Consequences of the U.S. Food and Drug Administration–Directed Moratorium on Silicone Gel Breast Implants: 1992 to 2006

Cole, Norman M.

doi:10.1097/prs.0000000000004284

Cited by 25 publications

(11 citation statements)

References 2 publications

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“…The strong disagreement and the heated debates among medical specialists in regards to the FDA decision allowed the following introduction of third-generation (1982), fourth-generation (1987), and fifth-generation implants with cohesive gels in 1992. 13 Their triple-layer shell with highly cross-linked silicone made capsular calcification a rare finding. The calcification of silicone-gel breast implant capsules occurs as small calcified plaques at the interface between the inner fibrous capsule and implant surface.…”

Section: Discussionmentioning

confidence: 99%

A Forgotten Entity following Breast Implant Contracture: Does Baker Need a Change?

Pagani

Aitzetmüller

Larcher³

2022

Arch Plast Surg

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Although capsular contracture represents one of the most important complications after breast augmentation, local inflammation and fibrosis can lead, in very rare cases, to capsular calcification, an often-forgotten radiological sign of capsular contracture. In this article, the authors present a clinical case of breast implant calcification in an 81-year-old patient. Although this complication has been rarely described, the literature was reviewed to clarify the role of the local microenvironment in capsular contracture and calcification. At present, capsular contracture patients are classified using the conventional Baker score and the histological Wilflingseder classification. As it was not possible to consider capsular calcification when classifying our patient using the traditional scores, the authors propose an updated version of the current scale.

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Section: Discussionmentioning

confidence: 99%

A Forgotten Entity following Breast Implant Contracture: Does Baker Need a Change?

Pagani

Aitzetmüller

Larcher³

2022

Arch Plast Surg

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“…In the early 1990s [11], first reports about the potential link between silicone breast implants and autoimmune or rheumatic diseases led to doubts concerning the safety of silicone implants. As a result, the FDA precluded third-generation silicone implants [6,12] without any specific reason [13]. Consequently, silicone breast implants were unapproachable [13].…”

Section: Silicone Breast Implants Crisismentioning

confidence: 99%

“…As a result, the FDA precluded third-generation silicone implants [6,12] without any specific reason [13]. Consequently, silicone breast implants were unapproachable [13]. For two years saline-filled implants were the only method accepted by the FDA for aesthetic breast augmentation.…”

Section: Silicone Breast Implants Crisismentioning

confidence: 99%

Current Challenges in Breast Implantation

et al. 2021

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Breast implantation (BI) is the most common plastic surgery worldwide performed among women. Generally, BI is performed both in aesthetic and oncoplastic procedures. Recently, the prevalence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) or breast implant illness (BII) has aroused concerns. As a result, several countries, like Australia, Korea or the United Kingdom, introduced national registries dedicated to the safety and quality of BI surgeries. This narrative review aimed to focus on the clinical challenges, management and the current state of knowledge of BI. Both short and long-term outcomes of BI are determined by various alternatives and differences, which surgeons must consider during the planning and performing breast augmentation along with further complications or risk of reoperation. Proper preoperative decisions and aspects of surgical technique emerged to be equally important. The number of performed breast reconstructions is increasing, providing the finest aesthetic results and improving patient’s quality of life. Choice of prosthesis varies according to individual preferences and anatomical variables. A newly diagnosed cases of BIA-ALCL with lacking data on prevention, diagnosis, and treatment are placing it as a compelling medical challenge. Similarly, BII remains one of the most controversial subjects in reconstructive breast surgery due to unspecified diagnostic procedures, and recommendations.

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“…Silicone is the implant material (i.e., foreign body) most widely used in routine medical practice. However, local and systemic complications in SMI carriers are still frequently reported and are controversially discussed in the literature [16][17][18][19][20][21][22][23][24][25][26][27][28][29]. The most common complication of SMI is fibrotic-implant encapsulation and peri-SMI capsular contracture, with a reported incidence from 0.5% to 50% [26,27,29,30].…”

Section: Introductionmentioning

confidence: 99%

Is it all about Surface Topography? An Intraindividual Clinical Outcome Analysis of Two Different Implant Surfaces in Breast Reconstruction

Schoberleitner¹,

Augustin²,

Egle³

et al. 2022

Preprint

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The most common long-term complication of silicone breast implants (SMI) remains capsular fibrosis. The etiology of this exaggerated implant encapsulation is multifactorial but primarily induced by the host response towards the foreign material silicone. Identified risk factors included specific implant topographies. Of note, breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), has only been observed in response to textured surface implants. We hypothesize that reduction of SMI surface roughness causes less host response hence better cosmetic outcome with fewer complications for the patient. A total of 7 patients received the routinely used CPX®4 breast expander (~60 µM Ra) and the novel SmoothSilk® (~ 4 µM Ra), fixed prepectoral with a titanised mesh pocket and randomized to the left or right breast after bilateral prophylactic NSME (nipple-sparing mastectomy). We aimed to compare the postoperative outcome regarding capsule thickness, seroma formation, rippling, implant dislocation as well as comfortability and practicability. Our analysis shows that surface roughness is an influential parameter in controlling fibrotic implant encapsulation. First time intra-individually compared in patients, our data confirm an improved biocompatibility with minor capsule formation around SmoothSilk® implants with an average shell roughness of 4 µM and in addition an amplification of host response by titanised implant pockets.

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Consequences of the U.S. Food and Drug Administration–Directed Moratorium on Silicone Gel Breast Implants: 1992 to 2006

Abstract: The FDA silicone gel breast implant moratorium occurred 25 years ago. The immediate and long-term consequences of the moratorium are reviewed and assessed.

Cited by 25 publications

References 2 publications

A Forgotten Entity following Breast Implant Contracture: Does Baker Need a Change?

A Forgotten Entity following Breast Implant Contracture: Does Baker Need a Change?

Current Challenges in Breast Implantation

Is it all about Surface Topography? An Intraindividual Clinical Outcome Analysis of Two Different Implant Surfaces in Breast Reconstruction

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