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Journal of Legal Medicine Volume 18, 1997 - Issue 2
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Original Articles

Silicone breast implants

Can emerging medical, legal, and scientific concepts be reconciled?

Jack W. Snyder M.D., J.D., Ph.D. Associate Professor, Jefferson Medical College, Thomas Jefferson University, ; Thomas Jefferson University Hospital, 401 Foerderer Pavilion, 125 South 11th Street, Philadelphia, PA, 19107–4998
Pages 133-220 | Published online: 23 Jul 2009

  • Spiera , Gibofsky and Spiera . 1992 . Silicone Gel‐Filled Breast Implants and Connective Tissue Disease: An Overview . Silicone Implants: The Medical‐Legal Implications, A Conference of the American College of Legal Medicine , Oct. 29–31 : 5 (citing Dept. of Health and Human Services: Background Information on the Possible Risks of Silicone Implants (Feb. 8,1991))
  • Spiera , Gibofsky and Spiera . 1994 . Silicone Gel‐Filled Breast Implants and Connective Tissue Disease: An Overview . J. Rheumatol. , 21 : 239
  • Hilts . 1992 . FDA Acts to Halt Breast Implants Made of Silicone . N.Y. Times , Jan. 7 : Al (stating “[o]f the estimated two million American women who have had the devices implanted, about 80 percent did so because they wanted larger or better shaped breasts, and 20 percent were seeking reconstruction after having had a breast removed for breast cancer")
  • Bright , Jeng and Moore . 1993 . National Survey of Self‐Reported Breast Implants . J. Long‐Term Effects Medical Implants , 3 : 81 (304,000 women; 530,000 implants as of 1988) Theta Corporation, Soft Tissue Implants Market, Theta Market Report No. 224, at 5 1991 Theta Corporation, Soft Tissue Implants Market, Theta Market Report No. 606, at 22–34 (1987) (one million recipients as of 1988)
  • Cook , Delongchamp , Woodbury , Perkins and Harrison . 1995 . The Prevalence of Women with Breast Implants in the United States—1989 . J. Clin. Epidemiol. , 48 : 519 (815,700 women as of 1989)
  • Gabriel , O'Fallon , Beard , Kurland , Woods and Melton . 1995 . Trends in the Utilization of Silicone Breast Implants, 1964–1991, and Methodology for a Population‐Based Study of Outcomes . J. Clin. Epidemiol. , 48 : 527 3d
  • Terry , Skovron , Garbers , Sonnenschein and Toniolo . 1995 . The Estimated Frequency of Cosmetic Breast Augmentation among U.S. Women, 1963–1988 . Am. J. Pub. Health , 85 : 1122 (890,000 U.S. women as of 1988)
  • Cook and Perkins . 1996 . The Prevalence of Breast Implants among Women in the United States . Curr. Top. Microbiol. Immunol. , 210 : 419 (between 800,000 and 900,000 recipients in United States)
  • Bright and Moore Jr. 1996 . Estimating the Prevalence of Women with Breast Implants . Am. J. Pub. Health , 86 : 891 [letter]
  • Terry , Skovron , Garbers , Sonnenschein and Toniolo . 1996 . Estimating the Prevalence of Women with Breast Implants [response] . Am. J. Pub. Health , 86 : 892
  • Blum . 1992 . Publicity Sparks Interest in Breast Implant Suits . The Nat'l L.J. , Apr. 29 : 14
  • Kessler . 1992 . The Basis of the FDA's Decision on Breast Implants . New Eng. J. Med. , 326 : 1713
  • Kessler , Merkatz and Schapiro . 1993 . A Call for Higher Standards for Breast Implants [comment] . J.A.M.A. , 270 : 2607
  • Lundberg . 1993 . The Breast Implant Controversy, A Clash of Ethics and Law [editorial] . J.A.M.A. , 270 : 2608
  • 1992 . also Six Major Areas of Litigation Predicted for the I990's . Inside Litigation , 6 Mar. : 32 Attorneys for breast implant plaintiffs report that their clients are primarily seeking “money, sympathy, advice on therapy, and access to support groups.”
  • Gordon , R. 1993 . Attorney‐at‐Law . Mar. 29 Personal Communication
  • Brodeur , P. 1985 . Outrageous Misconduct
  • Mintz , M. 1985 . At Any Cost: Corporate Greed, Women and the Dalkon Shield
  • Pilchen . 1992 . Asbestos, “The Magic Mineral,” Creates Toxic Tort “Avalanche,” . Judicature , 75 Apr./May : 320
  • Miller and Ainsworth . 1991 . Resolving the Asbestos Personal Injury Litigation Crisis . Rev. Litig. , 10 Spring : 419
  • Hagan , Bailey and Browne . 1990 . Totalling Up the Costs of Asbestos Litigation: Guess Who Will Pay the Price? . Temp. Envtl. L. & Tech. J. , 9 : 1
  • Zimand . 1991 . National Asbestos Litigation: Procedural Problems Must Be Solved . Wash. U.L.Q. , 69 Fall : 899
  • Sanders . 1992 . The Bendectin Litigation: A Case Study in the Life Cycle of Mass Torts . Hastings L.J. , 43 Jan. : 301
  • Green . 1992 . Expert Witnesses and Sufficiency of Evidence in Toxic Substances Litigation: The Legacy of Agent Orange and Bendectin Litigation . Nw. U.L. Rev. , 86 : 643
  • Sobol , R.B. 1991 . Bending the Law: The Story of the Dalkon Shield Bankruptcy
  • Youdelman . 1986 . Strategic Bankruptcies: Class Actions, Classification & the Dalkon Shield Cases . Cardozo L. Rev. , 7 : 817
  • Schuck , P.H. 1986 . Agent Orange on Trial: Mass Toxic Disasters in the Courts
  • 1986 . Procedural History of the Agent Orange Product Liability Litigation, Symposium: Mass Torts after Agent Orange . Brook. L. Rev. , 52 : 335
  • Gross . Nov. 1 1984 . “ Factual and Legal History of the Agent Orange Litigation to Date ” . In Litigation and Administrative Practice Course Handbook Series: Litigation Preparation and Trial of a Complex Toxic Chemical or Hazardous Waste Case Nov. 1 , PLI Order No. H4–4954
  • Schultz . 1991 . Market Share Liability in DES Cases: The Unwarranted Erosion of Causation in Fact . DePaul L. Rev. , 40 : 771
  • 1991 . Recognizing DES Granddaughter's Preconception Strict Product Liability Claim . J. Contemp. L. , 17 : 175
  • Mascaro . 1991 . Preconception Tort Liability: Recognizing a Strict Liability Cause of Action for DES Grandchildren . Am. J.L. & Med. , 17 : 435
  • Levine . Jan. 1 1989 . “ Identification of the Manufacturer of Diethylstilbestrol (DES) ” . In Litigation and Administrative Practice Course Handbook Series, Drug and Medical Device Litigation Jan. 1 , 370 PLI/Lit 191, PLI Order No. H4–5063
  • Campion . Mar. 3 1988 . “ DES and Litigation: The First Ten Years ” . In Litigation and Administrative Practice Course Handbook Series, Effective Coordination of Multiple Product Liability Litigation Mar. 3 , 344 PLI/Lit 315 PLI Order No. H4–5040
  • Levy . Oct./Nov. 1992 . “ Toxic Tort and Product Liability Litigation ” . In Litigation and Administrative Practice Course Handbook Series, Toxic Tort Case Essentials: Strategies, Experts, Motions and ADR Oct./Nov. , 446 PLI/Lit 321, PLI Order No. H4–5144
  • Levine . Nov. 12 1992 . “ Introductory Remarks ” . In Litigating Breast Implant Cases—A Satellite Program Nov. 12 , PLI Order No. H‐451
  • Seider . “ Implant Types, Related Complications and Methods of Removal ” . In Silicone Implants 45 supra note 1 (describing the evolution of the search for satisfactory soft tissue replacement and augmentation, using ivory, amber, silver, gold, paraffin, and glass, and dating back to the writings of the ancient Greeks, Egyptians, Romans, and Sasruta from India)
  • LeVier , Harrison , Cook and Lane . 1993 . What Is Silicone? . Plast. Reconstr. Surg. , 92 : 163
  • Yoshida , Chang , Teuber and Gershwin . 1993 . Silicon and Silicone: Theoretical and Clinical Implications of Breast Implants . Regul. Toxicol. Pharmacol. , 17 : 3
  • Lane and Bums . 1996 . Silica, Silicon and Silicones ... Unraveling the Mystery [review] . Curr. Top. Microbiol. Immunol. , 210 : 3
  • Cronin and Gerow . . Augmentation Mammoplasty: A New “Natural Feel” Prosthesis . Transactions of the Third International Congress of Plastic Surgery, Excerpta Medica . pp. 41 – 49 . Amsterdam No. 66
  • Sergott , Limoli , Baldwin Jr. and Laub . 1986 . Human Adjuvant Disease, Possible Autoimmune Disease after Silicone Implantation: A Review of the Literature, Case Studies, and Speculation for the Future . Plast. Reconst. Surg. , 78 : 104
  • Wilkerson . Feb. 1992 . “ General Silicone Chemistry ” . In Distributed Communication to FDA Advisory Panel Feb. ,
  • Heggers , Kos‐sovsky , Parsons , Robson , Pelley and Raine . 1983 . Biocompatibility of Silicone Implants . Annals Plast. Surg. , 11 : 38
  • Bridges and Vasey . 1993 . Silicone Breast Implants: History, Safety, and Potential Complications . Arch. Int. Med. , 152 : 2638
  • Chan , Birdsell and Gradeen . 1991 . Detection of Toluenediamines in the Urine of a Patient with Polyurethane‐Covered Breast Implants . Clin. Chem. , 37 : 756 FDA, Update on Silicone Gel‐Filled Breast Implants (May 27, 1992). Introduced in 1970, the polyurethane foam covering was designed to alleviate capsular contracture associated with the basic silicone model. See infra notes 47–63 and accompanying text (discussing capsular contracture). However, these designs were removed from the market in early 1991, following identification of decomposition products of polyurethane in the body fluids of breast implant recipients. See
  • Lilla and Vistres . 1973 . Long‐Term Study of Reactions to Various Silicone Breast Implants in Rabbits . Plast. Reconstr. Surg. , 57 : 79 The polyurethane cover may deteriorate and separate from the implant, with or without subsequent migration. See, e.g.
  • Cocke , Leathers and Lynch . 1975 . Foreign Body Reactions to Polyurethane Covers of Some Breast Prostheses . Plast. Reconstr. Surg. , 56 : 527
  • Wagner , Beller and Pfautsch . 1977 . Electron and Light Microscopy Examination of Capsules Around Breast Implants . Plast. Reconstr. Surg. , 60 : 49
  • Smahel . 1978 . Tissue Reactions to Breast Implants Coated with Polyurethane . Plast. Reconstr. Suro. , 61 : 80
  • Ashley . 1982 . Disappearance of the Polyurethane Cover of the Ashley Natural‐Y Prosthesis . Plast. Reconstr. Surg. , 70 : 383
  • Slade and Peterson . 1982 . Disappearance of the Polyurethane Cover of the Ashley Natural‐Y Prosthesis . Plast. Reconstr. Surg. , 70 : 379
  • 1991 . Safety of Polyurethane‐Covered Breast Implants . Can. Med. A.J. , 145 : 1125 At this writing, there is no consensus that the proposed complications of breast implant surgery are causally linked to the degradation products of polyurethane. Expert Panel on the Safety of Poly‐urethane‐Covered Breast Implants
  • Umeda . 1955 . Production of Rat Sarcoma by Injections of Propylene Glycol Solution of m‐Toluylenediamine . GANN , 46 : 597 There is concern, however, about the carcinogenic potential of the breakdown products of polyurethane, especially TDI (toluene 2,4‐diisocyanate) and TDA (toluene 2,4‐diamine), which were removed from hair dyes several years ago because these agents were shown to cause sarcomas in rats. (The EPA has listed these agents as class B2 animal carcinogens.) See, e.g.,
  • Ito , Hiasa , Konishi and Marugami . 1969 . The Development of Carcinoma in Liver of Rats Treated with m‐Toluylenediamine and the Synergistic and Antagonistic Effects with Other Chemicals . Cancer Res. , 29 : 1137
  • Cardy . 1979 . Carcinogenicity and Chronic Toxicity of 2,4‐Toluenediamine in F344 Rats . J. Nat'l Cancer Inst. , 62 : 1107
  • Sontag . 1981 . Carcinogenicity of Substituted‐Benzenediamines (Phenylenediamines) in Rats and Mice . J. Nat'l Cancer Inst. , 66 : 591
  • Sepai , Henschler , Czech , Eckert and Sabbioni . 1995 . Exposure to Toluenediamines from Polyurethane‐Covered Breast Implants . Toxicol. Lett. , 11 : 371
  • Delclos , Blaydes , Heflich and Smith . 1996 . Assessment of DNA Adducts and the Frequency of 6‐Thioguanine Resistant T‐Lymphocytes in F344 Rats Fed 2,4‐Toluenediamine or Implanted with a Toluenediisocyanate‐Containing Polyester Polyurethane Foam . Mutat. Res. , 367 : 210
  • Borenstein . Nov. 12 1992 . “ Silicone Induced Collagen and Connective Tissue Disease ” . In Litigating Breast Implant Cases—A Satellite Program, Litigation and Administrative Practice Course Handbook Series, Drug and Medical Device Litigation Nov. 12 , PLI Order No. H451
  • Levine . “ Fundamental Issues in Litigating Breast Implant Cases ” . In Litigating Breast Implant Cases 15 17 – 18 . supra note 10
  • Bolton . “ The Evolution of Breast Implant Litigation ” . In Litigating Breast Implant Cases 127 155 – 84 . supra note 25
  • Rosenbaum . 1996 . The American College of Rheumatology Statement on Silicone Breast Implants Represents a Consensus . Arthritis & Rheumatism , 39 : 1765 For a basic review of the medical and scientific literature on breast implants
  • Nemecek and Young . 1993 . How Safe Are Silicone Breast Implants? . South. Med. J. , 86 : 932
  • Barondes , Judge , Towne and Baxter . 1950 . The Silicones in Medicine . The Military Surgeon , 106 : 379
  • Rees , Platt and Ballantyne Jr. 1965 . An Investigation of Cutaneous Response to Dimethylpolysiloxane (Silicone Liquid) in Animals and Humans—A Preliminary Report . Plast. & Reconstr. Surg. , 35 : 131
  • Ballantyne , Rees and Seidman . 1965 . Silicone Fluid: Response to Massive Subcutaneous Injections of Dimethypolysiloxane Fluid in Animals . Plast. & Reconstr. Surg. , 36 : 330
  • Ben‐Hur , Ballantyne , Rees and Seidman . 1967 . Local and Systemic Effects of Dimelhylpolysiloxane Fluid in Mice . Rast. Reconstruct. Surg. , 39 : 423
  • Rees , Ballantyne , Seidman and Hawthorne . 1967 . Visceral Response to Subcutaneous and Intraperito‐neal Injections of Silicone in Mice . Rast. & Reconstr. Surg. , 39 : 402 At very high doses (equivalent to 4 to 6 gallons in a 60 kilogram woman), PDMS fluid appeared in the spleen, liver, adrenals, and kidneys, but significant inflammation was not seen in those organs
  • Ashley , Braley , Rees , Goulian and Ballantyne Jr. 1967 . The Present Status of Silicone Fluid in Soft Tissue Augmentation . Plast. Reconstr. Surg. , 39 : 411
  • Hine , Elliott , Wright , Cavalli and Porter . 1969 . Evaluation of a Silicone Lubricant Injected Spinally . Toxicol. Appl. Pharmacol. , 15 : 566 The animals were sacrificed 30 or 90 days following administration of PDMS
  • Lilla . 1976 . Long‐Term Study of Reactions to Various Silicone Breast Implants in Rabbits . PLAST. Reconstr. Surg. , 57 : 637
  • Nalbandian , Swanson and Maupin . 1983 . Long‐Term Silicone Implant Arthroplasty . J.A.M.A. , 250 : 1195
  • Raposo , deAmaral , Tiziani , Cintra , Amstalden and Palhares . 1993 . Local Reaction and Migration of Injected Silicone Gel . Aesth. Plast. Surg. , 17 : 335
  • Oppenheimer , Oppenheimer , Danishefsky , Stout and Eirich . 1955 . Further Studies of Polymers as Carcinogenic Agents in Animals . Cancer Res. , 15 : 333
  • Russell , Simmers , Hirst and Pudenz . 1959 . Tumors Associated with Imbedded Polymers . J. Nat'l Cancer Inst. , 23 : 305
  • Mullison . 1966 . Current Status of Silicones in Plastic Surgery . Arch. Otolaryngol. , 83 : 59
  • 1990 . U.S. House of Representatives, Hearing Before the Human Resources and Inter‐Governmental Relations Subcommittee, Protecting Patients from the Dangers of Silicone Breast Implants . Dec. 18 (two‐year study by Dow Corning Corp. showed 23% of rats developed sarcomas at the site of implantation of medical grade silicone gel)
  • Oppenheimer , Oppenheimer and Stout . 1952 . Sarcomas Induced in Rodents by Imbedding Various Plastic Films . Proc. Soc. Exper. Biol. Med. , 79 : 366
  • Hueper . 1960 . Experimental Production of Cancer by Means of Implanted Polyurethane Plastic . Am. J. Clin. Path. , 34 : 328
  • Hueper . 1964 . Cancer Induction by Polyurethane and Polysilicone Plastics . J. Nat'l Cancer Inst. , 33 : 1005
  • Bischoff and Bryson . 1964 . Carcinogenesis Through Solid State Surfaces . Prog. Exp. Tumor Res. , 5 : 85
  • Autian . 1967 . Toxicological Aspects of Implants . J. Biomaterials Res. , 1 : 433
  • Autian . 1973 . The New Field of Plastics Toxicology: Methods and Results . CRC Crit. Rev. Toxicol. , 2 : 1
  • Autian , Singh , Turner , Hung , Nunez and Lawrence . 1975 . Carcinogenesis from Polyurethanes . Cancer Res. , 35 : 1591
  • Memoli , Urban , Alroy and Galante . 1986 . Malignant Neoplasms Associated with Orthopedic Implant Materials in Rats . J. Orthoped. Res. , 4 : 346
  • Schoen . 1987 . Biomaterial‐Associated Infection, Neoplasia, and Calcification: Clinicopathologic Features and Pathophysiologic Concepts . Trans. Amer. Soc. Artif. Intern. Organs , 8 : 8
  • Food and Drug Administration . 1989 . Safety of Silicone Prostheses . FDA Drug Bull. , 19 : 2
  • 1990 . United States House of Representatives, Hearings Before the Subcommittee on Human Resources and Inter‐Govemmental Relations, Committee on Government Operations, Background Information on the Possible Health Risks of Silicone Breast Implants . Dec. 18 (comments of W. Grindaker)
  • Vinnik . 1976 . Spherical Contracture of Fibrous Capsules Around Breast Implants . Plast. Reconstruct. Surg. , 58 : 555 See Spiera, et al., supra note 13, at 9 (stating that “[a] local reaction of fibrous encapsulation and contracture is well‐described, and discomfort or deformity from excess contracture is a major cause of poor outcome post‐augmentation mammoplasty.”). See also
  • Gayou and Rudolph . 1979 . Capsular Contraction Around Silicone Mammary Prostheses . Annals Plast. Surg. , 2 : 62
  • Shapiro . 1989 . Smooth v. Rough: An 8‐Year Survey of Mammary Prostheses . Plast. Reconstr. Surg. , 84 : 449
  • Ersek . 1991 . Rate and Incidence of Capsular Contracture: A Comparison of Smooth and Textured Silicone Double‐Lumen Breast Prostheses . Plast. Reconstr. Surg. , 87 : 879
  • Pollock . 1993 . Breast Capsular Contracture: A Retrospective Study of Texture Versus Smooth Silicone Implants . Plast. Reconstr. Surg. , 91 : 404
  • Handel , Jensen , Black , Waisman and Silverstein . 1995 . The Fate of Breast Implants: A Critical Analysis of Complications and Outcomes . Plast. Reconstr. Surg. , 96 : 1521
  • Thuesen , Sum , Christensen and Schroder . 1995 . Capsular Contracture after Breast Reconstruction with the Tissue Expansion Technique: A Comparison of Smooth and Textured Silicone Breast Prostheses . Scand. J. Plast. Reconstr. Surg. , 29 : 9
  • Ashbell . 1980 . Outpatient Breast Surgery under Intercostal Block Anesthesia . Plast. Reconstr. Surg. , 65 : 239 The precise incidence and prevalence of encapsulation are difficult to determine. See
  • Capozzi . 1982 . Polyurethane‐Covered Gel Mammary Implants [letter] . Plast. Reconstr. Surg. , 69 : 904 (citing contracture incidence of 0.6%)
  • Asplund . 1984 . Capsular Contracture in Silicone Gel and Saline‐Filled Breast Implants after Reconstruction . Plast. Reconstr. Suro. , 73 : 270 (citing contracture incidence of 54% for silicone implants)
  • Gylbert , Asplund and Jurell . 1990 . Capsular Contracture after Breast Reconstruction with Sili‐cone‐Gel and Saline‐Filled Implants: A 6‐Year Follow‐Up . Plast. Reconstr. Surg. , 85 : 373 (no new cases of contracture)
  • Coleman , Foo and Sharpe . 1991 . Textured or Smooth Implants for Breast Augmentation? A Prospective Controlled Trial . Brit. J. Plast. Surg. , 44 : 444 (58% contracture rate for smooth implants and 8% rate for textured implants)
  • Copeland , Choi and Bleiweiss . 1994 . Silicone Breakdown and Capsular Synovial Metaplasia in Tex‐tured‐Wall Saline Breast Prostheses . Plast. Reconstr. Surg. , 94 : 634
  • Emery , Spanier , Kasnic Jr. and Hardt . 1994 . The Synovial Structure of Breast‐Implant‐Associated Bursae . Mod. Pathol. , 7 : 728
  • del Rosario , Bui , Petrocine , Sheehan , Pastore , Singh and Ross . 1995 . True Synovial Metaplasia of Breast Implant Capsules: A Light and Electron Microscopic Study . Ultrastruct. Pathol. , 19 : 83
  • Hameed , Erlandson and Rosen . 1995 . Capsular Synovial‐Like Hyperplasia Around Mammary Implants Similar to Dentritic Synovitis: A Morphologic and Immunohistochemical Study of 15 Cases . Am. J. Surg. Pathol. , 19 : 433
  • Ko , Ahn , Ko , Chopra and Shaw . 1996 . Capsular Synovial Metaplasia as a Common Response to Both Textured and Smooth Implants . Plast. Reconstr. Surg. , 91 : 1427
  • Raso and Schulte . 1996 . Immu‐nolocalization of Keratan Sulfate, Chondroitin‐4‐Sulfate, and Chondroitin‐6‐Sulfate in Periproslhetic Breast Capsules Exhibiting Synovial Metaplasia . Plast. Reconstr. Surg. , 98 : 78
  • Spear and Baker Jr. 1995 . Classification of Capsular Contracture after Prosthetic Breast Reconstruction . Plast. Reconstr. Surg. , 96 : 1119 Diagnosis and measurement of the severity of contracture is inherently subjective, making it difficult to compare studies that have used different diagnostic criteria. The widely used Baker scale ranks implant outcomes on a scale from I (a breast with a soft and natural appearance) to IV (a hard breast with obvious spherical distortion). See
  • Benjamin and Guy . 1977 . Calcification of the Fibrous Capsule about Mammary Implants . Plast. Reconstr. Surg. , 59 : 249 Calcification, or deposition of calcium, may occur in the fibrous tissue capsules that form around breast implants. These calcium deposits rarely, if ever, signify the presence of breast cancer in women who have mammary implants. See
  • Peters and Pritzker . 1985 . Massive Heterotopic Ossification in Breast Implant Capsules . Aesth. Plast. Surg. , 9 : 43
  • Peters and Smith . 1995 . Calcification of Breast Implant Capsules: Incidence, Diagnosis, and Contributing Factors . Annals Plast. Surg. , 34 : 8
  • Asplund . 1984 . Capsular Contracture in Silicone Gel and Saline‐Filled Breast Implants after Reconstruction . Plast. Reconstr. Surg. , 73 : 270 Encapsulation does not seem to require the presence of silicone gel, because capsular contractures have been reported in recipients of saline‐filled implants. See
  • Maxwell and Perry . 1995 . The Capsule in Various Types of Breast Implants . Plast. Reconstr. Surg. , 95 : 937 However, some investigators report an association between the amount of silicone “bleeding” from the prosthesis and the intensity of the inflammatory response of the capsule, and silicone has been shown to be present in the capsule
  • Smahel . 1977 . Histology of the Capsules Causing Constrictive Fibrosis Around Breast Implants . Brit. J. Plast. Surg. , 30 : 324
  • Thomsen , Christensen , Nielsen , Brandt , Breiting , Felby and Nielsen . 1990 . Histologic Changes and Silicone Concentrations in Human Breast Tissue Surrounding Silicone Breast Prostheses . Plast. Reconstr. Surg. , 85 : 38 The possibility that periprosthetic bacterial contamination may contribute to contracture is supported by reports that bacteria can survive and proliferate in implants, and by observations that local antibacterial agents reduce the incidence of encapsulation of implants
  • Burkhardt , Dempsey , Schnur and Tofield . 1986 . Capsular Contracture: A Prospective Study of the Effect of Local Antibacterial Agents . Plast. Reconstr. Surg. , 77 : 919
  • Netscher , Weizer , Wigoda , Walker , Thornby and Bowen . 1995 . Clinical Relevance of Positive Breast Periprosthetic Cultures Without Overt Infection . Plast. Reconstr. Surg. , 96 : 1125
  • Walsh , Kliewer , Sullivan , Hertzberg , Paulson , Soo , Saksouk and Kornguth . 1995 . Periprosthetic Mycobacterial Infection: CT and Mammographic Findings . Clin. Imaging , 19 : 193
  • Coleman , Foo and Sharpe . 1991 . Textured or Smooth Implants for Breast Augmentation? A Prospective Controlled Trial . Brit. J. Plast. Surg. , 44 : 444 Movement of the implant in the tissue bed and a smooth rather than textured surface also have been implicated as causes of capsular contracture
  • Lossing and Hansson . 1993 . Peptide Growth Factors and Myofibroblasts in Capsules Around Human Breast Implants . Plast. Reconstr. Surg. , 91 : 1277 The precise role of the immune system in capsular contracture has not been elucidated
  • Mena , Kossovsky , Chu and Hu . 1995 . Inflammatory Intermediates Produced by Tissues Encasing Silicone Breast Prostheses . J. Invest. Surg. , 8 : 31
  • Sanger , Komorowski , Larson , Gingrass , Yousif and Matloub . 1995 . Tissue Humoral Response to Intact and Ruptured Silicone Gel‐Filled Prostheses . Plast. Reconstr. Surg. , 95 : 1033
  • O'Hanlon , Okada , Love , Dick , Young and Miller . 1996 . Immunohistopathology and T Cell Receptor Gene Expression in Capsules Surrounding Silicone Breast Implants . Curr. Top. Microbiol. Immunol. , 210 : 237
  • Peters , Shaw and Raju . 1980 . The Influence of Vitamin E on Capsule Formation and Contracture Around Silicone Implants . Annals Plast. Surg. , 5 : 347
  • Baker . 1981 . The Effectiveness of Alpha‐Tocopherol (Vitamin E) in Reducing the Incidence of Spherical Contracture Around Breast Implants . Plast. Reconstr. Surg. , 68 : 696
  • Caffee . 1987 . Vitamin E and Capsular Contracture . Annals Plast. Surg. , 19 : 512
  • Burkhardt , Fried , Schnur and Tofield . 1981 . Capsules, Infection, and Intraluminal Antibiotics . Plast. Reconstr. Surg. , 68 : 43
  • Shah , Lehman , Stevenson and Vistnes . 1982 . Capsular Contracture Around Silicone Implants: The Role of Intraluminal Antibiotics . Plast. Reconstr. Surg. , 69 : 809
  • Burkhardt , Dempsey , Schnur and Tofield . 1986 . Capsular Contracture: A Prospective Study of the Effect of Local Antibacterial Agents . Plast. Reconstr. Surg. , 11 : 919
  • Burkhardt and Eades . 1995 . The Effect of Biocell Texturing and Povidone‐Iodine Irrigation on Capsular Contracture Around Saline‐Inflatable Breast Implants . Plast. Reconstr. Surg. , 96 : 1317
  • Peterson and Burt . 1974 . The Role of Steroids in Prevention of Circumferential Capsular Scarring in Augmentation Mammoplasty . Plast. Reconstr. Surg. , 54 : 28
  • Ksander , Vistnes and Fogarty . 1978 . Experimental Effects on Surrounding Fibrous Capsule Formation from Placing Steroid in a Silicone Bag‐Gel Prosthesis Before Implantation . Plast. Reconstr. Surg. , 62 : 873
  • Lemperle and Exner . 1993 . Effect of Cortisone on Capsular Contracture in Double‐Lumen Breast Implants: Ten Years’ Experience . Aesth. Plast. Surg. , 17 : 317
  • Rennekampff , Exner , Lemperle and Nemsmann . 1992 . Reduction of Capsular Formation Around Silicone Breast Implants by D‐Penicillamine in Rats . Scand. J. Plast. Reconstr. Surg. Hand Surg. , 26 : 253
  • Rybka . 1980 . The Experimental Value of Silicone‐Sheet, Dacron Felt Spacers in Prevention of Capsular Contractures . Plast. Reconstr. Surg. , 66 : 502
  • Ersek . 1991 . Rate and Incidence of Capsular Contracture: A Comparison of Smooth and Textured Silicone Double‐Lumen Breast Prostheses . Plast. Reconstr. Surg. , 87 : 879
  • Hakelius and Ohlsen . 1992 . A Clinical Comparison of the Tendency to Capsular Contracture Between Smooth and Textured Gel‐Filled Silicone Mammary Implants . Plast. Reconstr. Surg. , 90 : 247
  • Asplund , Gylbert , Jurell and Ward . 1996 . Textured or Smooth Implants for Submuscular Breast Augmentation: A Controlled Study . Plast. Reconstr. Surg. , 97 : 1200
  • Bern , Burd and May Jr. 1992 . The Biophysical and Histologic Properties of Capsules Formed by Smooth and Textured Silicone Implants in the Rabbit . Plast. Reconstr. Surg. , 89 : 1037 (textured implants produced thicker capsules)
  • Hester , Nahai , Bostwick and Cukic . 1988 . A Five‐Year Experience with Polyurethane‐Covered Mammary Prostheses for Treatment of Capsular Contracture, Primary Augmentation Mammoplasty, and Breast Reconstruction . Clin. Plast. Surg. , 15 : 569
  • Buckspan . 1989 . Inserting the Polyurethane‐Covered Breast Implant . Plast. Reconstr. Surg. , 84 : 858
  • Hoefflin . 1990 . Extensive Experience with Polyurethane Breast Implants . Plast. Reconstr. Surg. , 86 : 166
  • Pennisi . 1990 . Long‐Term Use of Polyurethane Breast Prostheses: A 14‐Year Experience . Plast. Reconstr. Surg. , 86 : 368
  • McKinney and Tresley . 1983 . Long‐Term Comparisons of Patients with Gel and Saline Mammary Implants . Plast. Reconstr. Surg. , 72 : 27
  • Reiffel , Rees , Guy and Aston . 1983 . A Comparison of Capsule Formation Following Breast Augmentation by Saline‐Filled or Gel‐Filled Implants . Aesth. Plast. Surg. , 1 : 113
  • Gylbert , Asplund and Jurell . 1990 . Capsular Contracture after Breast Reconstruction with Silicone‐Gel and Saline‐Filled Implants: A 6‐Year Follow‐up . Plast. Reconstr. Surg. , 85 : 373
  • Ellenberg and Braun . 1980 . A 3'A Year Experience with Double‐Lumen Implants in Breast Surgery . Plast. Reconstr. Surg. , 65 : 307
  • Cherrup , Antaki , Liang and Hamas . 1989 . Measurement of Capsular Contracture: The Conventional Breast Implant and the Pittsburgh Implant . Plast. Reconstr. Surg. , 84 : 893
  • Chang , Caldwell , Reading and Wray Jr. 1992 . A Comparison of Conventional and Low‐Bleed Implants in Augmentation Mammoplasty . Plast. Reconstr. Surg. , 89 : 79
  • Puckett , Croll , Reichel and Concannon . 1987 . A Critical Look at Capsule Contracture in Subglandular Versus Subpectoral Mammary Augmentation . Aesth. Plast. Surg. , 11 : 23
  • Vazquez , Given and Houston . 1987 . Breast Augmentation: A Review of Subglandular and Submuscular Implantation . Aesth. Plast. Surg. , 11 : 101
  • Arrillaga , Ersek , Baricos and Ryan . 1977 . Method for the Prevention of Firm Breasts from Capsular Contraction . Plast. Reconstr. Surg. , 60 : 752
  • Barker and Schultz . 1980 . The Theory of Natural Capsular Contraction Around Breast Implants and How to Prevent It . Aesth. Plast. Surg. , 4 : 357
  • McCurdy . 1989 . Capsular Contraction Following Augmentation Mammoplasty: Etiology, Management, and Prevention . Am. J. Cosmet. Surg. , 6 : 141
  • Baker , Bartels and Douglas . 1976 . Closed Compression Technique for Rupturing a Contracted Capsule Around a Breast Implant . Plast. Reconstr. Surg. , 58 : 137
  • Addington and Mallin . 1978 . Closed Capsulotomy Causing Fractures of the Scar Capsule and the Silicone Bag of a Breast Implant . Plast. Reconstruct. Surg. , 62 : 300
  • Gruber and Friedman . 1978 . The Pressures Generated by Closed Capsulotomies of Augmented Breasts . Plast. Reconstr. Surg. , 62 : 379
  • Tolhurst . 1978 . "Nutcracker” Technique for Compression Rupture of Capsules Around Breast Implants . Plast. Reconstr. Surg. , 61 : 795
  • Little and Baker . 1980 . Results of Closed Compression Capsulotomy for Treatment of Contracted Breast Implant Capsules . Plast. Reconstr. Surg. , 65 : 30 See also infra notes 6878 and accompanying text (cases resulting from capsular contracture problems)
  • Freeman . 1972 . Successful Treatment of Some Fibrous Envelope Contractures Around Breast Implants . Plast. Reconstr. Surg. , 49 : 253
  • Sugimoto . 1982 . Open Capsulotomy for Capsule Contracture: A New Procedure for the Prevention of Recurrence . Aesth. Plast. Surg. , 6 : 225
  • Melmed . 1990 . Treatment of Breast Contractures with Open Capsulotomy and Replacement of Gel Prostheses with Polyurethane‐Covered Implants . Plast. Reconstr. Surg. , 86 : 270
  • Burkhardt . 1988 . Capsular Contracture: Hard Breasts, Soft Data . Clin. Plastic Surg. , 15 : 521 Treatment of encapsulation is often difficult because recurrence is frequent
  • Bostwick , J. 1990 . Plastic and Reconstructive Surgery 272 – 73 . (recurrence rate may exceed 50%). Open capsulotomy or other procedures to disrupt or remove a capsule may therefore be appropriate in order to avoid the risk of implant rupture and silicone gel extrusion following closed capsulotomy
  • Herrmann . 1995 . Endoscopic Capsulotomy by Means of Laser—A New Therapeutic Method in Cases of Capsular Contracture . Endosc. Surg. Allied Technol. , 3 : 112 Alternative approaches to capsular contracture include endoscopic capsulotomy and curettage. See
  • Siegel . 1996 . Curettage: An Alternative to Capsulectomy after Breast Implant Removal [letter] . Plast. Reconstr. Surg. , 97 : 870 To avoid calcifications, spiculated masses, cystic masses, and other complications of retained capsules, total capsulectomy has been advocated
  • Hardt , Yu , LaTorre and Steinbach . 1995 . Complications Related to Retained Breast Implant Capsules . Plast. Reconstr. Surg. , 95 : 364
  • Feliberti , Arrillaga and Cohen . 1977 . Rupture of Inflated Breast Implants in Closed Compression Capsulotomy: Case Report . Plast. Reconstr. Surg. , 59 : 848
  • Laughlin , Raynor and Habal . 1977 . Complications of Closed Capsulotomies after Augmentation Mammoplasty . Plast. Reconstr. Surg. , 60 : 362
  • Addington and Mallin . 1978 . Closed Capsulotomy Causing Fractures of the Scar Capsule and the Silicone Bag of a Breast Implant . Plast. Reconstruct. Surg. , 62 : 300
  • Gruber and Jones . 1981 . Review of Closed Capsulotomy Complications . Annals Plast. Surg. , 6 : 271
  • Moufar‐rege , Beauregard , Bosse , Papillon and Perras . 1987 . Outcome of Mammary Capsulotomies . Annals Plast. Surg. , 19 : 62
  • Goin . 1978 . High Pressure Injection of Silicone Gel into an Axilla—A Complication of Closed Compression Capsulotomy of the Breast . Plast. Reconstr. Surg. , 62 : 891 The Silastic MSI Mammary Implant package insert is cited in Bolton, supra note 27, at 160–61. For evidence of extravasation or local migration of silicone gel following closed capsulotomy
  • Huang , Blackwell and Lewis . 1978 . Migration of Silicone Gel after the “Squeeze Technique” to Rupture a Contracted Breast Capsule . Plast. Reconstr. Surg. , 61 : 277
  • Oneal . 1979 . High‐Pressure Injection of Silicone Gel into an Axilla—A Complication of Closed Compression Capsulotomy of the Breast . Plast. Reconstr. Surg. , 64 : 700
  • Masson , Dessapt and Rochet . 1982 . Migration of Silicone Gel after Rupture of a Breast Prosthesis During an External Capsulotomy . Annales Chirurgie Plast. Esthet. , 27 : 369
  • Sanger , Matloub , Yousif and Komorowski . 1992 . Silicone Gel Infiltration of a Peripheral Nerve and Constrictive Neuropathy Following Rupture of a Breast Prosthesis . Plast. Reconstr. Surg. , 89 : 949
  • Peters , Keystone and Smith . 1994 . Factors Affecting the Rupture of Silicone Gel Breast Implants . Annals Plast. Surg. , 32 : 449 For detailed discussion of the factors (for example, trauma, mammography, implant age, closed capsulotomy) that may influence the rupture of breast implants,
  • Pickford and Webster . 1994 . Implant Rupture by Mammography . Brit. J. Plast. Surg. , 47 : 512
  • Pramod and Thoma . 1994 . Breast Implant Rupture Due to Gunshot Injury . Plast. Reconstr. Surg. , 94 : 893
  • Beraka . 1995 . Rupture of Implants Following Mammography . Plast. Reconstr. Surg. , 95 : 936 Extravasation of silicone is well‐described following non‐intentional rupture of breast implants
  • Wintsch , Smahel and Clodius . 1978 . Local and Regional Lymph Node Response to Ruptured Gel‐Filled Mammary Prostheses . Brit. J. Plast. Surg. , 31 : 349
  • Worten , Seifert and Sherwood . 1980 . Late Leakage of Inflatable Silicone Breast Prostheses . Plast. Reconstr. Surg. , 65 : 302
  • Cohen . 1984 . Leakage of Breast Prostheses . Arch. Surg. , 119 : 615
  • Reynaud , Gary‐Bobo and Baron . 1987 . Rupture of a Breast Prosthesis with Leakage of Silicone . Annales Chirurgie Plast. Esthet. , 32 : 367
  • Rice , Agasthian , Clay and Deschamps . 1995 . Silicone Thorax: A Complication of Tube Thoracostomy in the Presence of Mammary Implants . Annals Thorac. Surg. , 60 : 1417
  • Silverman , Brown , Bright , Kaczmarek , Arrowsmith‐Lowe and Kessler . 1996 . Reported Complications of Silicone Gel Breast Implants: An Epidemiologic Review . Annals Int. Med. , 124 : 744 (citing rupture rates from less than 5% to more than 50%)
  • Robinson Jr. , Bradley and Wilson . 1995 . Analysis of Explanted Silicone Implants: A Report of 300 Patients . Annals Plast. Surg. , 34 : 1
  • Council on Scientific Affairs, American Medical Association . 1993 . Silicone Gel Breast Implants . J.A.M.A. , 270 : 2602
  • Wise , Kent , Baines and Finegold . 1994 . Silicone Gel Breast Implants [comments] . J.A.M.A. , 272 : 271 See also Spiera, supra note 1, at 8–9. In his article, Dr. Spiera specifically asks, “what are the risks of rupture?” After reviewing the studies conducted on this subject, he concludes that the exact incidence of rupture is uncertain. Local effects may include inflammation accompanied by redness, swelling, and pain at the implantation site. He concludes, “thus, in effect, prosthesis rupture constitutes a direct exposure of subcutaneous tissue to silicone gel, and the changes that are seen are identical to those seen following direct silicone injection.” Id. at 9
  • de Camara , Sheridan and Kammer . 1993 . Ruptures and Aging of Silicone Gel Breast Implants . Plast. Reconstr. Surg. , 91 : 828 The currently preferred method for confirmation of rupture is explantation (removal) and inspection of the implant. Although flawed by sampling bias and nonuniform definitions of rupture and leakage, at least five studies of expiants suggest that the risk for rupture increases with the age of the implant
  • Schmidt . 1995 . Re: Analysis of Explanted Silicone Implants: A Report of 300 Patients [letter, comment] . Annals Plast. Surg. , 35 : 335
  • Netscher , Weizer , Malone , Walker , Thomby and Patten . 1996 . Diagnostic Value of Clinical Examination and Various Imaging Techniques for Breast Implant Rupture as Determined in 81 Patients Having Implant Removal . South. Med. J. , 89 : 397
  • Wolf , Brandon , Young , Jerina and Srivastava . 1996 . Chemical, Physical, and Mechanical Analysis of Explanted Breast Implants . Curr. Top. Microbiol. Immunol. , 210 : 25
  • Cohen . 1992 . Exploiting Ex‐plantation [letter] . Plast. Reconstr. Surg. , 90 : 931 As a treatment, explantation may be indicated not only for rupture, but also for infection, extrusion, capsular contracture, siliconoma, breast pain, malposition, and patient fear
  • Halleland . 1992 . Physician Liability for Failure to Remove Breast Implants . Minn. Med. , 75 : 31
  • Friedman . 1994 . Silicone Breast Prostheses Implantation and Explantation . Semin. Arthritis Rheum. , 24 ( Supp. 1 ) : 8
  • Slavin and Goldwyn . 1995 . Silicone Gel Implant Explantation: Reasons, Results, and Admonitions . Plast. Reconstr. Surg. , 95 : 63
  • van Rappard , Sonneveld , van Twisk and Borghouts . 1988 . Pressure Resistance of Breast Implants as a Function of Implantation Time . Annals Plast. Surg. , 21 : 566 Relying on compression, tensiometry, or “breaking force” tests of intact, explanted prostheses, at least three groups have suggested that, as implants age, they are more susceptible to rupture from external pressure. See
  • Greenwald , Randolph and May . 1996 . Mechanical Analysis of Explanted Silicone Breast Implants . Plast. Reconstr. Surg. , 98 : 269
  • Phillips , de Camara , Lockwood and Grebner . 1996 . Strength of Silicone Breast Implants . Plast. Reconstr. Surg. , 97 : 1215
  • Dowden . 1993 . Detection of Gel Implant Rupture: A Clinical Test . Plast. Reconstr. Surg. , 91 : 548
  • Stone and Dowden . 1994 . Breast Implant Endoscopy: Detecting Leaks in Silicone‐Gel Breast Implants . AORN J. , 50 : 1007
  • Beer and Kompatscher . 1995 . Endoscopic Plastic Surgery: The Endoscopic Evaluation of Implants after Breast Augmentation . Aesth. Plast. Surg. , 19 : 353
  • Caffee , Hardt and LaTorre . 1995 . Detection of Breast Implant Rupture with Aspiration Cytology . Plast. Reconstr. Surg. , 95 : 1145
  • Destouet , Monsees , Oser , Nemecek , Young and Pilgram . 1992 . Screening Mammography in 350 Women with Breast Implants: Prevalence and Findings of Implant Complications . Am. J. Roentgenol. , 159 : 973
  • Ganott , Harris , Ilkhanipour and Costa‐Greco . 1992 . Augmentation Mammoplasty: Normal and Abnormal Findings with Mammography and US . Radiographics , 12 : 281
  • Berg , Caskey , Hamper , Anderson , Chang , Sheth , Zerhouni and Kuhlman . 1993 . Diagnosing Breast Implant Rupture with MR Imaging, US, and Mammography . Radiographics , 13 : 1323
  • Beekman , Scot , Vavamerongen , Hage and Mulder . 1996 . Silicone Implant Bleed and Rupture—Clinical Diagnosis and Predictive Value of Mammography and Ultrasound . Annals Plast. Surg. , 36 : 345
  • Caccialanza , Magnani , Segalini and Canepari . 1994 . New Uses of Mammary Ultrasonography . Aesth. Plast. Surg. , 18 : 189
  • Liston , Malata , Varma , Scott and Sharpe . 1994 . The Role of Ultrasound Imaging in the Diagnosis of Breast Implant Rupture . Brit. J. Plast. Surg. , 47 : 477
  • Petro , Klein , Niazi , Salzberg and Byrne . 1994 . Evaluation of Ultrasound as a Tool in the Follow‐up of Patients with Breast Implants: A Preliminary, Prospective Study . Annals Plast. Surg. , 32 : 580
  • Berg , Caskey , Hamper , Kuhlman , Anderson , Chang , Sheth and Zerhouni . 1995 . Single‐ and Double‐Lumen Silicone Breast Implant Integrity: Prospective Evaluation of MR and US Criteria . Radiology , 197 : 45
  • Weizer , Malone , Netscher , Walker and Thornby . 1995 . Utility of Magnetic Resonance Imaging and Ultrasonography in Diagnosing Breast Implant Rupture . Annals Plast. Surg. , 34 : 352
  • Beekman , Scot , Vavamerongen , Hage and Mulder . 1996 . Silicone Implant Bleed and Rupture—Clinical Diagnosis and Predictive Value of Mammography and Ultrasound . Annals Plast. Surg. , 36 : 345
  • Chung , Wilkins , Beil Jr. , Helvie , Ikeda , Oneal , Forrest and Smith Jr. 1996 . Diagnosis of Silicone Gel Breast Implant Rupture by Ultrasonography . Plast. Reconstr. Surg. , 97 : 104
  • Venta , Salomon , Flisak , Venta , Izquierdo and Angelats . 1996 . Sonographic Signs of Breast Implant Rupture . Am. J. Roentgenol. , 166 : 1413
  • Ahn , Shaw , Narayanan , Gorczyca , Sinha , Debruhl and Bassett . 1993 . Definitive Diagnosis of Breast Implant Rupture Using Magnetic Resonance Imaging . Plast. Reconstr. Surg. , 92 : 681
  • Mukundan Jr. , Dixon , Kruse , Monticciolo and Nelson . 1993 . MR Imaging of Silicone Gel‐Filled Breast Implants In Vivo with a Method that Visualizes Silicone Selectively . J. Magn. Reson. Imaging , 3 : 713
  • DeAngelis , de Lange , Miller and Morgan . 1994 . MR Imaging of Breast Implants . Radiographics , 14 : 783
  • Harms , Flamig , Evans , Harries and Brown . 1994 . MR Imaging of the Breast: Current Status and Future Potential . Am. J. Roentgenol. , 163 : 1039
  • Kruggel . 1994 . MRI for Diagnosis of Breast Implant Rupture . Plast. Reconstr. Surg. , 94 : 741
  • Monticciolo , Nelson , Dixon , Bostwick 3d , Mukundan and Hester . 1994 . MR Detection of Leakage from Silicone Breast Implants: Value of a Silicone‐Selective Pulse Sequence . Am. J. Roentgenol. , 163 : 51
  • Frankel , Occhipinti , Kaufman , Kramer , Carlson , Mineyev , Eshima and Friedenthal . 1995 . MRI Findings in Subjects with Breast Implants . Plast. Reconstr. Surg. , 96 : 852
  • Mason , White , McAvoy and Goldberg . 1995 . MR Imaging of Slipped Stack Breast Implants: A Potential Pitfall in the Diagnosis of Intracapsular Rupture . Magn. Reson. Imaging , 13 : 339
  • Weizer , Malone , Netscher , Walker and Thornby . 1995 . Utility of Magnetic Resonance Imaging and Ultrasonography in Diagnosing Breast Implant Rupture . Annals Plast. Surg. , 34 : 352
  • Soo , Komguth , Walsh , Ellenberger and Georgiade . 1996 . Complex Radial Folds Versus Subtle Signs of Intracapsular Rupture of Breast Implants: MR Findings with Surgical Correlation . Am. J. Roentgenol. , 166 : 1421
  • Steinbach , Hiskes Jr. , Fitzsimmons and Lanier . 1992 . Phantom Evaluation of Imaging Modalities for Silicone Breast Implants . Invest. Radiol. , 27 : 841
  • Ahn , DeBruhl , Gorczyca , Shaw and Bassett . 1994 . Comparative Silicone Breast Implant Evaluation Using Mammography, Sonography, and Magnetic Resonance Imaging: Experience with 59 Implants . Plast. Reconstr. Surg. , 94 : 620
  • Brenner . 1994 . Breast MR Imaging: An Analysis of Its Role with Respect to Other Imaging Interventional Modalities . Magn. Reson. Imaging Clin. N. Am. , 2 : 705
  • Everson , Parantainen , Detlie , Stillman , Olson , Landis , Foshager , Cunningham and Griffiths . 1994 . Diagnosis of Breast Implant Rupture: Imaging Findings and Relative Efficacies of Imaging Techniques . Am. J. Roentgenol. , 163 : 57
  • Samuels , Rohrich , Weatherall , Ho and Goldberg . 1995 . Radiographic Diagnosis of Breast Implant Rupture: Current Status and Comparison of Techniques . Plast. Reconstr. Surg. , 96 : 865
  • Barker , Retsky and Schultz . 1978 . Bleeding of Silicone from Bag‐Gel Breast Implants and Its Clinical Relation to Fibrous Capsule Reaction . Plastic Reconstr. Surg. , 61 : 836
  • Rudolph , Abraham , Vecchione , Guber and Woodward . 1978 . Myofibroblasts and Free Silicon Around Breast Implants . Plast. Reconstr. Surg. , 62 : 185
  • Price and Barker . 1983 . Initial Clinical Experience with “Low Bleed” Breast Implants . Aesth. Plast. Surg. , 1 : 255
  • Caffee . 1986 . The Influence of Silicone Bleed on Capsular Contracture . Annals Plast. Surg. , 17 : 284
  • Cocke and Sampson . 1988 . Silicone Bleed Associated with Double‐Lumen Breast Prostheses . Annals Plast. Surg. , 20 : 399
  • Thomsen , Christensen , Nielsen , Brandt , Breiting , Felby and Nielson . 1990 . Histological Changes and Silicone Concentrations in Human Breast Tissue Surrounding Silicone Breast Prostheses . Plast. Reconstr. Surg. , 85 : 38
  • 1992 . Plast. Reconstr. Surg. , 90 : 340
  • Dowden . 1993 . Definition of Terms for Describing Loss of Gel from Breast Implants . Am. J. Roentgenol. , 160 : 1360
  • Hayes Jr. 1993 . Could Tight Breast Capsules “Squeeze” a Significant Amount of Silicone Gel Out of an Implant? [letter] . Plast. Reconstr. Surg. , 92 : 557 At least two in vitro studies have documented the potential for silicone to exude through the envelope of gel‐filled breast implants
  • Bergman and van der Ende . 1979 . Exudation of Silicone Through the Envelope of Gel‐Filled Prostheses: An In Vitro Study . Brit. J. Rast. Surg. , 32 : 31
  • Yu , LaTorre , Marotta , Batich and Hardt . 1996 . In Vitro Measurement of Silicone Bleed from Breast Implants . Plast. Reconstr. Surg. , 97 : 756 The value of MRI or NMR for monitoring the biostability of various types of implants remains to be determined
  • Cohen . 1993 . Identification and Location of Extravasated Silicone Gel Using Magnetic Resonance Imaging [letter] . Plast. Reconstr. Surg. , 91 : 1371
  • Dorne , Stroman , Rolland , Auger , Alikacem , Bronskill , Grondin , King and Guidoin . 1994 . Magnetic Resonance Study of Virgin and Explanted Silicone Breast Prostheses: Can Proton Relaxation Times Be Used to Monitor Their Biostability? . ASAIO J. , 40 : M625
  • Dorne , Alikacem , Guidoin and Auger . 1995 . High Resolution Solid‐State 29 Si NMR Spectroscopy ofSilicone Gels Used to Fill Breast Prostheses . Magn. Reson. Med. , 34 : 548 The contribution of gel “bleed” to periprosthetic inflammation or to possible migration of silicone to distant parts of the body remains controversial
  • Fisher . 1992 . Editorial: The Fate of Implantable Silicone . Hosp. Prac. , 27 : 9 (stating that the “unfortunate term ‘gel bleed’ ... suggests a process depicted by media artists as a spreading inkblot of vagrant silicone. This depiction simply does not reflect reality .... Silicone is hydrophobic and therefore does not move easily through the body's aqueous environment.”)
  • Brody . 1977 . Fact and Fiction about Breast Implant “Bleed,” . Plast. Reconstr. Surg. , 60 : 615
  • Vargas . 1979 . Shedding of Silicone Particles from Inflated Breast Implants [letter] . Plast. Reconstr. Surg. , 64 : 252 Textured silicone shells may shed fragments more frequently than smooth shells. See
  • Copeland , Choi and Bleiweiss . 1994 . Silicone Breakdown and Capsular Synovial Metaplasia in Textured‐Wall Saline Breast Prostheses . Plast. Reconstr. Surg. , 94 : 628
  • Baitch , DePalma , Morotta and LaTorre . 1996 . Silicone Degradation Reactions . Curr. Top. Microbiol. Immunol. , 210 : 13
  • Garrido , Pfleiderer , Jenkins , Hulka and Kopans . 1994 . Migration and Chemical Modification of Silicone in Women with Breast Prostheses . Magn. Reson. Med. , 31 : 328
  • Garrido , Bogdanova , Cheng , Pfleiderer , Tokareva , Ackerman and Brady . 1996 . Detection of Silicone Migration and Biodegradation with NMR . Curr. Top. Microbiol. Immunol. , 210 : 49
  • Leibman , Kossoff and Kruse . 1992 . Intraductal Extension of Silicone from a Ruptured Breast Implant . Plast. Reconstr. Surg. , 89 : 546
  • Raso . 1993 . Microscopic Demonstration of Intraductal Extension of Silicone from a Ruptured Breast Implant [letter] . Plast. Reconstr. Surg. , 92 : 176
  • Holten and Barnett . 1995 . Intraductal Migration of Silicone from Intact Gel Breast Prostheses . Plast. Reconstr. Surg. , 95 : 567
  • Seitchik . 1996 . Macroscopic Intraductal Silicone Gel [letter] . Plast. Reconstr. Surg. , 97 : 487
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  • Ahn and Shaw . 1994 . Regional Silicone‐Gel Migration in Patients with Ruptured Implants . Annals Plast. Surg. , 33 : 201
  • Kulber , Mackenzie , Steiner , Glassman , Hopp , Hiatt and Hoffman . 1995 . Monitoring the Axilla in Patients with Silicone Gel Implants . Annals Plast. Surg. , 35 : 580
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  • Benjamin , Ahmed , Rashid and Wright . 1982 . Silicone Lymphadenopathy: A Report of Two Cases, One with Concomitant Malignant Lymphoma . Diagnost. Histopathol. , 5 : 133
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  • Lin , DiLeonardo and Jacoby . 1993 . Silicone Lymphadenopathy: A Case Report and Review of the Literature . Am. J. Dermatopathol. , 15 : 82
  • Rivero , Schwartz and Mies . 1994 . Silicone Lymphadenopathy Involving Intra‐mammary Lymph Nodes: A New Complication of Silicone Mammoplasty . Am. J. Roentgenol. , 162 : 1089
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  • Chen , Lu and Perng . 1993 . Silicone Fluid‐Induced Pulmonary Embolism . Ann. Rev. Respir. Dis. , 147 : 1299
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  • Pfleiderer and Garrido . 1995 . Migration and Accumulation of Silicone in the Liver of Women with Silicone Gel‐Filled Breast Implants . Magn. Reson. Med. , 33 : 8
  • Teuber , Ito , Anderson and Gershwin . 1995 . Silicone Breast Implant‐Associated Scarring Dystrophy of the Arm . Arch. Dermatol. , 131 : 54
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  • Chen . 1995 . Silicone Injection Granulomas of the Breast: Treatment by Subcutaneous Mastectomy and Immediate Subpectoral Breast Implant . Brit. J. Plast. Surg. , 48 : 71
  • Kuiper . 1973 . Silicone Granulomatous Disease of the Breast Simulating Breast Cancer . Mich. Med. , Mar. : 215
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  • Silver , Sahn , Allen , Sahn , Greene , Maize and Garen . 1993 . Demonstration of Silicon in Sites of Connective‐Tissue Disease in Patients with Silicone‐Gel Breast Implants . Arch. Dermatol. , 129 : 63 To identify and document the presence of foreign material in tissues surrounding breast implants, various analytical techniques have been developed to complement light and electron microscopy
  • Hardt , Yu , LaTorre and Steinbach . 1994 . Fourier Transform Infrared Microspectroscopy Used to Identify Foreign Materials Related to Breast Implants . Mod. Pathol. , 7 : 669
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  • Greene , Raso , Walsh , Harley and Silver . 1995 . Electron Probe Microanalysis of Silicon and the Role of the Macrophage in Proximal (Capsule) and Distant Sites in Augmentation Mammoplasty Patients . Plast. Reconstr. Surg. , 95 : 513
  • Schaeberle , Kalasinsky , Luke , Lewis , Levin and Treado . 1996 . Raman Chemical Imaging: Histo‐pathology of Inclusions in Human Breast Tissue . Anal. Chem. , 68 : 1829
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  • Levin , Modan , Petit , Le , Mouriesse , Hall , Catnach , Fairclough , Deapen , Brody and Berkel . 1993 . Correspondence—Breast Augmentation and the Risk of Subsequent Breast Cancer . N. Eng. J. Med. , 328 : 661
  • Park , Black and Watson . 1993 . Silicone Gel Breast Implants, Breast Cancer and Connective Tissue Disorders . Brit. J. Surg. , 80 : 1097
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  • Leibman and Kruse . 1990 . Breast Cancer: Mammographic and Sonographic Findings after Augmentation Mammoplasty . Radiology , 174 : 195
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  • Flamm . “ Radiological Findings in Ruptured and Intact Implants: Mammography ” . In Silicone Implants 26 supra note 1
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  • Silverstein , Gierson , Gamagami , Handel and Waisman . 1990 . Breast Cancer Diagnosis and Prognosis in Women Augmented with Silicone Gel‐Filled Implants . Cancer , 66 : 97
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  • Cahan , Ashikari , Pressman , Cody , Hoffman and Sherman . 1995 . Breast Cancer after Breast Augmentation with Silicone Implants . Annals Surg. Oncol. , 2 : 121 (no difference between augmented and non‐augmented women in stage of presentation of tumor)
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  • Lee , Goldstein and Zarem . 1995 . Localized Mycobacterium Avium‐Intracellulare Mastitis in an Immunocompetent Woman with Silicone Breast Implants . Plast. Reconstr. Surg. , 95 : 142
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  • Marques , Brenda , Saldiva and Andrews . 1992 . Capsular Hematoma as a Late Complication in Breast Reconstruction with Silicone Gel Prostheses . Plast. Reconstr. Surg. , 89 : 543
  • Frankel , Occhipinti , Kaufman , Hunt and Kerley . 1994 . MRI of a Silicone Breast Implant Surrounded by an Enlarging Hemorrhagic Collection . Plast. Reconstr. Surg. , 94 : 865
  • Cederna . 1995 . Hematoma as a Late Complication in Breast Reconstruction with Silicone Gel Prostheses . Plast. Reconstr. Surg. , 96 : 235
  • Daw , Lewis and Smith . 1996 . Chronic Expanding Hematoma Within a Periprosthetic Breast Capsule . Plast. Reconstr. Surg. , 97 : 1469
  • Fisher . 1990 . Reactions at Silicone‐Injected Sites on the Face Associated with Silicone Breast Implant “Inflammation” or “Rejection,” . Cuns , 45 : 393
  • Lazar and Lazar . 1991 . Localized Morphea after Silicone Gel Breast Implantation: More Evidence for a Cause and Effect Relationship . Arch. Dermatol. , Y21 : 263
  • Spiers , Grotting and Osura . 1994 . An Epidermal Proliferative Reaction Associated with a Silicone Gel Breast Implant . Am. J. Dermatopathol. , 16 : 315
  • Schiller , Arndt and Brenner . 1995 . Aggressive Fibromatosis of the Chest Associated with a Silicone Breast Implant . Chest , 105 : 1466
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  • Lu , Shoaib and Patten . 1994 . Atypical Chest Pain Syndrome in Patients with Breast Implants . South. Med. J. , 87 : 978
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  • Signorini , Grisotti , Ponzielli , Pajardi and Gilardino . 1994 . Self‐Expanding Prostheses Complicating Augmentation Mammoplasties . Aesth. Rast. Surg. , 18 : 195
  • Levine and Buchanan . 1983 . Decreased Swimming Speed Following Augmentation Mammoplasty . Plast. Reconstr. Surg. , 71 : 255
  • Lissner . 1983 . Augmentation and Sports [letter] . Plast. Reconstr. Surg. , 72 : 735
  • Wall , Martin , Fritzler and Edworthy . 1995 . Non‐fasting Chylomicronaemia in Breast Implant Patients [letter] . Lancet , 345 : 1380
  • Kirwan . 1995 . Two Cases of Apparent Silicone Allergy [letter] . Rast. Reconstr. Surg. , 96 : 236
  • Sabbagh , Murphy Jr. , Kucirka and Okunski . 1996 . Idiosyncratic Allergic Reaction to Textured Saline Implants . Plast. Reconstr. Surg. , 97 : 820
  • Kossovsky , Cole and Zackson . 1990 . Giant Cell Myocarditis Associated with Silicone: An Unusual Case of Biomaterials Pathology Discovered at Autopsy Using X‐Ray Energy Spectroscopic Techniques . Am. J. Clin. Pathol. , 93 : 148
  • Sendagorta and Ledo . 1995 . Sezary Syndrome in Association with Silicone Breast Implant [letter; comment] . J. Am. Acad. Dermatol. , 33 : 1060
  • Duvic , Moore , Menter and Vonderheid . 1995 . Cutaneous T‐Cell Lymphoma in Association with Silicone Breast Implants . J. Am. Acad. Dermatol. , 32 : 939
  • Cook , Osborne , Connor and Strauss . 1995 . Follicular Lymphoma Adjacent to Foreign Body Granulomatous Inflammation and Fibrosis Surrounding Silicone Breast Prosthesis . Am. J. Surg. Pathol. , 19 : 712
  • Potter , Morrison , Wiener , Zhang and Miller . 1994 . Induction of Plasmacytomas with Silicone Gel in Genetically Susceptible Strains of Mice . J. Nat'l Cancer Inst. , 86 : 1058
  • Rabkin , Silverman , Tricot , Garland , Ballester and Potter . 1996 . The National Cancer Institute Silicone Implant/Multiple Myeloma Registry . Curr. Top. Microbiol. Immunol. , 210 : 385
  • Garland , Ballester , Vasey , Benson , Moscinski , Farmelo , Rodriguez and Rapaport . 1996 . Multiple Myeloma in Women with Silicone Breast Implants: Serum Immunoglobulin and Interleukin‐6 Studies in Women at Risk . CURR. Top. Microbiol. Immunol. , 210 : 361
  • Tricot , Naucke , Vaught , Vesole , Jagannath and Barlogie . 1996 . Is the Risk of Multiple Myeloma Increased in Patients with Silicone Implants? . Curr. Top. Microbiol. Immunol. , 210 : 357
  • Deapen and Brody . 1995 . Re: Induction of Plasmacytomas with Silicone Gel in Genetically Susceptible Strains of Mice [letter] . I. Nat'l Cancer Inst. , 87 : 315
  • Kyle . 1996 . Monoclonal Gammopathy of Undetermined Significance . Curr. Top. Microbiol. Immunol. , 210 : 375
  • Silverman , Vescio , Silver , Renner , Weiner and Berenson . 1996 . Silicone Gel Implants and Monoclonal Gammopathies: Three Cases of Multiple Myeloma and the Prevalence of Multiple Myeloma and Monoclonal Gammopathy of Undetermined Significance . Curr. Top. Microbiol. Immunol. , 210 : 367
  • Bernet and Finger . 1994 . Graves’ Disease Following Silicone Breast Implantation [letter, comment] . J. Rheumatol. , 21 : 2169
  • Olesen , Ejlertsen and Nielsen . 1991 . Toxic Shock Syndrome Following Insertion of Breast Prostheses . Brit. J. Surg. , 78 : 585
  • Poblete , Rodgers and Wolfort . 1995 . Toxic Shock Syndrome as a Complication of Breast Prostheses . Plast. Reconstr. Surg. , 96 : 1702
  • Levenson , Greenberger and Murphy . 1996 . Peripheral Eosinophilia, Hyperimmunoglobulinemia A, and Fatigue—Possible Complications Following Rupture of Silicone Breast Implants . Annals Al‐lerg. Asthma Immunol. , 77 : 119
  • Sergott , Limoli , Baldwin and Laub . 1986 . Human Adjuvant Disease, Possible Autoimmune Disease after Silicone Implantation: A Review of the Literature, Case Studies, and Speculation for the Future . Plast. Reconstr. Surg. , 78 : 104
  • Elberg , Kjoller and Krag . 1993 . Silicone Mammary Implants and Connective Tissue Disease . Scand. J. Plast. Surg. Hand Surg. , 27 : 243
  • Hirmand , Latrenta and Hoffman . 1993 . Autoimmune Disease and Silicone Breast Implants . Oncology (Huntingt) , 7 : 17
  • Rohrich and Clark 3d . 1993 . Controversy over the Silicone Gel Breast Implant: Current Status and Clinical Implications . Tex. Med. , 89 : 52
  • Edelman , Grant and van Oss . 1994 . Autoimmune Disease Following the Use of Silicone Gel‐Filled Breast Implants: A Review of the Clinical Literature . Semin. Arthritis Rheum. , 24 : 183
  • Swan . 1994 . Epidemiology of Silicone‐Related Disease . Semin. Arthritis Rheum. , 24 ( Supp. 1 ) : 38
  • Bridges . 1995 . Rheumatic Diseases in Patients with Silicone Implants: A Critical Review . J. Biomater. Sci. Polym. Ed. , 7 : 147
  • Patten and Ostermeyer . 1995 . Disquisition on Human Adjuvant Disease . Perspect. Biol. Med. , 38 : 274
  • Peters . 1995 . Silicone Breast Implants and Autoimmune Connective Tissue Disease . Annals Plast. Surg. , 34 : 103
  • Yoshida , Swan , Teuber and Gershwin . 1995 . Silicone Breast Implants: Immunotoxic and Epidemiologic Issues . Life Sci. , 56 : 1299
  • Silverman , Brown , Bright , Kaczmarek , Arrowsmith‐Lowe and Kessler . 1996 . Reported Complications of Silicone Gel Breast Implants: An Epidemiologie Review . Annals Int. Med. , 124 : 744
  • Wong . 1996 . A Critical Assessment of the Relationship Between Silicone Breast Implants and Connective Tissue Diseases . Regul. Toxicol. Pharmacol. , 23 : 74
  • Kumagai , Shiokawa , Medsger Jr. and Rodnan . 1984 . Clinical Spectrum of Connective Tissue Disease after Cosmetic Surgery: Observations on Eighteen Patients and a Review of the Japanese Literature . Arthritis Rheum. , 27 : 1
  • Weiner and Paulus . 1986 . Chronic Arthropathy Occurring after Augmentation Mammoplasty . Plast. Reconstruct. Surg. , 77 : 185
  • Brozena , Fenske , Cruse , Espinoza , Vasey , Germain and Espinoza . 1988 . Human Adjuvant Disease Following Augmentation Mammoplasty . Arch. Dermatol. , 124 : 1383
  • Varga , Schumacher and Jimenez . 1989 . Systemic Sclerosis after Augmentation Mammoplasty with Silicone Implants . Annals Int. Med. , 111 : 377
  • Weiner , Clements and Paulus . 1989 . Connective Tissue Disease after Augmentation Mammoplasty . Arthritis Rheum. , 32 : 23
  • Gutierrez and Espinoza . 1990 . Progressive Systemic Sclerosis Complicated by Severe Hypertension: Reversal after Silicone Implant Removal . Am. J. Med. , 89 : 390
  • Kaiser , Biesenbach , Stuby , Grafinger and Zazgomik . 1990 . Human Adjuvant Disease: Remission of Silicone‐Induced Autoimmune Disease after Explantation of Breast Augmentation . Annals Rheum. Dis. , 49 : 937
  • Marik , Kark and Zambakides . 1990 . Scleroderma after Silicone Augmentation Mammoplasty: A Report of Two Cases . S. Afr. Med. J. , 77 : 212
  • Sahn , Biesenbach , Stuby , Grafinger and Zazgomik . 1990 . Scleroderma Following Augmentation Mammoplasty: Report of a Case and Review of the Literature . Arch. Dermatol. , 126 : 1198
  • Hitoshi , Ito , Takehara , Fujita and Ogata . 1991 . A Case of Malignant Hypertension and Scleroderma after Cosmetic Surgery . Jpn. J. Med. , 30 : 97
  • Appleton and Lee . 1993 . The Development of Systemic Sclerosis (Scleroderma) Following Augmentation Mammoplasty . J. Rheumatol. , 20 : 1052
  • Bridges , Conley , Wang , Bums and Vasey . 1993 . A Clinical and Immunologie Evaluation of Women with Silicone Breast Implants and Symptoms of Rheumatic Disease . Annals Int. Med. , 118 : 929
  • Copeland , Kressel , Spiera , Hermann and Bleiweiss . 1993 . Systemic Inflammatory Disorder Related to Fibrous Breast Capsules after Silicone Implant Removal . Plast. Reconstr. Surg. , 92 : 1179
  • Spiera and Kerr . 1993 . Scleroderma Following Silicone Implantation: A Cumulative Experience of 11 Cases . J. Rheumatol. , 20 : 958
  • Duffy and Woods . 1994 . Health Risks of Failed Silicone Gel Breast Implants: A 30‐Year Clinical Experience . Plast. Reconstr. Surg. , 94 : 295
  • Englert , Howe , Penny and Brooks . 1994 . Scleroderma and Silicone Breast Implants . Brit. J. Rheumatol. , 33 : 397
  • Fenske , Davis and Aaron . 1994 . Human Adjuvant Disease Revisited: A Review of Eleven Post‐Augmentation Mammoplasty Patients . Clin. Exp. Rheumatol. , 12 : 477
  • Houpt and Sontheimer . 1994 . Autoimmune Connective Tissue Disease and Connective Tissue Disease‐Like Illnesses after Silicone Gel Augmentation Mammoplasty . J. Am. Acad. Dermatol. , 31 : 626
  • Shoaib , Patten and Calkins . 1994 . Adjuvant Breast Disease: An Evaluation of 1,000 Symptomatic Women with Breast Implants or Silicone Fluid Injections . Keio J. Med. , 43 : 79
  • Field and Bridges . 1996 . Clinical and Laboratory Features of Patients with Scleroderma and Silicone Implants . Curr. Top. Microbiol. Immunol. , 210 : 283
  • Weisman , Vecchione , Albert , Moore and Mueller . 1988 . Connective‐Tissue Disease Following Breast Augmentation: A Preliminary Test of the Human Adjuvant Disease Hypothesis . Plast. Reconstr. Surg. , 82 : 626 (no cases of inflammatory systemic rheumatic disease detected)
  • Dugowson , Daling , Koepsell , Voyt and Nelson . 1992 . Silicone Breast Implants and the Risk for Rheumatoid Arthritis [abstract] . Arthritis Rheum. , 35 (Supp.) : S66 (no association between rheumatoid arthritis and breast implants)
  • Schusterman , Kroll , Reece , Miller , Ainslie , Halabi and Balch . 1993 . Incidence of Autoimmune Disease in Patients after Breast Reconstruction with Silicone Gel Implants Versus Autogenous Tissue: A Preliminary Report . Annals Plast. Suro. , 31 : 1 (no difference in risk for diagnosed rheumatic disease)
  • Burns . 1994 . The Epidemiology of Systemic Sclerosis: A Population‐Based Case‐Control Study , Ann Arbor, MI : University of Michigan . [doctoral dissertation]
  • Englert and Brooks . 1994 . Scleroderma and Augmentation Mammoplasty—A Causal Relationship? . Austral. N.Z.J. Med. , 24 : 74 (no association between scleroderma and augmentation mammoplasty)
  • Gabriel , O'Fallon , Kurland , Beard , Woods and Melton . 1994 . Risk of Connective Tissue Diseases and Other Disorders after Breast Implantation . N. Eng. J. Med. , 330 : 1697 (no increased risk for “defined connective tissue disorders")
  • Giltay , Bernelot , Moens , Riley and Tan . 1994 . Silicone Breast Prostheses and Rheumatic Symptoms: A Retrospective Follow‐Up Study . Annals Rheum. Dis. , 53 : 194 (increased risk for rheumatic symptoms, painful joints, burning eyes, and skin abnormalities, but no difference in risk for defined connective tissue diseases)
  • Strom , Reidenberg , Freundlich and Schinnar . 1994 . Silicone Breast Implants and the Risk of Systemic Lupus Erythematosus . J. Clin. Epidemiol. , 47 : 1211 (no association between lupus and breast implants)
  • Wells , Cruse , Baker Jr. , Daniels , Stern , Newman , Seleznick , Vasey , Brozena , Albers and Fenske . 1994 . The Health Status of Women Following Cosmetic Surgery . Plast. Reconstr. Surg. , 93 : 907 (no cases of scleroderma or lupus detected; implant recipients had increased risk for “swollen” or “tender” glands under arms)
  • Goldman , Greenblatt , Joines , White , Aylward and Lamm . 1995 . Breast Implants, Rheumatoid Arthritis, and Connective Tissue Diseases in a Clinical Practice . J. Clin. Epidemiol. , 48 : 571 (no association between rheumatoid arthritis or connective tissue disease and breast implants)
  • Sanchez‐Guerrero , Colditz , Karlson , Hunter , Speizer and Liang . 1995 . Silicone Breast Implants and the Risk of Connective‐Tissue Disorders and Symptoms . N. Eng. J. Med. , 322 : 1697 (no increased risk for defined connective tissue disease (CTD) no increased risk for CTD symptoms in implant recipients between scleroderma and augmentation mammoplasty)
  • Hennekens , Lee , Cook , Hebert , Karlson , LaMotte , Manson and Buring . 1996 . Self‐Reported Breast Implants and Connective‐Tissue Diseases in Female Health Professionals: A Retrospective Cohort Study . J.A.M.A. , 275 : 616 (increased risk for “any CTD” and “other CTD” no increased risk for defined connective tissue disorder)
  • Hochberg , Perlmutter , Medsger Jr. , Nguyen , Steen , Weisman , White and Wigley . 1996 . Lack of Association Between Augmentation Mammoplasty and Systemic Sclerosis (Scleroderma) . Arthritis Rheum. , 39 : 1125 (no association between scleroderma and augmentation mammoplasty)
  • Varga and Jimenez . 1990 . Augmentation Mammoplasty and Scleroderma: Is There an Association? [comment] . Arch. Dermatol. , 126 : 1220
  • Brody , Conway , Deapen , Fisher , Hochberg , LeRoy , Medsger Jr. , Robson , Shons and Weisman . 1992 . Consensus Statement on the Relationship of Breast Implants to Connective‐Tissue Disorders . Plast. Reconstr. Surg. , 90 : 1102
  • Shons and Schubert . 1992 . Silicone Breast Implants and Immune Disease . Annals Plast. Surg. , 28 : 491
  • Fenske and Vasey . 1993 . Silicone‐Associated Connective‐Tissue Disease: The Debate Rages . Arch. Dermatol. , 129 : 97
  • Lappe . 1993 . Silicone‐Reactive Disorder: A New Autoimmune Disease Caused by Immunostimulation and Superantigens . Med. Hypotheses , 41 : 348
  • Macfarlane and Breedveld . 1993 . Silicone Breast Prostheses and Rheumatic Disorders [letter] . Brit. J. Rheumatol. , 32 : 1116
  • Ryan and Moore . 1993 . Silicone Breast Implants and Atypical Autoimmune Disease [letter] . Annals Int. Med. , 119 : 1053
  • Vasey , Seleznick and Germain . 1993 . The Breast Implant Controversy [letter] . N. Eng. J. Med. , 328 : 732
  • Angell . 1994 . Do Breast Implants Cause Systemic Disease? Science in the Courtroom . N. Eng. J. Med. , 330 : 1748
  • Royce , Levine , Wallace , Schwartz , Spiera , Gibofsky , Spiera , Naim , Lanzafame , van Oss , Solomon , Espinoza , Silverman and Wong . 1994 . Breast Implants and Connective‐Tissue Diseases [letters] . N. Eng. J. Med. , 331 : 1232
  • Cuellar and Espinoza . 1994 . Silicone Breast Implants and Connective Tissue Disease [letter] . J. Rheumatol. , 21 : 1979
  • Ehrlich . 1995 . Regarding Silicone Implants and Rheumatic Disorders [letter] . Arthritis Rheum. , 38 : 721
  • Fuchs , Johnson and Sergent . 1995 . Still More on Breast Implants and Connective‐Tissue Comments . N. Eng. J. Med. , 333 : 526
  • Handel . 1995 . Health Risks of Failed Silicone Gel Breast Implants [letter; comment] . Plast. Reconstr. Surg. , 95 : 1129
  • Kossovsky . 1995 . Can the Silicone Controversy Be Resolved with Rational Certainty? [editorial] . J. Biomater. Sci. Polym. Ed. , 7 : 97
  • Romanelli . 1995 . More on Breast Implants and Connective‐Tissue Diseases [letter; comment] . N. Eng. J. Med. , 332 : 1306
  • Spiera , Gibofsky and Spiera . 1995 . Scleroderma in Women with Silicone Breast Implants: Comment on the Article by Sanchez‐Guerrero et al. [letter; comment] . Arthritis Rheum. , 38 : 719
  • Valesini , Bavoillot and Pittoni . 1995 . Silicone Breast Implants and Connective‐Tissue Diseases [editorial; comment] . Clin. Exp. Rheumatol. , 13 : 421
  • Vasey , Aziz and Van Vollenhoven . 1995 . Breast Implants and Connective Tissue Diseases [letter] . N. Eng. J. Med. , 333 : 1423
  • Vasey , Seleznick , Wells , Espinoza and Cuellar . 1995 . Rheumatic Disease Symptoms and Silicone Breast Implants: Comment on the Article by Cook et al. and the Article by Sanchez‐Guerrero et al [letter; comment] . Arthritis Rheum. , 38 : 719
  • Vasey . 1995 . Observation on Women with Breast Implants . J. Fla. Med. A. , 82 : 348
  • Angell . 1996 . Shattuck Lecture—Evaluating the Health Risks of Breast Implants: The Interplay of Medical Science, the Law, and Public Opinion . N. Eng. J. Med. , 334 : 1513
  • Goldberg , Egilman , Stubbs , Barthel , Barraza , Meier , Sunshine and Greenwald . 1996 . Evaluating the Health Risks of Implants— Correspondence . N. Eno. J. Med. , 335 : 1154
  • Gatenby . 1996 . Silicone Breast Implants—Where Have We Been and Where Are We Now? . Austral. N.Z.J. Med. , 26 : 341
  • Karns , Cullison , Litvak , Romano and Whitmore . 1996 . Breast Implants and Connective‐Tissue Disease [letters] . J.A.M.A. , 276 : 101
  • Kurland and Homburger . 1996 . Epidemiology of Autoimmune and Immunological Diseases in Association with Silicone Implants: Is There an Excess of Clinical Disease or Antibody Response in Population‐Based or Other “Controlled” Studies? . Curr. Top. Microbiol. Immunol. , 210 : 427
  • Roven . 1996 . The Real Cause of Silicone Autoimmune Disease [letter] . Plast. Reconstr. Surg. , 97 : 1307
  • Shack . 1996 . Is Silicone Safe? Let Science Decide [editorial] . South. Med. J. , 89 : 251
  • Brody , Vasey and Meisenberg . 1993 . Correspondence—The Breast‐Implant Controversy . N. Eng. J. Med. , 328 : 732 The following systemic disorders are under investigation for possible connection to silicone breast implants: (1) fibromyalgia; (2) chronic fatigue syndrome; (3) rheumatoid arthritis; (4) lupus erythematosus/SLE; (5) scleroderma (progressive systemic sclerosis) (6) Sjogren's syndrome; (7) dermatomyositis; and (8) mixed connective tissue disease. See Levine, supra note 26, at 18. See also
  • Miyoshi , Miyramura and Kobayashi . 1964 . Hypergammaglobulinemia by Prolonged Adjuvanticity in Man: Disorders Developed after Augmentation Mammoplasty . Jpn. J. Med. , 9 : 2122 Since 1964, a systemic disorder known as “human adjuvant disease” occasionally has been reported following the injection of foreign substances such as paraffin or silicones. Patients who develop this problem may experience fever, joint pains, and swollen lymph nodes, but there is no evidence of infection or cancer. Some patients improve when the foreign material is removed
  • Nosanchuk . 1968 . Injected Dimethylpolysiloxane Fluid: A Study of Antibody and Histologic Response . Plast. Reconstr. Surg. , 42 : 562
  • Wilkie . 1977 . Late Development of Granuloma after Liquid Silicone Injections . Plast. Reconstr. Surg. , 60 : 179
  • Walsh , Solomon , Espinoza , Adams and Whitelocke . 1989 . Human Adjuvant Disease: A New Cause of Chylous Effusions . Arch. Int. Med. , 149 : 1194
  • Heggers , Kossovsky , Parsons , Robson , Pelley and Raine . 1983 . Biocompatibility of Silicone Implants . Annals Plast. Surg. , 11 : 38 To explain how silicone or breast implants may cause either expected or unexpected (desirable or undesirable) immune responses, scientists have proposed that: (1) silica (SiO2) filler may be released from hardened fumed (amorphous) silica bound to the silastic implant covering; (2) dimethylsiloxane may be an antigen that elicits production of antibodies; (3) silicone may act as a hapten that must be coupled with one or more larger molecules to elicit an antibody response; (4) silicone may be an adjuvant that enhances the ability of other antigens to elicit an immune response; (5) silicone may alter endogenous antigens and produce an “autoimmune” response; and/or (6) silicone may provoke the release of cytokines (messenger molecules) that act either locally or systemically to stimulate desired or undesired events. See
  • Kossovsky , Heggers and Robson . 1987 . Experimental Demonstration of the Immunogenicity of Silicone‐Protein Complexes . J. Biomed. Mater. Res. , 21 : 1125
  • Williams . 1992 . Can Silicone Breast Implants Cause Generalized Disease or Symptoms? A Review of Possible Pathophysiologic Pathways . Am. J. Cosm. Surg. , 9 : 333
  • Yoshida and Gershwin . 1993 . Autoimmunity and Selected Environmental Factors of Disease Induction . Semin. Arthritis Rheum. , 22 : 399
  • Yoshida , Teuber , German and Gershwin . 1994 . Immunotoxicity of Silicone: Implications of Oxidant Balance Towards Adjuvant Activity . Food Chem. Toxicol. , 32 : 1089
  • Bradley , White Jr. , McCay , Brown , Musgrove , Wilson , Stern , Luster and Munson . 1994 . Immunotoxicity of 180‐Day Exposure to Polydimethylsiloxane (Silicone) Fluid, Gel, and Elastomer and Polyurethane Disks in Female B6C3F1 Mice . Drug Chem. Toxicol. , 17 : 221 In one of the more extensive evaluations of possible immune effects in animals, the injection of silicone fluid or gel, or implantation of silicone elastomer, in mice at doses up to five percent of body weight did not produce changes in organ or body weights, blood counts, bone marrow morphology or function, or blood chemistries. Natural killer cell activity was moderately decreased, but the mice did not show significant changes in lymphocyte surface antigens, lymphocyte proliferation responses, lymphocyte antibody responses, or macrophage function. See
  • Bradley , Munson , McCay , Brown , Musgrove , Wilson , Stern , Luster and White Jr. 1994 . Subchronic 10 Day Immunotoxicity of Polydimethylsiloxane (Silicone) Fluid, Gel, and Elastomer and Polyurethane Disks in Female B6C3F1 Mice . Drug Chem. Toxicol. , 17 : 175
  • Wilson and Munson . 1996 . Silicone‐Induced Modulation of Natural Killer Cell Activity . Curr. Top. Microbiol. Immunol. , 210 : 199
  • Kossovsky and Freiman . 1994 . Silicone Breast Implant Pathology: Clinical Data and Immunologic Consequences . Arch. Pathol. Lab. Med. , 118 : 686
  • Kossovsky and Freiman . 1994 . Immunology of Silicone Breast Implants . J. Biomater. Appl. , 8 : 237
  • Brantley , Davidson , St. Arnold , Johnson , Talbot , Grogan , Cuchens , Hsu and Das . 1990 . Assessment of the Lymphocyte Response to Silicone . Plast. Reconstr. Surg. , 86 : 1131
  • Cohen . 1995 . T‐Cell Response in Women with Silicone Breast Implants [letter] . Clin. Diagn. Lab. Immunol. , 2 : 253
  • McDonald , Weir and Sanger . 1996 . Silicone‐Induced T Cell Proliferation in Mice . Curr. Top. Microbiol. Immunol. , 210 : 189
  • O'Hanlon , Okada , Love , Dick , Young and Miller . 1996 . Immunohistopathology and T‐Cell Receptor Gene Expression in Capsules Surrounding Silicone Breast Implants . Curr. Top. Microbiol. Immunol. , 210 : 237
  • Shanklin , Smalley , Hall and Stevens . 1996 . T‐Cell‐Mediated Immune Response to Silica in Silicone Breast Implant Patients . Curr. Top. Microbiol. Immunol. , 210 : 227
  • Freundlich , Sandorfi , Alunan and Tomaszewski . 1996 . Monocyte/Macrophage Infiltrates in the Salivary Glands of Women with Silicone Breast Implants . Curr. Top. Microbiol. Immunol. , 210 : 323
  • Hardt , Emery , LaTorre , Batich and Winter . 1996 . Macrophage‐Silicone Interactions in Women with Breast Prostheses . Curr. Top. Microbiol. Immunol. , 210 : 245
  • Ojo‐Amaize , Conte , Lin , Brucjer , Agopian and Peter . 1994 . Silicone‐Specific Blood Lymphocyte Response in Women with Silicone Breast Implants . Clin. Diagn. Lab. Immunol. , 1 : 689
  • Ciapetti , Granchi , Stea , Cenni , Schiavon , Giuliani and Pizzoferrato . 1995 . Assessment of Viability and Proliferation of In Vivo Silicone‐Primed Lymphocytes after In Vitro Re‐Exposure to Silicone . J. Biomed. Mater. Res. , 29 : 583
  • Marcus . 1996 . An Analytical Review of Silicone Immunology . Arthritis & Rheumatism , 39 : 1619
  • Garrido and Ackerman . 1995 . Re: Do Patients with Silicone‐Gel Breast Implants Have Elevated Levels of Blood Silicon Compared with Control Patients? [letter] . Annals Plast. Surg. , 35 : 441
  • Macdonald , Plavac , Peters , Lugowski and Smith . 1995 . Failure of Si NMR to Detect Increased Blood Silicon Levels in Silicone Gel Breast Implant Recipients . Anal. Chem. , 67 : 3799
  • Peters , Smith , Lugowski , McHugh and Baines . 1995 . Do Patients with Silicone‐Gel Breast Implants Have Elevated Levels of Blood Silicon Compared with Control Patients? . Annals Plast. Surg. , 34 : 343
  • Peters , Smith , Lugowski , McHugh , Keresteci and Baines . 1995 . Analysis of Silicon Levels in Capsules of Gel and Saline Breast Implants and of Penile Prostheses . Annals Plast. Surg. , 34 : 578
  • Teuber , Saunders , Halpern , Brucker , Conte , Goldman , Winger , Wood and Gershwin . 1995 . Elevated Serum Silicone Levels in Women with Silicone Gel Breast Implants . Biol. Trace Elem. Res. , 48 : 121
  • Wolf , Lappe , Peterson and Ezrailson . 1993 . Human Immune Response to Polydimethylsiloxane (Silicone): Screening Studies in a Breast Implant Population . FASEB J. , 7 : 1265
  • Vojdani , Brautbar and Campbell . 1994 . Antibody to Silicone and Native Macromolecules in Women with Silicone Breast Implants . Immunopharmacol. Immunotoxicol. , 16 : 497
  • Rohrich , Hollier and Robinson . 1996 . Determining the Safety of the Silicone Envelope—In Search of a Silicone Antibody . Plast. Reconstr. Surg. , 98 : 455
  • Rose , Landavere and Kuppers . 1996 . Silicone Binding Immunoglobulins in Human Sera . Curr. Top. Microbiol. Immunol. , 210 : 269
  • Rosenau , Schneebaun and Schnur . 1996 . The Development of an ELISA Method for the Detection of “Antibodies” to Silicone . Curr. Top. Microbiol. Immunol. , 210 : 69
  • Press , Peebles , Kumagai , Ochs and Tan . 1992 . Antinuclear Autoantibodies in Women with Silicone Breast Implants . Lancet , 340 : 1304
  • Claman and Robertson . 1994 . Antinuclear Antibodies and Breast Implants . West. J. Med. , 160 : 225
  • Cuellar , Scopelitis , Tenenbaum , Garry , Silveira , Cabrera and Espinoza . 1995 . Serum Antinuclear Antibodies in Women with Silicone Breast Implants . J. Rheumatol. , 22 : 236
  • Martin . 1995 . Silicone Breast Implants and Connective Tissue Diseases: An Ongoing Controversy [editorial] . J. Rheumatol. , 22 : 198
  • Claman and Robertson . 1996 . Antinuclear Antibodies in Apparently Healthy Women with Breast Implants . Curr. Top. Microbiol. Immunol. , 210 : 265
  • Lewy and Ezrailson . 1996 . Laboratory Studies in Breast Implant Patients: ANA Positivity, Gamma‐globulin Levels, and Other Autoantibodies . Curr. Top. Microbiol. Immunol. , 210 : 337
  • Kossovsky , Gornbein , Zeidler , Stassi , Chun , Papasian , Nguyen , Ly and Rajguru . 1995 . Self‐Reported Signs and Symptoms in Breast Implant Patients with Novel Antibodies to Silicone Surface Associated Antigens [anti‐SSAA (x)] . J. Appl. Biomater. , 6 : 153
  • Kossovsky , Conway , Kossowsky and Petrovich . 1996 . Novel Anti‐Silicone Surface‐Associated Antibodies (anti‐SSAA(x)) May Help Differentiate Symptomatic Patients with Silicone Breast Implants from Patients with Classical Rheumatological Disease . Curr. Top. Microbiol. Immunol. , 210 : 327
  • Bridges . 1994 . Autoantibodies in Patients with Silicone Implants . Semin. Arthritis Rheum. , 24 ( Supp. 1 ) : 54
  • Peters , Keystone , Snow , Rubin and Smith . 1994 . Is There a Relationship Between Autoantibodies and Silicone Gel Implants? . Annals Plast. Surg. , 32 : 1
  • Rowley , Cook , Teuber and Gershwin . 1994 . Antibodies to Collagen: Comparative Epitope Mapping in Women with Silicone Breast Implants, Systemic Lupus Erythematosus, and Rheumatoid Arthritis . J. Autoimmun. , 7 : 775
  • Tan . 1994 . Meaning of Autoantibodies in Lupus‐Like Syndromes . Lupus , 3 : 483
  • Bar‐Meir , Teuber , Lin , Alosacie , Goddard , Terybery , Barka , Shen , Peter and Blank . 1995 . Multiple Autoantibodies in Patients with Silicone Breast Implants . J. Autoimmun. , 8 : 267
  • Bridges , Anderson , Burns , Kemple , Kaplan and Lorden . 1996 . Autoantibodies in Patients with Silicone Implants . Curr. Top. Microbiol. Immunol. , 210 : 277
  • Rowley , Cook , Mackay , Teuber and Gershwin . 1996 . Comparative Epitope Mapping of Antibodies to Collagen in Women with Silicone Breast Implants, Systemic Lupus Erythematosus and Rheumatoid Arthritis . Curr. Top. Microbiol. Immunol. , 210 : 307
  • Silverman , Gluck , Silver , Tesser , Wallace , Neumann , Metzger and Morris . 1996 . The Prevalence of Autoantibodies in Symptomatic and Asymptomatic Patients with Breast Implants and Patients with Fibromyalgia . Curr. Top. Microbiol. Immunol. , 210 : 317
  • Tan , Ochs , Kumagai , Cuellar and Espinoza . 1996 . Re‐evaluation of Autoantibodies and Clinical Overview of Silicone‐Related Disorders . Curr. Top. Microbiol. Immunol. , 210 : 291
  • Cotran , Kumar and Robbins . 1989 . “ Diseases of Immunity ” . In Robbins Pathologic Basis of Disease 163 The development of immunologic responsiveness to self is called autoimmunity and reflects the impairment of self‐tolerance. Immunologic, environmental, and genetic factors are closely interrelated in the pathogenesis of autoimmunity. Clinical disorders in which autoimmune responses may contribute to the illness are referred to as autoimmune diseases. However, autoantibodies can be found in the serum or tissues of many normal individuals. Apparently innocuous autoantibodies also are formed following damage to tissue and may serve a physiologic role in the removal of tissue breakdown products. Thus, it is difficult to distinguish normal, physiologic autoimmunity from pathologic autoimmunity. Ideally, at least three requirements should be met before a disorder can be categorized as truly due to autoimmunity. These include the following: (1) the presence of an autoimmune reaction; (2) clinical or experimental evidence that such a reaction is not secondary to tissue damage but is of primary pathogenetic significance; and (3) the absence of another well‐defined cause of the disease. Of note, it is now clear that there are various ways by which tolerance can be bypassed, thus terminating a previously unresponsive state to autoantigens
  • Goldblum , Pelley , O'Donell , Pyron and Heggers . 1992 . Antibodies to Silicone Elastomers and Reactions to Ventriculoperitoneal Shunts . Lancet , 340 : 510 (suggesting that specific immune reactivity to elastomers of polydimethylsiloxane can develop in human beings)
  • Ojoamaize , Lawless and Peter . 1996 . Elevated Concentrations of Interleukin‐1‐Beta and Interleukin‐1 Receptor Antagonist in Plasma of Women with Silicone Breast Implants . Clin. Diag. Lab. Immunol. , 3 : 257
  • Thomsen , Christensen , Nielsen , Brandt , Breiting , Felby and Nielson . 1990 . Histological Changes and Silicone Concentrations in Human Breast Tissue Surrounding Silicone Breast Prostheses . Plast. Reconstr. Surg. , 85 : 38
  • Marion . 1995 . Silicone Tissue Assays [letter] . Plast. Reconstr. Surg. , 95 : 770
  • Evans , Netscher , Schusterman , Kroll , Robb , Reece and Miller . 1996 . Silicon Tissue Assays: A Comparison of Nonaugmented Cadaveric and Augmented Patient Levels . Plast. Reconstr. Surg. , 97 : 1207
  • Peters , Smith and Lugowski . 1996 . Silicon Capsule Assays with Low‐Bleed Silicone Gel Implants [letter; comment] . Plast. Reconstr. Surg. , 97 : 1311
  • Raso , Greene , Harley and Maize . 1996 . Silicone Deposition in Reconstruction Scars of Women with Silicone Breast Implants . J. Am. Acad. Dermatol. , 35 : 32
  • Schur , Weinzweig , Harris , Moyer , Petty , Nixon and McConnell . 1996 . Silicon Analysis of Breast and Periprosthetic Capsular Tissue from Patients with Saline or Silicone Gel Breast Implants . Plast. Reconstr. Surg. , 98 : 798
  • Lewy . 1993 . Laboratory Findings Reveal Potential Harm of Breast Implants [letter] . Tex. Med. , 89 : 7
  • Anonymous . 1996 . Diagnostic Tests for Silcone Breast Disease . J.A.M.A. , 275 : 680
  • Young . 1996 . Testing the Test: An Analysis of the Reliability of the Silicone Sensitivity Test (SILS) in Detecting Immune‐Mediated Responses to Silicone Breast Implants [letter] . Plast. Reconstr. Surg. , 97 : 681
  • Chang . 1993 . Adjuvanticity and Arthritogenicity of Silicone . Plast. Reconstr. Surg. , 92 : 469
  • Naim , Lanzafame and van Oss . 1993 . The Adjuvant Effect of Silicone‐Gel on Antibody Formation in Rats . Immunol. Invest. , 22 : 151
  • Nairn and van Oss . 1995 . Silicone Gels as Adjuvants: Effects on Humoral and Cell‐Mediated Immune Responses . Adv. Exper. Med. Biol. , 383 : 1
  • Naim and van Oss . 1995 . The Effect of Molecular Weight and Gel Preparation on Humoral Adjuvancy of Silicone Oils and Silicone Gels . Adv. Exper. Med. Biol. , 383 : 7
  • Naim , Lanzafame and van Oss . 1995 . The Effect of Silicone Gel on the Immune Response . J. Biomat. Sci. Polym. Ed. , 7 : 123
  • Peters . 1995 . Silicone Gel as an Adjuvant [letter] . Plast. Reconstr. Surg. , 95 : 417
  • Butler , Lu , Navarro and Christiansen . 1996 . The Adsorption of Proteins on a Polydimethylsiloxane Elastomer (PEP) and Their Antigenic Behavior . Curr. Top. Microbiol. Immunol. , 210 : 75
  • Frondoza , Jones , Rose , Hatakeyama , Phelps and Bona . 1996 . Development of Scleroderma‐like Syndrome in Tsk/+ Mice Is Not Enhanced by Silicone Adminstration . Curr. Top. Microbiol. Immunol. , 210 : 299
  • Hill , Landavere and Rose . 1996 . The Adjuvant Effect of Silicone Gel and Silicone Elastomer Particles in Rats . Curr. Top. Microbiol. Immunol. , 210 : 123
  • Klykken and White Jr. 1996 . The Adjuvancy of Silicones: Dependency on Compart‐mentalization . Curr. Top. Microbiol. Immunol. , 210 : 113
  • Nairn , Ippolito , Lanzafame and van Oss . 1996 . Induction of Type II Collagen Arthritis in the DA Rat Using Silicone Gel as Adjuvant . Curr. Top. Microbiol. Immunol. , 210 : 103
  • Nicholson 3d , Wong , Frondoza and Rose . 1996 . Silicone Gel and Octamethylcyclotetrasiloxane Potentiate Antibody Production to Bovine Serum Albumin in Mice . Curr. Top. Microbiol. Immunol. , 210 : 139
  • van Oss and Nairn . 1996 . Aspecific Immunoglobulin Binding to Hydrophobic Surfaces . Curr. Top. Microbiol. Immunol. , 210 : 85
  • Berlin Jr. 1994 . Silicone Breast Implants and Breast‐Feeding . Pediatrics , 94 : 547
  • Grant and Edelman . 1994 . Pregnancy, Lactation, and the Use of Silicone Breast Implants . Adv. Contracept. , 10 : 187
  • Kacew . 1994 . Current Issues in Lactation: Advantages, Environment, Silicone . Biomed. Environ. Sci. , 7 : 307
  • Teuber and Gershwin . 1994 . Autoantibodies and Clinical Rheumatic Complaints in Two Children of Women with Silicone Gel Breast Implants . Int'l Arch. Allergy Immunol. , 103 : 105
  • Jordan and Blum . 1996 . Should Breast‐Feeding by Women with Silicone Implants Be Recommended? . Arch. Pediatr. Adolesc. Med. , 150 : 880
  • Flick . 1994 . Silicone Implants and Esophageal Dysmotility: Are Breast‐Fed Infants at Risk? [editorial] . J.A.M.A. , 271 : 240
  • Levine and Ilowite . 1994 . Sclerodermalike Esophageal Disease in Children Breast‐Fed by Mothers with Silicone Breast Implants . J.A.M.A. , 271 : 213
  • Brody , Liau , Ito , Koren , Levine , Placik , Epstein , Cook and Bartel . 1994 . Comments on Sclerodermalike Esophageal Disease in Children of Mothers with Silicone Breast Implants . J.A.M.A. , 272 : 769
  • Williams . 1994 . Silicone Breast Implants, Breastfeeding, and Scleroderma [letter] . Lancet , 343 : 1043
  • Gedalia , Cuellar and Espinoza . 1995 . Skin Rash and Anti‐Ro/SS‐A Antibodies in an Infant from a Mother with Silicone Breast Implants . Clin. Exp. Rheumatol. , 13 : 521
  • Epstein . 1996 . Silicone Breast Implants and Sclerodermalike Esophageal Disease in Breast‐Fed Infants [letter] . J.A.M.A. , 275 : 184
  • Levine , Trachtman , Gold and Pettei . 1996 . Esophageal Dysmotility in Children Breast‐Fed by Mothers with Silicone Breast Implants: Long‐Term Follow‐up and Response to Treatment . Dig. Dis. Sci. , 41 : 1600
  • Levine , Ilowite , Pettei and Trachtman . 1996 . Increased Urinary Nitrate, Nitrite and Neopterin Excretion in Children Breast Fed by Mothers with Silicone Breast Implants—Evidence for Macrophage Activation . J. Rheumatol. , 23 : 1083
  • Levine , Lin , Rowley , Cook , Teuber and Ilowite . 1996 . Lack of Auto‐antibody Expression in Children Born to Mothers with Silicone Breast Implants . Pediatrics , 97 : 243
  • 1991 . Amid Heavy Lobbying, Government Is Considering Ban on Breast Implants . N.Y. Times , : Al A12
  • Levine . “ From the Manufacturer's Standpoint ” . In Litigating Breast Implant Cases 277 supra note 25
  • Rensberger . 1992 . Breast Implant Records Were ‘'Faked,’’ Dow Corning Acknowledges that Technicians Changed Some Charts . Wash. Post , : A3 On March 19, 1992, Dow Corning abandoned the silicone breast implant market and gave up its position as the largest manufacturer of the product. See
  • Cohen . 1994 . Impact of the FDA Ban on Silicone Breast Implants [editorial] . J. Surg. Oncol. , 56 : 1
  • The FDA's Regulation of Silicone Breast Implants . 1993 . A Staff Report Prepared by the Human Resources and Intergovernmental Relations Subcommittee of the Committee on Government Relations 61 – 505 . (statement of chairman Donald M. Payne). The subcommittee issued the following findings and conclusions: (1) FDA ignored warnings about the need to regulate breast implants for more than 12 years; (2) scientists have been concerned about the risks of connective tissue/autoimmune disorders since 1975; (3) physicians, engineers, and employees of implant manufacturers have been concerned about breakage and leakage of silicone gel implants since the 1970s; (4) FDA ignored their own scientist's advice to reject manufacturers’ PMA applications in 1991; (5) professional proimplant lobbyists included former FDA officials and provided patient lobbyists with misleading information; (6) manufacturers have never provided proof of safety to the FDA; (7) FDA officials and manufacturers prevented the 1991 FDA breast implant advisory committee from considering crucial safety information; (8) FDA concerns about cancer led to the removal of breast implants covered with polyurethane from the market in 1991; (9) the 1992 FDA advisory panel lacked crucial information about interference with mammography and other problems; (10) in 1992, Dow Corning disclosed that the company sold implants to physicians before they were shown to be safe in animals, failed to disclose problems with the implants, and submitted fabricated information about quality control; (11) patients have been misled about the safety of breast implants for at least the last 15 years; (12) patients continue to be misled by the FDA‐approved informed consent form; (13) FDA's public statements about breast implants minimized the risks; (14) FDA inspections in 1992 indicated that McGhan had violated good manufacturing practices, but FDA allowed McGhan to resume sales before problems were corrected; (15) from April 1992 to the present, the FDA has failed to monitor the use of silicone breast implants, despite the promises of the FDA Commissioner; (16) FDA has failed to evaluate available safety information that attorneys have obtained from manufacturers; (17) NIH has failed to support research on the safety of breast implants for cancer patients; and (18) Medicare and Medicaid are required to pay for removal of breast implants for medical reasons
  • Palley . 1995 . The Evolution of FDA Policy on Silicone Breast Implants: A Case Study of Politics, Bureaucracy, and Business in the Process of Decision‐Making . Int'l J. Health Serv. , 25 : 573
  • Shiffman . 1994 . Silicone Breast Implant Litigation, Parts 1 & 2 . Med. & LAW , 13 : 681
  • 1995 . Med. & Law , 14 : 59
  • Cotran , Kumar and Robbins . 1989 . “ Diseases of Immunity ” . In Robbins Pathologic Basis of Disease 163 Mixed connective tissue disease (MCTD) is a rheumatic disorder or syndrome characterized by overlapping clinical features similar to those of systemic lupus erythematosus, scleroderma, poly‐myositis, and dermatomyositis. Serological tests may reveal high titers of circulating antibody to a nuclear ribonucleoprotein (RNP) antigen
  • 1992 . Around the Nation . Wash. Post , : A7
  • 1993 . State the Case Simply, Starting with Voir Dire . Nat'l L.J. , 15 : S10 – 11 .
  • 1996 . Toxics Law Rptr. , 11 : 520
  • Schwarzer , Weiss and Hirsch . 1992 . Judicial Federalism in Action: Coordination of Litigation in State and Federal Courts . Va. L. Rev. , 78 : 1689 For an overview of the Multidistrict Litigation as of June 1, 1993, see MDL‐926 Case Management Orders (CMO) Nos. 1–9. In particular, CMO No. 5 provided for: (1) appointment of special masters, lead counsel, and liaison counsel; (2) uniform pleadings, including a master complaint, a master answer, and simplified service of process; (3) timetables and reasonably uniform processes for discovery, including disclosures from experts; (4) a document depository on CD‐ROM (containing almost 3.5 million documents by June 1, 1993) (5) dissolution of all existing and conflicting protective orders and secrecy documents; and (6) liaison with state court cases. For a discussion of the issues involved in the management of complex litigation
  • McGovern . 1986 . Toward a Functional Approach for Managing Complex Litigation . U. Chi. L. Rev. , 53 : 440
  • Carter‐Stein . 1995 . In Search of Justice: Foreign Victims of Silicone Breast Implants and the Doctrine of Forum Non Conveniens . Suffolk Transnat'l L. Rev. , 18 : 167 Id. (Sept. 15, 1994). Foreign plaintiffs seeking compensation in other American courts also have encountered resistance. For example, the District Court of Harris County, Texas, dismissed without prejudice the actions of 31 Canadian plaintiffs and directed them to file in their home forum of British Columbia. See Matherson v. Dow Corning Corp., No. 93–035109 (Dec. 12, 1994). Exercising its discretion under the Texas forum non conveniens statute, the trial court ruled that the litigants’ private interests and best sources of proof favored Canada over Texas. See Tex. Civil Prac. & Rem. Code § 71.051(a) (1993). Moreover, the public interest and Texas conflict of law principles (which use the “most significant relationship test” for personal injury suits) also dictated that Canadian plaintiffs should sue in Canadian courts. See generally
  • Meyer . 1995 . Silicone Breast Implants and Hospital Liability: A New Forum for Hybrid Transactions . Dickinson L. Rev. , 99 : 439
  • Levy . Mar. 1 1990 . “ Toxic Tort and Product Liability Litigation ” . In Litigation and Administrative Practice Course Handbook Series, Preparation and Trial of a Toxic Tort Case Mar. 1 , PLI Order No. H4–5086
  • Leebron . 1991 . An Introduction to Products Liability: Origins, Issues & Trends . Ann. Surv. Am. L. , : 395 1990
  • Lippes . 1991 . “ Toxic Torts: A Plaintiff's Perspective ” . In Toxic Tort Litigation, Law Journal Seminars‐Press No. 985 3
  • Blum . 1993 . Second‐Generation Cases: Breast Implants Hurt Children? . Nat'l L.J. , : 3
  • Boodman . 1992 . Can Breast Implants Cause Birth Defects . Wash. Post , : 14 This article states
  • Blumenberg . 1992 . Medical Monitoring Funds: The Periodic Payment of Future Medical Surveillance Expenses in Toxic Exposure Litigation . Hastings L.J. , 43 : 661
  • Rudlin and Stravitz . “ Innovative Remedies and Damages Theories ” . In Litigation and Administrative Practice supra note 10
  • Lovell . “ Remedies and Damages Theories in Toxic Tort Actions ” . In Litigation and Administrative Practice supra note 10
  • Graubard . 1990 . Preface to the Issue “Risk,” . Daedalus , 119 (4) : v – vi . Lovell, supra note 270. It appears that issues in toxic tort litigation have been increasingly reoriented around the question of risk. The concept of risk has evolved substantially in recent decades. The older idea, that risk is essentially a wager, which individuals make in the hope of gaining something significant, has almost disappeared from common parlance. Today risk is perceived as a danger to health, to property, to lifestyle, which must be controlled. See
  • Priest . 1990 . The New Legal Structure of Risk Control . Daedalus , 119 (4) : 207 In breast implant litigation, a major issue is whether a manufacturer or a learned intermediary has appropriately minimized the risk of product injury. That is, the focus is no longer on whether the physician or manufacturer was morally culpable for breaching standards of community practice. Instead, the major issue is: Did the surgeon or manufacturer have sufficient control over determinants of the risk of mishap to justify liability?
  • Priest . 1987 . The Current Insurance Crisis and Modern Tort Law . Yale LJ. , 96 : 1521 This creates at least two problems. First, lawsuits increasingly serve only to determine which insurers for corporate, professional, and governmental defendants will foot the bill. If the bill is too high, then premiums increase and some products and services are withdrawn from the market. Second, although insurance through the legal system may help innocent victims by providing otherwise unavailable dollars, it also can be argued that the poor are simply subsidizing the rich through payment of insurance premiums
  • Farrell . Oct. 5 & 19 1991 . “ Statute of Limitations ” . In Litigation and Administrative Practice Course Handbook Series Litigation, New York Civil Practice 1991 Oct. 5 & 19 , PLI Order No. H4–5120
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  • Rose . 1992 . Invited Comment . Annals Plast. Surg. , 28 : 499 Some of the more important medical/scientific questions include the following: (1) is there a human adjuvant disease? (2) do silicone implants produce immune disorders? (3) do silicone implants cause connective tissue disease? (4) how might silicone implants produce disease and is there a critical silicone burden leading to latent systemic disease? (5) is the incidence or prevalence of immune disorder or connective tissue disease increased in silicone recipients? (6) precisely what kind of studies need to be carried out? (7) in the absence of definite epidemiologic and experimental evidence, is it prudent to attribute the broad array of reported signs and symptoms to the silicone implants? (8) should silicone breast implants be removed from some or all women? (9) are there women who should not be given breast implants because of genetic susceptibility to immune disease? (10) should all silicone breast implantation be stopped? See
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  • Associate Professor, Jefferson Medical College, Thomas Jefferson University. Address correspondence to Professor Snyder at 401 Foerderer Pavilion, Thomas Jefferson University Hospital, 125 South 11th Street, Philadelphia, PA 19107–4998.

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