A formal risk assessment of silicone breast implants.

Biomaterials 1999 Vol.20(11) p. 1063-9

Gerszten PC

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Abstract

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.

추출된 의학 개체 (NER)

유형영어 표현한국어 / 풀이UMLS CUI출처등장
해부 breast 유방 dict 4
시술 mammoplasty 유방성형술 dict 1
해부 connective-tissue scispacy 1
약물 silicone C0037114
silicones
scispacy 1
약물 FDA → Food and Drug Administration scispacy 1
질환 silicone breast scispacy 1
질환 silicone gel-filled breast implants since the FDA's decision in 1992. scispacy 1
기타 women scispacy 1
기타 human scispacy 1

MeSH Terms

Animals; Autoimmune Diseases; Biocompatible Materials; Breast Implantation; Breast Implants; Breast Neoplasms; Contracture; Female; Humans; Mammography; Neoplasms; Prosthesis Failure; Risk Assessment; Safety; Silicones; United States; United States Food and Drug Administration

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