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PubMed1992

Experimental evaluation of in vitro stability of purified polydimethylsiloxanes (silicone oil) in viscosity ranges from 1000 to 5000 centistokes.

One of the main problems in the clinical use of silicone oil in vitreoretinal surgery is the instability of the material in terms of emulsification. Fine silicone oil droplets can cause a secondary glaucoma by blocking aqueous outflow. Intravitreally applicable silicone oils comprise an inhomogeneous group of materials, and the rate of emulsification depends on the physicochemical properties of the silicone oils. Clinically most frequently used silicone oils are highly purified polydimethylsiloxanes with a viscosity of 1000 centistokes (cs) to 5000 cs. Low-viscosity silicone oils are preferred by some surgeons because of easier surgical handling and easier removal out of the vitreous. The authors investigated highly purified polydimethylsiloxanes in viscosity ranges of 1000 cs, 2000 cs, 3000 cs, 4000 cs, and 5000 cs with regard to their in vitro stability to evaluate the optimal range of viscosity with acceptable material stability. The comparative stability tests were performed with 0.1% salt solutions of albumin, acidic alpha-1-glycoprotein, fibrin, fibrinogen, gamma globulins, and very-low-density lipoprotein as emulsifiers. Silicone oil at 5000 cs was in all cases distinctly more stable than the silicone oils with a viscosity up to 4000 cs. A positive correlation between the degree of viscosity and an increase of material stability was not found with all emulsifiers. When very-low-density lipoprotein, albumin, and fibrin served as detergents, a remarkable stability gain was achieved only at 5000 cs.(ABSTRACT TRUNCATED AT 250 WORDS)

Blood Proteins↗
PubMed2002

Comparison of silicone oil removal with passive drainage alone versus passive drainage combined with air-fluid exchange.

PURPOSE: To compare silicone oil removal with passive drainage alone versus passive drainage combined with air-fluid exchange in regard to floaters. METHODS: Twenty-five consecutive patients who were seen at the Retina Center in St. Louis, Missouri between May 1996 and May 1999 and underwent silicone oil removal were requested to complete a mailed questionnaire regarding the presence of floaters. The medical records of the 21 patients (22 eyes) who returned the questionnaire were also reviewed retrospectively for clinical evidence of floaters if they were identified in the postoperative fundus examination. RESULTS: Fifteen patients (16 eyes) (73%) reported floaters after silicone oil removal. Three (14%) of these eyes also had clinical evidence of floaters on postoperative fundus examination. Univariate analyses of primary eye disease other than proliferative diabetic retinopathy, duration of silicone oil retention in the eye, and final visual acuity were not associated with the patients' reported incidence of floaters. No patients with proliferative diabetic retinopathy reported floaters after silicone oil removal. Silicone oil removal procedure (i.e., removal with passive drainage alone or passive drainage combined with air-fluid exchange) did not influence the reported occurrence of floaters (P = 0.65). CONCLUSION: Silicone oil removal is often associated with floaters from residual oil droplets. There is no difference in the incidence of floaters seen after silicone oil removal with passive drainage alone versus passive drainage combined with air-fluid exchange.

Acetates↗
PubMed2003

Late swelling and removal of Miragel buckles: a comparison with silicone indentations.

BACKGROUND: To describe the indications for removal of Miragel episcleral buckles and to compare them with removed silicone sponges and solid silicone indentations. METHODS: Retrospective analysis of the charts of patients successfully treated for retinal detachment in whom the episcleral buckle was removed after surgery, with a minimal follow-up of 6 months. RESULTS: In a series of 90 eyes of 90 patients, including 38 cases of Miragel elements, 25 cases of solid silicone, and 27 cases of silicone sponge removal, the duration of indentation before removal was significantly longer with Miragel (91.9 months) than with solid silicone (10.6 months) and silicone sponges (18.6 months). In eyes treated with Miragel elements, swelling of the material with progressive limitation of ocular motility and protrusion of the buckle beneath the eyelids indicated its removal in 34 (89.5%) eyes. Infection of the buckle and erosion of the conjunctiva with an exposed indentation were significantly more common with silicone buckles. Overall, scleral perforation occurred in four (4.4%) eyes, and retinal redetachment occurred in eight (8.8%) eyes. CONCLUSION: Late swelling of Miragel buckling elements represents a common indication for buckle removal, significantly different from silicone indentations.

Adult↗
PubMedDate not supplied

Interaction of different ocular endotamponades as a risk factor for silicone oil emulsification.

PURPOSE: To investigate the influence of other substances used intraoperatively in vitreoretinal surgery on the emulsification of silicone oil in patients' eyes. METHODS: Gas chromatography coupled mass spectroscopy of the headspace (GC/MS/HS) was used to detect volatile compounds in silicone oil samples explanted from patients qualitatively as well as quantitatively. Surface and interfacial tensions of the explanted samples were measured using the pendent drop technique. RESULTS: Some samples of nonemulsified explanted silicone oil were not different in their content of volatile substances measured by GC-MS/HS. In all explanted samples of emulsified silicone oil volatile substances could be detected, which do not exist or are at the detection limit in native silicone oil for ophthalmic use. The majority of contaminants are heavy liquids, cleaning substances, and oligosiloxanes. CONCLUSION: The contact of silicone oil with all types of substances should be reduced to a minimum. Reuse of tubing sets must be avoided. If a direct exchange between heavy liquids and silicone oil seems necessary, turbulence at the interfaces must be avoided and the contact time between these two endotamponades must be kept as short as possible. If these precautions are obeyed, the risk of emulsification of silicone oil used as an ocular endotamponade can be significantly reduced, down to the influence of individual patients' conditions.

Device Removal↗
PubMedDate not supplied

Long-term stability of circumferential silicone sponge scleral buckling exoplants.

PURPOSE: The historical extrusion/explantation rate of silicone sponge scleral buckle exoplants is 3.5 to 24.4%. This contrasts with the published 0.6 to 1.2% explantation rate of solid silicone elements. Previously reported silicone sponge exoplants studies were noncircumferential (quadrantic or multiple). This study was undertaken to assess the long-term stability of 360 degrees circumferentially placed 3 x 5 mm silicone sponge exoplants. METHODS: Interventional case series of 840 consecutive circumferentially placed 3 x 5 mm silicone sponge exoplants. A retrospective review of operative reports and patient charts was performed. RESULTS: A total of 552 patients had documented follow-up over 1 year. Median follow-up was 32.8 months. Six patients underwent removal of the scleral buckling element (two for diplopia, one acute postoperative infection, and three for extrusion). Median time to removal was 7.3 months. Extenuating circumstances contributed to two of the three extrusions. Of the entire series, fewer than 1% of patients required removal of the silicone sponge implant. Excluding patients with less than 1 year of documented follow-up, the long-term infection/extrusion rate was 0.7%. CONCLUSIONS: Circumferentially placed silicone scleral buckling sponge elements are very stable and are well tolerated. The explantation/extrusion rate is comparable to published solid silicone element series.

Device Removal↗
PubMed2005

Posterior chamber compartments demonstrated by optical coherence tomography, in silicone-filled eyes, following macular hole surgery.

PURPOSE: To report visualization with optical coherence tomography of a prefoveal space in silicone oil-filled eyes following surgery for idiopathic macular hole. METHODS: Seven eyes of seven consecutive patients undergoing macular hole surgery with silicone oil tamponade were prospectively evaluated with optical coherence tomography preoperatively, on the first postoperative day, after 6 weeks and before removal of silicone oil. RESULTS: In all seven eyes the posterior face of the silicone oil bubble was visualized with optical coherence tomography. In all of these patients, who had a silicone oil fill of over 90%, the silicone oil bubble in the upright position did not conform to the foveal depression. Closure of the macular hole was achieved in all seven eyes after one operation. CONCLUSIONS: Macular hole closure can occur without complete tamponade of the central fovea. A prefoveal space can be visualized in silicone oil-filled eyes. Concentration of growth factors, adjuvants and indocyanine green in this compartment may influence postoperative visual outcome, as may changes in retinal homeostasis induced by removal of silicone oil.

Aged↗
PubMed1997

Safety of silicone liquid in the postoperative management of Dupuytren's contracture.

BACKGROUND: Recently the New Zealand Department of Health expressed concerns about the safety of applying silicones to open wounds and banned their use. For 30 years silicone liquid has been used for the management and rehabilitation of the injured hand. It has been reported that the application of silicone fluids to the skin and ordinary handling over a period of years of various methyl and phenyl polymers by laboratory workers caused no skin disorders or sensitization, nor was absorption observed. There are no reports in the literature of the safety of the use of silicones applied to open wounds. METHODS: In the present study, 116 hands that had been mobilized in silicone liquid following surgery for Dupuytren's contracture over the last 12 years were reviewed. In the cases of 64 hands, the patients could be traced and contacted, and 47 patients (hands) agreed to attend for a clinical review. The hands were examined for areas of inflammation, granuloma formation and abnormal scar formation. RESULTS: No patient showed any evidence of adverse effects from the use of silicone liquid. CONCLUSIONS: There is no evidence that the use of silicone liquid, in contact with open wounds of the hands, for the mobilization of the hand following surgery for Dupuytren's contracture has any of the adverse effects reported as being associated with implanted silicone prostheses.

Adult↗
PubMed2006

Immunopathology of intraocular silicone oil: retina and epiretinal membranes.

AIMS: To determine the inflammatory response in retina and epiretinal membranes after intraocular silicone oil tamponade. METHODS: 14 proliferative vitreoretinopathy (PVR) epiretinal membranes, 33 retro-oil epiretinal membranes, 19 retinectomies, 14 retro-oil retinectomies and 37 idiopathic epiretinal membranes (controls) underwent immunohistochemical analysis using the avidin-biotin complex technique and a panel of monoclonal and polyclonal antibodies. The number of positive cells counted in five 0.5 mm diameter fields of immunohistochemical sections was graded on a score of 1-4. RESULTS: Macrophage cell counts were significantly greater in membranes with a history of exposure to silicone oil (p<0.001). An inflammatory response could be observed within 1 month of silicone oil exchange, and the intensity seemed to be unrelated to the duration of exposure. Macrophages were confined to epiretinal membranes on the surface of retinectomy specimens in 10 of 14 cases and intraretinal macrophages were observed only in specimens with gliotic retina. T and B lymphocytes were rarely seen in the specimens examined. Marked glial cell up regulation was observed in 11 of 16 retinectomy specimens and in 8 of 11 retro-oil retinectomies. Glial cell content was variable in the membranes, but there was a trend of increased presence after exposure to silicone oil. CONCLUSION: This study has shown that the use of silicone oil is accompanied by an inflammatory reaction, primarily mediated by bloodborne macrophages. This response can be observed within 1 month of silicone oil injection and continues after silicone oil removal. Retinal surgeons should be aware of the potential secondary effects of intraocular silicone oil when they are considering its use (and removal) in vitreoretinal surgery.

B-Lymphocytes↗
PubMed1999

Imaging spectrum of extracapsular silicone: correlation of US, MR imaging, mammographic, and histopathologic findings.

The appearance of free silicone at mammography, ultrasonography (US), and magnetic resonance (MR) imaging is variable. The classic appearance is dense areas of opacity on mammograms, a highly echogenic pattern with or without hypoechoic masses on US images, and foci of low signal intensity on fat-suppressed T1-weighted MR images or high signal intensity on water-suppressed T2-weighted MR images. Mammography is a reliable, cost-effective, and readily available means of demonstrating silicone. The major disadvantage of US is that its accuracy depends on the capability of the operator to recognize the abnormality. Although MR imaging outperforms US or mammography in detection of implant rupture, it is not clear that MR imaging is superior in detection of free or residual silicone. The sequelae of noncontained silicone include granuloma formation, fibrosis, and migration. After extrusion from an implant, silicone migrates primarily to local sites, such as the ipsilateral chest wall and axillary nodes. Migration of silicone into the axilla can involve the brachial plexus, resulting in neuropathy. Silicone can also migrate into more distal regions, including the arm and subcutaneous tissues of the abdominal wall. Whatever the source, silicone in breast tissue interferes with the interpretation of mammographic findings.

Adult↗
PubMed1986

Silicon metabolism. II. Renal handling in chronic renal failure patients.

In 36 patients suffering from chronic renal failure (mean creatinine clearance 26 ml/min), serum silicon levels were significantly increased (mean 0.52 microgram/ml compared with 0.265 microgram/ml in normals; p less than 0.005). Urinary silicon excretion per 24 h was significantly decreased (15.71 mg/24 h compared with 21.4 mg/24 h in normals; p less than 0.001). Fractional excretion of silicon (FESi) was significantly increased in chronic renal failure (p less than 0.001), with overall tubular secretion of silicon in 33% of patients. Urinary excretion of silicon was significantly related to urinary calcium excretion (p less than 0.0001) urinary magnesium excretion (p less than 0.0001) creatinine clearance (p less than 0.05) and sodium excretion (p less than 0.05). It is suggested that urinary silicon is in the form of orthosilicate, principally bound to calcium and magnesium; and that in chronic renal failure the increase in FESi, and the decrease in absorbed Si from the gastrointestinal tract, moderate the increase in plasma silicon levels and prevent excessive entry of silicon into the tissues.

Adult↗
PubMed1994

Controlled release of beta-estradiol from biodegradable microparticles within a silicone matrix.

Novel, biodegradable controlled release systems were prepared from biodegradable microparticles of poly(lactic acid-co-glycolic acid) containing beta-estradiol in the presence or absence of silicone. The release behavior of beta-estradiol from free microparticles as well as from microparticles embedded within a silicone matrix was compared with the release behavior shown by nonencapsulated beta-estradiol within a silicone matrix. It was found that incorporating biodegradable microparticles within a silicone matrix lessens the initial burst of release often seen with these types of formulations and provides a controlled rate of drug release. In addition, the release rate of beta-estradiol from biodegradable microparticles within silicone is higher than for unencapsulated beta-estradiol in silicone. This type of formulation may be useful in a number of instances such as release of drugs from implants for which a simple drug-silicone formulation does not yield desired release behavior, formulations which are currently developed for microparticles but which may need to be removed if necessary, and implant formulations containing drugs which will not diffuse through silicone.

Biodegradation, Environmental↗
PubMed1995

Do silicone breast implants cause autoimmune rheumatic diseases?

Current estimates are that up to a million women in the U.S. have breast implants with the predominant type being the silicone gel implant. Concerns have been raised regarding the safety of silicone gel breast implants with focus upon whether escaped gel might cause inflammatory and immune responses that subsequently lead to autoimmune rheumatic diseases such as progressive systemic sclerosis (scleroderma), systemic lupus erythematosus (SLE), Sjögren's syndrome or rheumatoid arthritis. A spectrum of illnesses ranging from local symptoms to systemic disease is seen in some patients with silicone breast implants, however, it remains to be determined whether such illnesses in these patients are coincidentally associated or are secondary to the implants. Our understanding of the relationship between the presence of autoimmune rheumatic diseases and silicone breast implants is limited. The available data indicate that silicone elicits a minimal immunological response as compared to conventional antigens. The histological, immunological and epidemiological experimental data derived from patients with silicone implants, as well as those from animal studies, are reviewed. These data do not convincingly demonstrate that there is a cause and effect relationship between silicone breast implants and autoimmune diseases. Further investigations are needed to clarify the interaction of silicone with the cellular and humoral immune systems, as well as with host and environmental factors.

Antibodies, Antinuclear↗
PubMed1992

Histopathological study of balloon embolization: silicone versus latex.

Bilateral, symmetrical, experimental aneurysms were produced with anastomosed vein flap in the carotid arteries of 24 mongrel dogs. Aneurysms were occluded with latex or silicone balloons on each side and observed angiographically from 2 weeks to 2 months. A histopathological study was performed subsequently using light and scanning electron microscopy. Rupture after balloon embolization occurred in five aneurysms; all of which were incompletely occluded by a silicone balloon. On subsequent angiograms, four silicone balloons and one latex balloon were found to have migrated into the aneurysm, resulting in aneurysmal expansion. Parent artery occlusion was more common with latex balloons than silicone balloons. Histopathologically, residual fresh thrombi, decreased proliferation of fibroblasts within the aneurysmal cavity, and poor endothelialization were present around the silicone balloon. These results suggest that the intra-aneurysmal organization, as seen in the aneurysm occluded by the silicone balloon, will be delayed because the balloon is not fixed within the aneurysm, and that this free-floating and rotating balloon causes repeated trauma to the aneurysm wall, contributing to subsequent enlargement and rupture of the aneurysm. The superior antithrombogenic nature of silicone may be responsible for the bias of such phenomena toward the silicone balloon.

Aneurysm↗
PubMed2005

Comparison of PMMA, foldable silicone and foldable acrylic hydrophobic intraocular lenses in combined phacoemulsification and trabeculectomy.

PURPOSE: To compare the postoperative results of phacotrabeculectomy with implantation of PMMA, foldable silicone or foldable hydrofobic acrylic intraocular lens (IOL). SETTING: Glaucoma unit, The Royal Liverpool University Hospital, Liverpool, United Kingdom. METHODS: We studied a total of 124 eyes of three consecutive groups of patients with glaucoma and cataract that underwent phacotrabeculectomy with implantation of a PMMA (30 eyes), a foldable silicone (57 eyes) or a foldable acrylic (37 eyes) IOL. Postoperative Snellen visual acuity and intraocular pressure (IOP), and early and late complications were assessed. All data were analyzed by means of chi2 test, Fisher's exact test, ANOVA/MANOVA tests or a combination whenever appropriate. RESULTS: In all three groups the early and late mean postoperative IOPs were significantly lower than the preoperative ones (p<0.001), with no intergroup differences (p=0.48). The number of eyes with early postoperative hypertension (IOP>25 mmHg) and hypotony (IOP<7 mmHg) was similar in the three groups (p=0.91 and p=0.92 respectively). All groups showed improvement in mean visual acuity (p<0.001), and the differences among the groups were not significant (p=0.79). By 9-12 months after surgery IOPs lower than 22 mmHg without glaucoma medication were found in 76.9% in the PMMA group, 76.6% in the silicone group and in 76.9% in the acrylic group. At the same interval, best visual acuity of 6/12 or better was attained in 80.8%, 83% and 80.8%, in the PMMA, silicone and acrylic groups respectively. The silicone group had significantly more postoperative fibrin reaction into the anterior chamber (p=0.01) and giant cell deposits on the IOL (p<0.0001) than the PMMA and the acrylic groups. The rate of Yag laser posterior capsulotomy was lower with the acrylic IOL (0%) than with the silicone (12.2%) or PMMA (13.3%) IOLs (p=0.08). CONCLUSION: In patients with glaucoma and cataract, phacotrabeculectomy with PMMA, silicone or acrylic IOL was equally effective in lowering the IOP and improving visual acuity. However, incidence of fibrin reaction and lens deposits was higher in those eyes which received a silicone IOL. The PMMA and the acrylic groups did not differ with respect to postoperative complications, but those eyes with an acrylic IOL had a lower rate of posterior capsule opacification.

Acrylic Resins↗
PubMed2004

Gingival cell proliferation induced by use of a sonic toothbrush with warmed silicone rubber bristles.

BACKGROUND: Toothbrushing promotes gingival cell proliferation, which may occur as the result of the physical stimulation of the gingiva. The present study evaluated the effects of temperature and silicone rubber bristles of a sonic toothbrush on gingival cell proliferation in dogs. METHODS: During the 5-week experimental period, one quadrant in each of eight dogs received a different toothbrushing regimen: a manual toothbrush or a sonic toothbrush with 1) nylon, 2) silicone rubber, or 3) warmed silicone rubber bristles. The proliferative activity of gingival cells was evaluated based on expression of proliferating cell nuclear antigen (PCNA). RESULTS: Use of the sonic toothbrushes produced a higher density of PCNA-positive and total fibroblasts than did use of a manual toothbrush. The warm silicone rubber bristles resulted in a higher density of PCNA-positive fibroblasts compared with the cooler silicone rubber bristle. The number of PCNA-positive basal cells in the junctional epithelium also increased following electric toothbrushing with warmed silicone rubber bristles. CONCLUSIONS: The sonic toothbrush with silicone rubber bristles induced gingival fibroblast proliferation to a greater degree than a manual toothbrush. Warming the silicone rubber bristles increased their stimulatory effects on the proliferative activity of gingival cells.

Analysis of Variance↗
PubMed1992

Ruptured gel-filled silicone breast implants: sonographic findings in 19 cases.

OBJECTIVE: The purpose of this study was to describe and illustrate the sonographic appearances of 19 ruptured silicone gel breast implants. MATERIALS AND METHODS: We retrospectively reviewed the sonograms of 16 patients with 19 ruptured silicone gel implants from two institutions. The ruptured implant was confirmed at surgery in 17 cases and by mammographic and clinical findings of a ruptured implant combined with biopsy findings of a silicone granuloma in two cases. Breast sonograms were available for review in all patients. The clinical presentation of each patient was recorded. The sonograms and mammograms were reviewed, and the findings were correlated with the surgical findings. In 16 of the 19 ruptured implants, mammographic findings suggested rupture, including lobulation of the contour of the implant and/or silicone extrusion into the breast parenchyma or axilla. In two ruptured implants, mammographic findings were normal, and in one case, no mammogram was available. In those three patients, palpable masses and clinical findings were suggestive of rupture. RESULTS: Sonography showed a unique echogenic appearance called echo-dense noise, in 17 of the 19 ruptured implants; in 10 of the 17, sonograms showed hypoechoic masses of extruded silicone also. In two ruptured implants, sonograms showed only the hypoechoic masses of extruded silicone gel. CONCLUSION: Our experience suggests that echogenic noise is a unique sonographic sign of ruptured silicone gel breast implants and may be caused by phase aberration related to the speed of sound being slower in silicone than in soft tissue.

Equipment Failure↗
PubMed2000

Prevalence of rupture of silicone gel breast implants revealed on MR imaging in a population of women in Birmingham, Alabama.

OBJECTIVE: Silicone gel breast implants have been reported to rupture, but the prevalence of implant rupture in an unreferred population of women is not known. The objective of this study was to assess the prevalence of implant rupture and the presence of extracapsular silicone gel in an unreferred population of women without regard to the absence or presence of any local or systemic symptoms. SUBJECTS AND METHODS: Women identified as part of a National Cancer Institute cohort study on breast implants, living in the Birmingham, AL, area were invited to undergo MR imaging of their current silicone gel breast implants at the Kirklin Clinic at the University of Alabama at Birmingham. Three radiologists independently examined and rated all MR images for signs of implant rupture and extracapsular silicone. RESULTS: A total of 344 women with silicone gel breast implants underwent MR imaging. Breast implant rupture was reported by at least two of three radiologists for 378 (55.0%) of the 687 implants in this study. Another 50 implants (7.2%) were rated as indeterminate (suspicious) for rupture. A majority of women in this study, 265 (77.0%) of 344, had at least one breast implant that was rated as ruptured or indeterminate. Radiologists also agreed that silicone gel could be seen outside the fibrous capsule that forms around the implant in 85 (12.4%) of the 687 implants affecting 73 women (21.2%). Factors that affected implant rupture were implant age and location (submuscular or subglandular). The median implant age at rupture was estimated to be 10.8 years with a 95% confidence interval of 8.4-13.9 years. CONCLUSION: The prevalence of silent or occult silicone gel breast implant rupture is higher than was previously suspected. Most women in this study had MR imaging evidence of at least one ruptured silicone gel breast implant.

Adult↗
PubMed1999

Changes in refraction and axial length according to the viscosity of intraocular silicone oil.

We performed this study to evaluate the changes in refraction and axial length induced by intraocular silicone oil, and to compare with various clinical parameters between 1,000 and 5,000 cSt silicone oil. The refraction length was measured with an autorefractometer, and the axial length was measured with A-scan ultrasonography. These measurements were performed before and after removal of the silicone oil, using a clear cornea technique in which the silicone oil was injected in combination with pars plana vitrectomy. The mean age of the 25 patients was 38.73 years. On average the intraocular retention after the removal of the silicone oil lasted 5.13 months, and the follow-up time following silicone oil removal was 4.37 months. The changes in refraction and axial length were 6.32 diopters and 12.02 mm, respectively. Eyes injected with 5,000 cSt (11 eyes) tended to have higher changes in the refraction (5.84 vs 6.86 diopters) and axial length (11.70 vs 12.34 mm) than did eyes injected with 1,000 cSt silicone oil (14 eyes). Statistically significant differences were shown for the changes in refraction (p = 0.010) and intraocular pressure (0.63 vs 2.00 mmHg; p = 0.006), whereas but not for the changes in axial length (p = 0.306) and visual acuity (14/100 vs 15/100; p = 0.125). Intraocular silicone oil induced changes in refraction and axial length, and these changes seemed to vary with different viscosities.

Adolescent↗