Safety of Silicone Breast Implants (1999) / Chapter Skim
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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, 4546, 47, 49, 92-99, 141-142, 156 525 see also Gel implants; Polyurethanecoated 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, 3435, 36, 37, 57-58 types of implants, 57-58 Amorphous silica, 3, 3940, 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, 179181, 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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, 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 INDEX 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, 108109 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)
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; 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, 234240, 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, 256263, 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, 283284 527 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, 127128, 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, 201208, 212-214 local complications, 120, 122, 133, 153, 155, 156, 158, 162, 163, 166 platinum toxicity, 109-110
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, 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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, 115, 185, 200, 205, 212, 215, 217-218, 221, 224, 257, 501, 503 Sjogrens 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)
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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 Fertility, 85 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 INDEX 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, 165166, 265 Eyes, 83, 101, 102, 246 F Fascia, 21, 91 Fatigue, 172, 184, 201, 205, 206, 207, 224, 227-232 (passim)
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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, 250 531 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)
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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 INDEX see also Magnetic resonance imaging; Mammography; Ultrasound; Xrays 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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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, 61 533 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)
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; 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 INDEX 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)
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, 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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, 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, 4245,134 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, 256263 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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. 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, 227232 (passim)
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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, 280282 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, 146147, 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, 4042, 43, 44, 47, 60, 80, 134 consumer products, 2, 10 immune response, general, 179-182, 193-194
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, 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)
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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 .
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