Electron and light microscopy examination of capsules around breast implants.

An investigation, by scanning electron microscopy of the capsules formed around silicone breast implants revealed that they consist almost entirely of connective tissue. In contrast, the capsules around the Y-prostheses (with a polyurethane foam surface) showed a foreign body reaction. We believe that excessive capsule formation around silicone implants is, among other factors, most likely due to discrete or moderate bleeding with subsequent hematoma formation. Therefore, we favor a two-stage procedure for subcutaneous mastectomy with insertion of the implant at 4 to 6 months after the excision.     

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.     

The long-term effects of hard alloplastic implants when put on bone.

The resorption of bone beneath 4 alloplastic materials has been studied for periods up to 18 months in rabbit skulls. When the effects of pressure were negated, there was no significant difference in bone resorption attributable to placement above or below the periosteum. Dacron backing or polyurethane backing were associated with more inflammation and greater bone reaction than were plain silicone or stainless steel. The changes noted at 18 months were essentially the same as those noted at 6 months.     

Fine needle aspiration cytology of silicone lymphadenopathy in a patient with an artificial joint. A case report.

Three years after replacement of the left first metatarsophalangeal joint with a silicone prosthesis, a patient noted enlargement of a left femoral lymph node. Fine needle aspiration of the node revealed a foreign body giant cell reaction to particulates morphologically compatible with silicone elastomer. This finding suggests the potential utility of fine needle aspiration in the evaluation of patients' responses to a variety of foreign materials used in prosthetic devices and as pharmaceuticals.     

Natural-Y Même polyurethane versus smooth silicone: analysis of the soft-tissue interaction from 3 days to 1 year in the rat animal model

The polyurethane foam-covered breast prosthesis is experiencing increased clinical use. The polyurethane is felt to be responsible for altering capsule formation and reducing the contracture rate. This study characterizes the soft-tissue response to the Natural-Y Même polyurethane foam versus smooth silicone in a rat model. Implants were fashioned from an unbacked polyurethane foam specimen used to cover the Natural-Y prosthesis, a silicone shell covered with the Natural-Y foam, and a smooth silicone control. Materials were placed subcutaneously into the backs of male Lew/SsN rats (n = 81) for 3, 7, 14, and 28 days and 3, 6, and 12 months. Implants were then harvested with their soft-tissue response and evaluated histologically. Analysis demonstrates that microstructuring of a surface, as opposed to a smooth material, will dramatically alter the early, intermediate, and late wound-healing events. The soft-tissue response was observed to be dependent on implant site, material chemistry, and morphology as characterized by exudate formation, macrophage invasion, multinucleated giant cell formation, collagen deposition, foam degradation, and angiogenesis.     

Acceleration of capsule formation around silicone implants by infection in a guinea pig model

Fibrous capsules surrounding silicone implants were investigated in a new guinea pig model to delineate some of the factors leading to capsular contracture. Both the implant surfaces and tissue capsules were examined by light and scanning transmission electron microscopy (STEM + SEM) with x-ray energy spectroscopy (XES). The capsular tissues were qualitatively similar to those recovered clinically, showing dense parallel collagen deposits, fibroblasts, myofibroblasts, macrophages, and foreign-body giant cells. Silicone was positively identified within intercellular vacuoles and the rough endoplasmic reticulum of macrophages by XES. Tissue recovered from the capsules that surrounded implants that were contaminated with S. aureus presented a qualitatively similar histologic spectrum. The contaminated specimens did show an accelerated response. SEM showed a cellular invasion of the silicone envelopes. We conclude that the model accurately simulates the clinical situation and suggests that immune mechanisms may play a key role in capsular contracture.     

"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.     

The biomechanical and histopathologic effects of surface texturing with silicone and polyurethane in tissue implantation and expansion.

There has been considerable interest in determining the effect of morphologic alterations of prosthetic surfaces on capsule response in breast surgery. The purpose of this study was to provide a precise, three-dimensional evaluation of soft-tissue response to surface modifications in both implantation and expansion. Expandable 100-cc prostheses were designed with one of three surfaces: textured silicone (Biocell), standard smooth silicone, or polyurethane (Natural-Y, Meme). A new submuscular implantation site in the rabbit was developed. Each animal randomly received a smooth-surface device on one side and either a textured silicone or polyurethane device on the other. In one group of animals, the prostheses were expanded monthly. Capsular response was evaluated monthly in vivo using standardized techniques as well as biomechanical methods for up to 6 months in the expander group (n = 7 to 16) and 8 months in the implant group (n = 7 to 15). Analysis of biomechanical and histologic data revealed that prosthetic surface morphology can specifically alter capsular response. Polyurethane was the only effective surface in preventing capsular contracture in implantation. In expansion, both textured silicone and polyurethane surfaces resulted in significantly less capsular contracture and less resistance to expansion than comparable smooth-surfaced controls. Statistical comparisons reveal that the biomechanical methods utilized in this study provide the most precise and objective method of defining overall soft-tissue contracture around implanted biomaterials.     

Polyurethane implants: a 6-year review of 416 patients

The author reviews 6 years of experience and 416 patients in whom polyurethane implants were used for augmentation and reconstruction of the breast. As with many other plastic surgeons, early use was confined to "salvage cases." Owing to the impressive results, use was extended to routine augmentation. Polyurethane implants are now used exclusively for aesthetic breast surgery. Results are evaluated for replacement of gel capsules and simple and radical mastectomy reconstruction. Gel capsules (Baker stages III to IV), in which prostheses were removed and replaced with polyurethane-covered implants, improved in 29 of 32 patients (87 percent). For reconstruction, placement of polyurethane implants in unscarred situations gives far superior results than following repeated procedures. The incidence of infection is no higher than with gel implants. Removal without capsulectomy was not a problem in most instances. However, on two recent occasions capsulectomy was extremely difficult.     

Polymer biocompatibility—effect on hybridoma growth and metabolism

Summary Hybridoma concentrations were reduced in shake flask and continuous culture by medical-grade PVC and polyurethane samples. Cell viability was unaffected and nutrient uptake rates were increased. No inhibition was observed for silicone, C-Flex or Teflon samples. The inhibition by PVC could be reduced by conditioning the sample with complete medium. The reduction in final cell yield and growth rate may result from extraction of one or more growth factors from the medium.     

Histologic changes and silicone concentrations in human breast tissue surrounding silicone breast prostheses

Using a previously developed method for quantitative measurements of silicone concentrations in breast tissue, material from 86 biopsies from 67 breasts in 55 patients who had silicone implants was examined. In the 49 breast with unruptured prostheses, there was a positive relation between the concentrations and inflammatory reactions, the only exception being the amount of plasma cells, which showed a negative relation. It is concluded that silicone prostheses provoke an inflammatory response not only because they act as foreign bodies, but also because of silicone seepage through intact membranes.     

Biocompatibility and fatigue properties of polystyrene-polyisobutylene-polystyrene, an emerging thermoplastic elastomeric biomaterial

This paper will discuss the biocompatibility and dynamic fatigue properties of polystyrene-b-polyisobutylene-b-polystyrene thermoplastic elastomer with 30 wt % polystyrene (SIBS30), an emerging FDA-approved biomaterial. SIBS30 is a very soft, transparent biomaterial resembling silicone rubber, with superior mechanical properties. Using the hysteresis method adopted for soft biomaterials, the dynamic fatigue properties of SIBS30 were found to be between those of polyurethane and silicone rubber, with fatigue life twice as long as that of silicone. Under single load testing (SLT, 1.25 MPa), SIBS30 displayed less than half the dynamic creep compared to silicone, both in air and in vitro (37 degrees C, simulated body fluid). Hemolysis and 30- and 180-day implantation studies revealed excellent biocompatibility of the new biomaterial. The results presented in this paper indicate that, in comparison with silicone rubber, SIBS30 has similar biocompatibility and superior dynamic fatigue properties.     

Phosphatase activity and level of cyclic nucleotides upon implantation of polyurethane with lactose in the main chain

Activity of hydrolases, acid and alkaline phosphatases (AP and A1P) in connective-tissue capsules as well as the amount of cyclic nucleotides in the rat blood plasma with implantation of polyurethane on the basis of polyoxytetramethylenglycol and 4,4'-diphenylmethane diisocyanate with lactose in the main chain were studied. Data obtained indicate that polyurethane with lactose in the main chain is biocompatible and nontoxic and may be recommended for the purposes of endoprosthesis.     

Fibronectin in cultured mouse sarcoma cells induced by foreign bodies

Indirect fluorescence was used to study distribution of fibronectin in cultured cells of 5 mouse foreign body-induced sarcomas (PS-4, PS-84, PS-100, PS-103, PS-130) and cells of early (2-3 months postimplantation) capsules surrounding implanted plastic films. Accumulation of pericellular or matrix fibronectin in dense cultures compared to sparse ones was noted in all the lines except PS-84. In confluent cultures of these lines, a three-dimensional fibrillar network of fibronectin typical for fibroblast-like cells was observed. The pattern was very similar to that found in dense cultures of non-neoplastic early capsule cells. The data obtained show that loss of pericellular fibronectin would not serve as a marker of neoplastic transformation in this cellular system.     

A One-Piece Ocular Drainage Implant for Glaucoma Surgery: A Preliminary Report

A one-piece silicone filtration implant for glaucoma surgery was evaluated in 18 normotensive rabbits. During the follow-up period of 60 days the function of the implant and the effect of the implant on intraocular pressure (IOP) and local reaction in operated eyes were examined. Mean IOP in operated eyes during the whole follow-up period stayed in a level that was statistically significantly (p<0.001) lower than the preoperative starting value. Despite of a slight inflammatory reaction in the immediate postoperative period the implants were well tolerated. No marked foreign body reaction were noted around the implants in histological sections. In 3 eyes the implants had to be removed due to complications caused by surgical technique.     

Obscure carcinoma encountered in subcutaneous mastectomy in silicone- and paraffin-injected breasts: two patients

Two patients are presented whose breasts were injected directly or indirectly with paraffin and silicone, respectively. Both patients had breast cancer that was obscured by the overwhelming granulomatous resection produced by both these foreign substances. It is suggested that paraffin could have been a causative agent in the development of cancer. The role of injected silicone in breast cancer is questionable.     

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.     

Label‐free stimulated Raman scattering imaging reveals silicone breast implant material in tissue

Millions of women worldwide have silicone breast implants. It has been reported that implant failure occurs in approximately a tenth of patients within 10 years, and the consequences of dissemination of silicone debris are poorly understood. Currently, silicone detection in histopathological slides is based on morphological features as no specific immunohistochemical technique is available. Here, we show the feasibility and sensitivity of stimulated Raman scattering (SRS) imaging to specifically detect silicone material in stained histopathological slides, without additional sample treatment. Histology slides of four periprosthetic capsules from different implant types were obtained after explantation, as well as an enlarged axillary lymph node from a patient with a ruptured implant. SRS images coregistered with bright‐field images revealed the distribution and quantity of silicone material in the tissue. Fast and high‐resolution imaging of histology slides with molecular specificity using SRS provides an opportunity to investigate the role of silicone debris in the pathophysiology of implant‐linked diseases.     

Effects of corticosterone on the negative feedback action of testosterone, 5 alpha-dihydrotestosterone and estradiol in the adult male rat

Corticosterone acetate (10 mg/day) was administered to gonadectomized and adrenalectomized male rats bearing 5, 10 or 15 mm long testosterone filled silicone elastomer capsules. It was found that the serum testosterone levels induced by these capsules were not influenced by corticosterone treatment and that the weights of the prostates in the corticosterone treated rats were not different from their controls. In contrast, corticosterone acetate increased markedly the LH and FSH inhibitory effects of testosterone. Since several brain structures are able to convert testosterone into 17-beta-hydroxy-5-alpha-androstan-3-one (5-alpha-dihydrotestosterone) and/or estradiol, and these metabolites are probably involved in mechanisms controlling gonadotropin secretion, we studied also the effects of corticosterone on the feedback action of dihydrotestosterone and estradiol. 5 alpha-Dihydrotestosterone was administered by 5, 10 or 20 mm long elastomere capsules whereas estradiol was given by daily s.c. injections of 0.125, 0.25 or 0.50 micrograms estradiol benzoate. In the presence of corticosterone acetate the gonadotropin inhibitory action of testosterone, 5 alpha-dihydrotestosterone and estradiol increased more than 2 times.     

Effects of different disinfection and sterilization methods on tensile strength of materials used for single-use devices

Driven by economic and time constraints, some medical centers and third parties are resterilizing single-use devices (SUDs) for reuse. The steam autoclave is quick, but most plastics used in SUDs cannot survive the temperature. Thus, a number of new methods of cleaning, disinfecting, and sterilizing these complex devices are being introduced on the market. The present study investigated the effects of a range of methods on the tensile strength of latex rubber, silicone elastomer, 2 different formulations of polyurethane, nylon, and high-density polyethylene (HDPE) specimens. The methods used were sodium hypochlorite bleach (Clorox), peracetic acid + hydrogen peroxide (Steris), formaldehyde gas (Chemiclave), low-temperature peracetic acid and gas plasma (Plazlyte), and low-temperature hydrogen peroxide gas plasma (Sterrad). The results showed that silicone elastomer was minimally affected, whereas the strengths of nylon, polyethylene, and latex were reduced by some of the methods. Depending on the formulation, the strength of polyurethane either increased or decreased. The data demonstrated that disinfection and sterilization can affect the tensile strength of certain materials used in medical devices.