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Lisbet Rosenkrantz Hölmich - One of the best experts on this subject based on the ideXlab platform.

  • the diagnosis of Silicone Breast Implant rupture clinical findings compared with findings at magnetic resonance imaging
    Annals of Plastic Surgery, 2005
    Co-Authors: Lisbet Rosenkrantz Hölmich, Jon P. Fryzek, Kim Kjøller, Vibeke Breiting, Anna Jorgensen, Christen Krag, Joseph K. Mclaughlin
    Abstract:

    Abstract:The objective was to evaluate the usefulness of clinical examination in the evaluation of Breast-Implant integrity, using the diagnosis at magnetic resonance imaging (MRI) as the “gold standard.” Fifty-five women with 109 Implants underwent a Breast examination either just before or shortly

  • Untreated Silicone Breast Implant rupture.
    Plastic and reconstructive surgery, 2004
    Co-Authors: Lisbet Rosenkrantz Hölmich, Ilse Vejborg, Carsten Conrad, Susanne Sletting, Mimi Høier-madsen, Jon P. Fryzek, Joseph K. Mclaughlin, Kim Kjøller, Allan Wiik, Søren Friis
    Abstract:

    Implant rupture is a well-known complication of Breast Implant surgery that can pass unnoticed by both patient and physician. To date, no prospective study has addressed the possible health implications of Silicone Breast Implant rupture. The aim of the present study was to evaluate whether untreate

  • incidence of Silicone Breast Implant rupture
    Archives of Surgery, 2003
    Co-Authors: Lisbet Rosenkrantz Hölmich, Ilse Vejborg, Carsten Conrad, Susanne Sletting, Jon P. Fryzek, Joseph K. Mclaughlin, Kim Kjøller, Søren Friis, Jorgen H Olsen
    Abstract:

    Hypothesis The incidence of Silicone Breast Implant rupture varies with Implantation time and type of Implant. Objective To measure the incidence of Implant rupture by repeated magnetic resonance imaging (MRI) among women with Silicone Breast Implants. Design, Setting, and Participants In 1999, 271 women who had received Breast Implants at least 3 years before, and who were randomly chosen from a larger cohort of women with cosmetic Breast Implants, underwent a baseline MRI. A second MRI was performed in 2001; 317 Silicone Implants (in 186 women) that were intact at the baseline MRI (n = 280) or were intact at baseline but removed before the second MRI (n = 37) were included in the rupture incidence analyses. Main Outcome Measures Implants were diagnosed with definite or possible rupture. Crude and Implant age–adjusted incidence rates were calculated, and Implant survival was estimated based on the observed rupture rates. Results We found 33 definite ruptures (10%) and 23 possible ruptures (7%) during the 2-year period. The overall rupture incidence rate for definite ruptures was 5.3 ruptures/100 Implants per year (95% confidence interval, 4.0-7.0). The rupture rate increased significantly with increasing Implant age. Double-lumen Implants were associated with substantially lower rupture risk than single-lumen Implants. For modern Implants intact 3 years after Implantation, we estimated rupture-free survival of 98% at 5 years and 83% to 85% at 10 years. Conclusions The risk of Implant rupture increases with Implant age. A minimum of 15% of modern Implants can be expected to rupture between the third and tenth year after Implantation.

  • prevalence of Silicone Breast Implant rupture among danish women
    Plastic and Reconstructive Surgery, 2001
    Co-Authors: Lisbet Rosenkrantz Hölmich, Ilse Vejborg, Carsten Conrad, Susanne Sletting, Jon P. Fryzek, Joseph K. Mclaughlin, Kim Kjøller, Vibeke Breiting, Anna Jorgensen, Jorgen H Olsen
    Abstract:

    The durability of Silicone gel-filled Breast Implants is of concern, but there are few epidemiological studies on this issue. To date, most of the relevant findings are derived from studies of explantation, which suffer from bias by including women with symptoms or concerns about their Implants. As part of a long-term magnetic resonance imaging study of the incidence of rupture, this study involved 271 women with 533 cosmetic Breast Implants who were randomly selected from among women who underwent cosmetic Breast Implantation from 1973 through 1997 at one public and three private plastic-surgery clinics in Denmark. The prevalence of rupture was determined from the first magnetic resonance screening. The images were evaluated by four independent readers, using a standardized, validated form. The outcomes under study were rupture, possible rupture, and intact Implant. Ruptures were categorized as intracapsular or extracapsular. Overall, 26 percent of Implants in 36 percent of the women examined were found to be ruptured, and an additional 6 percent were possibly ruptured. Of the ruptured Implants, 22 percent were extracapsular. In multiple regression analyses, age of Implant was significantly associated with rupture among second- and third-generation Implants, with a 12-fold increased prevalence odds ratio for rupture of Implants that were between 16 and 20 years of age, compared with Implants between 3 and 5 years of age. Surgitek Implants (Medical Engineering Corporation, Racine, Wis.) had a significantly increased prevalence odds ratio of 2.6 for rupture, compared with the reference Implants. No significant association was found with the position (subglandular or submuscular) or the type of Implant (single- or double-lumen). Extracapsular ruptures were significantly associated with a history of closed capsulotomy (p = 0.001). In the future, the authors plan to examine the women in their cohort with a second magnetic resonance imaging scan to establish the incidence of rupture, a parameter unknown to date in the literature, and to further characterize those factors associated with the actual risk of rupture.

Noel R. Rose - One of the best experts on this subject based on the ideXlab platform.

  • Silicone gel and octamethylcyclotetrasiloxane [D4] enhances antibody production to bovine serum albumin in mice
    Journal of biomedical materials research, 1996
    Co-Authors: J. J. Nicholson, Susan L. Hill, Carmelita G. Frondoza, Noel R. Rose
    Abstract:

    Earlier studies, in the rat, have shown that Silicone gel acts as a potent adjuvant for antibody production against bovine serum albumin (BSA). The purpose of the present study is to determine whether components of the Silicone Breast Implant (Silicone oil, Silicone gel, and octamethylcyclotetrasiloxane [D4]) potentiate the antibody response to BSA in mice. Groups of ten A/J mice received a single subcutaneous injection of 0.1 ml of BSA emulsified with the following: a) Silicone preparations, b) incomplete Freund’s adjuvant, or c) saline alone. Antibodies to BSA were measured using an enzyme-linked immunosorbant assay. The results indicate that both D4 and the Silicone gel potentiate antibody production to BSA in mice. Known adjuvants have been shown to induce autoimmune syndromes in animal models. Whether Silicones can act in a similar mechanism is still unclear.

  • Silicone gel and octamethylcyclotetrasiloxane potentiate antibody production to bovine serum albumin in mice.
    Current topics in microbiology and immunology, 1996
    Co-Authors: J. J. Nicholson, Carmelita G. Frondoza, G. E. Wong, Noel R. Rose
    Abstract:

    Earlier studies, in the rat, have shown that Silicone gel acts as a potent adjuvant for antibody production against bovine serum albumin (BSA). The purpose of the present study is to determine whether components of the Silicone Breast Implant (Silicone oil, Silicone gel, and octamethylcyclotetrasiloxane [D4]) potentiate the antibody response to BSA in mice. Groups of ten A/J mice received a single subcutaneous injection of 0.1 ml of BSA emulsified with the following: a) Silicone preparations, b) incomplete Freund's adjuvant, or c) saline alone. Antibodies to BSA were measured using an enzyme-linked immunosorbant assay. The results indicate that both D4 and the Silicone gel potentiate antibody production to BSA in mice. Known adjuvants have been shown to induce autoimmune syndromes in animal models. Whether Silicones can act in a similar mechanism is still unclear.

D P Gorczyca - One of the best experts on this subject based on the ideXlab platform.

  • The Diagnosis of Silicone Breast Implant Rupture
    Plastic and Reconstructive Surgery, 2007
    Co-Authors: D P Gorczyca, Stephanie M Gorczyca, Kathryn L Gorczyca
    Abstract:

    Magnetic resonance imaging of the Breast in the diagnosis of Silicone Breast Implant rupture is widely accepted to be the imaging study of choice for most women. Magnetic resonance imaging in the detection of Silicone Implant failure has been shown to have the highest sensitivity and specificity and has the ability to image the entire Implant without the use of ionizing radiation. Unfortunately, some women are unable to have a magnetic resonance imaging examination of the Breast because of contraindications such as cardiac pacemakers, aneurysm clips, and claustrophobia. Therefore, mammography, ultrasonography, and computed tomography will have roles in the diagnosis of Silicone Breast Implant ruptures. This article illustrates the spectrum of imaging appearances of normal Silicone gel Implants and the appearances of Silicone Breast Implant ruptures.

  • comparative Silicone Breast Implant evaluation using mammography sonography and magnetic resonance imaging experience with 59 Implants
    Plastic and Reconstructive Surgery, 1994
    Co-Authors: Christina Y Ahn, D P Gorczyca, Nanette Debruhl, William W Shaw, Lawrence W Bassett
    Abstract:

    With the current controversy regarding the safety of Silicone Implants, the detection and evaluation of Implant rupture are causing concern for both plastic surgeons and patients. Our study obtained comparative value analysis of mammography, sonography, and magnetic resonance imaging (MRI) in the detection of Silicone Implant rupture. Twenty-nine symptomatic patients (total of 59 Silicone Implants) were entered into the study. Intraoperative findings revealed 21 ruptured Implants (36 percent). During physical examination, a positive "squeeze test" was highly suggestive of Implant rupture. Mammograms were obtained of 51 Implants (sensitivity 11 percent, specificity 89 percent). Sonography was performed on 57 Implants (sensitivity 70 percent, specificity 92 percent). MRI was performed on 55 Implants (sensitivity 81 percent, specificity 92 percent). Sonographically, Implant rupture is demonstrated by the "stepladder sign." Double-lumen Implants may appear as false-positive results for rupture on sonography. On MRI, the "linguine sign" represents disrupted fragments of a ruptured Implant. The most reliable imaging modality for Implant rupture detection is MRI, followed by sonogram. Mammogram is the least reliable. Our study supports the clinical indication and diagnostic value of sonogram and MRI in the evaluation of symptomatic Breast Implant patients.

  • Silicone Breast Implant rupture comparison between three point dixon and fast spin echo mr imaging
    American Journal of Roentgenology, 1994
    Co-Authors: D P Gorczyca, E Schneider, Nanette Debruhl, T K F Foo, Christina Y Ahn, James Sayre, William W Shaw, Lawrence W Bassett
    Abstract:

    This study was designed to compare the three-point Dixon technique with our present MR protocol incorporating T2-weighted fast spin echo and fast spin echo with water suppression to detect ruptured Silicone Breast Implants.Eighty-two symptomatic women with Silicone Breast Implants were examined with both the three-point Dixon technique and fast spin-echo MR sequences. Of these patients, 41 had surgery to remove their Implants. Four radiologists reviewed the images from only those patients who had surgery and graded each for rupture by using a scale of 1-5. Receiver-operating-characteristic analysis was performed.Of 81 Implants removed, 18 were ruptured. Silicone Implant ruptures were identified more frequently on the fast spin-echo sequence than on the three-point Dixon sequence, with areas under the ROC curves of .95 and .84, respectively. Although the difference was not statistically significant, the sensitivity for detecting Silicone Implant rupture was 89% for the fast spin-echo sequence and 61% for t...

Jorgen H Olsen - One of the best experts on this subject based on the ideXlab platform.

  • incidence of Silicone Breast Implant rupture
    Archives of Surgery, 2003
    Co-Authors: Lisbet Rosenkrantz Hölmich, Ilse Vejborg, Carsten Conrad, Susanne Sletting, Jon P. Fryzek, Joseph K. Mclaughlin, Kim Kjøller, Søren Friis, Jorgen H Olsen
    Abstract:

    Hypothesis The incidence of Silicone Breast Implant rupture varies with Implantation time and type of Implant. Objective To measure the incidence of Implant rupture by repeated magnetic resonance imaging (MRI) among women with Silicone Breast Implants. Design, Setting, and Participants In 1999, 271 women who had received Breast Implants at least 3 years before, and who were randomly chosen from a larger cohort of women with cosmetic Breast Implants, underwent a baseline MRI. A second MRI was performed in 2001; 317 Silicone Implants (in 186 women) that were intact at the baseline MRI (n = 280) or were intact at baseline but removed before the second MRI (n = 37) were included in the rupture incidence analyses. Main Outcome Measures Implants were diagnosed with definite or possible rupture. Crude and Implant age–adjusted incidence rates were calculated, and Implant survival was estimated based on the observed rupture rates. Results We found 33 definite ruptures (10%) and 23 possible ruptures (7%) during the 2-year period. The overall rupture incidence rate for definite ruptures was 5.3 ruptures/100 Implants per year (95% confidence interval, 4.0-7.0). The rupture rate increased significantly with increasing Implant age. Double-lumen Implants were associated with substantially lower rupture risk than single-lumen Implants. For modern Implants intact 3 years after Implantation, we estimated rupture-free survival of 98% at 5 years and 83% to 85% at 10 years. Conclusions The risk of Implant rupture increases with Implant age. A minimum of 15% of modern Implants can be expected to rupture between the third and tenth year after Implantation.

  • prevalence of Silicone Breast Implant rupture among danish women
    Plastic and Reconstructive Surgery, 2001
    Co-Authors: Lisbet Rosenkrantz Hölmich, Ilse Vejborg, Carsten Conrad, Susanne Sletting, Jon P. Fryzek, Joseph K. Mclaughlin, Kim Kjøller, Vibeke Breiting, Anna Jorgensen, Jorgen H Olsen
    Abstract:

    The durability of Silicone gel-filled Breast Implants is of concern, but there are few epidemiological studies on this issue. To date, most of the relevant findings are derived from studies of explantation, which suffer from bias by including women with symptoms or concerns about their Implants. As part of a long-term magnetic resonance imaging study of the incidence of rupture, this study involved 271 women with 533 cosmetic Breast Implants who were randomly selected from among women who underwent cosmetic Breast Implantation from 1973 through 1997 at one public and three private plastic-surgery clinics in Denmark. The prevalence of rupture was determined from the first magnetic resonance screening. The images were evaluated by four independent readers, using a standardized, validated form. The outcomes under study were rupture, possible rupture, and intact Implant. Ruptures were categorized as intracapsular or extracapsular. Overall, 26 percent of Implants in 36 percent of the women examined were found to be ruptured, and an additional 6 percent were possibly ruptured. Of the ruptured Implants, 22 percent were extracapsular. In multiple regression analyses, age of Implant was significantly associated with rupture among second- and third-generation Implants, with a 12-fold increased prevalence odds ratio for rupture of Implants that were between 16 and 20 years of age, compared with Implants between 3 and 5 years of age. Surgitek Implants (Medical Engineering Corporation, Racine, Wis.) had a significantly increased prevalence odds ratio of 2.6 for rupture, compared with the reference Implants. No significant association was found with the position (subglandular or submuscular) or the type of Implant (single- or double-lumen). Extracapsular ruptures were significantly associated with a history of closed capsulotomy (p = 0.001). In the future, the authors plan to examine the women in their cohort with a second magnetic resonance imaging scan to establish the incidence of rupture, a parameter unknown to date in the literature, and to further characterize those factors associated with the actual risk of rupture.

Michael V Stevens - One of the best experts on this subject based on the ideXlab platform.

  • lymphocyte response to silica among offspring of Silicone Breast Implant recipients
    Immunobiology, 1997
    Co-Authors: David L Smalley, Jeremiah Levine, Douglas R Shanklin, Mary F Hall, Michael V Stevens
    Abstract:

    Abstract The current study evaluated immune response to silicon dioxide in children born to women with Silicone Breast Implants. In part one of the study, the T lymphocytes of 21 of 24 such children were significantly stimulated by silicon dioxide (silica). Part two consisted of eleven children, four born preImplantation and seven born postImplantation. None of the preImplant offspring showed T cell responses to silica; five of the seven postImplant children were positive for T cell memory for silica. Part three was a blinded study based on statistically significant differences in T cell stimulation with silicon dioxide between postImplant children and controls. These findings indicate a common immune reaction, that of T cell memory, occurs in mothers and their children born after exposure to Silicone mammary Implants placed prior to pregnancy. Since not all such children were Breast fed the result favors transplacental passage of immunogens such as Silicone oligomers or through maternofetal cellular traffic.

  • t cell mediated immune response to silica in Silicone Breast Implant patients
    Current Topics in Microbiology and Immunology, 1996
    Co-Authors: Douglas R Shanklin, David L Smalley, Mary F Hall, Michael V Stevens
    Abstract:

    During the last 25 or more years, Silicone has been used as a filler in Breast Implants and is the major constituent of the outer elastomer. It was once thought to be biologically and metabolically inert; however, studies strongly suggested that Silicone can be metabolized to lower molecular weight structures and that it deteriorates to silica [1–3]. Biologically, Silicone has been shown to produce reactions by macrophages in vivo to promote the release of interleukin 1 [4], and to be antigenic with the production of antibodies to Silicone [5] and to the native proteins that adhere to the Silicone [6]. Recently, it has been shown that Breast Implant patients can develop T cell response to silicon dioxide [7,8], and to Silicone [9]. In the studies with silicon dioxide, the primary form of silica used was a crystalline form, yet the form used in the outer elastomer was an amorphous silica. The present study undertook to further define the cell-mediated immune response to silica by evaluating the potential of blocking the reactions with an antibody directed against interleukin 2 (IL2). In addition, various forms of silica were tested in parallel with the crystalline form to determine if the silica form varied the immune recognition, and two elements not involved with Silicone Breast Implants were tested to evaluate the specificity of T cell reactions in Implant recipients.