Serum proteins and paraproteins in women with silicone implants and connective tissue disease: a case-control study

Prior studies have suggested abnormalities of serum proteins, including paraproteins, in women with silicone implants but did not control for the presence of connective-tissue disease (CTD). This retrospective case-control study, performed in tertiary-care academic centers, assessed possible alterations of serum proteins, including paraproteins, in such a population. Seventy-four women with silicone implants who subsequently developed CTD, and 74 age-matched and CTD-matched women without silicone implants, were assessed in the primary study; other groups were used for additional comparisons. Routine serum protein determinations and high-sensitivity protein electrophoresis and immunofixation electrophoresis were performed for detection of paraproteins. Women with silicone implants, either with or without CTD, had significantly lower serum total protein and alpha1-globulin, alpha2-globulin, beta-globulin, gamma-globulin, and IgG levels compared with those without silicone implants. There was no significant difference, however, in the frequency of paraproteinemia between women with silicone implants and CTD (9.5%) and age-matched and CTD-matched women without silicone implants (5.4%) (odds ratio, 1.82; 95% confidence interval, 0.51-6.45). Paraprotein isotypes were similar in the two groups, and the clinical characteristics of the 13 women with paraproteinemia were comparable with an independent population of 10 women with silicone breast implants, CTD, and previously diagnosed monoclonal gammopathies. In summary, this first comprehensive study of serum proteins in women with silicone implants and CTD found no substantially increased risk of monoclonal gammopathy. Women with silicone implants, however, had unexpectedly low serum globulin and immunoglobulin levels, with or without the subsequent development of CTD. The causes and clinical implications of these findings require further investigation.     

PHEMA as a fibrous capsule-resistant breast prosthesis

The presence of a silicone (poly-dimethyl siloxane) breast prosthesis in a breast reconstruction patient typically leads to fibrous tissue encapsulation of the prosthesis. Fibrous capsular contracture forces the prosthesis into a hardened sphere. The initially satisfactory cosmetic result can thus be changed into a deformed mass of inappropriate compliance. It is the author's hope with the present study to identify a material for implantation with a diminished tendency to form fibrous encapsulation, to improve the long-term results of prosthetic implants. The purpose of this investigation was to compare the early capsule production quality of poly-2-hydroxyethyl methacrylate (PHEMA) and poly-dimethyl siloxane (silicone). Each of five rats subcutaneously underwent implantation with both a disk of poly-dimethyl siloxane (control) and a similar disk of PHEMA. In this study, the extent of fibrous encapsulation was assessed at 6 weeks after implantation of the two disk types. The five disks of poly-dimethyl siloxane were embedded in fibrous tissue, whereas there was no apparent fibrous tissue surrounding the implants of PHEMA. The author concludes that the results for PHEMA were superior to those for silicone at 6 weeks with regard to fibrous encapsulation (p = 0.0312).     

Serum proteins and paraproteins in women with silicone implants and connective tissue disease: a case–control study

Prior studies have suggested abnormalities of serum proteins, including paraproteins, in women with silicone implants but did not control for the presence of connective-tissue disease (CTD). This retrospective case–control study, performed in tertiary-care academic centers, assessed possible alterations of serum proteins, including paraproteins, in such a population. Seventy-four women with silicone implants who subsequently developed CTD, and 74 age-matched and CTD-matched women without silicone implants, were assessed in the primary study; other groups were used for additional comparisons. Routine serum protein determinations and high-sensitivity protein electrophoresis and immunofixation electrophoresis were performed for detection of paraproteins. Women with silicone implants, either with or without CTD, had significantly lower serum total protein and α₁-globulin, α₂-globulin, β-globulin, γ-globulin, and IgG levels compared with those without silicone implants. There was no significant difference, however, in the frequency of paraproteinemia between women with silicone implants and CTD (9.5%) and age-matched and CTD-matched women without silicone implants (5.4%) (odds ratio, 1.82; 95% confidence interval, 0.51–6.45). Paraprotein isotypes were similar in the two groups, and the clinical characteristics of the 13 women with paraproteinemia were comparable with an independent population of 10 women with silicone breast implants, CTD, and previously diagnosed monoclonal gammopathies. In summary, this first comprehensive study of serum proteins in women with silicone implants and CTD found no substantially increased risk of monoclonal gammopathy. Women with silicone implants, however, had unexpectedly low serum globulin and immunoglobulin levels, with or without the subsequent development of CTD. The causes and clinical implications of these findings require further investigation.     

Silicone gel-filled breast implant integrity: a retrospective review of 478 consecutively explanted implants

Concern has been expressed over the long-term integrity of silicone gel breast implants. There are no large series representing experience with these implants outside of the United States. A retrospective case note review of explanted silicone breast implants was performed; 478 implants have been explanted during the past 11 years and relate to the use of these devices since 1971. Loss of implant integrity was not simply related to its age in vivo. Failure was more likely with implants of the late 1970s and early 1980s (second generation) and with subpectoral placement. Implant failure was independent of capsular contracture as the indication for removal (p = 0.09). There is no evidence that the currently used textured silicone gel breast implants are subject to the same loss of integrity as previous examples of these devices. The life span of these implants, the first of which are approaching 10 years in vivo, is at present unknown. Information concerning the integrity of silicone gel breast implants is essential in the current climate for counseling of both new and old implant recipients.     

Self-reported diseases and symptoms by rupture status among unselected Danish women with cosmetic silicone breast implants

Epidemiologic evidence does not support an association between silicone breast implants and connective tissue or other rheumatic diseases. However, a recent study has suggested that women with ruptured implants may be at increased risk of developing fibromyalgia. An analysis of adverse health outcomes according to breast implant rupture status was conducted in 238 unselected Danish women with cosmetic silicone breast implants. Ninety-two of the women had definite implant rupture, and 146 had intact implants as determined by magnetic resonance imaging. Before undergoing imaging, the women provided blood samples and completed a self-administered questionnaire. Women with ruptured implants overall, and the subgroup with extracapsular ruptures (n = 23), were compared with women with intact implants regarding a number of self-reported diseases and symptoms and the presence of specific autoantibodies, such as antinuclear antibodies, rheumatoid factor, and cardiolipin immunoglobulin G and M antibodies. Overall, there were no differences in the occurrence of self-reported diseases or symptoms or in the presence of autoantibodies between women with intact implants and women with ruptured implants, including extracapsular rupture. The only exception was capsular contracture, which was reported six times more frequently by women with extracapsular ruptures than by women with intact implants (OR, 6.3; 95 percent CI, 1.7 to 23.5). In conclusion, this study of unselected women with silicone breast implants could establish no association between silicone implant rupture and specific diseases or symptoms related to connective tissue disease or other rheumatic conditions, except for an excess of capsular contracture among women with extracapsular rupture.     

Rate and incidence of capsular contracture: a comparison of smooth and textured silicone double-lumen breast prostheses

Capsular contracture results in dissatisfaction and deformity among the 2 million women who have had silicone implants. The literature describes contracture rates as high as 74 percent. I present a comparison of rates and incidences of contracture in patients augmented with smooth and textured double-lumen silicone implants. A total of 165 "smooth" and 63 "textured" implant patients were included in this study, which spans 12 years, 1978-1990. All patients underwent bilateral aesthetic augmentation performed by the same surgeon. Of the 165 smooth implant patients, 74 (44.8 percent) experienced contractures requiring treatment. Of the 63 textured implant patients, 3 (4.8 percent) previous contracture patients experienced sudden fibrosis within 3 months. All others remained soft. It appears that deeply textured silicone surfaces delay or decrease the rate and incidence of clinical capsular contracture, at least for 2 years.     

Ten-year review of a prospective randomized controlled trial of textured versus smooth subglandular silicone gel breast implants

Although textured silicone breast implants have been shown to reduce the incidence of capsular contracture, there is little evidence if this effect is maintained in the long term. It has been 10 years since the double-blind randomized trial in which 53 patients received either Mentor smooth (26) or textured silicone gel implants (27). Of the 14 patients who were not known to have developed a contracture in the smooth group, 11 were reviewed. Three had bilateral contractures. In the textured group, 18 of the 24 patients not known to have contractures were reviewed. None had developed contractures. At 10 years, the incidence of capsular contracture was 65 percent of patients with smooth implants (an increase of 6 percent on the 3-year results) and 11 percent for the textured implant patients (no change on the 3-year results). A database containing the details of 1100 patients reinforces these results by examining the differences in contracture rates of textured, smooth, and polyurethane-coated implants. The effect of submuscular placement on reducing contracture rates regardless of texturing is discussed, as is the apparent increase in capsular contracture in patients who smoke.     

Polyurethane foam-covered implants and capsular contracture: a laboratory investigation

Experiments were conducted in rabbits comparing polyurethane foam-covered implants with otherwise identical smooth silicone gel implants. Using five objective methods of measurement of capsular contracture, no significant difference could be identified. The foam-covered implants consistently developed capsular contracture, although in most cases this was of mild degree and would not have been clinically significant. In the two foam-covered implants with hard contractures, there was no evidence of hematoma or separation of the foam.     

Capsular contracture in silicone gel and saline-filled breast implants after reconstruction

Comparisons between results with randomly allotted silicone-gel and saline-filled prostheses in breast reconstruction after mastectomy led to the following conclusions. Neither prosthesis type is ideal. Leakage from saline-filled implants occurred in 2 of the 37 implants, with resultant deflation. Silicone prostheses had a significantly higher rate of capsular contracture [surgeon's evaluation: 54 percent capsular contracture for silicone-gel compared with 20 percent for saline-filled prostheses (p = 0.006); patients' evaluation for the same figures: 54 percent compared with 29 percent (p = 0.03)]. Other authors have shown the presence of silicone in the tissue around silicone-gel-filled silicone implants, but less or none around saline-filled silicone implants. Since the only difference between the two groups was the randomly allotted implants, we assume that the free silicone around silicone-gel-filled prostheses is the major cause of capsular contracture. Since the saline-filled implants showed a 20 percent capsular contracture rate, there could be other causes of capsular contracture in this study. For prevention of contracture, improved implant encapsulation and use of a less reactive filling substance seem to offer possibilities. Surgical technique should aim to preserve the integrity of the prosthesis.     

"Bleeding" of silicone from bag-gel breast implants, and its clinical relation to fibrous capsule reaction.

We present evidence of the following. 1. Modern silicone bag-gel breast implants leak silicone gel through the bag. 2. The amount of silicone leaked by an intact implant varies from one implant to another, and is not constant for any type or brand. 3. The leaked silicone, together with fibrous thickening and various degrees of inflammation will be found in capsules surrounding the implants if extensive biopsies are taken and many sections are examined.     

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.     

Textured-surface saline-filled silicone breast implants for augmentation mammaplasty

The earliest silicone breast implants were smooth-surface, silicone rubber devices filled with either silicone gel or saline. Because of persistent problems with capsular contracture, polyurethane-covered silicone implants were developed as an alternative. Particularly in the short run, these alternatives proved highly successful at reducing the incidence of capsular contracture. By 1990, polyurethane-covered implants were rapidly becoming the preferred implant choice of many plastic surgeons, but for legal, regulatory, financial, and safety reasons they were withdrawn from the market by Bristol-Myers in 1991. Meanwhile, during the late 1980s, surface texturing and improved materials became available on other silicone breast implants and expanders. Most studies suggest that textured-surface silicone gel-filled implants, saline-filled implants, and tissue expanders have less frequent capsular contracture than their smooth-surface counterparts.     

Long-term use of polyurethane breast prostheses: a 14-year experience

I have used polyurethane prostheses for the past 14 years, implanting 220 implants into 130 patients who desired breast reconstruction after subcutaneous mastectomy or cancer ablation or simply breast augmentation. I theorize that a polyurethane-covered implant resists contracture, retaining its compressibility because the fibroblasts proliferate into the polyurethane in many different directions. When the fibrils contract, the forces of contracture counterbalance one another, resisting contracture. However, when smooth prostheses are implanted, fibrils are directed in a circular fashion around the implant and naturally contract, leading to firmer breasts. There were 115 prostheses inserted following subcutaneous mastectomy, and 22 percent developed contracted capsules. Seven implants became exposed because of skin necroses; one was removed because of a Staphylococcus infection; and two patients developed a combination of polyurethane and silicone granulomas. These developed only with the earlier implant, where there was shedding of the polyurethane sponge layer and silicone bled from the low-viscosity silicone used in the earlier implants. No granulomas were noted with the currently used Surgitek Replicon implant. Eighty-five breasts were reconstructed after cancer ablation with polyurethane implants, and the contracture rate was 2.3 percent. Other complications were minimal. A smaller group of patients had augmentation mammaplasty, and 20 prostheses were placed in 10 patients. A 15 percent contracture rate was noted in this group. In this study, 82 percent of patients were followed for up to 14 years. Capsular contractures occurred in 30 implants between 1 and 11 years, for an average recurrence at 6.3 years. The overall contracture rate was 13 percent. Other complications were minimal. All implants were placed subcutaneously or subglandularly, and all were drained.     

Breast reconstruction by superior gluteal microvascular free flaps without silicone implants

The author's experience with 10 gluteus maximus myodermal free flap breast reconstructions is reviewed against the current methods of reconstruction using silicone implants, latissimus dorsi flaps, regional skin flaps, and rectus abdominis myodermal flaps. The superior gluteal free flap can achieve a reliable, permanent, and aesthetic reconstruction of the breast without silicone implants. The softness, projection, natural appearance, and patient satisfaction are excellent compared with other methods. It is particularly useful in patients who object to the use of artificial implants, are not suitable for regional flaps, or have disappointing results from previous reconstructions. Technical modifications of the flap design and selection of the recipient vessels are important.     

The biophysical and histologic properties of capsules formed by smooth and textured silicone implants in the rabbit.

Capsular contracture remains the major complication of reconstructive and aesthetic breast surgery. The purpose of this investigation was to determine if a silicone implant with a textured surface will form a capsule of significantly different biophysical and histologic properties than conventional smooth silicone. Thirty smooth and 30 textured silicone tissue expanders were implanted under the panniculus carnosus of rabbits. After 3 months, measurements related to contracture were performed on anesthetized animals in an investigator-blinded, controlled manner. Intraexpander pressures were measured as saline was injected over time. We found a significant correlation between intraexpander pressures, applanation tonometry, and Baker class. Histology revealed a thicker, more adherent, and inflammatory capsule around the textured silicone implants as compared with the smooth silicone implants. Dynamic pressures were plotted against volume of saline within the two types of implants. Statistical analysis revealed that the textured implants form a tighter and thicker capsule than the smooth implants after 3 months of observation (p less than 0.005).     

Capsular synovial metaplasia mimicking silicone leak of a breast prosthesis: a case report

Introduction

Synovial metaplasia around a prosthesis and in particular around silicone breast implants has been noted by various investigators, but has unknown clinical significance. We report on a patient where a large amount of synovial fluid mimicked rupture of an implant. We believe this to be an unusual clinical presentation of this phenomenon. Review of the English language literature failed to identify a comparable case.

Case presentation

A 25-year-old woman had undergone bilateral breast augmentation for cosmetic reasons. One implant was subsequently subjected to two attempts at expansion to correct asymmetry. The patient was later found to have a large quantity of viscous fluid around the port of that same prosthesis. Histological assessment of the implant had consequently confirmed capsular synovial metaplasia. This had initially caused the suspicion of a silicone 'bleed' from the implant and had resulted in an unnecessary explantation.

Conclusion

Capsular synovial metaplasia should be ruled out before the removal of breast implants where a leak is suspected. Manipulation and expansion of an implant may be risk factors for the development of synovial metaplasia.

     

The silicone gel-filled breast implant controversy: an update

Learning Objectives: After studying this article, the participant should: 1. Be familiar with the medical uses of silicone. 2. Have a working knowledge of the most important epidemiologic studies regarding silicone gel-filled breast implants. 3. Be aware of the issues about which patients desiring breast augmentation or reconstruction with implants must be counseled.     

Eighty-four consecutive breast reconstructions using a textured silicone tissue expander.

Breast reconstruction utilizing smooth-surface silicone tissue expanders is associated with certain problems. Significant capsular contracture may develop around the expander with subsequent expander displacement necessitating repositioning or capsulectomy at the time of expander removal. Infection, pain on expansion, chest-wall compression, and complications related to the remote fill valve also have been reported. A textured-surface silicone expander with an integrated fill valve was developed to address these issues. Eighty-four consecutive breast reconstructions were performed by a single surgeon using textured expanders in 55 patients. Intraexpander pressures were measured during expansion for a group of these patients, and both initial and postinflation pressure readings were quite low (average initial pressure 2.88 mmHg; average postinflation pressure 12.87 mmHg). Eighty-one of the reconstructions have been completed without any expander losses and with minimal complications. Tissue expander volume averaged 580 cc, and the expansion duration averaged 5.6 months. Various types and configurations of permanent implants were used to complete the reconstructions. Eighty-four percent of our patients' completed reconstructions (including nippleareola reconstruction and opposite breast alteration, when necessary) were accomplished with just two procedures. Seventeen long-term adjustable textured-surface expander/implants with anatomic breast shape are still in place, all after only one operation. The inframmary fold has generally been established passively by the expansion process alone. Textured-surface silicone expanders have stayed where positioned, have expanded easily with minimal patient pain, and have created a noncontractile soft-tissue cover for the final implant. The textured expander with an integrated fill valve has simplified breast reconstruction by helping to limit the problems encountered with smooth silicone expanders. The resulting reconstructions have remained soft with a very acceptable aesthetic appearance. The patient office and hospital charts and photographs of this consecutive series were notarized and submitted to the Editor of this Journal, whose biostatistician randomly selected the cases illustrated.