Correspondence
Evaluating the Health Risks of Breast Implants
N Engl J Med 1996; 335:1154-1156October 10, 1996
- Article
To the Editor:
As an educator and academic biomedical scientist, I found the lengthy Special Article by Dr. Angell on silicone-gel–filled breast implants (June 6 issue)1 inconsistent with the scientific standards we have come to expect from the Journal. This article leads one to believe that (1) there is good scientific evidence that such implants are safe for general clinical use, (2) attorneys who protect plaintiffs' interests are “bad guys,” (3) scientists who serve as expert witnesses for plaintiffs are “hired guns,” and (4) the law conspires to harm manufacturers of medical devices.
The article suggests that the silicone-gel implants are safe for general use because good epidemiologic science (i.e., the Mayo2 and Harvard3 studies) “proves” that they produce no “autoimmune disease.” However, the scientific flaws in these studies need not be invoked for one to question seriously the conclusions of Angell's article. Its credibility is lost because of the total disregard of a substantial body of scientifically sound data on the extraordinary rate of implant failure4-9 (now estimated to involve rupture and gross leakage of silicone in 50 percent of cases after approximately eight years),4,5 the substantial degradation of the silicone shell and gel with time,4,6-8 the pain and disfigurement that result from contraction of the fibrous capsule, the chronic inflammation due to immune-system responses involving the phagocytosis of fine silicone droplets by macrophages and giant cells,4,6-8 and the spread of silicone throughout the body.6-8,10,11
On the basis of all the best scientific evidence to date, it is quite reasonable to conclude that silicone breast implants pose an unacceptable safety risk for general clinical use.
11 ReferencesEugene P. Goldberg, Ph.D.
University of Florida, Gainesville, FL 326111
Angell M . Evaluating the health risks of breast implants: the interplay of medical science, the law, and public opinion. N Engl J Med 1996;334:1513-1518
Full Text | Web of Science | Medline2
Gabriel SE ,O'Fallon WM ,Kurland LT ,Beard CM ,Woods JE ,Melton LJ III . Risk of connective-tissue diseases and other disorders after breast implantation. N Engl J Med 1994;330:1697-1702
Full Text | Web of Science | Medline3
Sanchez-Guerrero J ,Colditz GA ,Karlson EW ,Hunter DJ ,Speizer FE ,Liang MH . Silicone breast implants and the risk of connective-tissue diseases and symptoms. N Engl J Med 1995;332:1666-1670
Full Text | Web of Science | Medline4
Goldberg EP. Silicone breast implant safety: physical, chemical, and biological problems. Plastic Reconstr Surg (in press).
5
Robinson OG Jr ,Bradley EL ,Wilson DS . Analysis of explanted silicone implants: a report of 300 patients. Ann Plast Surg 1995;34:1-6
CrossRef | Web of Science | Medline6
Wolf CJ ,Brandon HJ ,Young VL ,Jerina KL ,Srivastava AP . Chemical, physical and mechanical analysis of explanted breast implants. Curr Top Microbiol Immunol 1996;210:25-37
Web of Science | Medline7
Peters W ,Smith D ,Lugowski S ,McHugh A ,MacDonald P ,Baines C . Silicon and silicone levels in patients with silicone implants. Curr Top Microbiol Immunol 1996;210:39-48
Web of Science | Medline8
Garrido L ,Bogdanova A ,Cheng LL , et al. Detection of silicone migration and biodegradation with NMR. Curr Top Microbiol Immunol 1996;210:49-58
Web of Science | Medline9
Berg WA ,Caskey CI ,Hamper UM , et al. Single- and double-lumen silicone breast implant integrity: prospective evaluation of MR and US criteria. Radiology 1995;197:45-52
Web of Science | Medline10
Hardt NS . Cellular transport of silicone from breast prostheses. Int J Occup Med Toxicol 1995;4:127-127
Web of Science11
Pfleiderer B ,Ackerman JL ,Garrido L . Migration and biodegradation of free silicone from silicone gel-filled implants after long-term implantation. Magn Reson Med 1993;30:534-543
CrossRef | Web of Science | Medline
To the Editor:
Angell asserts that epidemiologic studies are required to establish cause-and-effect relations. By limiting the discussion of causation to such studies, she creates a preclusive standard of medical epistemology for the courtroom that is not applied elsewhere to medical decision making. As Hill noted, medical inference is based on all available evidence, including case reports (the Physicians' Desk Reference is loaded with these), toxicologic information, pathological findings, and data from other disciplines.1
An extensive body of scientific evidence composed of case series, immunologic investigations, and studies in animals has been published in peer-reviewed journals. Angell categorically dismisses all this evidence as being of “inferior quality.” She also excludes corporate research from her causal analysis. Dow Corning researchers were aware of problems caused by breast implants, such as chronic inflammation, silicone migration, and rupture.2 Contrary to its assertion that silicone compounds were inert, in 1974 Dow Corning considered marketing silicone as a vaccine adjuvant on the basis of research “indicating that organo-silicon compounds can stimulate the immune response.” 3 In addition, evidence needs to be considered consistently. Angell criticizes the positive study of breast implants for not verifying diagnoses independently, but she fails to mention the potential problem with the negative study of not verifying exposure to breast implants.4
We agree that “we dare not abandon science” in policy making, but we challenge Angell's narrow prescription. Public health decisions must be based on all the available evidence and, as Hill warned, must be made on available (and always incomplete) evidence.
4 ReferencesDavid S. Egilman, M.D., M.P.H.
Brown University, Providence, RI 02912Cassandra Stubbs
South Shore Health Center, Braintree, MA 021841
Hill AB . The environment and disease: association or causation? Proc R Soc Med 1965;58:295-300
Medline2
Byrne J. Informed consent. New York: McGraw-Hill, 1996.
3
Boley W, LaVier R. Immunological enhancing activities of organosilicon compounds and non-functional fluids. Report no. 4319. Midland, Mich.: Dow Corning, October 2, 1974.
4
Sanchez-Guerrero J ,Colditz GA ,Karlson EW ,Hunter DJ ,Speizer FE ,Liang MH . Silicone breast implants and the risk of connective-tissue diseases and symptoms. N Engl J Med 1995;332:1666-1670
Full Text | Web of Science | Medline
To the Editor:
Although several issues in Angell's article are well addressed, one does not have to imply ignorance in matters of science, cynicism, or financial agendas to arrive at an understanding of the juries' decision making. The conclusions of a study are primarily restricted by the limitations of the study design and may not be generally transferable. Scientists' thinking follows strict evidence under defined circumstances, whereas juries must consider all possible circumstances and, furthermore, take into account the necessarily evolutionary character of science.1
People do not have “cynicism about scientists and the scientific method” so much as they are aware of past cases of the use of incomplete studies to counter the public's suspicion that health risks exist. Examples include the Agent Orange2 and Gulf War syndromes, both of which were originally denied. Also, the connection between diethylstilbestrol and cancer that Angell mentions was not verified until hundreds of women were already at risk.
2 ReferencesHans Richard Barthel, M.D.
Olga Barraza, M.T.
Arthritis Institute and Osteoporosis Center, Santa Barbara, CA 93105Lothar G. Meier, M.D.
Rheumaklinik 1, 65191 Wiesbaden, Germany1
Vidmar N. Medical malpractice and the American jury: confronting the myths about jury incompetence, deep pockets, and outrageous damage awards. Ann Arbor: University of Michigan Press, 1995.
2
Stephenson J . New IOM report links agent orange exposure to risk of birth defect in Vietnam vets' children. JAMA 1996;275:1066-1067
CrossRef | Web of Science | Medline
To the Editor:
In her article, Dr. Angell thoughtfully describes the controversy over silicone breast implants, highlighting seemingly antiscientific public attitudes and aspects of our legal system. I can't help reacting with “Yes, but.” There's usually more to the story.
For example, few would dispute her view that we have far too many lawsuits. Indeed, we often laud Japan, where lawyers are few and lawsuits are shunned. However, the hundreds killed and thousands disabled in Minamata, Japan, from 1953 through 1960, in possibly the worst incident of industrially discharged mercury poisoning in the world, are only now receiving compensation, 40 years later — and only at $24,200 per victim.1 Western Europe is also less litigious than the United States, possibly because the United States attempts to use lawsuits to provide security that is offered in Europe by a more extensive system of social insurance. However, most economists judge the generosity of that insurance system to be the principal reason European unemployment has stagnated at a frightfully high rate — 10 to 12 percent, about twice the U.S. level — for the past decade.2 In short, real-world social arrangements that produce less litigation than there is in the United States are not necessarily preferable.
Dr. Angell laments the public's belief that the causes of disease are known, or at least easily ascertained, because this belief makes the public accept coincidences as causes when the true causes are unknown. However, it is just this sort of optimism about the capabilities of science that helps sustain public funding for medical science at a level that is far more generous in the United States than elsewhere.
3 ReferencesJonathan Sunshine, Ph.D.
6720 Western Ave., Chevy Chase, MD 208151
Mercury poison case ends. New York Times. May 23, 1996:A8.
2
Bean CR . European unemployment: a survey. J Econ Lit 1994;23:573-6193
Committee to Review the Health Effects in Vietnam Veterans of Exposure to Herbicides, Institute of Medicine. Veterans and Agent Orange: update 1966. Washington, D.C.: National Academy Press, 1996.
To the Editor:
How discouraging to read Dr. Angell's article on the risks of breast implants and the invisible influence of science on public opinion and the law.
Clearly, our educational system has failed to provide the American people with the ability to reason deductively.
Michael S. Greenwald, M.D.
Joliet Orthopedic and Sports Medicine Center, Joliet, IL 60435Author/Editor Response
Dr. Angell replies:
Contrary to Goldberg's assertion, I did not say that epidemiologic studies “prove” that breast implants produce no autoimmune diseases — something these studies could not do. They could only look for an association between implants and the diseases studied, which they did not find, and calculate how big an association they might have missed, and with what probability. I also did not deny that breast implants can leak, rupture, or cause painful contractures — complications well known for years. Goldberg's references, however, do not support some of his assertions in this regard. For example, rupture rates as high as 50 percent are based on findings in women who wanted their implants removed — a highly selected sample.1,2 In unselected samples, the rate is probably closer to 5 percent, although we certainly need more studies on this question.3,4
Egilman and Stubbs are correct that we need to consider evidence from all types of research, not just epidemiologic studies. But in the breast-implant case, epidemiologic studies were necessary, since the fundamental question was whether the prevalence of connective-tissue disease is higher in women with implants than in other women. Case series cannot answer that question. Furthermore, in view of the recent publicity about breast implants, case series are highly suspect. It was to avert contamination by the publicity that Sanchez-Guerrero et al. designed their study with a cutoff date of mid-1990 for reporting cases of connective-tissue disease, which they then validated. Although they validated reports of implant surgery in only a subgroup of women, reports of surgery were far more likely to be accurate than reports of illness. As for immunologic and animal studies, I stand by my assessment that they have been generally inferior. Finally, Egilman and Stubbs make far too much of speculations in Dow Corning's internal memoranda and animal studies that the Food and Drug Administration rightly found inadequate to demonstrate either safety or risk.5
Barthel et al. seem not to realize that there is still considerable scientific uncertainty about Agent Orange and the Gulf War syndrome. Although it may take time to accumulate enough scientific evidence to demonstrate health risks, there is no substitute for doing so — certainly not courtroom speculation or the “public's suspicion.”
Sunshine implies that good ends may justify dubious means. I don't agree. It is also quite a stretch to see our peculiar tort system as part of the price we pay for relatively low unemployment.
I heartily agree with Greenwald.
5 ReferencesMarcia Angell, M.D.
1
de Camara DL ,Sheridan JM ,Kammer BA . Ruptures and aging of silicone gel breast implants. Plast Reconstr Surg 1993;91:828-834
CrossRef | Web of Science | Medline2
Robinson OG Jr ,Bradley EL ,Wilson DS . Analysis of explanted silicone implants: a report of 300 patients. Ann Plast Surg 1995;34:1-7
CrossRef | Web of Science | Medline3
Destouet JM ,Monsees BS ,Oser RF ,Nemecek JR ,Young VL ,Pilgram TK . Screening mammography in 350 women with breast implants: prevalence and findings of implant complications. AJR Am J Roentgenol 1992;159:973-978
Web of Science | Medline4
Silverman BG ,Brown SL ,Bright RA ,Kaczmarek RG ,Arrowsmith-Lowe JB ,Kessler DA . Reported complications of silicone gel breastimplants: an epidemiologic review. Ann Intern Med 1996;124:744-756
Web of Science | Medline5
Kessler DA . The basis of the FDA's decision on breast implants. N Engl J Med 1992;326:1713-1715
Full Text | Web of Science | Medline
- Citing Articles (3)
Citing Articles
1
Alicia D. Gruber, Chris W. Widenhouse, Steven Mathes, Ronald P. Gruber. (2000) Exhaustive soxhlet extraction for the complete removal of residual compounds to provide a nonleaching silicone elastomer. Journal of Biomedical Materials Research 53:5, 445-448
CrossRef2
James S. Marotta, Christopher W. Widenhouse, Mutaz B. Habal, Eugene P. Goldberg. (1999) Silicone gel breast implant failure and frequency of additional surgeries: Analysis of 35 studies reporting examination of more than 8000 explants. Journal of Biomedical Materials Research 48:3, 354-364
CrossRef3
Jack W. Snyder. (1997) Silicone breast implants. Journal of Legal Medicine 18:2, 133-220
CrossRef
