breast implants.

Several generations of silicone gel breast implants have been produced by implant manufacturers. The primary material usually viewed as the base material in the manufacture of implants is polydimethylsiloxane. Polymeric reactions are notorious for their variability and nonuniformity. The elastomer used in different types of implants can have vastly different properties. Furthermore, the material properties associated with a particular type of implant can vary considerably from one lot to the next. Considering the various designs, styles, and manufacturing techniques associated with silicone gel implants, knowledge of the original properties of the implants before implantation is important in determining the effects of aging in vivo. This study was conducted to investigate differences in key mechanical and chemical properties of silicone gel breast implant materials. The two types of implants chosen for analysis were Silastic I and Silastic II control implants. Material property data were determined for both types of controls and significant differences were found in their values. Lot-to-lot variability was also investigated and found to be significant.