Thanks Toxic Discovery-BI Study& Article Reseach Finds-May 2005

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Subj: BI Study and Article Reseach Finds - May 2005

Date: 5/2/2005 5:55:39 PM Eastern Standard Time

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BREAST IMPLANT RESEARCH - MAY 2005

Pathology of Lymph Nodes From Patients With Breast Implants: A Histologic and Spectroscopic Evaluation.

American Journal of Surgical Pathology. 29(4):506-511, April 2005.

Katzin, E MD, PhD *; Centeno, A PhD +; Feng, Lu-MD ++; Kiley, Maureen MS +; Mullick, Florabel G MD +

Abstract:

There are only a few published reports describing the pathology of regional lymph nodes from patients with silicone breast implants. Systematic analytical chemical verification of foreign material has not previously been reported. In this study, biopsies of regional lymph nodes from 96 patients with breast implants were studied using conventional histology as well as laser-Raman microprobe spectroscopy and Fourier transform infrared microspectroscopy. Lymph nodes from 12 patients without implants served as negative controls. Foamy macrophages, ranging from rare scattered cells to confluent sheets, were observed in sections of lymph nodes from 91 patients with implants and only rare foamy macrophages were observed in sections from 4 patients without implants. Refractile material consistent with silicone was observed in sections from 86 patients with implants and in no sections from patients without implants. Fragments of foreign material consistent with polyurethane were observed in sections from 16 patients with implants and in no sections from patients without implants. Using spectroscopy, the presence of silicone was confirmed in 71 patients with implants, and the presence of polyurethane was confirmed in 2 patients with implants. Spectroscopy was negative for silicone and polyurethane in all patients without implants. In summary, regional lymph nodes from patients with breast implants often have histologic evidence of silicone migration. Characteristic histologic findings include foamy macrophages and refractile droplets of clear material. Polygonal fragments of polyurethane were observed in lymph nodes from a number of patients. This finding has not been previously reported. The presence of silicone and polyurethane was confirmed using confocal laser-Raman microprobe and Fourier transform infrared microspectroscopy. Other than two prior case reports, this is the first confirmatory evidence of silicone migration to lymph nodes in patients with breast implants and this is the first confirmatory report of polyurethane migration to lymph nodes. © 2005 Lippincott & Wilkins, Inc. ==============================================

Cardiac Imaging Impaired by a Silicone Breast Implant.

Clinical Nuclear Medicine. 30(4):262-264, April 2005.

Meine, Trip J. MD *+; Patel, Manesh R. MD *+; Heitner, MD +; Fortin, Terry A. MD +; Pagnanelli, A. BSRT®(N), CNMT ++; Gehrig, R. MD +; Kim, MD +; Borges-Neto, Salvador MD +++

Abstract:

The authors report a case of a left-sided silicone breast implant interfering with nuclear imaging of the myocardium. Cardiac SPECT imaging of a woman documented widespread infarct in the anterolateral, inferior, and posterolateral walls, as well as mixed ischemia/infarct in the anterior wall. Subsequent cardiac MRI revealed just anterolateral and inferolateral infarct. The anterior wall was completely viable. Also apparent on the MR images was a left breast implant overlying the anterior myocardial wall. This case of a left-sided silicone breast implant interfering with nuclear imaging of the myocardium highlights the importance of understanding the potential interference from silicone breast implants.

© 2005 Lippincott & Wilkins, Inc.

=============REPORTS OF "DISSOLVING" SHELLS OF SILICONE GEL-FILLED BREAST IMPLANTS.

Lane, Tom Ph.D.; Curtis, Jim

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SAMPLE:

Outline

STUDIES AND FINDINGS

OPPORTUNITIES TO EDUCATE

Breast Implant Basics

Silicone-Filled Breast Implants Specifics

Resources for Information

CONCLUSION

BOX 1

REFERENCE

It is a matter of time before the next generation of silicone-gel filled breast implants will become an available option for all patients seeking breast augmentation. The confusion, anxieties, and fears about silicone and silicone breast implants that emerged following restricted use by the federal Food and Drug Administration (FDA) in 1992 still remain for many. Will we, as healthcare professionals, be prepared to address these questions and concerns?

The FDA has indicated when silicone gel-filled breast implants again become an available choice for breast augmentation, it will require that patients be more extensively educated and informed about the risks and benefits of silicone-gel filled breast implants and the results of clinical studies that have been conducted.

Clinical studies to determine the effects of silicone-filled breast implants on human health and extensive laboratory testing of silicone have been conducted over the past 12 years. As patient advocates, plastic surgery nurses must be familiar with the results of these studies and findings and be able to provide reliable resources for this information.

STUDIES AND FINDINGS

In 1997, the U.S. House of Representatives requested the federal Department of Health and Human Services to sponsor an extensive study of silicone breast implants. This comprehensive evaluation would include:

* a scientific look at the components of implants, including an analysis of silicone chemistry, toxicology, and immunology

* a history of breast implants and a description of their modern “generations,†or the many forms they have taken over time ... Management Department: The Return of Silicone Gel-Filled Breast Implants Will You Be Ready?

Joanne Gladfelter RN, CPSN

$2.95 Plastic Surgical Nursing

January/March 2005

Volume 25 Number 1

Pages 44 - 46

PDF Version Available!

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http://www.wlf.org/upload/040805RS.pdf

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http://www.wlf.org/upload/IMPLANTS.pdf

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Plastic and Reconstructive Surgery - Fulltext: Volume 102(7 ... ... An Analysis of Silicone Gel-Filled Breast Implants: Diagnosis and Failure Rates ... Copyright © 2005, American Society of Plastic Surgeons. ...

www.plasreconsurg.com/pt/re/ prs/fulltext.00006534-199812000-00005.htm - Similar pages

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ls of Plastic Surgery - Fulltext: Volume 54(4) April 2005 p ... ... April 2005, 54:4 > Surgical Intervention and Capsular. ... silicone breast implants: report of the Committee on the Safety of Silicone Breast Implants, ...

www.annalsplasticsurgery.com/pt/ re/annps/fulltext.00000637-200504000-00001.htm - Similar pages

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Journal of Women's Imaging - Fulltext: Volume 7(1) March 2005 p 44 ... ... Chest wall fibromatosis associated with silicone breast implants. ... MRI; desmoid tumor; fibromotosis; breast implants. © 2005 Lippincott ...

www.jwijournal.com/pt/re/jwi/ fulltext.00130747-200503000-00005.htm - Similar pages

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http://www.nixonpeabody.com/linked_media/publications/PMLA_03152005.pdf

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http://www.implantinfo.com/breast_implants/silicone_gel/reason_pro_choice.pdf

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US News World Rep. 2005 Apr 25;138(15):57-8. Related Articles, Links

No scientific consensus on silicone breast implants Health risk or a woman's choice?

Querna E.

Publication Types:

News

PMID: 15852609 [PubMed - in process] ------------- Research Article

Effects of age and pregnancy on cytochrome P450 induction by octamethyltetracyclosiloxane in female Sprague-Dawley rats

N. Falany *, Ge Li

Department of Pharmacology and Toxicology, University of Alabama at Birmingham, Birmingham, AL 35294, USA

email: N. Falany (cfalany@...)

*Correspondence to N. Falany, Department of Pharmacology and Toxicology, University of Alabama at Birmingham, Birmingham, AL 35294, USAsetDOI("ADOI=10.1002/jbt.20059")

Funded by:

National Plaintiffs Liaison Council.

Keywords

Dimethylcyclosiloxanes • Cytochromes P4-50 • Induction • Breast Implants • Octamethyltetracyclosiloxane

Abstract

Dimethylcyclosiloxanes (DMCS) are components of silicone gel containing implants and are known inducers of human drug metabolizing enzymes. The effects of the major DMCS, octamethyltetracyclosiloxane (D4) on cytochrome P450 (CYP) induction were examined in young adult, mature, and pregnant female Sprague-Dawley rats. Also, the ability of D4 administered to pregnant dams to affect CYP expression in fetal liver was examined. Female young, mature, and pregnant Sprague-Dawley rats were administered 0, 5, 20, and 100 mg/kg D4 daily by gavage for 8 days. Liver microsomal CYP (CYP2B, CYP3A, CYP1A) concentrations were evaluated by Western blots using specific antisera, and CYP activities were assayed using CYP selective assays. D4 treatment resulted in a significant induction of CYP2B and CYP3A isoforms. CYP induction was dose and age dependent. A comparison of the inducibility of CYP3A protein by D4 in rats from different age groups showed that the degree of increase was the highest in the pregnant rats at doses of 20 mg/kg D4 or higher. The mature rats had a lesser degree of responsiveness than did the young rats at the dose of 100 mg/ kg D4. Significant increases in CYP2B immunoreactive protein concentrations were observed in young and mature rats given D4 at doses >5 mg/kg and in pregnant rats at doses >20 mg/kg. Maximal CYP2B induction detected with blotting was more than 90-fold in mature rats; however, no significant changes were detected in CYP1A expression. There was a 20% increase of liver to body weight ratio in the mature rats treated with 100 mg/kg D4. D4 has different inductive properties in female rats of different ages and reproductive status. Also, D4 administered to the pregnant dam is capable of inducing CYP expression in fetal liver as well as decreasing fetal body weight. © 2005 Wiley Periodicals, Inc. J Biochem Mol Toxicol 19:129-138, 2005; Published online in Wiley InterScience (www.interscience.wiley.com). DOI 10.1002/jbt.20059

Received: 25 October 2004; Revised: 15 February 2005; Accepted: 17 February 2005

----------------------------------------------------------------- BMJ. 2005 Apr 23;330(7497):919. Related Articles, Links

FDA panel approves one make of silicone breast implant in the US.

Moynihan R.

Publication Types:

News

PMID: 15845957 [PubMed - in process] ---------------------------------------------- Plast Reconstr Surg. 2005 Apr 15;115(5):1442-5. Related Articles, Links

Reports of "dissolving" shells of silicone gel-filled breast implants.

Lane T, Curtis J.

Publication Types:

Letter

PMID: 15809630 [PubMed - in process] -------------------------------------------- J Biomed Mater Res A. 2005 Feb 1;72A(2):161-7. Related Articles, Links

In vitro interaction between silicone gel and human monocyte-macrophages.

Tavazzani F, Xing S, Waddell JE, D, Boynton EL.

Institute of Biomaterials and Biomedical Engineering, University of Toronto, Toronto, Ontario, Canada.

Controversy remains regarding the ability of silicone materials to induce a specific immune reaction versus a nonspecific inflammatory response. Histopathological analysis of the tissue around failed breast implants reveals chronic inflammation with silicone gel droplets either surrounded by giant cells or engulfed by macrophages, areas of fibrosis, and necrosis. Macrophages are the key cells engulfing or forming foreign body giant cells. To address the mechanisms of silicone-induced inflammation a model of human monocyte-derived macrophages (MDMs) was developed. After sonication of silicone gel, the silicone droplets were embedded in Type I collagen and used to coat glass coverslips; human MDMs were subsequently seeded on the coverslips and maintained in culture for up to 7 days. The advantage of the model was that human macrophages could be studied histologically, and cytochemically as they interacted with well-characterized silicone materials. Initial analysis of the human macrophages shows phagocytosis of the silicone gel within hours of exposure to the material. Analysis for pro-inflammatory cytokines reveals significant transient secretion of IL-1 (p < 0.01) over controls by human macrophages upon exposure to silicone gel at 24 h. Copyright 2004 Wiley Periodicals, Inc.

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