Reasonably safe? Breast implants and informed consent

Zuckerman, Diana M.

doi:10.1016/s0968-8080(10)35520-0

Cited by 8 publications

(7 citation statements)

References 14 publications

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“…Burkhardt [ 36 ] reported that saline implants resulted in better control of postoperative capsular contracture compared with silicone implants. Other studies confirmed these results: with increases in the number of silica particles present, macrophages in the capsule around an implant also increase, causing an aggravation of local inflammation [ 61 – 62 ] that can promote capsular fibrosis and trigger contracture [ 14 , 61 ]. Silicone implants are commonly used in breast reconstruction and breast augmentation [ 63 ].…”

Section: Discussionmentioning

confidence: 79%

Comparison of the Postoperative Incidence Rate of Capsular Contracture among Different Breast Implants: A Cumulative Meta-Analysis

et al. 2015

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BackgroundA large number of clinical studies have reported that the different materials used in breast implants were a possible cause of the different incidence rates of capsular contracture observed in patients after implantation. However, this theory lacks comprehensive support from evidence-based medicine, and considerable controversy remains.ObjectivesIn this study, a cumulative systematic review examined breast augmentation that used implants with textured or smooth surfaces to analyze the effects of these two types of implants on the occurrence of postoperative capsular contracture.MethodsWe conducted a comprehensive search of literature databases, including PubMed and EMBASE, for clinical reports on the incidence of capsular contracture after the implantation of breast prostheses. We performed a cumulative meta-analysis on the incidence of capsular contracture in order from small to large sample sizes and conducted subgroup analyses according to the prosthetic material used, the implant pocket placement, the incision type and the duration of follow-up. Relative risks (RR) and 95% confidence intervals (CI) were used as the final pooled statistics.ResultsThis meta-analysis included 16 randomized controlled trials (RCTs) and two retrospective studies. The cumulative comparison of textured and smooth breast implants showed statistical significance at 2.13 (95% CI, 1.18-3.86) when the fourth study was entered into the analysis. With the inclusion of more reports, the final results indicated that smooth breast implants were more likely to be associated with capsular contracture, with statistical significance at 3.10 (95% CI, 2.23-4.33). In the subgroup analyses, the subgroups based on implant materials included the silicone implant group and the saline implant group, with significant pooled statistical levels of 4.05 (95% CI, 1.97-8.31) and 3.12 (95% CI, 2.19-4.42), respectively. According to implant pocket placement, a subglandular group and a submuscular group were included in the analyses, and only the subglandular group had a statistically significant pooled result of 3.59 (95% CI, 2.43-5.30). Four subgroups were included in the analyses according to incision type: the inframammary incision group, the periareolar incision group, the transaxillary incision group and the mastectomy incision group. Among these groups, only the pooled results of the inframammary and mastectomy incision groups were statistically significant, at 2.82 (95% CI, 1.30-6.11) and 2.30 (95% CI, 1.17-4.50), respectively. Three follow-up duration subgroups were included in the analyses: the one-year group, the two- to three-year group and the ≥five-year group. These subgroups had statistically significant results of 4.67 (95% CI, 2.35-9.28), 3.42 (95% CI, 2.26-5.16) and 2.71 (95% CI, 1.64-4.49), respectively.ConclusionIn mammaplasty, the use of textured implants reduces the incidence of postoperative capsular contracture. Differences in implant pocket placement and incision type are also likely to affect the incidence of capsular contractu...

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Section: Discussionmentioning

confidence: 79%

Comparison of the Postoperative Incidence Rate of Capsular Contracture among Different Breast Implants: A Cumulative Meta-Analysis

et al. 2015

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“…Approximately 1.5 million units are sold per year by the world’s leaders in the market for the production of silicone breast implants. The main potential complications after silicone breast implantation have shown to be breast implant failure by rupture, distortion, or leakage; capsular fibrosis and contracture; silicone gel bleeding and spreading throughout the organism; chronic inflammation around the silicone implant; and potential carcinogenicity of foreign implants 2,4,5,8–10. The development of capsular contracture (CC; Table 1, Figure 1) occurs at a rate of up to 80%, as previously shown in a review article by Berry et al,11 and is therefore a severe problem for patients.…”

Section: Introductionmentioning

confidence: 99%

Capsular contracture by silicone breast implants: possible causes, biocompatibility, and prophylactic strategies

Steiert¹,

Boyce²,

Sorg³

2013

MDER

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The most common implanted material in the human body consists of silicone. Breast augmentation and breast reconstruction using silicone-based implants are procedures frequently performed by reconstructive and aesthetic surgeons. A main complication of this procedure continues to be the development of capsular contracture (CC), displaying the result of a fibrotic foreign body reaction after the implantation of silicone. For many years, experimental and clinical trials have attempted to analyze the problem of its etiology, treatment, and prophylaxis. Different theories of CC formation are known; however, the reason why different individuals develop CC in days or a month, or only after years, is unknown. Therefore, we hypothesize that CC formation, might primarily be induced by immunological mechanisms along with other reasons. This article attempts to review CC formation, with special attention paid to immunological and inflammatory reasons, as well as actual prophylactic strategies. In this context, the word “biocompatibility” has been frequently used to describe the overall biological innocuousness of silicone in the respective studies, although without clear-cut definitions of this important feature. We have therefore developed a new five-point scale with distinct key points of biocompatibility. Hence, this article might provide the basis for ongoing discussion in this field to reduce single-publication definitions as well as increase the understanding of biocompatibility.

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“…Why then in the case of physical defects can an implant for breast augmentation or rhinoplasty not be authorized before she reaches the age of majority, after adequate counseling? [15,23] Furthermore, it is not clear why the Italian law provides for the prohibition of breast implant operations for minors to be waived only in the case of ''serious congenital malformations.'' Perhaps in the case of serious acquired pathologic conditions, the therapeutic value of breast implants is diminished?…”

Section: Cosmetic Surgery and The Minor: Some Peculiar Aspects Of The...mentioning

confidence: 99%

Informed Consent in Italy—Traditional Versus the Law: A Gordian Knot

et al. 2014

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Reasonably safe? Breast implants and informed consent

Cited by 8 publications

References 14 publications

Comparison of the Postoperative Incidence Rate of Capsular Contracture among Different Breast Implants: A Cumulative Meta-Analysis

Comparison of the Postoperative Incidence Rate of Capsular Contracture among Different Breast Implants: A Cumulative Meta-Analysis

Capsular contracture by silicone breast implants: possible causes, biocompatibility, and prophylactic strategies

Informed Consent in Italy—Traditional Versus the Law: A Gordian Knot

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