National Academies Press: OpenBook

Safety of Silicone Breast Implants (1999)

Chapter: Index

« Previous: Appendix D: Glossary
Suggested Citation:"Index." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×

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

Suggested Citation:"Index." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×

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

Suggested Citation:"Index." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×

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

Suggested Citation:"Index." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×

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

Suggested Citation:"Index." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×

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"

Suggested Citation:"Index." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×

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

Suggested Citation:"Index." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×

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

Suggested Citation:"Index." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×

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

Suggested Citation:"Index." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×

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

Suggested Citation:"Index." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×

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

Suggested Citation:"Index." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×

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

Suggested Citation:"Index." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×

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

Suggested Citation:"Index." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×

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

Suggested Citation:"Index." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×

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

Suggested Citation:"Index." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×

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

Suggested Citation:"Index." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×

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

Suggested Citation:"Index." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×
Page 525
Suggested Citation:"Index." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×
Page 526
Suggested Citation:"Index." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×
Page 527
Suggested Citation:"Index." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×
Page 528
Suggested Citation:"Index." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×
Page 529
Suggested Citation:"Index." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×
Page 530
Suggested Citation:"Index." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×
Page 531
Suggested Citation:"Index." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×
Page 532
Suggested Citation:"Index." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×
Page 533
Suggested Citation:"Index." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×
Page 534
Suggested Citation:"Index." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×
Page 535
Suggested Citation:"Index." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×
Page 536
Suggested Citation:"Index." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×
Page 537
Suggested Citation:"Index." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×
Page 538
Suggested Citation:"Index." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×
Page 539
Suggested Citation:"Index." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×
Page 540
Safety of Silicone Breast Implants Get This Book
×
Buy Paperback | $71.00 Buy Ebook | $54.99
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

The Dow Corning case raised serious questions about the safety of silicone breast implants and about larger issues of medical device testing and patient education.

Safety of Silicone Breast Implants presents a well-documented, thoughtful exploration of the safety of these devices, drawing conclusions from the available research base and suggesting further questions to be answered. This book also examines the sensitive issues surrounding women's decisions about implants. In reaching conclusions, the committee reviews:

  • The history of the silicone breast implant and the development of its chemistry.
  • The wide variety of U.S.-made implants and their regulation by the Food and Drug Administration.
  • Frequency and consequences of local complications from implants.
  • The evidence for and against links between implants and autoimmune disorders, connective tissue disease, neurological problems, silicone in breast milk, or a proposed new syndrome.
  • Evidence that implants may be associated with lower frequencies of breast cancer.

Safety of Silicone Breast Implants provides a comprehensive, well-organized review of the science behind one of the most significant medical controversies of our time.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text.

    « Back Next »
  6. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  7. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  8. ×

    View our suggested citation for this chapter.

    « Back Next »
  9. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!