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

necrosis, 142, 281

Adjuvants

animal studies, 6, 146

human adjuvant disease, 6, 72, 180

Adrenal steroids, 5, 115

methylprednisolone, 164, 165, 166

triamcinolone, 164, 165

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

adjuvant effects, 6, 146

breast milk, 259

capsular contracture, 141, 145, 147, 156, 157, 161

carcinogenic effects, 3, 85, 238, 241

esophageal disorders, 9, 259

granulomas, 83, 87, 91

hematomas, 173-174

immunologic effects, 6, 146, 170, 179-181, 188-189, 198, 199

neurologic effects, 8, 243-244, 247

polyurethane-coated implants, 61-62, 89, 90-91, 94, 97, 102



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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 necrosis, 142, 281 Adjuvants animal studies, 6, 146 human adjuvant disease, 6, 72, 180 Adrenal steroids, 5, 115 methylprednisolone, 164, 165, 166 triamcinolone, 164, 165 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 adjuvant effects, 6, 146 breast milk, 259 capsular contracture, 141, 145, 147, 156, 157, 161 carcinogenic effects, 3, 85, 238, 241 esophageal disorders, 9, 259 granulomas, 83, 87, 91 hematomas, 173-174 immunologic effects, 6, 146, 170, 179-181, 188-189, 198, 199 neurologic effects, 8, 243-244, 247 polyurethane-coated implants, 61-62, 89, 90-91, 94, 97, 102

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Page 526 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 polyclonal, 186, 195-197 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 assays, 199-205, 210 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 Apoptosis, 92, 146 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 Asthma, 108, 109, 112 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 infections, 168, 169 connective tissue disease, 224-225 historical perspectives, 20, 25 immune response, 182, 207 infections, 168, 169 injection, 22-24, 59-60, 70-71, 91 paraffin, 21, 22, 103, 146, 150 toxicologic studies, 89-91, 98-99, 108-109 mammography, 272-273, 280-282 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 Bacteria, 5, 115, 167-172 anaerobic bacteria, 167, 168, 169-170 contracture, 5, 149 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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Page 527 Bioplasty, 63, 76 Bioplaxm, 22 Bleed (of implant), see Leakage (of implant); Ruptures Blood and blood measurements, 101, 104, 183, 209-210, 213 breast milk, 250-251, 258 capsular contractures, 5, 152, 153, 154 edema, 87, 115 emboli, 21, 23, 91 HLA, 6, 181, 182, 185, 197, 206-207 seromas, 25, 117, 118, 120, 121, 122, 173 see also Hematomas; Immunoglobulin B-lymphocytes, 107, 180, 182 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 Canada, 216, 235 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 cytokines, 142, 182 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 breast cancer, 24, 235, 236 breast milk, 8, 256-257 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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Page 528 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 apoptosis, 92, 146 B-lymphocytes, 107, 180, 182 cytokines, 6, 142, 182-183, 192, 197, 231 endothelial cells, 91, 99 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 leukocytes, 90, 142; see also Human leukocyte antigen macrophages, 89, 90, 91, 142, 143, 146, 151, 186-187, 191-192, 259 monocytes, 142, 182, 191-192 natural killer cells, 6, 106, 180, 182, 184, 511 necrosis, 25, 121, 122, 142, 281 phagocytes, 63, 143, 144 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 breast milk, 252-254, 262-263 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 bursa, 64, 225, 231 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 fascia, 21, 91 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 novel syndrome, 7, 10-11, 229, 230, 231-232 pain, 202, 223, 225, 228, 230

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Page 529 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 bacteria, 5, 149 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 hematomas, 5, 148, 172-173 immunologic effects, 142, 146 inflammation, 142, 157, 164 pain, 142, 148, 150, 171, 177 patient satisfaction, effect on, 26-27, 29 PDMS, 152, 155 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 steroids, 162, 164-167, 178 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 Cosmetics, 2, 10, 45, 85, 152 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 study at hand, 1, 13, 15 see also terms beginning "National Institute"

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Page 530 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 texturing, 63, 67 toxicologic studies, 82, 89-92, 102, 107, 108, 110, 111 E Edema, 87, 115 Elastomers, 46-47, 49, 51, 56, 60, 78, 134-135, 144, 156 toxicologic studies, 90-91, 97, 99, 112 see also Shell factors Electrolytes, 25, 252 Electron microscopy, 132, 133 ELISA, 104, 182, 192, 193, 211, 212 Emboli, 21, 23, 91 Endothelial cells, 91, 99 Eosinophils, 143, 188 Epidemiological studies, 6, 9, 17, 18, 200-201, 215-232, 510, 511, 512 autoantibodies, 6-7, 197, 198 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 number of implants, 2, 8, 19 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 pain, 122, 171 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 number of, 36, 37 pain, 177 polyurethane-coated implants, 62, 63 sensory loss, 177 Extrusion, 115, 116, 121, 122, 124, 127, 165-166, 265 Eyes, 83, 101, 102, 246 F Fascia, 21, 91 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 legislation, 1, 13, 30 study at hand, mandate, 1, 13 see also specific departments and agencies Fertility, 85 see also Pregnancy Fetuses, 97 PDMS, 249 resorption, 101 transplacental delivery, 8, 248-249, 256-263

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Page 531 Fibroblasts, 57, 61, 64, 93, 107, 142-145 (passim), 157, 162, 190, 191-192 collagens, 57, 143 Fibrocystic disease, 20, 36, 61, 93, 103, 115, 121, 129, 281 Fibromas, 103, 239 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 food additives, 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 saline-filled implants, 2, 31 study at hand, 2, 13, 14 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 France, 58, 76 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 Gavage, 85, 88, 102 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 infections, 168, 171, 172 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 granulomas, 58, 59, 76, 129 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 infections, 168, 171, 172 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 symptoms, 56, 177 textured, 26, 58, 162 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 contracture, 146, 149 DNA, 92-93, 146, 210-211, 212, 213-214 polymorphism, 142, 185, 190

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Page 532 Gentamycin, 170 Germany, 77, 207 Giant cells, 99, 142, 143, 144, 157, 191-192 macrophages, 89, 90, 91, 142, 143, 146, 151, 186-187, 191-192, 259 monocytes, 142, 182, 191-192 Granulomas, 148, 190, 228 animal studies, 83, 87, 91 gel implants, 58, 59, 76, 129 injection augmentation, 23 saline implants, 144 H Hair loss, 172, 206, 288 Headaches, 223, 229, 230, 246, 501 Health insurance, 32, 207 Hearing loss, 243 Hematomas, 4, 118, 120, 121, 123, 125, 127, 172-174 contracture, 5, 148, 172-173 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 study at hand, 1, 14-16 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 Imaging, 9, 264-284, 500 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 adjuvants, 6, 72, 146, 180 animal studies, 6, 146, 170, 179-181, 188-189, 198, 199 augmentation, 182, 207 B-cells, 107, 180, 182 breast milk, 8-9, 260-262 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 contractures, 142, 146 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 interleukin, 183, 191, 231 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 saline-filled implants, 187, 209-210, 214 silica, 186-187, 261-262

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Page 533 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 Infections, 4, 10, 210, 255 augmentation, 168, 169 capsules, 62-63, 169-170 explantation due to, 168-169, 170 fungal infections, 167, 168, 240 rashes, 115, 116, 144, 226, 228, 230, 260, 501, 503 gel implants, 168, 171, 172 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 texturing, 64, 172 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 animal studies, 83, 87, 91 capsular contracture, 142, 157, 164 granulomas, 58, 59, 76, 83, 87, 91, 129, 144, 148, 190, 228 neuritis, 242, 245 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 infections, 168, 171 leakage, 66, 137 reconstruction, 57, 74 saline-filled, 58, 66, 70, 71, 169, 174-175 see also Deflations Informed consent, 12, 78-79, 504 complications, 5, 19, 20 Inhalation exposure, 80, 85, 88-89, 103-107, 108, 152 Injections, 1, 22-24 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 Interleukin, 183, 191, 231 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 Japan, 77, 201, 250 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

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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 inflatable implants, 66, 137 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 study at hand, mandate, 1, 13 Leukocytes, 90, 142 see also Human leukocyte antigen Lipids and lipoproteins, 101, 134-135, 191 Litigation, see Court cases Liver and liver diseases, 104, 153 hepatomegaly, 104, 105, 106 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 infections, 168, 169 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 infections, 168, 171, 172 hematomas, 4, 5, 118, 120, 121, 123, 125, 127, 148, 172-174 infections, 114, 118, 120, 121, 122, 123, 125, 127, 148, 167-172 informed consent, 5, 19, 20 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 infections, 168, 169 pain associated with, 176-177 RTV silicone, 117, 123 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 Longitudinal studies, 3, 11 see also Cohort studies; Prospective studies Low-molecular-weight cyclic and linear poly(dimethylsiloxanes), 85-88, 99, 100 Lubricants, 2, 10, 45, 243 Lumen implants, see Double-lumen implants; Single-lumen implants; Triple-lumen implants Lungs, 89, 104, 105, 108, 237, 501 embolisms, 21, 23 injection augmentation, 23 pneumonitis, 108 Lupus, see Systemic lupus erythematosus Lymphocytes, 143, 157 B-lymphocytes, 107, 180, 182 T-lymphocytes, 6, 143, 146, 181, 182-184, 186-190, 261-262, 500 Lymphomas, 107, 233, 239-240, 241

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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 Monocytes, 142, 182, 191-192 Morphea, 115 Mortality data, 22, 33, 36 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 atrophy, 142, 145, 165, 254 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 SEER, 36, 239 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 Netherlands, 32, 195 Neuritis, 242, 245 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 cohort studies, 242-243, 247 epidemiologic studies, other, 8, 242-243, 507 hearing loss, 243 multiple sclerosis, 8, 242, 246 neuritis, 242, 245 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 ruptures, 8, 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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Page 536 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 expanders, 122, 171 explantations, 177 headaches, 223, 229, 230, 246, 501 infections, 5, 168, 171, 172 injection augmentation, 23 mastectomies, 176-177 myalgia, 172, 206, 227, 228, 230, 245, 256; see also Fibromyalgia neuritis, 242, 245 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 contractures, 26-27, 29 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 Pedicles, 21, 125 Peer review, 16, 17-18, 20, 37, 38, 81 Penile implants, 99, 172 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 Phagocytes, 63, 143, 144 Pharmacokinetic processes, 55, 85, 105 Placenta, 8, 248-249, 256-263 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 Pneumothorax, 114, 115, 116 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 uses of, 45, 46 reproductive/developmental, 3, 9, 87-88, 96-97, 249 Polyethylene, 21, 94, 95 Polymers, general, 42-45, 134 antibodies, 194-195 Polymorphism, 142, 185, 190 Polymorphonuclear leukocytes, 142 Polymyositis, see Dermatomyositis/polymyositis Polyurethane-coated implants, 3, 27 breast cancer, 61-62 capsular contracture, 61, 62-63, 64 complications, 56, 121, 148 explantations, 62, 63 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 Ptosis, 165, 223

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Page 537 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 infections, 168, 169 pain associated with, 176-177 deflation, 136 immunologic effects, 207 infections, 168, 169 inflatable implants, 57, 74 number performed, 2, 31-36 pain associated with, 176-177 regulatory controls, 31 replacement surgery, 119, 122 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 FDA, 96, 252 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 local complications, 5, 54 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 standards, 3, 12, 84, 96, 112 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 asthma, 108, 109, 112 pneumothorax, 114, 115, 116 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 complications, 117, 123 toxicologic studies, 90, 93, 111

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Page 538 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 closed capsulotomies, 4, 56 frequency, 135-141, 265 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 neurologic effects, 8, 247 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 FDA regulation, 2, 31 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 textured, 26, 144, 159 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 Scotland, 224, 237 Screening and diagnosis, 7, 9-10, 278-284, 504 applanation tonometry, 149-150 capsules, 148, 149 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 Silica, 3, 8, 39-40, 42 amorphous silica, 3, 39-40, 42, 50, 60, 261 crystalline silica, 3, 39, 60, 154, 247 immunologic effects, 186-187, 261-262 toxicologic effects, 8, 80 Silicon, general, 2, 3, 40-41, 43, 47, 49 Silicone, general, 2, 11 chemistry of, 40-42, 43, 44, 47, 60, 80, 134 consumer products, 2, 10 immune response, general, 179-182, 193-194

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Page 539 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 complications, 161, 163 Sjögrens syndrome (SS), 200, 224, 501, 506 Skin and skin diseases, 25, 57, 115, 192, 246 bacteria, 5 dimethylsiloxanes, 85, 86-87 discoloration, 23, 221 epidermolysis, 25 necrosis, 25, 121, 122 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 Standards, 1, 12, 504 breast feeding, 255 capsule monitoring, 149, 150, 153, 158 informed consent, 12 outcome measures, 12 toxicologic studies, 3, 12, 84, 96, 112 Steroids, 55, 178 adrenal, 5, 115, 164, 165, 166 contracture, 162, 164-167, 178 immunologic effects, 184 methylprednisolone, 164, 165, 166 triamcinolone, 164, 165 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 surgical skill, 124, 125 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

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Page 540 Dow Corning, 63, 67 gel, 26, 58, 162 infection, 64, 172 local complications, 117, 122-123; see also ''capsular contracture" supra number of, 37 patient satisfaction, 26 saline-filled, 26, 144, 159 seromas, 117, 173 types of, 55, 60, 61, 63-64, 67, 69, 70, 72, 74 Tin, 71, 110-112, 113 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 RTV silicone, 90, 93, 111 silica, 8, 80 skin and skin diseases, 81, 83, 89, 101, 108-109, 152 standards, 3, 12, 84, 96, 112 see also Cancer; Immunologic effects; Neurologic effects; Reproductive effects Toxic shock syndrome, 115, 116, 169 Transplacental delivery of silicone, see Placenta Triamcinolone, 164, 165 Triple-lumen implants, 55, 59, 74, 75 Tumors, 93-95, 241 carcinomas, 93-95, 233, 238-239 fibromas, 103, 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 United Kingdom, 224, 237 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 materials, 39, 59 see also Mammography; Magnetic resonance imaging