Correspondence
The Breast-Implant Controversy
N Engl J Med 1993; 328:732-735March 11, 1993
- Article
To the Editor:
Dr. Angell's editorial (June 18 issue)1 on the breast-implant controversy refreshingly highlights the forgotten half of the risk-benefit ratio: efficacy. As Dr. Kessler points out in the same issue,2 the 1976 Medical Device Amendments to the Food, Drug and Cosmetic Act require evidence of both safety and efficacy on the basis of which the Food and Drug Administration is to make a risk-benefit assessment. So much attention has been given to the risks, known and unknown (no matter how unlikely), that the benefits have been minimized. In the past year and a half, the media and consumer advocacy groups have dramatically exaggerated even hints of risk, dealing a cruel setback to the almost 2 million women who have received these devices in order to enhance their own sense of well-being. Even the most secure and rational woman cannot have escaped the blitz of sensationalized news and titillating horror stories without some gnawing insecurity about whether she has done terrible harm to her health.
How can the FDA evaluate a risk-benefit ratio in a climate in which it has contributed to diminishing the benefit? The agency has said that there is no evidence that the implant is unsafe; there is just not enough evidence that it is safe. Yet its public statements and actions imply great concern over some yet-to-be-discovered health risk.
Commissioner Kessler apparently still does not understand the value of cosmetic augmentation. Did he not hear the advice of his own advisory panel of November 1991, which saw no difference between the benefits of breast implantation for reconstruction and those of implantation for cosmetic purposes? Does he not understand the implication of a recent sampling showing that in the face of all the negative reports, only 3 percent of women with implants have considered their removal and only 1.5 percent have gone through with it? Just because the average citizen who is not exposed to these issues may think that this surgery is frivolous, the commissioner of the FDA should not consider such a view a social mandate.
2 ReferencesGarry S. Brody, M.D.
11411 Brookshire Ave., Downey, CA 902411
Angell M . Breast implants -- protection or paternalism? N Engl J Med 1992;326:1695-1696
Full Text | Web of Science | Medline2
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
To the Editor:
There is a lack of science in this controversy, because those involved in the placement of silicone-gel implants made no attempt to assess the long-term consequences of the use of these devices. The FDA has rightly demanded evidence of the long-term safety of such implants before they are placed in more women.
We dispute Dr. Fisher's statement (June 18 issue)1 that “no convincing evidence shows that the removal of breast implants reverses the musculoskeletal symptoms.” Observations of the first 50 women we have seen with breast implants and signs and symptoms of rheumatic disease were presented at the Southeastern Meeting of the American College of Rheumatology on March 14, 19922. Thirty-three women had their breast implants removed. Follow-up averaging two years showed that 24 had improvement in their rheumatic signs and symptoms. Four women had complete resolution of symptoms and clinical findings. These observations do not constitute definitive proof, but they raise the suspicion that some women have a substantial reaction to silicone implants and that this problem should be studied further. We suggest that some women do have a syndrome of chronic fatigue, anterior chest-wall pain, myalgias, arthralgias, arthritis, and lymphadenopathy in association with silicone implants, particularly if the implants rupture. We suggest that in such women these symptoms may improve if the implants are removed.
2 ReferencesFrank B. Vasey, M.D.
Mitchel J. Seleznick, M.D.
Bernard F. Germain, M.D.
University of South Florida College of Medicine, Tampa, FL 336121
Fisher JC . The silicone controversy -- when will science prevail? N Engl J Med 1992;326:1696-1698
Full Text | Web of Science | Medline2
Vasey FB ,Havice D ,Bocanegra T ,Bridgeford P ,Seleznick MJ ,Germain BF . Clinical manifestations of fifty consecutive women with silicone breast implants and connective tissue disease. Arthritis Rheum 1992;35:Suppl:S212-S212 abstract.
Web of Science
To the Editor:
The public's demonstrated ability to perform risk assessment in matters of public health is not good, as shown by the response to the recent scare involving Alar-tainted apples and, before that, the menace of grape contamination with cyanide -- reactions that can only be classified as near-hysterical and foolish. The much-maligned news media did not distinguish themselves in those controversies. Despite the work of many fine science writers and reporters, it is clear that the public at large has not received the information it needs to make rational judgments about the risk of breast implantation, even if it were inclined to do so. Even interested physicians are unlikely to be much better apprised of the facts.
Barry Meisenberg, M.D.
Duke University Medical Center, Durham, NC 27710To the Editor:
The FDA's decision to ban cosmetic breast implants1 will have a profound impact on our society if it is applied consistently to other devices. Consider, for example, the use of contact lenses for cosmetic purposes. In contrast to breast implants, contact lenses have well-documented adverse effects, and in some instances they can be severe2. In spite of this, millions of people use these lenses even though they can have excellent visual acuity with regular glasses. Will the FDA continue to tolerate this practice? Modern glasses, with impact-resistant plastic lenses, provide considerable protection to the eye and have no adverse effects, or at most trivial ones. On the other hand, the only benefits of contact lenses for most users are cosmetic ones, and they are worthy of no more consideration by the FDA than are the benefits of cosmetic breast implants.
2 ReferencesWilliam D. Dupont, Ph.D.
Vanderbilt University School of Medicine, Nashville, TN 372321
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 | Medline2
Smith RE ,MacRae SM . Contact lenses -- convenience and complications. N Engl J Med 1989;321:824-826
Full Text | Web of Science | Medline
To the Editor:
In his otherwise excellent article, Fisher refers to the absence of reliable imaging methods. Kessler makes a similar suggestion: “We are concerned about `silent rupture,' the undetected failure of the device in women who have no symptoms of rupture. Mammography is the only reliable procedure for detecting silent rupture, but [it is] not advisable for young women.” Could it be that both authors have overlooked the simple, safe, and reliable investigation of ultrasound mammography (ultrasonography)? The technique was reported in January 1989,1 and our series is gradually enlarging, mainly because of the infrequent occurrence of rupture. To date only suspected cases have been screened, and we have yet to come across a patient with a false positive result (one that could not be confirmed surgically). The value of ultrasound mammography has since gained wider acceptance,2-4 and it could very well become the imaging method of choice for all breast implants because of its safety and reliability, provided the correct technique is adhered to.
4 ReferencesJan J. van Wingerden, M.B., Ch.B., M.Med. (Plast. Chir)., M.B., Ch.B., M.Med. (Plast. Chir).
Universiteit van Pretoria, 0001 Pretoria, South Africa1
van Wingerden JJ ,van Staden MM . Ultrasound mammography in prosthesis-related breast augmentation complications. Ann Plast Surg 1989;22:32-35
CrossRef | Web of Science | Medline2
Herzog P . Silicone granulomas: detection by ultrasonography. Plast Reconstr Surg 1989;84:856-857
CrossRef | Web of Science | Medline3
van Wingerden JJ ,van Staden MM . Ultrasound mammography for the diagnosis of a ruptured breast implant. Plast Reconstr Surg 1990;86:383-383
CrossRef | Web of Science | Medline4
Levine RA ,Collins TL . Definitive diagnosis of breast implant rupture by ultrasonography. Plast Reconstr Surg 1991;87:1126-1128
CrossRef | Web of Science | Medline
To the Editor:
I strongly disagree with Dr. Angell's criticism of the FDA's decision to limit the availability of silicone gel-filled breast implants. Dr. Angell's chief argument -- that the FDA gives the benefits of breast implants short shrift -- does not take into account the agency's painstaking study of all facts pertinent to the issue. Agency staff members, for instance, assembled qualitative data about the beneficial effect of implants by carefully analyzing more than 20,000 letters from consumers. Another closely consulted source of information was the medical literature describing the scope of benefits of breast implants1-5. At the last two advisory-panel meetings that dealt with the issue, several women testified about the important role of breast implants in their recovery from cancer. As a participant in the FDA's decision-making process, I know that the advantages of the implants received a scrutiny no less thorough than that of the risks.
In fact, it was the recognition of the benefits that had persuaded the agency to accept a degree of risk associated with the uncertainties of breast implants. But these risks become more worrisome in younger women choosing augmentation, because there were serious questions about the long-term safety of the implants and their interference with critical screening for breast cancer.
Dr. Angell asserts that the FDA decision has provoked fears among women with breast implants. The large volume of letters and calls to the FDA attests that this concern is genuine. However, the concern stems not from the FDA's action, but from a lack of answers about the safety of the implants. After the devices have been in use for 30 years, neither the manufacturers nor the physicians implanting them have provided the necessary, scientifically sound data.
Dr. Angell also alleges that it was sexist for the FDA to target a device used only by women. The converse is equally true. It would have been sexist to ignore the safety of a device for women and to allow its use without a full scientific review of previously undisclosed risks. If there was any sexism involved, it was related to a lack of studies of safety and to disregard for the professional responsibility of first doing no harm.
Finally, I must take issue with Dr. Angell's position that the FDA is coercing women by requiring them to enroll in studies in order to obtain a silicone implant. The need for studies of safety and efficacy has been agreed on by consumers, manufacturers, health professionals, and government officials. Thousands of women are requesting participation and asking for a registry. They find comfort in knowing they are to be followed medically, and they are willing to share with researchers their personal experiences with breast implants, despite the potential intrusions that concern Dr. Angell. These studies must be conducted in public, not behind closed doors. The results will benefit women's health.
5 ReferencesRuth B. Merkatz, Ph.D., R.N.
Food and Drug Administration, Rockville, MD 208571
Dean C ,Chetty U ,Forrest AP . Effects of immediate breast reconstruction on psychosocial morbidity after mastectomy. Lancet 1983;2:459-462
CrossRef2
Goin MK ,Goin JM . Midlife reactions to mastectomy and subsequent breast reconstruction. Arch Gen Psychiatry 1981;38:225-227
Web of Science | Medline3
Johnson CH ,van Heerden JA ,Donohue JH ,Martin JK Jr ,Jackson IT ,Ilstrup DM . Oncological aspects of immediate breast reconstruction following mastectomy for malignancy. Arch Surg 1989;124:819-823
Web of Science | Medline4
Maguire P . Breast conservation versus mastectomy: psychological considerations. Semin Surg Oncol 1989;5:137-144
CrossRef | Web of Science | Medline5
Schlebusch L . Negative bodily experience and prevalence of depression in patients who request augmentation mammoplasty. South Afr Med J 1989;75:323-326
Medline
Author/Editor Response
The authors reply:
To the Editor: I do not accept the charge of Dr. Vasey and colleagues that a need for research has been ignored. The investigation of the silicone issues still concerning us actually began before the FDA had jurisdiction over medical devices. Data collection started in 1974 for the Los Angeles-University of Southern California study that eventually demonstrated no increased risk of breast cancer among implant recipients. The FDA was informed in 1983, and the findings were published in 19861. The first American report of concurrent scleroderma and silicone exposure appeared in 1982, stimulating Weisman, a rheumatologist, and Vecchione, a plastic surgeon, to conduct their study, published in 1988,2 which could not confirm a cause-and-effect relation. Also in 1988, the Plastic Surgery Educational Foundation met with manufacturers of silicone medical products to discuss the conduct of larger epidemiologic studies. Five are in progress, at the University of Michigan, New York University, Johns Hopkins University, the Mayo Clinic, and the University of Alberta.
I am aware of Dr. Vasey's clinical observations. He has also acknowledged that his patient population is an extremely biased sample. Beecher has taught us that a surgical procedure can be a powerful placebo3.
Dr. van Wingerden's favorable experience with ultrasonography parallels that of others using mammography and magnetic resonance imaging. However, our surveys of radiologists nationwide tell us that false positive and false negative findings can be attributed to each technique.
I agree with Dr. Meisenberg's observations. The medical profession cannot expect to be reliably informed on medical issues from reading their newspapers.
3 ReferencesJack C. Fisher, M.D.
University of California, San Diego, San Diego, CA 921031
Deapen DM ,Pike MC ,Casagrande JT ,Brody GS . The relationship between breast cancer and augmentation mammaplasty: an epidemiologic study. Plast Reconstr Surg 1986;77:361-368
CrossRef | Web of Science | Medline2
Weisman MH ,Vecchione TR ,Albert D ,Moore LT ,Mueller MR . Connective-tissue disease following breast augmentation: a preliminary test of the human adjuvant disease hypothesis. Plast Reconstr Surg 1988;82:626-630
CrossRef | Web of Science | Medline3
Beecher HK . Surgery as placebo: a quantitative study of bias. JAMA 1961;176:1102-1107
Web of Science | Medline
Author/Editor Response
The comments of Drs. Brody and Meisenberg highlight our challenge to work with the medical community to make the legal obligations of the FDA more widely understood and appreciated. The Medical Device Amendments of 1976 require the FDA to evaluate the risks and benefits of implants on the basis of submitted data and studies that are the responsibility of manufacturers. Without such data -- which in the case of breast implants are yet to be generated, three decades after the devices first entered the market -- no reliable judgment of the risk-benefit ratio is possible, and therefore the devices cannot legally qualify for FDA approval.
The difficulty of making decisions in the absence of scientific data is also reflected in Dr. Brody's reference to the advisory committee's opinion of November 1991. At that time, the group found it could not differentiate between the relative benefits of implants for reconstruction and those made for cosmetic purposes. At its next meeting, three months later, the advisory committee considered newly available information on possible risks, including what became known as silent rupture, and concluded that the acceptability of these risks varies among different groups of patients. As a result, it called for different levels of availability of breast implants for different types of patients. The complexities of this issue only underscore the need for a closer exchange of views and cooperation among all the involved parties, including the FDA, manufacturers, plastic surgeons, and patients.
The comparisons drawn by Dr. Dupont between contact lenses and silicone breast implants for cosmetic use overlook several important differences between the two devices. From the FDA's viewpoint, the most important difference is the fact that unlike breast implants, contact lenses have been shown by studies to be safe and effective. This essential dissimilarity is heightened by the ease with which the user can remove contact lenses at the first sign of trouble, whereas the removal of breast implants requires a surgical procedure. Dr. Dupont correctly points out that there are risks associated with the use of contact lenses, but these risks -- again, unlike those with breast implants -- are well known, and the product label includes appropriate precautions and warnings.
Finally, I wish to thank Dr. van Wingerden for calling attention to alternative techniques of detecting implant rupture. At the time my article was written, x-ray mammography was the imaging method most widely used to detect implant ruptures. Since then, studies have found new evidence bearing on the possible use of ultrasonography and magnetic resonance imaging to detect such ruptures. Since neither of the latter methods uses x-rays, we look forward to studies showing the relative effectiveness of mammography, ultrasonography, and magnetic resonance imaging in evaluating implants and identifying cancer of the breast in its earliest stages, when it can be most effectively treated.
David A. Kessler, M.D.
Food and Drug Administration, Rockville, MD 20857Author/Editor Response
Editor's reply:
Dr. Merkatz argues that the concern among women with breast implants does not stem from the FDA's action in banning them, but rather from the 30-year failure of the manufacturers to establish safety. I disagree. The widespread fear -- and the multimillion-dollar lawsuits -- have dated largely from the FDA's removal of breast implants from the market. As Dr. Brody points out, it is understandable that the FDA's unusual action would generate such concern.
I disagree even more with Dr. Merkatz's implication that because many (or even most) women receiving breast implants would like to become subjects of clinical studies, all must do so.
Marcia Angell, M.D.
- Citing Articles (3)
Citing Articles
1
Arshad R. Muzaffar, Rod J. Rohrich. (2002) The Silicone Gel–Filled Breast Implant Controversy: An Update. Plastic and Reconstructive Surgery 109:2, 742-748
CrossRef2
Jack W. Snyder. (1997) Silicone breast implants. Journal of Legal Medicine 18:2, 133-220
CrossRef3
Mary Lou Logothetis. (1995) Women's Reports of Breast Implant Problems and Silicone-Related Illness. Journal of Obstetric, Gynecologic, <html_ent glyph="@amp;" ascii="&"/> Neonatal Nursing 24:7, 609-616
CrossRef
