The Use of Anatomic Implants in Aesthetic Breast Surgery.

Anatomic implants were introduced in the late 1980s, gaining popularity through the 1990s and beyond. The moratorium on silicone meant that the use of theses devices was less diffuse in the US and has remained so. Fifth-generation devices had improved form stability with more aggressive texturization to enhance soft tissue interaction. The ability to vary height, width and projection independently creates much versatility in their use for complex anatomical situations producing natural results. The impact of BIA-ALCL has had a significant impact on their use.

Silicone Gel Breast Implants: Past, Present, and Future.

The authors have provided an in-depth review of the history of saline and silicone gel-filled breast implants. In the history of medicine, no devices have been more scrutinized and thoroughly studied than breast implants. Although we as plastic surgeons recognize and appreciate the benefits that our patients derive from these devices, society as a whole continues to remain skeptical. The reasons for this are complex and multifactorial but appear to be fueled by the media, oppositional organizations, and several trial lawyers. Prior to 1990, when the silicone gel implant controversy began, there were only eight indexed publications that dealt with the issue of silicone gel breast implants. Since 1990, there have been more than 500 indexed publications dealing with silicone gel implants. At the time of the moratorium in 1992, we as plastic surgeons did not have a leg to stand on because there was a paucity of scientific evidence to support our observations that silicone breast implants were safe and effective devices.

The history and development of breast implants.

This review discusses the historical development of smooth and textured silicone gel filled implants, and examines the reasoning behind product development and aspects of surgical technique from a surgeon's perspective.

[A historical view of breast implants: Controversy on silicones and breast implant associated -anaplastic large cell lymphoma]. / Seins à dessein. Une histoire d' implants mammaires : controverses autour de la silicone et du lymphome anaplasique a grandes cellules-associe implants mammaires.

Since the dawn of breast implantation back in the sixties, five generations of breast implants have tried to provide the most natural-looking results while striving to eliminate the risk of unpleasant ruptures or capsular contractures. National Health regulators (i.e. the FDA in USA and ANSM in France) have had an "after the facts" reaction, which led to a so-called "dirty war" among producers in the form of a 1992 Silicone's Moratorium (after suspicions of associated cancer or immune-related disorders) all this under the rigid oversight of a FDA director, who seemed more sensible to media scandal than scientific data. After more than a decade of consistent scientific evidence, the interdiction was finally ended in France in 2001 and in the USA in 2006, however the scandals resurfaced again in 2011 after a proven fraud on the "PIP - affair" and most recently with "breast implant associated - anaplastic large cell lymphoma", an extremely serious and rare pathology, treated only by surgical means, until further research. We describe also a chronology on the way the FDA finally recognized this dramatic complication.

Pioneers of Breast Implant-Associated Anaplastic Large Cell Lymphoma: History from Case Report to Global Recognition.

The first case of breast implant-associated anaplastic large cell lymphoma (breast implant ALCL) was described by John Keech and the late Brevator Creech in 1997. In the following 2 decades, much research has led to acceptance of breast implant ALCL as a specific clinicopathologic entity, a process that we bring up to life through the memories of 6 persons who were involved in this progress, although we acknowledge that many others also have contributed to the current state of the art of this disease. Dr. Keech recalls the events that led him and Creech to first report the disease. Ahmet Dogan and colleagues at the Mayo Clinic described a series of 4 patients with breast implant ALCL, and led to increased awareness of breast implant ALCL in the pathology community. Daphne de Jong and colleagues in the Netherlands were the first to provide epidemiologic evidence to support the association between breast implants and ALCL. Garry Brody was one of the first investigators to collect a large number of patients with the disease, present the spectrum of clinical findings, and alert the community of plastic surgeons. Roberto Miranda and L. Jeffrey Medeiros and colleagues studied the pathologic findings of a large number of cases of breast implant ALCL, and published the findings in 2 impactful studies in the medical oncology literature. The recognition and acceptance of this disease by surgeons, epidemiologists, and medical oncologists, working together, has led to subsequent studies on the pathogenesis and optimal therapy of this disease.

The "Game of Implants": A Perspective on the Crisis-Prone History of Breast Implants.

Since their introduction into the market, breast implants have been the subject of many controversies. It is timely to examine the forces that have shaped the breast implant industry to make it what it is today. This review will concentrate more on the use of implants in aesthetic surgery rather than their use in breast reconstruction, but some of the factors have relevance to both indications.

[History of breast cancer reconstruction treatment]. / Historique du traitement du cancer du sein.

The authors summarize in those six pages of drawings the history of breast cancer reconstruction treatment. The focus is on the variety of techniques available for breast reconstruction and on the debates around different indications.

The history and safety of breast implants.

Breast implants are medical devices used for augmentation of the breast, to reconstruct the breast after mastectomy and to correct breast asymmetry. The breast prostheses are likely the most frequently used medical implants. The evolution of modern silicone breast implants was not straightforward and is characterised with a lot of medical, forensic and public attention. Currently it is sufficiently established that implants are safe and can be used for breast reconstruction and aesthetic augmentation. Prosthesis can rupture and produce local symptoms but there is no evidence that silicone breast implants can be of any health hazards for the patients.

The evolution of breast implants.

Breast augmentation remains one of the most common aesthetic procedures performed in the United States. Silicone implants have undergone an evolution with the availability of both fourth- and fifth-generation devices from the 3 leading manufacturers in the United States. This article explores the evolution of breast implants with special emphasis on the advancement of the silicone implants. Clinicians should strive to provide ongoing data and sound science to continue to improve clinical outcomes in the future.

The biology and evolution of cohesive gel and shaped implants.

The introduction of the silicone gel implant in 1962 began the modern era of breast augmentation, and over the past 50 years, breast implants have evolved to encompass a wide array of commercially available implants today. In April 1992, the moratorium on silicone gel breast implants began, and much of the experience and development of the cohesive shaped implants occurred outside the United States. During this time, saline implants were used almost exclusively in North America, whereas silicone implants continued to be used throughout the rest of the world. In 2001, cohesive gel implants became available in the United States under an Investigational Device Exemption Study. Three companies have US Food and Drug Administration approval of fifth-generation implants: Sientra, Allergan, and Mentor. These implants are unique due to the texture of the shell, implant dimensions, gel-shell interaction, gel fill ratio, degree of cross-linking, and form stability. Although form stability is a relative term, it may best be reserved to describe the increased ability of the implant to maintain its basic, intended shape. The cross-linking, form stability, and cohesiveness of these fifth-generation implants provide surgeons with an innovative tool to more closely create a natural breast in both shape and softness.

[Actuality with the breast implants]. / Actualités des implants mammaires.

The author presents the history of breast implants, and the modern evolution where breast implants are largely used in both cosmetic and reconstructive surgery. Breast augmentation is one of the most performed cosmetic procedures, with a high satisfaction rate. However, one needs to remind that breast implants have a limited duration of life. The estimated rate of breast implant rupture after 10 years is of 10% in the current literature, This rate will probably become lower with the new more cohesive implants recently available on the market. It is therefore essential to propose a regular follow-up to all patients having breast implants. This follow-up is performed using a combination of physical examination, mammograms, ultrasound and MRI. The more specific therapeutic approach for patients having a PIP prosthesis will also be discussed.

Breast implants: the good, the bad and the ugly. Can nanotechnology improve implants?

This advanced review will discuss the history of implants used in breast reconstruction and augmentation, the most frequently performed plastic surgery today. Currently, only silicone rubber-based silica nanocomposite implants are available in the United States. The most prevalent issues involving breast implants include capsular contracture, gel bleed, implant rupture, and infection. In the past, studies have also been reported which linked breast implants to increased incidence of systemic diseases such as autoimmune disease, various forms of cancer, and psychological disease. The goal of this review is to survey the literature from the perspective of material science. It is also largely unnoticed that nanotechnology is involved: the silicone rubber shell is reinforced with nanosilica so implants appear to be homogeneous and crystal clear. We are hoping that this review will contribute to a better understanding of the controversial issues and motivate material scientists and medical doctors to work together to develop alternatives based on new nanotechnology for the women who opt for a device made of synthetic materials.

The evolution of breast implants.

Female glandular hypomastia is a frequently encountered entity that occurs either developmentally or by postpartum involution. Historically, women have long sought breast enlargement to improve physical proportions, to foster a more feminine appearance, or to enhance self-image. This article explores the evolution of breast implants.

History of breast implants and the food and drug administration.

Over the past 30 years, silicone-gel breast implants and their manufacturers have experienced a tumultuous relationship with the FDA and the public, which has changed the modern climate of industry oversight and the field of plastic surgery. We present an account of the events leading up to and resulting from the 1992 FDA moratorium on silicone implants. We highlight the involvement of the manufacturers, the scientific and legal communities, regulators, the plastic surgery community, and others as they strive to come to terms with a fearful public opinion shaped by the influence of the media. Finally, we describe how these past events will help the field of plastic surgery grow and continue to push the bounds of medicine.

[Breast implants from 1957 changed on 2005: a 48-year exceptional and historical follow-up]. / Prothèses mammaires de 1957 changées en 2005: un recul exceptionnel et historique de 48 ans.

A 78-year-old woman underwent a breast implants removal on August 2005. The prosthetic breast augmentation was performed during 1957, in France. The photos of these polyethylene made breast implants are shown.

[Evolutive French regulation and materiovigilance specific to the breast implants]. / Normes régissant les implants mammaires.

Too much a long time the manufacture of the breast implants does not have the object of a specific regulation. This lack led partly to the prohibition of the implants filled with silicone in 1995. It took 10 years for the European Union to create and to set up a standard EC specific to the breast prosthesis. It's the history of these steps as well on the level of Europe as has the French scale as we report you. Initially classified as implantable devices of IIb level, the breast implants were reclassified on level III in 1993, the highest level of requirement of CE marking. In accordance with the recommendations of the group of experts named by the Afssaps, the technical standard IN ISO 14630:1997, fixing the mechanical properties of the prosthesis, is in the course of revaluation since 2004. According to Council Directive 93/42/EEC of the June 14th 1993, the French government instituted a materiovigilance specific to the breast implants. All these evolutions allow, now a serene use of the breast implants.