Silicone gel in biological systems

1992 ◽  
Vol 50 (1) ◽  
pp. 650-651
Author(s):  
William B. Greene ◽  
Lyle G. Walsh ◽  
Richard M. Silver ◽  
Joann Allen ◽  
John C. Maize
Keyword(s):  
Breast Augmentation ◽  
Latency Period ◽  
Breast Implants ◽  
The United States ◽  
Tissue Reaction ◽  
Silicone Implants ◽  
Clinical Group ◽  
Silicone Breast Implants ◽  
Silicone Gel ◽  
Silica Filler

Electron probe microanalysis of biopsies from two patients who had received silicone gel breast implants has revealed silicon (Si) in macrophages in an arthritic finger joint synovium (Fig. 1) and in a sclerodermatous skin lesion as well as in the fibrous capsule surrounding the implants in both patients (Fig. 2). The silastic envelope has been reported to be semipermeable with substances passing freely into and out of the implant. The polymer usually contains silica filler with a particle size of 30μm to impart added firmness, however, these sharp pointed crystals have not been fully characterized by Electron Microscopy. Silicone has been thought to be relatively inert, eliciting little or no tissue reaction. The substance has been injected or surgically placed into the human body as liquid, joints or in the form of breast augmentation prostheses. Recent reports have indicated that there is more than sufficient reason to change our thinking regarding this chemical and it's significance in biological reactions. There are 100,000 patients who undergo breast augmentation each year in the United States alone with over one million reported silicone implants. One clinical group reported that 4.4% of all new scleroderma patients had silicone breast implants. The patients reported in the study had implants from 2 to 21 years duration. The latency period may mean that scleroderma will increase parallel to the increase in breast augmentation over the last decade.

scholarly journals The Evolution of Breast Implants

2019 ◽  
Vol 33 (04) ◽  
pp. 217-223 ◽  
Author(s):  
Christodoulos Kaoutzanis ◽  
Julian Winocour ◽  
Jacob Unger ◽  
Allen Gabriel ◽  
G. Patrick Maxwell
Keyword(s):  
United States ◽  
Clinical Outcomes ◽  
Breast Augmentation ◽  
Breast Implants ◽  
The United States ◽  
Scientific Data ◽  
Silicone Implants ◽  
Fifth Generation ◽  
History Of ◽  
Aesthetic Procedures

AbstractBreast augmentation remains one of the most commonly performed aesthetic procedures in the United States and worldwide. Throughout the last few decades, the implants used for this procedure have undergone significant advancements, which has allowed surgeons to provide safer and more aesthetically pleasing outcomes. This article discusses the history of breast implants since their invention in 1962. Particular emphasis is given to the evolution of silicone implants with its many challenges, which has resulted in the development of the currently used fourth- and fifth-generation devices. Knowledge of these advances will allow physicians to more critically evaluate their results, and also will encourage them to provide more up-to-date scientific data on these devices to further improve the clinical outcomes of their patients.

Immune Functional Impairment in Patients with Clinical Abnormalities and Silicone Breast Implants

1992 ◽  
Vol 8 (6) ◽  
pp. 415-429 ◽  
Author(s):  
Aristo Vojdani ◽  
Andrew Campbell ◽  
Nachman Brautbar
Keyword(s):  
Connective Tissue ◽  
Cytotoxic Activity ◽  
Immune Complexes ◽  
Breast Augmentation ◽  
Clinical Symptoms ◽  
Breast Implants ◽  
Silicone Implant ◽  
Silicone Implants ◽  
T Helper ◽  
Silicone Breast Implants

Silicone, previously thought to be a biologically inert and harmless material, has now been reported to elicit antibody response and to be responsible for adjuvant disease in humans. The present study was designed to evaluate the immune function of forty individuals who had undergone silicone breast augmentation for a period of longer than ten years and who were compared with 40 sex and age-matched controls. The following immunological functions were studied: lymphocyte subset analysis, lymphocyte mitogenic response, NK cytotoxic activity and markers for autoimmunity such as ANA, rheumatoid factor immune complexes such as smooth muscle, myelin, and thyroid, and tissue antibodies. Results of lymphocyte subpopulation analysis showed significantly elevated T helper/suppressor ratio in 60% and significantly decreased T helper/suppressor ratio in 7.5% of the silicone implant group, while the control group showed increased helper/suppressor ratio only in 10% of tested individuals and no significant decrease in the T helper/suppressor ratio. There was 20% inhibition in T cell mitogenic responses in the silicone implant group, which is significant when compared to the controls. When NK cytotoxic activity was compared between the two groups, significant inhibition in the ability of lymphocytes to kill tumor target cells was observed in the silicone implant group. This inability of target cell lysis was attributed to the demonstrated lack of granularity of NK cells from the silicone implant group. There was significant increase in: immune complexes, anti-nuclear antibodies, anti-thyroid antibodies, anti-striated muscle cell antibody, and anti-myelin basic protein antibodies. These immunological abnormalities in individuals who underwent silicone breast augmentation indicate a mechanism of tissue injury to these patients, causing autoimmune diseases or syndromes. Since autoimmunity in some other conditions is associated with abnormalities in the HLA serotyping system, and since some collagen vascular diseases have been associated with a higher incidence of the HLA serotyping system, it is recommended that HLA studies be included in future investigations of immune-mediated abnormalities associated with silicone breast augmentation. Our findings here show definite abnormalities of the T helper/suppressor ratio, increased autoimmunity, as well as increased production of immune complexes. Silicone implants have been used in cosmetic and reconstructive surgery more than 30 years (Brown et al., 1960). The gel used in the implant is produced from silicone, reduced to form silicone, which is then reacted with methyl chloride and polymerized to form stable polydimethylsiloxane (Brown et al., 1960). There have been a number of reports describing the occurrence of connective tissue disease in patients after the implantation of silicone. This includes scleroderma, systemic lupus erythematosus, polyarthritis, and Sjögren's syndrome which became clinically apparent 2–21 years after implantation of silicone (Yoshida, 1973; Van Nunen et al., 1983; Fack et al., 1984; Okano et al., 1984; Sergott et al., 1986; Endo et al., 1987; Spiera, 1988; Varga et al., 1989; Varga and Jimenez, 1990; Silverstein, 1992). Routine laboratory tests showed normal findings for red and white blood cell counts, platelets, liver and renal functions, urine analysis, thyroid function tests, serum enzymes, and immunoglobulins (Kaiser et al., 1990). Immunopathological findings were reported for complement cascade, rheumatoid factor immune complexes, and anti-nuclear antibody (Kaiser et al., 1990). After removal of the silicone implants, the clinical symptoms improved along with improvement in laboratory parameters (Kaiser et al., 1990). Despite these reported signs and symptoms of connective tissue disease (Yoshida, 1973; Van Nunen et al., 1983; Fack et al., 1984; Okano et al., 1984; Sergott et al., 1986; Endo et al., 1987; Spiera, 1988; Varga et al., 1989; Kaiser et al., 1990; Varga and Jimenez, 1990; Silverstein, 1992), and reported higher percentage of breast cancer in patients with silicone breast implants (Silverstein, 1992), immune functional studies were not reported in these patients. In this study, we examined the immune function in women with clinical symptoms following silicone breast implants.

scholarly journals Five-Year Retrospective Analysis of Eurosilicone’s Silicone Gel–Filled Breast Implants

2019 ◽  
Vol 1 (3) ◽  
Author(s):  
Maurizio Saturno ◽  
Sharon Stewart ◽  
Erin Bell ◽  
Emanuela Esposito
Keyword(s):  
Clinical Study ◽  
Breast Augmentation ◽  
Capsular Contracture ◽  
Breast Implants ◽  
Magnetic Resonance Images ◽  
Implant Removal ◽  
Actual Rate ◽  
Silicone Breast Implants ◽  
Silicone Gel ◽  
Retrospective Clinical Study

Abstract Background Silicone breast implants have been widely used for breast augmentation and reconstruction. During this time, silicone breast implants have undergone several modifications to improve their safety, quality, and clinical performance. Complications such as reoperation, capsular contracture, and rupture are risks often associated with breast implants. Objectives The authors conducted a retrospective study to analyze and report complication rates associated with Eurosilicone’s (Eurosilicone S.A.S, Apt, Cedex, France) silicone gel–filled breast implants over a period of 5 years. Methods In this retrospective clinical study, 2151 women who underwent either breast augmentation or breast reconstruction with Eurosilicone breast implants were diagnosed. Data on early and late complications including implant removal (explantation/exchange), capsular contracture, and rupture were collected using questionnaires, completed by 39 surgeons across Italy. Results Of the 2151, only 60 patients (2.78%) required implant removal. Twenty-five patients experienced capsular contracture (Baker Grade III/IV), giving an actual rate of 1.2%. The actual rate of implant rupture confirmed by breast magnetic resonance images was 0.18% (4 implants). Six patients (0.27%) were diagnosed with breast cancer following breast augmentation, and local complications including hematoma (1 patient) and seroma (2 patients) were experienced. Conclusions This retrospective clinical study involving Eurosilicone’s round and anatomical textured silicone gel–filled mammary implants demonstrates an excellent safety profile through 5 years. Level of Evidence: 2

The Silicone Gel Breast Implant Controversy—A Chronology of Recent Regulations and Decisions

1993 ◽  
Vol 10 (2) ◽  
pp. 89-93
Author(s):  
Howard A. Tobin
Keyword(s):  
Drug Administration ◽  
Breast Implant ◽  
Breast Implants ◽  
Press Coverage ◽  
Silicone Breast Implants ◽  
Consumer Activism ◽  
Silicone Gel ◽  
Congressional Investigations ◽  
Regulatory Actions

This article summarizes the regulatory actions of the Food & Drug Administration as related to gel-filled silicone breast implants. It also relates the actions to the influences of outside forces such as press coverage, congressional investigations, and consumer activism.

The Evolution of Breast Implants

2002 ◽  
Vol 10 (5) ◽  
pp. 223-236 ◽  
Author(s):  
Walter Peters
Keyword(s):  
United States ◽  
Breast Augmentation ◽  
Capsular Contracture ◽  
Surface Texturing ◽  
Breast Implants ◽  
Early Years ◽  
Present Review ◽  
Thick Wall ◽  
The Past ◽  
Silicone Gel

The present review traces the evolution of breast implants over the past 50 years. During the early years (from 1951 to 1962), a number of different sponges were used for breast augmentation. The first of these was Ivalon, a polyvinyl alcohol sponge. Other sponges were introduced subsequently, including Etheron (a poly-ether sponge popularized by Dr Paule Regnault in Montreal) and Polystan (fabric tapes that were wound into a ball). Subsequently, polyethylene strips enclosed in a fabric or polyethylene casing were also used for breast augmentation. All of these materials had similar outcomes. Although the initial results were encouraging, within one year of augmentation, breasts became very firm and lost over 25% of their volume. This was due to capsular contracture, a process that would lead to the collapse of the sponge and would continue to plague plastic surgeons and their patients for the next 50 years. In 1963, Cronin and Gerow introduced the silicone gel ‘natural feel’ implant, which revolutionized breast augmentation surgery. Approximately 10 companies have manufactured many types of silicone gel breast implants over the years. They obtained their raw materials for gels and shells from a similar number of other companies that entered and left the market at intervals. Many of the suppliers and manufactures changed their names and ownership over the years, and most of the companies no longer exist. No formal process of United States Food and Drug Administration premarket testing was in effect until 1988. There have been three generations of gel implants and a number of other lesser variations. First-generation implants (1963 to 1972) had a thick gel and a thick wall. They have generally remained intact over the years. Second-generation implants (1973 to the mid-1980s) had a thin gel and a thin wall. They have tended to disrupt over time. Third-generation implants (mid-1980s to 1992) had a thick wall and a thick gel. Except for those made by Surgitek, these implants remain intact. The breast implant business was competitive and companies introduced changes such as softer gels; barrier low-bleed shells; greater or lesser shell thickness; surface texturing; different sizes, contours and shapes; and multiple lumens in search of better aesthetics. Ultimately, more than 240 styles and 8300 models of silicone gel breast implants were manufactured in the United States alone. Inflatable breast implants were introduced in Toulons, France in 1965 (the Simaplast implant). There have been three main eras of inflatable implants: seamed, high-temperature vulcanized and room temperature vulcanized implants. In 1973, spontaneous deflation rates of 76% to 88% over three years were reported for many types of inflatable implants. Because of this, most plastic surgeons abandoned their use. From 1963 until the moratorium on gel implants (January 6, 1992), about 95% of all breast implants inserted were silicone gel filled. Only 5% were saline filled. Since the moratorium, this ratio has been reversed and 95% of all implants have been saline-filled, with only 5% being gel filled. Polyurethane-coated (PU) silicone gel implants were introduced in 1968. Over the next 20 years, they were shown to reduce the prevalence of capsular contracture to 2% to 3%. Other forms of surface texturing (Biocell, Siltex, multistructured implant) also appear to reduce capsular contracture with gel implants, but the reduction has been much less dramatic than that seen with PU implants. Contoured (anatomical) shaping appears to have advantages in some patients with gel implants. No such advantage has been seen for texturing or shaping with saline-filled implants. The story of gel implants has culminated in the largest class action lawsuit in medical history, with US$4.2 billion being awarded to women with silicone gel implants. During the past decade, there has been a tremendous amount of research on the reaction of a woman's body to gel implants. A plethora of studies have demonstrated that silicone gel implants are not associated with the development of any medical diseases. Silicone gel-filled implants have therefore been approved for use under Health Canada's Special Access Program. Silicone gel-filled implants may now be used in certain patients in whom they would provide advantages over saline implants. Silicone gel implants have not been approved for unrestricted general use. The evolution of breast implants occupies the past half century. It has been a stormy course, with many exciting advances and many bitter disappointments. The universe of breast implants is large and the variation among the implants is substantial. The purpose of the present review is to trace the evolution of breast implants over the past 50 years.

scholarly journals Capsular Flap for Implant Coverage in Breast Reconstruction Following Nipple-Sparing Mastectomy in Women With Previous Breast Augmentation

2019 ◽  
Vol 5 ◽  
pp. 2513826X1982879
Author(s):  
Miguel Sabino Neto ◽  
Luiz Henrique Gebrim
Keyword(s):  
Breast Cancer ◽  
Breast Reconstruction ◽  
Breast Augmentation ◽  
Prophylactic Mastectomy ◽  
Breast Implants ◽  
Immediate Breast Reconstruction ◽  
Silicone Implants ◽  
Capsular Flap ◽  
Nipple Sparing Mastectomy ◽  
Nipple Sparing

An increased incidence of breast cancer has been observed in women, including in those with silicone breast implants. We describe here the use of a flap made of fibrous capsule to complete the coverage of breast implants in patients undergoing nipple-sparing mastectomy with immediate breast reconstruction, who previously had undergone breast augmentation with silicone implants. All patients underwent ipsilateral therapeutic mastectomy and contralateral prophylactic mastectomy for breast cancer risk reduction and breast symmetrization. The capsular flap was successfully used in 16 patients. No postoperative complications occurred. This is a simple and safe technique and an additional option for this procedure.

Injected Breast Materials: Review of Imaging Features and Characteristics

2021 ◽  
Author(s):  
Yukun Gao ◽  
E Jane Karimova ◽  
Jordana Phillips ◽  
Valerie Fein-Zachary ◽  
Vandana Dialani ◽  
...  
Keyword(s):  
Cancer Detection ◽  
Breast Augmentation ◽  
Breast Imaging ◽  
Breast Implants ◽  
The United States ◽  
Imaging Features ◽  
Imaging Findings ◽  
Imaging Appearance ◽  
Characteristic Imaging ◽  
Optimal Patient Management

Abstract In the United States, silicone and saline breast implants with their familiar radiologic appearance are the mainstays of breast augmentation. However, less well-known sequelae of unconventional injected materials introduced for cosmetic and noncosmetic purposes may also be encountered on breast imaging—for example, free silicone, paraffin and/or oil, polyacrylamide gel, autologous fat, and hyaluronic acid, which are encountered in the setting of breast augmentation. Breast injection of go-yak is not cosmetic but also results in characteristic imaging findings. Breast changes due to extravasation of chemotherapy or interstitial brachytherapy can mimic the appearance of injected noncosmetic materials. Because many of these materials can mimic or obscure imaging findings of breast cancer, it is important to recognize their varied appearances and the limitations of imaging alone in delineating breast injection material from cancer. Given the relatively uncommon incidence of injected materials into the breast, this article aims to review the imaging appearance in order to aid radiologists in maximizing cancer detection and ensuring optimal patient management.

scholarly journals Does Implant Surface Texture Affect the Risk of Capsular Contracture in Subglandular Breast Augmentation and Breast Augmentation-Mastopexy?

2019 ◽  
Vol 40 (5) ◽  
pp. 499-512 ◽  
Author(s):  
Frank Lista ◽  
Ryan E Austin ◽  
Maryam Saheb-Al-Zamani ◽  
Jamil Ahmad
Keyword(s):  
Breast Augmentation ◽  
Bacterial Contamination ◽  
Capsular Contracture ◽  
Surgical Techniques ◽  
Breast Implants ◽  
Textured Surface ◽  
Implant Surface ◽  
Silicone Gel ◽  
Increased Risk ◽  
Augmentation Mastopexy

Abstract Background Previous studies have reported decreased rates of capsular contracture associated with the use of textured surface breast implants placed in the subglandular plane during breast augmentation. However, since the publication of these studies, our understanding of the pathophysiology of capsular contracture, as well as the surgical techniques utilized to minimize bacterial contamination of the implant, have advanced considerably. Objectives The purpose of this study was to re-evaluate the relation between implant surface texturization and capsular contracture rates for breast implants placed in the subglandular plane during primary breast augmentation. Methods Retrospective chart review was performed of all primary subglandular breast augmentation procedures involving the use of either smooth or textured round silicone gel implants, with or without simultaneous mastopexy. The primary outcome measures included clinically significant capsular contracture (Baker grade III/IV) and revision surgery for capsular contracture. Results Between 2010 and 2017, 526 patients underwent primary subglandular breast augmentation with either smooth (n = 212) or textured (n = 314) round silicone gel implants; 248 patients underwent breast augmentation, whereas 278 underwent breast augmentation-mastopexy. Average follow-up was 756 days in the textured group and 461 days in the smooth group. Five cases of capsular contracture were observed in the textured group, and 7 cases of capsular contracture were observed in the smooth group (P = 0.20). Conclusions Smooth surface implants placed in the subglandular plane were not at a significantly increased risk of capsular contracture compared with textured surface implants. We suggest that adherence to a surgical technique focused on minimizing bacterial contamination of the implant is of greater clinical significance than implant surface characteristics when discussing capsular contracture. Level of Evidence: 4

Dermis fat grafts for bilateral augmentation mammaplasty

1995 ◽  
Vol 3 (3) ◽  
pp. 1-8
Author(s):  
John Michael Drever
Keyword(s):  
Body Contouring ◽  
Breast Implants ◽  
Augmentation Mammaplasty ◽  
Silicone Implants ◽  
Lower Abdomen ◽  
Silicone Breast Implants ◽  
Fat Grafts ◽  
Level Of Satisfaction ◽  
High Level

Dermis fat grafts for body contouring have been used for over a century and extensively reported and researched, but since the advent of the more reliable silicone implants they have been dropped and neglected. As a consequence of the present controversy surrounding silicone breast implants, women are inquiring about augmentation with their own tissues. Healthy patients with good vascularity are the best candidates. These grafts are removed from the lower abdomen and placed with the dermis side facing the muscle, ‘take’ and then lose about 30 to 50% of their initial volume. Thirty-six cases were performed with this technique, and a two-and-a-half year follow-up with few complications and a high level of satisfaction is reported.

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