Biomaterial Database

Silicone breast implants and connective tissue disease: no association. 2011

Loren Lipworth, and Lisbet R Holmich, and Joseph K McLaughlin

International Epidemiology Institute, 1455 Research Blvd, Suite 550, Rockville, MD 20850, USA. loren@iei.ws

The association of silicone breast implants with connective tissue diseases (CTDs), including systemic sclerosis, systemic lupus erythematosus, rheumatoid arthritis, and fibromyalgia, as well as a hypothesized new "atypical" disease, which does not meet established diagnostic criteria for any known CTD, has been extensively studied. We have reviewed the epidemiologic literature regarding an association between cosmetic breast implants and CTDs, with particular emphasis on results drawn from the most recent investigations, many of which are large cohort studies with long-term follow-up, as well as on those studies that address some of the misinformation and historically widespread claims regarding an association between breast implants and CTDs. These claims have been unequivocally refuted by the remarkably consistent evidence from published studies, as well as numerous independent meta-analyses and critical reviews, which have demonstrated that cosmetic breast implants are not associated with a subsequent increased occurrence of individual CTDs or all CTDs combined, including fibromyalgia. Moreover, there is no credible evidence for the conjectured excess of "atypical" CTD among women with cosmetic breast implants, or of a rheumatic symptom profile unique to these women. No increased risk of CTDs is evident in women with extracapsular ruptures in two studies, which evaluated risk by implant rupture status, and no consistent association has been observed between silicone breast implants and a variety of serologic markers or autoantibodies. Thus, any claims that remain regarding an association between cosmetic breast implants and CTDs are not supported by the scientific literature but rather are a residual byproduct of the unprecedented large-scale product liability litigation in the USA.

UI	MeSH Term	Description	Entries
D003240	Connective Tissue Diseases	A heterogeneous group of disorders, some hereditary, others acquired, characterized by abnormal structure or function of one or more of the elements of connective tissue, i.e., collagen, elastin, or the mucopolysaccharides.	Connective Tissue Disease,Disease, Connective Tissue,Diseases, Connective Tissue
D005260	Female		Females
D005356	Fibromyalgia	A common nonarticular rheumatic syndrome characterized by myalgia and multiple points of focal muscle tenderness to palpation (trigger points). Muscle pain is typically aggravated by inactivity or exposure to cold. This condition is often associated with general symptoms, such as sleep disturbances, fatigue, stiffness, HEADACHES, and occasionally DEPRESSION. There is significant overlap between fibromyalgia and the chronic fatigue syndrome (FATIGUE SYNDROME, CHRONIC). Fibromyalgia may arise as a primary or secondary disease process. It is most frequent in females aged 20 to 50 years. (From Adams et al., Principles of Neurology, 6th ed, p1494-95)	Diffuse Myofascial Pain Syndrome,Fibrositis,Rheumatism, Muscular,Fibromyalgia, Primary,Fibromyalgia, Secondary,Fibromyalgia-Fibromyositis Syndrome,Fibromyositis-Fibromyalgia Syndrome,Myofascial Pain Syndrome, Diffuse,Fibromyalgia Fibromyositis Syndrome,Fibromyalgia-Fibromyositis Syndromes,Fibromyalgias,Fibromyalgias, Primary,Fibromyalgias, Secondary,Fibromyositis Fibromyalgia Syndrome,Fibromyositis-Fibromyalgia Syndromes,Fibrositides,Muscular Rheumatism,Primary Fibromyalgia,Primary Fibromyalgias,Secondary Fibromyalgia,Secondary Fibromyalgias,Syndrome, Fibromyalgia-Fibromyositis,Syndrome, Fibromyositis-Fibromyalgia,Syndromes, Fibromyalgia-Fibromyositis,Syndromes, Fibromyositis-Fibromyalgia
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D001323	Autoantibodies	Antibodies that react with self-antigens (AUTOANTIGENS) of the organism that produced them.	Autoantibody
D018427	Breast Implants	Implants used to reconstruct and/or cosmetically enhance the female breast. They have an outer shell or envelope of silicone elastomer and are filled with either saline or silicone gel. The outer shell may be either smooth or textured.	Breast Prosthesis, Internal,Implants, Breast,Breast Implant,Breast Prostheses, Internal,Implant, Breast,Internal Breast Prostheses,Internal Breast Prosthesis,Prostheses, Internal Breast,Prosthesis, Internal Breast
D020034	Silicone Gels	Synthetic organosiloxane gels that are formed from synthetic polymers of silicone oxide with organic sidechains (polydimethylsiloxane) by lengthening the polymer chains. Unlike silicone elastomers, they are not treated with amorphous silica. They are used as fillers in breast implants.	Gels, Silicone