This study will examine the possible relationship between silicone implants or injections
and the connective tissue diseases scleroderma and myositis. It will explore whether
certain factors in the blood or the immune system or other factors are involved in the
development of these diseases following silicone implantation or injection.
Men and women 18 years of age and older who meet the following criteria may be eligible for
Group 1-Patients who have had silicone implants or injections and who later developed
scleroderma or myositis
Group 2-Patients with scleroderma or myositis who have not had silicone implants or
Group 3-Healthy volunteers who have had silicone implants or injections and did not develop
symptoms or other medical features of connective tissue disorders.
Participants will have a thorough history and physical examination, blood and urine tests,
chest X-ray and lung function tests. In addition, patients will complete a questionnaire
about their procedure (including information such as the types of implanted devices and
injections, reason for the procedure, post-operative complications, other illnesses or
medical conditions present before and after the procedure, etc.).
This multicenter study will attempt to determine the epidemiologic, clinical, serologic and
immunogenetic factors associated with patients who develop scleroderma/systemic sclerosis
after silicone prosthesis implantation or silicone injection. This will be accomplished by
comparing these patients to groups of appropriately matched patients with idiopathic
scleroderma/systemic sclerosis without silicone exposure, and appropriately matched
volunteers who have received similar silicone implants or injections and have not developed
symptoms, physical examination findings, or laboratory abnormalities associated with
autoimmune/connective tissue diseases. Patient and physician questionnaires will be
self-administered, and will collect data regarding: the number and types of implanted
silicone devices or injections; the indications for and nature of the surgical procedures;
peri- and post-operative complications; initial and subsequent clinical presentations; and
therapy and clinical course of the patients. Routine clinical tests and immunologic
laboratory evaluations will be performed. Also, studies will be conducted on the proportion
of circulating activated lymphocytes and levels of soluble mediators of inflammation
(cytokines, sIL-2R, sCD4, sCD8, TNF), the types of HLA and T cell receptor genes present in
the patients, and the presence and titers of anti-silicone antibodies and autoantibodies.
For all groups: Age greater than 18 years; ability to give informed consent.
Must not have severe medical disease requiring intensive care or any other conditions in
which the drawing of the amount of blood required for research purposes is not deemed
medically appropriate by the treating physician or the principal investigator.
For Group 1: Patients who have had silicon prostheses, or silicone injection, who
subsequently developed scleroderma/systemic sclerosis or myositis as defined by criteria
established by the American College of Rheumatology.
For Group 2: Patients with idiopathic scleroderma/systemic sclerosis or myositis as
defined by criteria established by the American Collage of Rheumatology, without silicone
implantation or injection, age-, sex-, and race-matched to Group 1.
Group 3: Patients who have had silicone prostheses or silicone injection, age-, sex-,
race- and silicone exposure-matched to patients in Group 1, who have not developed chronic
symptoms, physical findings, or laboratory abnormalities associated with autoimmune or
connective tissue diseases.