Page 525
Index
A
Adaptive immune response, 104, 142, 146, 185-190, 191-192
HLA, 6, 181, 182, 185, 197, 206-207
Adenopathy, 95, 115, 239, 281, 282
axillary, 23, 58, 115, 116, 124, 126, 141, 228, 230
injection augmentation, 23
lymphomas, 107, 233, 239-240, 241
Adipose tissue, 21
Adjuvants
human adjuvant disease, 6, 72, 180
methylprednisolone, 164, 165, 166
Aesthetech Corporation, 72
Age factors
implant, 55, 56, 62, 64, 116-117, 118-119, 133-134, 138, 139
patient, 34, 95, 124, 200-201, 235, 260
Agency for Health Care Policy and Research, 17
Agency for Toxic Substances and Disease Registry, 111
Alloplastic implants, 20, 21-22, 27, 37
other than breast, 2, 45-46, 47, 49, 92-99, 141-142, 156
see also Gel implants; Polyurethane-coated implants; Saline-filled implants; Shell factors
American Academy of Cosmetic Surgery, 24, 35, 37
American Society for Testing and Materials, 132
American Society of Plastic and Reconstructive Surgeons, 27
number of implants, estimates, 33, 34-35, 36, 37, 57-58
types of implants, 57-58
Amorphous silica, 3, 39-40, 42, 50, 60, 261 see also Gel implants
Anaerobic bacteria, 168, 169-170
clostridia, 167
Animal studies, 25
breast milk, 259
capsular contracture, 141, 145, 147, 156, 157, 161
carcinogenic effects, 3, 85, 238, 241
hematomas, 173-174
immunologic effects, 6, 146, 170, 179-181, 188-189, 198, 199
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radiation therapy, gel implant effects, 68
toxicologic studies, review, 81-113
Antibiotics, 115, 159, 168, 170, 171
cephalosporin, 170
gentamycin, 170
Antibodies, 104, 105, 142, 244, 259, 510
antipolymer, 194-195
antisilicone, 193-194
monoclonal, 63, 196-197, 240, 241, 511
see also Antinuclear antibodies; Autoantibodies; Immunoglobulin
Antigens, 180, 186, 190, 194, 197
human leukocyte antigen (HLA), 6, 181, 182, 185, 197, 206-207
superantigens, 6, 182, 183-184, 197
Antinuclear antibodies, 6-7, 9, 192, 198-214, 245, 258-259
HEp-2 cells, 199, 202, 203, 204, 206, 208, 210, 211, 212, 228
connective tissue disease, 192, 200, 201, 202-203, 207, 210-212, 225-226, 228, 231, 256
Antipolymer antibodies, 194-195
Antisilicone antibodies, 193-194
Applanation tonometry, 149-150
Armpit, see Axilla
Arthralgia, 172, 192, 201, 206, 207, 227-232 (passim), 256
Arthritis, 180, 182, 183, 192, 195, 202, 211, 215, 217, 218, 221, 224, 225, 226, 231, 256, 501
Assays, see Bioassays
Atrophy, 101, 104, 142, 145, 165, 254
Attitudes, see Patient satisfaction
Augmentation implants, 25, 58, 136
breast feeding, 252-254
carcinogenic effects, 7-8, 24, 234, 235, 236, 237, 272-273, 280
classification of, 150
complications, 23-24, 115-120 (passim), 123-124, 138, 175, 178
contracture, 147, 150-151, 158, 159-160, 162-163, 165
connective tissue disease, 224-225
historical perspectives, 20, 25
injection, 22-24, 59-60, 70-71, 91
paraffin, 21, 22, 103, 146, 150
toxicologic studies, 89-91, 98-99, 108-109
neurologic effects, 242
number of, 2, 31, 32, 33-35, 37, 234
pain associated with, 176
regulatory controls, 31
reoperation, 119
Autoantibodies, 6, 8, 56, 186, 192-195, 210, 245, 258, 511
epidemiological studies, 6-7, 197, 198
research methodology, 6-7, 199, 201, 214
see also Antinuclear antibodies; Autoimmune disease
Autogenous tissues, 20-21, 27, 32, 220
Autoimmune disease, 157, 179, 181-182, 187, 190, 223, 511, 512
hearing loss, 243
natural killer cells, 6, 106, 180, 182, 184, 511
systemic lupus erythematosus (SLE), 200, 207, 211, 215, 224, 226, 231, 260, 501
transmammary/transplacental delivery, 256-259
see also Autoantibodies
Axilla, 99, 125, 128-129, 151, 154, 155, 157, 177, 221, 253, 279, 282
adenopathy, 23, 58, 115, 116, 124, 126, 141, 228, 230
B
anaerobic bacteria, 167, 168, 169-170
dimethylsiloxanes, 85
mycobacteria, 167
see also Infections
Barrier shells, 3, 4, 51, 64-66, 69, 70, 72, 74, 77-78, 115
capsular contracture, 151, 160-161, 178
B-cells, see B-lymphocytes
Bioassays, 104, 107, 153, 193-195
antinuclear antibodies, 199-205, 210
ELISA, 104, 182, 192, 193, 211, 212
natural killer cells, 184
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Bioplaxm, 22
Bleed (of implant), see Leakage (of implant); Ruptures
Blood and blood measurements, 101, 104, 183, 209-210, 213
capsular contractures, 5, 152, 153, 154
HLA, 6, 181, 182, 185, 197, 206-207
seromas, 25, 117, 118, 120, 121, 122, 173
see also Hematomas; Immunoglobulin
Bradford Hill, Sir Austin, 17
Brain, 92, 93, 95, 99, 156, 243-246 (passim), 501, 503
Breast cancer, 7, 9, 11, 36, 95, 209, 233, 234-240, 241, 278-284
antinuclear antibodies, 201
case control studies, 24, 235, 236
gel implants, irradiation, 68
injection augmentation, 24
polyurethane-coated implants, 61-62
radiation therapy, gel implant effects, 68
see also Mammography; Mastectomies; Reconstruction implants
Breast milk, 8-9, 11, 104-105, 249-252, 256-263, 503
autoimmune disease, 256-259
case control studies, 8, 256-257
case series and reports, 252-262
cohort studies, 252-254, 262-263
connective tissue disease, 256-259
galoctoceles, 115, 116, 254, 255
gel implants, 250
immunologic studies, 8-9, 260-262
research methodology, 257-258
see also Lactation
Breast reduction surgery, see Reduction surgery
Bursa and bursitis, 64, 225, 231
C
Calcification, 23, 56, 66, 115, 116, 126, 132, 145-147, 148, 157, 177
imaging technology, 265, 266, 276, 283-284
Cancer, 7-8, 32, 84, 92-96, 103, 114, 233-241
animal studies, 3, 85, 238, 241
augmentation implants, 7-8, 24, 32, 234, 235, 236, 237, 272-273, 280
case control studies, 24, 94-95, 234-235, 236
case series and reports, 234-235, 236, 238-240
cohort studies, 8, 234-235, 236-237
dimethylsiloxanes, 85
gel implants, 94-95, 236, 237, 240-241
injection augmentation, 24
plastocytomas, 180
polyurethane-coated implants, 61-62
reconstruction implants, 32, 237-238
regulatory controls and, 30, 62
see also Breast cancer; Carcinomas; Mammography; Myelomas; Sarcomas; Screening and diagnosis; Tumors
Capsules, 4, 94, 115, 116, 123, 126, 127, 131, 133, 135, 141-142
bacterial infections, 169-170
capsulectomies, 64, 132, 148, 284
capsulotomies, 4, 56, 114, 119, 121, 127-128, 130, 132, 134, 138, 159, 178
infections, 62-63
monitoring standards, 149, 150, 153, 158
pain associated with, 142, 148, 150, 171, 177
pharmacological reactivity, 55
polyurethane-coated implants, 61, 62-63
see also Calcification; Contractures
Carcinomas, 93-95, 233, 238-239
Cardiac response, 45, 91, 260, 501
Caseation, 190
Case control studies, 17-18, 166
carcinogenic effects, 24, 94-95, 234-235, 236
connective tissue disease, 201, 202-203, 207, 210-212, 217-219, 226-227, 230-231
immunologic effects, 183-184, 196, 201-208, 212-214
local complications, 120, 122, 133, 153, 155, 156, 158, 162, 163, 166
platinum toxicity, 109-110
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Case series and reports, 18
breast feeding/milk/transplacental delivery, 252-262
carcinogenic effects, 234-235, 236, 238-240
connective tissue disease, 202-203, 207, 229-230, 232
contracture, 151, 154-155, 159, 165-166, 167
immunologic effects, 185, 186, 187, 192-193, 195-197, 199, 201, 202-207
local infections, 168
neurologic effects, 8, 243-247
Cells and cellular processes, 64, 82, 107, 108, 142, 163
cytokines, 6, 142, 182-183, 192, 197, 231
epithelial cells, 95, 143, 249
HEp-2 cells, 199, 202, 203, 204, 206, 208, 210, 211, 212, 228
fibroblasts, 57, 61, 64, 93, 107, 142-145 (passim), 157, 162, 190, 191-192
giant cells, 99, 142, 143, 144, 157, 191-192;
see also ''macrophages" and " monocytes" infra
see also Human leukocyte antigen
macrophages, 89, 90, 91, 142, 143, 146, 151, 186-187, 191-192, 259
natural killer cells, 6, 106, 180, 182, 184, 511
necrosis, 25, 121, 122, 142, 281
plasma cells, 143, 153, 157, 190, 191
proliferation, 93, 142, 146, 162, 186, 187-188; see also Cancer
T-lymphocytes, 6, 143, 146, 181, 182-184, 186-190, 261-262, 500
Centers for Disease Control and Prevention, 13, 194, 200
number of procedures, 33
Cephalosporin, 170
Chemical processes, 40-42, 43, 44, 47-52
manufacturers' information, 78-79
polyurethane-coated implants, 61
Children, see Breast milk; Placenta; Pregnancy
Chlorosilanes, 42
Chromatography, 99
Clostridia, 167
Cognitive effects, 172, 206, 223, 228, 245
Cohort studies
capsular contracture, 159-160
carcinogenic effects, 8, 234-235, 236-237
connective tissue disease, 210-211, 216, 219-226, 230, 241
immunologic effects, 194-195, 204-206, 209-211, 214
local complications, 116-124, 136-138
natural killer cells, 184
neurologic effects, 242-243, 247
number of implants, 32-34, 35-36
patient satisfaction, 28-29
Collagens, 57, 143, 147-148, 187-188, 192-193, 202, 203, 259, 260, 511
arthritis, 180-181
Complications, see Deflations; Local complications; Patient satisfaction; Perioperative complications; Ruptures
Connective tissue and tissue disease, 6, 7, 8, 11, 29, 30, 89, 90, 143, 148, 157, 179, 181, 189-190, 192, 207, 215-232, 262-263, 501, 512-513
antinuclear antibodies, 192, 200, 201, 202-203, 207, 210-212, 225-226, 228, 231, 256
augmentation implants, 224-225
case control studies, 201, 202-203, 207, 210-212, 217-219, 226-227, 230-231
case series and reports, 202-203, 207, 229-230, 232
cohort studies, 210-211, 216, 219-226, 230, 241
epidemiological studies, general, 6, 7, 11, 35, 215-232
fibroblasts, 57, 61, 64, 93, 107, 142-145 (passim), 157, 162, 190, 191-192
gel implants, 189, 210, 212, 215-217, 220-221, 223-224, 225-226, 228, 230-231
National Science Panel, 10, 14, 81, 504-514
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periosteum, 83, 85, 89, 90-93 (passim), 99, 100, 111, 180, 188, 196, 240
research methodology, 189-190, 216, 218-219
saline-filled implants, 216-217, 225, 230-231
scleroderma (SSc), 115, 185, 200, 205, 212, 215, 217-218, 221, 224, 257, 501, 503
Sjögrens syndrome, 200, 224, 501, 506
symptoms, 226-231
systemic lupus erythematosus (SLE), 200, 207, 211, 215, 224, 226, 231, 260, 501
transmammary/transplacental delivery, 256-259
Consent, see Informed consent
Consumer products, 2, 10, 45, 46, 85, 100, 106-107, 152
see also Cosmetics; Food products
Contractures, 4-5, 56, 59, 78, 115, 117, 118, 122, 123, 125, 127-128, 138-139, 141-167, 178, 205, 228, 265
animal studies, 141, 145, 147, 156, 157, 161
augmentation implants, 147, 150-151, 158, 159-160, 162-163, 165
barrier shells, 151, 160-161, 178
blood and blood measurements, 5, 152, 153, 154
case series and reports, 151, 154-155, 159, 165-166, 167
cohort studies, 158-160
FDA, 142
frequency, 158-159
gel implants, 144, 145, 147, 150, 154, 156-166 (passim), 174
genetic predisposition, 146, 149
patient satisfaction, effect on, 26-27, 29
polyurethane-coated implants, 61, 62-63, 64
reconstruction implants, 68, 147, 158-160, 175
saline-filled implants, 144, 147, 151, 155, 158-160, 163-167 (passim), 170-171, 175
submammary implants, 158, 159, 160, 162, 167, 174-175
submuscular implants, 158, 159-163 (passim), 166, 174, 175
texturing, 5, 55, 60, 63, 64, 72, 76, 77-78, 143-144, 147, 159, 160, 161-164, 265-266
Cosmetic surgery, general, 1, 20, 221, 223
patient satisfaction, 26, 28-29
see also Augmentation implants; Injections; Reconstruction implants
Cost and cost-benefit factors
imaging technology, 271
implant removal, 29
ruptures, MRI screening, 9
Court cases, 4, 14, 37-38, 69, 81, 204, 206, 245
Independent Review Group (UK), 4, 10, 14, 81, 505-514
National Science Panel, 10, 14, 81, 505-514
Cox Uphoff International, 75-76, 122
Cross-sectional studies, 4, 34, 138, 216-217, 230, 242
Crystalline silica, 3, 39, 60, 154, 247
CUI, see Cox Uphoff International
Cyclosiloxanes, 99
Cysts, see Fibrocystic disease; Seromas
Cytokines, 6, 142, 182-183, 192, 197, 231
D
Deaths, see Mortality data
Deflations, 3, 4, 5, 55-56, 58, 59, 78, 115-124 (passim), 127, 129-130, 132-133, 136-137, 139, 178
Demographics, 33
age factors, 34, 95, 124, 200-201, 235, 260
race/ethnicity, 33
Denmark, 222-223, 224, 236, 242, 243, 262-263
Department of Health and Human Services
Agency for Health Care Policy and Research, 17
Agency for Toxic Substances and Disease Registry, 111
see also terms beginning "National Institute"
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Dermatomyositis/polymyositis, 215, 224
Desmoids, 239
Desmosomes, 144
Developmental effects, see Breast milk; Lactation; Placenta; Pregnancy
Diagnosis, see Screening and diagnosis; Symptoms
Diet, see Food products
Diffusion (from implant), see Leakage (of implant)
Dimethylsiloxanes, 43, 85-88, 99-100, 103, 105-107, 160
DNA, 92-93, 146, 210-211, 212, 213-214
Dose-response relationships, 68, 82, 83, 85, 88, 89, 91, 92, 95, 107
Double-lumen implants, 37, 55, 58-59, 71-75 (passim), 76, 210
complications, 120-121, 122, 163, 165-166
Dow Corning Corporation, 33, 47, 49-50, 51, 60, 67, 69-71, 72, 75, 78, 484, 486-487, 503
barrier shells, 64-65
local complication studies, 133
toxicologic studies, 82, 89-92, 102, 107, 108, 110, 111
E
Elastomers, 46-47, 49, 51, 56, 60, 78, 134-135, 144, 156
toxicologic studies, 90-91, 97, 99, 112
see also Shell factors
ELISA, 104, 182, 192, 193, 211, 212
Epidemiological studies, 6, 9, 17, 18, 200-201, 215-232, 510, 511, 512
breast milk, 262-263
carcinogenic effects, 7, 234-241
connective tissue disease, 6, 7, 11, 35, 215-232
cross-sectional studies, 4, 34, 138, 216-217, 230, 242
neurologic effects, 8, 242-243, 507
novel syndrome, 7, 10-11, 229, 230, 231-232
polyurethane-coated implants, 61-62
respiratory disorders, 109
study at hand, workshop agenda, 485
see also Case control studies; Cohort studies; Mortality data; Prospective studies
Epidermolysis, 25
Epithelial cells, 95, 143, 249
HEp-2 cells, 199, 202, 203, 204, 206, 208, 210, 211, 212, 228
Esophageal disorders, 9, 256-257, 259-260, 262-263
Expanders, 57-58, 59, 66, 74, 75
complications, 119, 120, 121-123, 155, 159
gel implants, 117-118
saline-filled implants, 71-72, 73, 75, 155, 168, 170-171
Explantations, 29, 56, 59, 115, 116, 117, 120, 121, 122, 132, 138, 167, 278, 500, 501, 503-504
infected implants, 168-169, 170
pain, 177
polyurethane-coated implants, 62, 63
sensory loss, 177
Extrusion, 115, 116, 121, 122, 124, 127, 165-166, 265
F
Fatigue, 172, 184, 201, 205, 206, 207, 224, 227-232 (passim), 245, 246, 247, 501, 503
Fatty tissue, see Adipose tissue
Federal government, 504
funding, study at hand, 14
see also specific departments and agencies
Fertility, 85
see also Pregnancy
Fetuses, 97
PDMS, 249
resorption, 101
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Fibroblasts, 57, 61, 64, 93, 107, 142-145 (passim), 157, 162, 190, 191-192
Fibrocystic disease, 20, 36, 61, 93, 103, 115, 121, 129, 281
Fibromyalgia, 185, 187, 195, 224, 225, 229, 501
antinuclear antibodies, 204, 206-207, 213
polyurethane-coated implants, 61
Fibrosis, 87, 93, 148, 157, 265
see also Contractures
Fistulas, 21
Fold flaws, see Wrinkling and fold flaws
Food and Drug Administration, 5, 30-31, 77, 489, 499, 503
capsular contracture, 142
developmental/reproductive toxicology, 96, 252
gel implants, 2, 31, 37, 58, 72, 74, 500
General and Plastic Surgery Devices Panel, 13, 30
liquid silicone injection, 24
local complications, 116
number of implants, estimates, 33
patient satisfaction studies, 29
polyurethane-coated implants, 61-62
Food, Drug and Cosmetic Act, 30
Food products, 2, 10, 100-103, 152, 251, 259 see also Breast milk
Foreign countries
connective tissue studies, 216
U.S. women receiving implants in, 35
see also specific countries
Formalin, 155
Funding, study at hand, 14
Fungus infections, 167, 168, 240
rashes, 115, 116, 144, 226, 228, 230, 260, 501, 503
G
Galoctoceles, 115, 116, 254, 255
Gammopathy, 196-197, 240, 507, 511
Gel implants, 1, 2-3, 4, 115-116
breast feeding, 254
breast milk, 250
carcinogenic effects, 94-95, 236, 237, 240-241
chemistry of, 50
complications, 115-118, 119, 121, 122, 126, 128-129, 178, 228; see also Ruptures
capsular contracture, 144, 145, 147, 150, 154, 156-166 (passim), 174
connective tissue disease, 189, 210, 212, 215-217, 220-221, 223-224, 225-226, 228, 230-231
contractures, 144, 145, 147, 150, 154, 156-166 (passim), 174
expanders, 117-118
FDA regulation, 2, 31, 37, 58, 72, 74, 500
immunologic effects, 180, 186, 188, 189, 203-204, 206, 208-209, 210, 212, 214, 225-226, 511
Independent Review Group (UK), 4, 10, 14, 81, 505-514
inflatable, 58
injection augmentation as analogy, 24
mammography,
cancer detection, 9, 25, 68, 126, 127, 131, 145, 176, 272-279
rupture diagnosis, 127, 131, 135, 136, 137-138, 265-267, 271, 274-275, 277
National Science Panel, 10, 14, 81, 504-514
number of, 37
pain associated with, 177
radiation therapy, effects on, 68
shell not used, 59-60
submuscular vs submammary placement, 174
toxicologic studies, 90-91, 94-96, 97, 98, 107, 110-111, 113
types of, 55, 57-60, 64-71, 72-78 (passim) see also Barrier shells
General and Plastic Surgery Devices Panel, 13, 30
General Electric, 72, 73, 75, 78
Genetics, 107
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Gentamycin, 170
Giant cells, 99, 142, 143, 144, 157, 191-192
macrophages, 89, 90, 91, 142, 143, 146, 151, 186-187, 191-192, 259
injection augmentation, 23
saline implants, 144
H
Headaches, 223, 229, 230, 246, 501
Hearing loss, 243
Hematomas, 4, 118, 120, 121, 123, 125, 127, 172-174
HEp-2 cells, 199, 202, 203, 204, 206, 208, 210, 211, 212, 228
Hepatic system, see Liver and liver diseases
Heyer-Schulte-Mentor Corporation, 71-72, 118, 119, 122, 137
High-temperature vulcanized silicone, 56, 71, 78, 123, 140
Histiocyte, see Macrophages
Histology, see Tissue response
Historical perspectives, 1, 2, 4, 19, 31-37, 69-78, 234
cosmetic breast surgery, 20-22
injections to augment breasts, 22-24
number of implants, 2, 8, 19, 31-36, 61
patient satisfaction, 28-29
polyurethane implants, 3, 60-61
toxicological studies, 3, 82-84
Human leukocyte antigen (HLA), 6, 181, 182, 185, 197, 206-207
Hypergammaglobulinemia, 195-197
Hypodermic syringes, 2, 10, 45, 91, 92, 243
I
calcification and, 265, 266, 276, 283-284
saline implants, 270, 276, 277-278
see also Magnetic resonance imaging; Mammography; Ultrasound; X-rays
Immunofluorescence, 212
Immunoglobulin, 6, 191, 193, 194, 195-197, 205, 210, 228, 249-250, 500
gammopathy, 196-197, 240-241, 507, 511
Immunologic effects, 6, 10, 84, 85, 90-91, 106, 112, 179-198, 247, 258, 499, 510, 511
adaptive immune response, 104, 142, 146, 185-190, 191-192
HLA, 6, 181, 182, 185, 197, 206-207
animal studies, 6, 146, 170, 179-181, 188-189, 198, 199
capsular contracture, 142, 146
case control studies, 183-184, 196, 201-208, 212-214
case series and reports, 185, 186, 187, 192-193, 195-197, 199, 201, 202-207
cohort studies, 194-195, 204-206, 209-211, 214
ELISA, 104, 182, 192, 193, 211, 212
gel implants, 180, 186, 188, 189, 203-204, 206, 208-209, 210, 212, 214, 225-226, 511
humoral immunity, 90-91, 107, 180, 182
interferon, 91
leukocytes, 90, 142; see also Human
leukocyte antigen
National Science Panel, 10, 14, 81, 504-514
natural killer cells, 6, 106, 180, 182, 184, 511
PDMS, 88
polyurethane-coated implants, 61
prospective studies, 208-209, 214
reconstruction implants, 207
regulatory controls and, 30
research methodology, 186, 187, 189-190, 195
ruptures, 205
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silicone, general, 179-182, 193-194
steroids, 184
study at hand, workshop agenda, 485-486
T-cells, 6, 143, 146, 181, 182-184, 186-190, 261-262, 500
see also Antibodies; Antigens; Autoimmune disease; Cancer; Infections; Inflammation and inflammatory diseases; Rheumatic diseases
Implant removal, see Explantations
Implant shells, see Shell factors
Inamed-McGhan Medical, 31, 63, 73-76, 111, 122, 136-137, 483
Income, see Socioeconomic status
Independent Review Group (UK), 4, 10, 14, 81, 505-514
Infants, see Breast milk; Fetuses; Placenta; Pregnancy
explantation due to, 168-169, 170
fungal infections, 167, 168, 240
rashes, 115, 116, 144, 226, 228, 230, 260, 501, 503
inflatable (valved) implants, 168, 171
injection augmentation, 23
local complications, 114, 118, 120, 121, 122, 123, 125, 127, 148, 167-172
pain associated with, 5, 168, 171, 172
polyurethane-coated implants, 62
reconstruction implants, 168, 169
reoperations, 168-169
saline-filled implants, 118, 120, 121, 168, 169, 170-171, 172
shell factors, 170
toxic shock syndrome, 115, 116, 169
wounds, 167-169
see also Antibiotics
Inflammation and inflammatory diseases, 39, 63, 83, 104, 105, 181, 183, 191, 225, 243, 246, 501, 510
capsular contracture, 142, 157, 164
granulomas, 58, 59, 76, 83, 87, 91, 129, 144, 148, 190, 228
pneumonitis, 108
polyurethane-coated implants, 61
swelling (symptom), 115, 116, 202, 206, 221, 230, 245, 500, 501
systemic lupus erythematosus, 200, 207, 211, 215, 224, 226, 231, 260, 501
see also Swelling (symptom)
Inflatable (valved) implants, 3, 57, 58, 66, 69, 70, 74, 76, 129, 130, 137
saline-filled, 58, 66, 70, 71, 169, 174-175
see also Deflations
Informed consent, 12, 78-79, 504
Inhalation exposure, 80, 85, 88-89, 103-107, 108, 152
augmentation via, 22-24, 59-60, 70-71, 91
paraffin, 21, 22, 103, 146, 150
toxicologic studies, 89-91, 98-99, 108-109
types of implants, 59-60, 70-71, 74
see also Hypodermic syringes
Insurance, see Health insurance
Interferon, 91
International perspectives, see also Foreign countries; specific countries
International Union of Immunological Societies, 199-200
Interstitial processes, 104, 105, 501
Intraperitoneal exposure, 83, 85, 89, 90-93 (passim), 99, 100, 111, 180, 188, 196, 240
J
K
Kidney and kidney diseases, 76, 88, 90, 91, 99, 103, 108, 153, 199, 204, 211, 273
L
Labor, Health and Human Services, and Education and Related Agencies Appropriations Bill (House Report 104-659), 1, 13
Page 534
Lactation, 104-105, 125, 252-256
galoctoceles, 115, 116, 254, 255
see also Breast milk
Leakage (of implant), 99, 115-116, 125-126, 158, 163, 165, 502
steroids, 164
types of implants, 56, 58, 64, 66, 67, 74, 75, 77
see also Barrier shells; Bleed (of implant); Deflations; Ruptures
Legal issues
court cases, 4, 14, 37-38, 69, 81, 204, 206, 245, 505-514
informed consent, 5, 12, 19, 20, 78-79, 504
Legislation
Food, Drug and Cosmetic Act, 30
Labor, Health and Human Services, and Education and Related Agencies Appropriations Bill, 1, 13
Nevada law banning injection augmentation, 23
see also Human leukocyte antigen
Lipids and lipoproteins, 101, 134-135, 191
Litigation, see Court cases
Liver and liver diseases, 104, 153
injection augmentation, 23
Local complications, 3-5, 10, 11, 114-178, 500
augmentation, 23-24, 115-120 (passim), 123-124, 138, 175, 178
contracture, 147, 150-151, 158, 159-160, 162-163, 165
calcification, 23, 56, 66, 115, 116, 126, 132, 145-147, 148, 157, 177, 265, 266, 276, 283-284
case control studies, 120, 122, 133, 153, 155, 156, 158, 162, 163, 166
cohort studies, 116-124, 136-138
double-lumen implants, 120-121, 122, 163, 165-166
expanders, 119, 120, 121-123, 155, 159
extrusion, 115, 116, 121, 122, 124, 127, 165, 265
frequency of, 116-124, 135-141
gel implants, 115-118, 119, 121, 122, 126, 128-129, 178, 228; see also Ruptures
capsular contracture, 144, 145, 147, 150, 154, 156-166 (passim), 174
hematomas, 4, 5, 118, 120, 121, 123, 125, 127, 148, 172-174
infections, 114, 118, 120, 121, 122, 123, 125, 127, 148, 167-172
injection augmentation, 23-24
prospective studies, 115, 117, 119, 122, 131, 140, 162, 171
reconstruction implants, 25, 115-123 (passim), 178
contracture, 68, 147, 158-160, 175
pain associated with, 176-177
submammary vs submuscular placement, 174-176
textured implants, 117, 122-123
capsular contracture, 5, 55, 60, 63, 64, 72, 76, 77-78, 143-144, 147, 159, 160, 161-164, 265-266
see also Contractures; Deflations; Leakage (of implant); Perioperative complications; Reoperations; Ruptures
see also Cohort studies; Prospective studies
Low-molecular-weight cyclic and linear poly(dimethylsiloxanes), 85-88, 99, 100
Lumen implants, see Double-lumen implants; Single-lumen implants; Triple-lumen implants
Lungs, 89, 104, 105, 108, 237, 501
injection augmentation, 23
pneumonitis, 108
Lupus, see Systemic lupus erythematosus
T-lymphocytes, 6, 143, 146, 181, 182-184, 186-190, 261-262, 500
Page 535
M
Macrophages, 89, 90, 91, 142, 143, 146, 151, 186-187, 191-192, 259
Magnetic resonance imaging, 119, 152-154, 187
rupture diagnosis, 9-10, 131, 135, 140-141, 269-272, 274-275
Mammography
augmentation implants, 272-273, 280-282
cancer detection, 9, 16, 25, 38, 63, 68, 69, 76, 114, 126, 127, 131, 132, 145, 176, 272-273, 277-284
gel implants,
cancer detection, 9, 25, 68, 126, 127, 131, 145, 176, 272-279
rupture diagnosis, 127, 131, 135, 136, 137-138, 265-267, 271, 274-275, 277
see also Magnetic resonance imaging
Mastectomies, 20, 31, 34, 209, 219-220, 501
pain associated with, 176-177
see also Reconstruction implants
McGhan Medical Corporation, see Inamed-McGhan Medical
Medical Engineering Corporation (Surgitek), 68, 72-73, 94
Memory loss, see Cognitive effects
Mentor Corporation, 31, 71-72, 117-118, 123, 483, 486-487
see also Heyer-Schulte-Mentor Corporation
Mesenchymal tissues, 94
Methodology, see Research methodology
Methylphenylpolysiloxane, 82, 83
Methylprednisolone, 164, 165, 166
Methyl tetramer, 44-45
Microscopy, 132, 133, 152-153, 247
Microsurgical flaps, 21
Monoclonal antibodies, 63, 196-197, 240, 241, 511
Morphea, 115
augmentation vs reconstruction, 32, 36
MRI, see Magnetic resonance imaging
Multiple sclerosis, 8, 242, 246, 501, 507
Muscle atrophy, 142, 145, 165, 254
Musculocutaneous flaps, 21
Musculoskeletal system, 192, 193, 204
see also Arthralgia; Arthritis; Connective tissue and tissue disease;
Myalgia; Rheumatic diseases Myalgia, 172, 206, 227, 228, 230, 245, 256
see also Fibromyalgia
Mycobacteria, 167
see also Fungus infections
Myelomas, 6, 196, 233, 236, 237, 240, 241, 507, 511
N
National Cancer Institute, 29
National Health Interview Survey, 33, 35, 36
National Institute of Allergy and Infectious Diseases, 14
National Institute of Arthritis and Musculoskeletal and Skin Diseases, 1, 14
National Institutes of Health, 13, 14, 15
National Science Panel, 10, 14, 81, 504-514
Natural killer cells, 6, 106, 180, 182, 184, 511
Necrosis, 25, 121, 122, 142, 281
Neoplasia, see Cancer; Tumors
Neurologic effects, 8, 91-92, 129, 242-247, 507
animal studies, 8, 243-244, 247
brain, 92, 93, 95, 99, 156, 243-246 (passim), 501, 503
case series and reports, 8, 243-247
cognitive effects, 172, 206, 223, 228, 245
epidemiologic studies, other, 8, 242-243, 507
hearing loss, 243
multiple sclerosis, 8, 242, 246
nipple/breast sensory loss, 177
peripheral nerves, general, 8, 92, 108, 243-244, 245
Raynaud's phenomenon, 211, 221, 226, 228, 230, 501
research methodology, 244-245, 247
see also Pain
Non-dimethyl siloxanes, 88-89
Novel syndrome, 7, 10-11, 229, 230, 231-232
Nurses' Health Study, 209-210
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O
Omentum, 83
Organogen, 22
P
Pain, 4, 5, 10, 114, 115, 127, 176-177, 202, 501
capsular contracture, 142, 148, 150, 171, 177
connective tissue disease, 202, 223, 225, 228, 230
explantations, 177
headaches, 223, 229, 230, 246, 501
injection augmentation, 23
mastectomies, 176-177
myalgia, 172, 206, 227, 228, 230, 245, 256; see also Fibromyalgia
reconstruction implants, 176-177
submammary vs submuscular placement, 176
Palpation, 26, 126, 150, 175, 176, 279, 280-282
Paraffin injection, 21, 22, 103, 146, 150
Patient satisfaction, 1-2, 19-20, 25-30, 38, 114-115, 118, 122, 488-490, 499-504
cosmetic surgery, general, 26, 28-29
informed consent, 5, 12, 19, 20, 78-79, 504
PDMS, see Poly(dimethylsiloxanes), 2
Peanut oil, 22, 68, 76, 273, 276
Peer review, 16, 17-18, 20, 37, 38, 81
Perioperative complications, 5, 10, 114, 115, 120, 178
infections, 114, 118, 120, 121, 122, 123, 125, 127, 148, 167-172
Peripheral nerves, general, 8, 92, 108, 243-244, 245
Peritoneal cavity, 83, 85, 89, 90-93 (passim), 99, 100, 111, 180, 188, 196, 240
Pharmacokinetic processes, 55, 85, 105
Plasma cells, 143, 153, 157, 190, 191
myelomas, 6, 196, 233, 236, 237, 240, 241, 507, 511
Plastocytomas, 180
Platinum and platinum curing, 3, 46, 48, 52, 68, 69, 71, 74-75
toxicologic studies, 107-110, 112-113
Pneumonitis, 108
Polyclonal antibodies, 186, 195-197
Poly(dimethylsiloxanes) (PDMS), 2, 3, 9, 70, 74, 75, 510
capsular contracture, 152, 155
chemistry of, 40-44 (passim), 47, 48
developmental effects, 252
toxicology of, 86, 87-88, 91-92, 96-97, 98, 152
reproductive/developmental, 3, 9, 87-88, 96-97, 249
antibodies, 194-195
Polymorphonuclear leukocytes, 142
Polymyositis, see Dermatomyositis/polymyositis
Polyurethane-coated implants, 3, 27
breast cancer, 61-62
capsular contracture, 61, 62-63, 64
pain associated with, 177
regulatory controls, 30-31
ruptures, 56
toxicologic studies, 89, 90-91, 94, 97, 102
types of, 58, 60-63, 66, 72-73, 76-77
Pregnancy, 96-97
transplacental delivery, 8, 248-249, 256-263
see also Fetuses
Preventive Services Task Force, 17
Prospective studies, 54, 55, 263, 274, 276, 486
immunologic effects, 208-209, 214
local complications, 115, 117, 119, 122, 131, 140, 162, 171
Psychological factors, 20, 25, 28
see also Patient satisfaction
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R
Race/ethnicity, 33
Rashes, 115, 116, 144, 226, 228, 230, 260, 501, 503
Raynaud's phenomenon, 211, 221, 226, 228, 230, 501
Reconstruction implants, 20, 230, 499
carcinogenic effects, 32, 237-238
complications, 25, 115-123 (passim), 178
contracture, 68, 147, 158-160, 175
pain associated with, 176-177
deflation, 136
immunologic effects, 207
pain associated with, 176-177
regulatory controls, 31
types of, 57-58
Reduction surgery, 155, 170, 177, 223, 224, 242-243, 257, 262
Regional trends, number of implants, 33
Regulatory issues, 11, 13, 30-31, 82
carcinogenic effects and, 30, 62
see also Food and Drug Administration
Removal of implants, see Explantations
Renal system, see Kidney and kidney diseases
Reoperations, 3, 4, 5, 10, 26, 114-115, 116-117, 118-119, 121, 122, 123, 159, 500
capsulectomies, 64, 132, 148, 284
capsulotomies, 4, 56, 114, 119, 121, 127-128, 130, 132, 134, 138, 159, 178
infections, 168-169
inflatable implants, 57
number of, 35
pain associated with, 177
patient attitudes, 19
Reproductive effects, 11, 87, 103, 104-105
non-dimethyl siloxanes, 88
PDMS toxicology, 3, 9, 87-88, 96-97, 249
teratogenic, 9, 85, 96, 97, 249
see also Fetuses; Placenta; Pregnancy
Research methodology, 4, 6, 11-12, 84
Austin Bradford Hill criteria for causation, 17
autoantibodies, 6-7, 199, 201, 214
breast milk, 257-258
complications, 116, 119, 149, 164-165
connective tissue disease, 189-190, 216, 218-219
immunologic effects, 186, 187, 189-190, 195
neurologic effects, 244-245, 247
novel syndrome, 7, 10-11, 229, 230, 231-232
NSP/IRG, 505-514
number of procedures, estimates, 34-35
patient satisfaction studies, 2, 27-28
peer review, 16, 17-18, 20, 37, 38, 81
study at hand, 1, 15-20, 37-38, 80-81, 483-514
technological tools, 157-158, 199, 201
chromatography, 99
microscopy, 132, 133, 152-153, 247
spectroscopy, 99, 110, 152-153, 250
see also Bioassays; Magnetic resonance imaging; Mammography
teratogenic effects, 9, 85, 96, 97
toxicological studies, 80-81, 84
see also Animal studies; Case control studies; Case series and reports; Cohort studies; Epidemiological studies; Longitudinal studies; Prospective studies; Standards
Respiratory tract, 23, 89, 104, 105, 109, 255, 503
see also Inhalation exposure; Lungs
Rheumatic diseases, 122, 192, 215-232, 245, 262-263, 512-513
antinuclear antibodies, 200, 201-203, 206, 207, 208, 210, 212-214
arthralgia, 172, 192, 201, 206, 207, 227-232 (passim), 256
arthritis, 180, 182, 183, 192, 195, 202, 211, 215, 217, 218, 221, 224, 225, 226, 231, 256, 501
human adjuvant disease, 6, 72, 180
see also Connective tissue and tissue disease; Fibromyalgia
Room-temperature vulcanized (RTV) silicone, 46, 60, 67, 71, 78
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Ruptures, 3, 4, 5, 56, 58, 70, 77, 78, 115, 117, 124, 125-141, 148, 151, 155-156, 178, 228, 498, 502-503, 509-510
age of implant, 56
imaging technology, 9-10, 131, 135, 140-141, 264-276
mammography, 127, 131, 135, 136, 137-138, 265-267, 271, 274-275, 278
MRI, 9-10, 131, 135, 140-141, 269-272, 274-275
ultrasound, 131, 138, 267-269, 271
immunologic effects, 205
injection augmentation as analogy, 24
pain associated with, 177
patient satisfaction, 29
polyurethane-coated implants, 56
shell thickness and strength, 4, 55, 56, 60, 69, 70, 72, 74, 115, 132-135, 139, 146-147, 148, 151, 164, 167
submammary vs submuscular placement, 175
S
Saline-filled implants, 1, 2-3, 4, 59
breast feeding, 253-254
complications, 56, 117-121 (passim), 123-124, 174-175, 178
capsular contracture, 144, 147, 151, 155, 158-160, 163-167 (passim), 170-171, 175
infections, 118, 120, 121, 168, 169, 170-171, 172
see also Deflations
connective tissue disease, 216-217, 225, 230-231
expanders, 71-72, 73, 75, 155, 168, 170-171
granulomas, 144
imaging technology, 270, 276, 277-278
immunologic effects, 187, 209-210, 214
infections, 118, 120, 121, 168, 169, 170-171, 172
inflatable (valved), 58, 66, 70, 71, 169, 174-175
neurologic effects, 242
number of, 37
symptoms, 56
types of, 55, 57, 58-59, 66, 67, 70-78(passim)
Sarcomas, 7, 93, 94, 95, 234, 238-239, 241
Satisfaction, see Patient satisfaction
Scars and scar tissue, 8, 66, 87, 125, 142, 143, 151, 164, 182, 239, 278
capsulectomies, 64, 132, 148, 284
Scleroderma (SSc), 185, 200, 205, 212, 215, 217-218, 221, 257, 501, 503
morphea, 115
Screening and diagnosis, 7, 9-10, 278-284, 504
applanation tonometry, 149-150
electron microscopy, 132
palpation, 26, 126, 150, 175, 176, 279, 280-282
submammary vs submuscular placement of implant, 264, 280-282
ultrasound, 131, 138, 267-269, 271
see also Bioassays; ELISA; Imaging; Mammography; Symptoms; specific symptoms
Secondary surgery, see Reoperations
Seromas, 25, 117, 118, 120, 121, 122, 173
Shell factors, 2-3, 4, 5, 60-69, 70, 74
chemistry of, 50-51, 53, 74-75
double-lumen implants, 58-59
infections, 170
thickness and strength, 4, 55, 56, 60, 69, 70, 72, 74, 115, 132-135, 139, 146-147, 148, 151, 164, 167
see also Barrier shells; Deflations; Polyurethane-coated implants; Ruptures; Textured implants
Sicca syndrome, 202, 206, 226, 228, 230, 245, 501
amorphous silica, 3, 39-40, 42, 50, 60, 261
crystalline silica, 3, 39, 60, 154, 247
immunologic effects, 186-187, 261-262
Silicon, general, 2, 3, 40-41, 43, 47, 49
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implants other than breast, 2, 45-46, 47, 49, 92-99, 141-142, 156
in products other than implants, 2, 10, 190, 243; see also Consumer products
uses of, general, 45-49
viscosity, 41, 44, 45, 49, 50-51, 78, 84
see also High-temperature vulcanized silicone; Room-temperature vulcanized (RTV) silicone
Silicone injections, see Injections
Silicones Environmental Health and Safety Council, 81
Siloxanes, see Cyclosiloxanes; Dimethylsiloxanes; Non-dimethyl siloxanes
Single-lumen implants, 37, 57, 58, 59, 72, 73, 74, 76
Sjögrens syndrome (SS), 200, 224, 501, 506
Skin and skin diseases, 25, 57, 115, 192, 246
bacteria, 5
epidermolysis, 25
rashes, 115, 116, 144, 226, 228, 230, 260, 501, 503
scleroderma (SSc), 115, 185, 200, 205, 212, 215, 217-218, 221, 257, 501, 503
toxicologic studies, 81, 83, 89, 101, 108-109, 152
wrinkling and fold flaws, 4, 24, 56, 59, 71, 126, 130, 133
see also Cosmetics
Socioeconomic status, 33
Sonographic techniques, see Ultrasound
Spectroscopy, 99, 110, 152-153, 250
Sperm and semen, 88
Spleen, 90, 91, 98, 99, 103, 154, 188, 503
breast feeding, 255
capsule monitoring, 149, 150, 153, 158
informed consent, 12
outcome measures, 12
toxicologic studies, 3, 12, 84, 96, 112
adrenal, 5, 115, 164, 165, 166
contracture, 162, 164-167, 178
immunologic effects, 184
methylprednisolone, 164, 165, 166
Submammary implants, 28, 61, 118, 120, 123, 125, 136, 140, 171
capsular contracture, 158, 159, 160, 162, 167, 174-175
pain associated with, 176
screening and diagnosis, 264, 280-282
Submuscular implants, 9, 26, 37, 61, 118, 121, 126, 129, 130, 136, 140, 174-176, 178, 238, 253, 254
capsular contracture, 158, 159-163 (passim), 166, 174, 175
pain associated with, 176
screening and diagnosis, 264, 280-282
Superantigens, 6, 182, 183-184, 197
Surgical procedures
implant integrity assessment, 274-276
wound infections, 167-169
see also Perioperative complications; Reduction surgery; Reoperations
Surgitek, see Medical Engineering Corporation
Surveillance, Epidemiology and End Results registry, 36, 239
Sweden, 223-224, 236-237, 242, 279
Swelling (symptom), 115, 116, 202, 206, 221, 230, 245, 500, 501
galoctoceles, 115, 116, 254, 255
see also Inflammation and inflammatory diseases
Symptoms, general, 19, 56, 172, 499-504, 513
connective tissue disease, 226-231
fatigue, 172, 184, 201, 205, 206, 207, 224, 227-232 (passim), 245, 246, 247, 501, 503
novel syndromes, 7, 10-11, 229, 230, 231-232
see also specific symptoms (e.g., Fatigue; Pain; Swelling)
Synovial linings, 61, 63-64, 143-144
Systemic lupus erythematosus (SLE), 200, 207, 211, 215, 224, 226, 231, 260, 501
Systemic sclerosis, see Scleroderma
T
T-cells, see T-lymphocytes
Teratogenic effects, 9, 85, 96, 97, 249
Testes, 88
Textured implants, 4
capsular contracture, 5, 55, 60, 63, 64, 72, 76, 77-78, 143-144, 147, 159, 160, 161-164, 265-266
Page 540
local complications, 117, 122-123; see also ''capsular contracture" supra
number of, 37
patient satisfaction, 26
types of, 55, 60, 61, 63-64, 67, 69, 70, 72, 74
Tissue response, general, 4, 25, 39, 103, 112, 141-146, 152, 154-155, 189, 191-192
atrophy, 101, 104, 142, 145, 165, 254
autogenous tissues, 20-21, 27, 32, 220
inflatable implants, 57
interstitial processes, general, 104, 105, 501
mesenchymal tissues, 94
synovial lining, 61, 63-64, 143-144
see also Connective tissue and tissue disease; Inflammation and inflammatory diseases; Scars and scar tissue; Skin and skin diseases; Textured implants
T-lymphocytes, 6, 143, 146, 181, 182-184, 186-190, 261-262, 500
Tonometry, 149-150
Toxicology, 3, 9, 10, 11, 51, 80-113, 243, 247
dose-response relationships, 68, 82, 83, 85, 88, 89, 91, 92, 95, 107
Dow Corning, 82, 89-92, 102, 107, 108, 110, 111
elastomers, general, 90-91, 97, 99, 112
gel implants, 90-91, 94-96, 97, 98, 107, 110-111, 113
historical perspectives, 3
injection augmentation, 89-91, 98-99, 108-109
PDMS, 86, 87-88, 91-92, 96-97, 98, 152
reproductive/developmental, 3, 9, 87-88, 96-97, 249
polyurethane-coated implants, 89, 90-91, 94, 97, 102
research methodology, 80-81, 84
skin and skin diseases, 81, 83, 89, 101, 108-109, 152
see also Cancer; Immunologic effects; Neurologic effects; Reproductive effects
Toxic shock syndrome, 115, 116, 169
Transplacental delivery of silicone, see Placenta
Triple-lumen implants, 55, 59, 74, 75
carcinomas, 93-95, 233, 238-239
lymphomas, 107, 233, 239-240, 241
myelomas, 6, 196, 233, 236, 237, 240, 241, 507, 511
sarcomas, 7, 93, 94, 95, 234, 238-239, 241
see also Breast cancer; Cancer
U
Ultrasound, 131, 138, 267-269, 271
gel implants, other than IRG, 37, 77
Independent Review Group (IRG, UK), 4, 10, 14, 81, 505-514
United Nations, UNICEF, 255
Urethra, 25
Urine, 85, 98, 101, 102, 104, 105, 106, 152, 157, 259
V
Valved implants, see Inflatable (valved) implants
Viscosity, 41, 44, 45, 49, 50-51, 78, 84
W
World Health Organization, 255
Wrinkling and fold flaws, 4, 24, 56, 59, 71, 126, 130, 133
X
X-rays
capsules, 158
gel implants, irradiation, 68
see also Mammography; Magnetic resonance imaging