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Coalition of Silicone Survivors
Prof. Dr. Bettina Pfleiderer
COSSkids is onderdeel van Coalition of Silicone Survivors - Boulder Collorado USA
Oktober 2016
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Onderzoek aan het Institüt Klinische Radiologie,
Universiteit Münster
geboren  20. September 1961 in Geislingen aan de Steige, Duitschland
Akademische Graad

Diploma der Chemie, Johannes-Gutenberg-Universituit Mainz

Promotie aan het Instituut voor Organische Chemie aan de Eberhard-Karls-Universität Tübingen

Habilitatie aan de medichinische Fakulteit aqan de Westfalische Wilhelms-Universiteit Münster

2. Staatsexamen in Humanmedizin, Münster

Vak historie:
Wetenschappelijke Mederwerker aan het Instituut voor Organische Chemie aan de Eberhard-Karls-Universität Tübingen

Onderzoek periode aan het NMR Center van het Massachusetts General Hospital van de Harvard Medical School te Boston USA

Research Associate aan het MGH-NMR Center

vanaf  1997:
eerste Privaatdosent, daarna Professor aan het Instituut voor Klinische Radiologie aan de Westfalische Wilhelms-Universiteit Münster, Leider van de Arbeidsgroep Cognition & Gender
MRI and MR spectroscopy after silicone breast implants in the female breast.

B. Pfleiderer; W. Heindel
Rofo 173 (2001)
Institüt für Klinische Radiologie, Universität Münster. pfleide@uni-muenster.de


This paper reviews the evaluation of the breast of women by MR-techniques after implantation with silicon gel protheses. The main topics are the diagnosis of implant defects such as extensive "gel bleed" and intra- and extracapsular ruptures. Moreover, the MR-detection of siliconomas (encapsulated silicone) and differentiation from malignomas as well as MR-features of chronic foreign body reactions are presented.

"Gel bleed" is difficult to diagnose unambiguously by MRI alone. The "linguini" sign is the only reliable mans to diagnose intracapsular ruptures. The presence of silicone outside the implant capsule indicates extracapsular rupture. The MR-spectroscopic detection of silicone in the liver suggests after short implantation times and a normal MR scan the diagnosis "gel bleed", and after longer implantation times of more than 10 years and missing "linguini" sign the diagnosis of ruptures due to a dissolved shell of the implant.

MRI, in comparison to other imaging modalities, has the highest specificity and sensitivity in the diagnosis of implant defects. Due to its high costs, however, MR is not suitable as a screening tool and should only be used in cases of sonographic suspected rupture or after radical mastectomy. In these cases MRI is the method of choice.

Comparative examination of complaints of breast-cancer with and without silicone implants.

Imke Berner; Markus Gaubitz; Christian Jackisch; Bettina Pfleiderer
Eur. J. Obstet. Gynecol. Reprod. Biol. 102, 61 (2002a)
Institute for Clinical Radiology, University of Münster, Albert-Schweitzer-Strasse 33, D-48149 Münster, Germany


OBJECTIVE: To measure the relationship between silicone breast implants and various symptoms using a control group.

STUDY DESIGN: A matched-pair-analysis of 96 women with breast-cancer (32 with silicone implants (K I); 64 without implants (K II)) was performed with help of a standardized questionnaire in respect to 50 single criteria. The condition of implants was monitored by MR-imaging.

RESULTS: Athralgias and myalgias were not significantly more frequent in K I. Only six symptoms were reported significantly more often in patients with implants. Positive correlation with implant rupture was given only for the numb feeling/tingling sensation in extremities (P=0.02). There was no correlation between silicone implants and the symptoms of the "chronic-fatigue syndrome" nor any other described silicone-induced disease.

CONCLUSIONS: According to our analysis many of the symptoms examined here are present in middle-aged women regardless of silicone implants and underlying disease.

Silicone breast implants; corrolation between implant ruptures, magnetic resonance spectroscopically estimated silicone presence in the liver, antibody status and clinical symptoms.

M. Gaubitz; C. Jackisch; W. Domschke; W. Heindel; B. Pfleiderer
Rheumatology (Oxford) 41 (2002b)
Department of Medicine B, University of Münster, Münster, Germany


OBJECTIVE: To determine the impact of implant integrity on clinical symptoms and antibody status in women with silicone breast implants (SBIs). METHODS: Ninety consecutive women were examined by means of magnetic resonance imaging (MRI) to assess the integrity of their silicone breast implants. The presence of silicone in the liver was estimated by (1)H localized stimulated echo acquisition mode (STEAM) magnetic resonance spectroscopy (MRS). Results were correlated with patients' complaints, as evaluated by a standardized questionnaire, physical examination by a rheumatologist and antibody screening.

RESULTS: Breast MRI revealed defects in 24 patients (26.6%); in 13 (54.2%) of these women, silicone was detected in the liver by MRS. Of the 66 patients with MRI-estimated intact implants, 15 (22.7%) had apparent silicone in their liver, arguing for gel bleeding. Clinically, two patients had had rheumatoid arthritis before SBIs, whereas the other patients revealed no typical symptoms of arthritis or connective tissue disease (CTD). The patients with MRS evidence of silicone in the liver had no statistically significant differences in their complaints with the exception of the most frequent symptom, tingling/numbness of the fingers (82.1 vs 51.6%, P=0.006). A positive pattern of antinuclear antibodies (ANA) was obtained in 13 of the 28 MRS-positive patients (46.4%) and in 15 of the 62 MRS-negative patients (24.2%, P=0.033). However, in only one of these 28 ANA-positive patients was a specific weak antibody titre against SS-A detected by ELISA.

CONCLUSION: Implant integrity has no major impact on rheumatic symptoms of women with SBIs. This finding supports the standpoint that silicone does not cause either a specific CTD or any other distinct disease entity. However, the moderately increased incidences of ANA-positivity and neuropathy-associated symptoms require explanation.

Determination of siloxanes, silicon, and platinum in tissues of woman with silicone-gel filled implants.

Daniela Flassbeck; Bettina Pfleiderer; Patrick Klemens; Klaus G. Heumann; Elke Eltze; Alfred V. Hirner
Anal Bional Chem 375, 356 (2003a)
Institute of Environmental Analytical Chemistry, University of Essen , Germany


Silicone [poly(dimethylsiloxane)] gel used in breast implants has been known to migrate through intact silicone elastomer shells, resulting in the clinically observable "gel bleed" on the implant surface. Although silicon concentrations in capsular tissues of women with silicone prostheses have been measured with element-specific silicon analyses, no silicone-specific investigation of these tissues has been performed as yet.

A combination of element-specific inductively coupled plasma high-resolution isotope dilution mass spectrometry (ICP-HR-IDMS) and species-specific gas chromatography coupled mass spectrometry (GC-MS) was used to analyze silicon, platinum, and siloxanes in prosthesis capsule, muscle, and fat tissues of women (n=3) who had silicone gel-filled breast implants and in breast tissue of non-augmented women (n=3) as controls.In all tissues of augmented women, siloxanes, in particular octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5), and dodecamethylcyclohexasiloxane (D6) were identified.

Depending on the siloxane species and type of tissue analyzed, siloxane levels in the range of about 10-1,400 ng g(-1) were detected; total silicon was found in all tissue samples in the range of about 8,900-85,000 ng g(-1). Higher platinum levels ranging from 25-90 ng g(-1 )were detected in fibrin layer and fat tissue of two patients with prostheses.
No siloxanes were detected in control breast tissue samples. This investigation of human tissues by a combination of element-specific and species-specific analytical techniques clearly demonstrates for the first time that platinum and siloxanes leak from prostheses and accumulate in their surrounding tissues

Liquid and solid-state high-resolution NMR methods for the investigation of aging processes of silicone breast implants.

Anja Britta Birkefeld; Rüdiger Bertermann; Hellmut Eckert; Bettina Pfleiderer
Biomaterials 24, 35 (2003b)
Department of Clinical Radiology, University of Münster, Albert-Schweitzer-Strasse 33, D-48149 Münster, Germany


To investigate aging processes of silicone gel breast implants, which may include migration of free unreacted material from the gel and rubber to local (e.g. connective tissue capsule) or distant sites in the body, chemical alteration of the polymer and infiltration of body compounds, various approaches of multinuclear nuclear magnetic resonance (NMR) experiments (29Si, 13C, 1H) were evaluated.
While 29Si, 13C, and 1H solid-state magic angle spinning (MAS) NMR techniques performed on virgin and explanted envelopes of silicone prostheses provided only limited information, high-resolution liquid-state NMR techniques of CDCl(3) extracts were highly sensitive analytical tools for the detection of aging related changes in the materials.

Using 2D 1H, 1H correlation spectroscopy (COSY) and 29Si, 1H heteronuclear multiple bond coherence (HMBC) experiments with gradient selection, it was possible to detect lipids (mainly phospholipids) as well as silicone oligomer species in explanted envelopes and gels.
Silicone oligomers were also found in connective tissue capsules, indicating that cyclic polysiloxanes can migrate from intact implants to adjacent and distant sites. Furthermore, lipids can permeate the implant and modify its chemical composition.

A study of the aging of silicone breast implants using 29Si, 1H relaxation and DSC measurments.

Anja Britta Birkefeld; Hellmut Eckert; Bettina Pfleiderer
Biomaterials 25, 4404 (2004)
Institute of Physical Chemistry, University of Münster, Schlossplatz 4/7, D-48149 Muenster, Germany


In this study 26 previously implanted silicone breast implants from the same manufacturer (Dow Corning) were investigated with two different analytical methods to characterize potential aging processes such as migration of monomer material from the gel and shell to local and distant sites, chemical alterations of the polymer, and infiltration of body compounds such as lipids.
(1)H and (29)Si NMR relaxation measurements (spin-lattice, T1, and spin-spin, T2, relaxation times) were used to study the molecular dynamics of polysiloxane chains, both in gels and in shells. In addition, changes in physical properties were monitored by differential scanning calorimetry (DSC).
The results of these measurements indicate that NMR relaxation times are influenced by implant generation, implantation time, shell texture and implant status. (1)H T2 values of shells and gels show a tendency to increase with increasing implantation time, indicating higher mobility and possible disintegration of the polymer network of older implants. Furthermore, the data suggest that aging also involves the migration of low cyclic molecular weight (LMW) silicone and linear chain polymer material from the gels into the shells.

The high "bleeding" rate of second-generation (G2) implants (implantation period around 1973-1985), exhibiting thin shells is reflected in reduced relaxation times of these devices, most likely due to a loss of low molecular weight fractions from the gels. Moreover, "gel bleeding" also influences the melting behavior observed in DSC studies. Increased shell rigidity (high Tm and Tg) tends to be correlated with longer (29)Si relaxation times of the corresponding gels, suggesting a reduced transfer of LMW silicones and linear chain polymer from the gel to the shell and to the outside. Remarkably, textured implants seem to be less susceptible to degradation processes than implants with thin shells.
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