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17 citations found

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Neurology 1999 Jul 22;53(2):293-7

Pathologic findings in nerve and muscle biopsies from 47 women with silicone breast implants.

Vogel H

Department of Pathology, Baylor College of Medicine, Houston, TX, USA.

[Medline record in process]

OBJECTIVE: To describe the pathologic findings in 47 consecutively received nerve and muscle biopsies from patients with silicone breast implants (SBI). BACKGROUND: The controversial proposal that systemic illness may result from SBI includes diseases of the central and peripheral nervous system. METHODS: All of the biopsies were processed in full according to current standard methodologies in nerve and muscle pathology. Myelinated fiber histograms were prepared in 40 of the 47 cases. RESULTS: Eight of the 47 nerves showed pathologic changes likely to be symptomatic: 7 with an axonal neuropathy, including 1 with a granulomatous neuritis and myositis and 1 with diabetic neuropathy, and the eighth with a hypertrophic onion bulb neuropathy. Eleven showed minor morphologic or morphometric alterations of uncertain clinical significance. The remaining 28 nerve biopsies were normal, including 1 in which the accompanying muscle showed an inflammatory myopathy typical of polymyositis. CONCLUSIONS: These findings represent the largest set of reported pathologic data derived from women with SBI. Within this highly selected cohort of women with SBI, the majority of the biopsies were normal, and in 9 of 47 diverse abnormalities were detected including axonal and demyelinating neuropathies and inflammatory myopathies. These findings do not support a consistent association between SBI and any neuropathologic entity.

PMID: 10430416, UI: 99357485

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Mod Pathol 1999 Jul;12(7):714-21

Laser-Raman microprobe identification of inclusions in capsules associated with silicone gel breast implants.

Centeno JA, Mullick FG, Panos RG, Miller FW, Valenzuela-Espinoza A Department of Environmental and Toxicologic Pathology, Armed Forces Institute of Pathology, Washington, DC 20306-6000, USA. centeno@afip.osd.mil

[Medline record in process]

Raman spectroscopy (the analysis of scattered photons after excitation with a monochromatic light source) provides a nondestructive method for identifying organic and inorganic materials on the basis of the molecule's characteristic spectrum of vibrational frequencies. Although the technique has been predominantly applied in sciences other than pathology, the recent advent of high-quality microscope optics coupled to optical Raman spectrometers (a variation known as a Raman microprobe) rendered this technique amenable to applications in human pathology. In the Raman microprobe, a laser beam is focused on a spot approximately 1 microm in diameter on the surface of the sample, e.g., tissue, and the scattered light is collected and analyzed. In this investigation, we used the Raman microprobe for the identification of foreign materials in breast implant capsular tissues. The characteristic silicone group frequencies associated with the silicon-oxygen stretch, the silicone-carbon stretch, the silicon-methyl and the methyl carbon-hydrogen stretch frequencies were used to identify polydimethylsiloxane and to define chemical differences among the various other implant-related inclusions. All of the inclusions were positively identified in a series of 44 capsules from silicone gel-filled implants: polydimethylsiloxane was found in 44 of 44 capsules surrounding silicone gel-filled implants; polyurethane was seen in 4 of 4 capsules around polyurethane foam-coated gel-filled implants; 4 of 4 capsules enveloping Dacron patch gel-filled implants revealed Dacron; and talc was identified in 8 of these 44 capsules. Raman microspectroscopy provides a rapid, accurate, and sensitive method for identifying inclusions associated with silicone and other implant materials in tissue.

PMID: 10430276, UI: 99357345

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Med J Aust 1999 Jun 21;170(12):588-91

Scintimammography: an adjunctive test for the detection of breast cancer.

Howarth D, Sillar R, Lan L, Clark D, Miles T

Department of Nuclear Medicine, John Hunter Hospital, Newcastle, NSW.

OBJECTIVE: To describe the diagnostic utility of scintimammography in patients with a breast mass, including patients who have undergone previous breast surgery or radiotherapy. DESIGN: Descriptive outcome study. SETTING: A university teaching hospital and a private hospital breast clinic in New South Wales. SUBJECTS: 115 consecutively referred women investigated by x-ray mammography and scintimammography before surgical excision biopsy of a breast mass. MAIN OUTCOME MEASURES: Sensitivity and specificity of x-ray mammography and scintimammography in the detection of breast cancer overall, and in women who had or had not undergone previous breast surgery. RESULTS: 44 (38%) patients had undergone previous breast surgery or external beam radiotherapy, including nine with bilateral silicone breast implants. The overall (n = 115) sensitivity for the detection of breast cancer with scintimammography was 84%, compared with 66% for x-ray mammography (P = 0.004), and the respective specificities were 84% and 67% (P = 0.194). For patients who had a history of previous breast surgery, the respective sensitivities of the two tests were 83% and 50% (P = 0.006), compared with 85% and 73% (P = 0.087) for patients who had had no previous surgery. CONCLUSIONS: Scintimammography offers additional diagnostic advantage in the detection of breast cancer in patients who have had previous breast surgery or local radiotherapy.

PMID: 10416428, UI: 99344938

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Science 1999 Jun 25;284(5423):2065-6

Panel discounts implant disease risk.

Kaiser J

Publication Types:

News

PMID: 10409056, UI: 99334689

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Ann Plast Surg 1999 Jul;43(1):99-100

RE: The life span of silicone gel breast implants and a comparison of mammography, ultrasonography, and magnetic resonance imaging in detecting implant rupture: a meta-analysis.

Dowden R

[Medline record in process]

PMID: 10402997, UI: 99331429

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Ann Plast Surg 1999 Jul;43(1):97-9

The life span of silicone gel breast implants and a comparison of mammography, ultrasonography, and magnetic resonance imaging in detecting implant rupture: a meta-analysis.

Peters W, Smith D, Lugowski S

[Medline record in process]

PMID: 10402996, UI: 99331428

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J Biomed Mater Res 1999;48(3):354-364

Silicone gel breast implant failure and frequency of additional surgeries: Analysis of 35 studies reporting examination of more than 8000 explants.

Marotta JS, Widenhouse CW, Habal MB, Goldberg EP Biomaterials Center, Department of Materials Science and Engineering, University of Florida, Gainesville, Florida. [Record supplied by publisher]

Although it is well known that silicone gel breast implants (SGBIs) produce many "local" complications (i.e., pain, hard fibrous capsules, disfigurement, chronic inflammation, implant shell failure) and necessitate frequent surgical revisions, no large cohort retrospective quantitative analysis of clinical data has been reported to date, especially for the prevalence of failures and additional surgeries. Data from 35 different studies that encompass more than 8000 explanted SGBIs have now been analyzed and are reported here. Because examination of a prosthesis when explanted is the definitive method for determining shell integrity, the only studies that were used were ones that reported implant duration, the total number of SGBIs explanted, and the number of SGBIs for which shell rupture or failure ("not intact") was confirmed upon surgical removal. An exponential regression plot of data indicated a direct correlation of implant duration with percent shell failure (r2 = 0.63 and r = 0.79 ). SGBI failure was found to be 30% at 5 years, 50% at 10 years, and 70% at 17 years. The failure rate was 6% per year during the first 5 years following primary implant surgery. ANOVA comparison of three implant age groups (mean implant durations of 3.9, 10.2, and 18.9 years) indicated a highly significant statistical correlation of percent failure with implant duration (p < 0.001). Complications necessitating at least one additional surgery occurred for 33% of implants within 6 years following primary implant surgery. Shell failure was found to be an order of magnitude greater than the 4 to 6% rupture prevalence suggested by the AMA Council on Scientific Affairs in 1993, the 0.2 to 1.1% cited by manufacturers at that time, and the 5% rupture that was stated to be "not a safety standard that the FDA can accept." Copyright 1999 John Wiley & Sons, Inc.

PMID: 10398041

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Lancet 1999 Jun 26;353(9171):2215

No syndrome linked to breast implants, says IoM. Insitute of Medicine.

Mitchell P

Publication Types:

News

PMID: 10392995, UI: 99320166

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BMJ 1999 Jul 3;319(7201):8A

United States clears silicone breast implants.

Josefson D

San Francisco.

[Record supplied by publisher]

PMID: 10390437

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Aesthetic Plast Surg 1999 May-Jun;23(3):189-96

A ten-year experience using polyurethane-covered breast implants.

Vazquez G

Buenos Aires, Argentina.

[Medline record in process]

The purpose of this study is to disclose the low incidence (0.98%) ofcapsular contracture using polyurethane-covered silicone gel breastimplants. Four hundred seven surgical interventions were performed duringthe 10-year period, 404 for hypomastia and 3 for breast reconstruction.

PMID: 10384018, UI: 99315072

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Biomaterials 1999 Jun;20(11):1063-9

A formal risk assessment of silicone breast implants.

Gerszten PC

Department of Neurosurgery, Presbyterian University Hospital, Pittsburgh, PA 15213-2582, USA.

In 1992, the United States Food and Drug Administration (FDA) announced that breast implants filled with silicone gel would be available only through controlled clinical studies despite the fact that they had been used for mammoplasty in millions of women around the world for more than 30 years. The safety of silicone gel breast implants had come into question after several reports on a possible association between the implants and subsequent development of connective-tissue diseases. Risk assessment refers to the systematic, scientific characterization of potential adverse effects of human exposures to hazardous agents or activities. The following risk assessment is intended to review the current scientific evidence for the safety of silicone gel-filled breast implants since the FDA's decision in 1992. There now appears ample evidence from the scientific literature for the safety of these prostheses.

PMID: 10378807, UI: 99305152

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Rheumatology (Oxford) 1999 May;38(5):480-1

Silastic prostheses--a forgotten cause of lymphadenopathy in rheumatoid arthritis.

Hopkinson N, Parham D, Benjamin S

Publication Types:

Letter

PMID: 10371296, UI: 99297706

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J Biomed Mater Res 1999 Jul;46(1):132-4

Adjuvancy effect of different types of silicone gel.

McDermott MR, Brook MA, Bartzoka V Publication Types:

Letter

PMID: 10357144, UI: 99284036

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Br J Plast Surg 1999 Jan;52(1):78

Consensus declaration of EQUAM.

Nicolai JP

Publication Types:

Consensus development conference

Letter

Review

PMID: 10343599, UI: 99275067

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Ann Plast Surg 1999 May;42(5):571

Re: The life span of silicone gel breast implants.

Melmed EP

Publication Types:

Letter

PMID: 10340871, UI: 99270719

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Ann Plast Surg 1999 May;42(5):564-7

False-positive radiographic diagnosis of breast implant rupture because of breast abscess.

Sanger JR, Sinha R, Walker AP Department of Plastic and Reconstructive Surgery, Medical College of Wisconsin, Milwaukee 53226, USA.

A case of a periprosthetic abscess simulating breast implant rupture is presented. Both clinical findings and film-screen mammography suggested extravasation of a radiodense material adjacent to an implant.

Ultrasonography was thought to confirm the extraluminal silicone. However, at surgery the mass was found to be a breast abscess that had herniated through the capsule. The double-lumen implant outer saline-filled chamber had deflated, but the silicone-containing inner chamber was intact. Magnetic resonance imaging would have distinguished between abscess and silicone.

PMID: 10340868, UI: 99270716

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J Rheumatol 1999 May;26(5):1172-5

"Silicone related symptoms" are common in patients with fibromyalgia: no evidence for a new disease. Wolfe F

Arthritis Research Center and University of Kansas School of Medicine, Wichita 67214, USA. fwolfe@southwind.net

OBJECTIVE: To ascertain if the symptom content and rate of symptoms in patients with fibromyalgia (FM) are similar to those in what has been called silicone implant associated syndrome (SIAS), and to determine if SIAS is indeed a new disease or whether it is largely recognizable as FM. METHODS: Mailed survey to 901 patients in Wichita, KS, Portland, OR, Los Angeles, CA, Peoria, IL, Boston, MA, San Antonio, TX, and eastern Kansas who were participating in a longterm outcome study of FM. Laboratory data were available from Wichita patients. RESULTS: Content of symptoms was similar to that in SIAS, and rates were generally as high or higher in patients with FM than in SIAS. In patients with FM, 37.2% had all of the following 5 items: arthralgias, myalgias, sicca complex, atypical rash, and symptoms of a peripheral neuropathy; and 55.2% had 4 of the 5 items. CONCLUSION: These data do not suggest that SIAS is an unrecognized new disease, but suggest the opposite, that such symptoms are well known and previously recognized, and are common among those with musculoskeletal complaints and those seen in rheumatology clinics.

Comments:

Comment in: J Rheumatol 1999 May;26(5):1018-9

Comment in: J Rheumatol 1999 May;26(5):1080-1

PMID: 10332986, UI: 99263781