Safety of Silicone Breast Implants (1999) / Chapter Skim
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1 Introduction
1 Introduction
Pages 13-38
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From page 13... ...
. Important meetings of the FDA General and Plastic Surgery Devices Panel, other meetings and workshops under the auspices of NIH, and studies and notices from CDC had informed and advanced the regulation and science of silicone breast implants.
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From page 14... ...
Important contractual items included a scientific workshop, held on fuly 22, 1998, which provided the committee with information on a number of scientific matters from researchers in the federal government and academia and offered former and current major silicone breast implant manufacturers Dow Corning, Mentor, and McGhan an opportunity to present data from clinical observational and other research studies. Also included was a public meeting held on fuly 24, 1998, at which more than 60 women formerly or currently with silicone breast implants, professional association representatives, scientists of all perspectives, consumer group representatives, and others addressed the committee.
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From page 15... ...
THE IOM COMMITTEE ON THE SAFETY OF SILICONE BREAST IMPLANTS The Committee on the Safety of Silicone Breast Implants was assembled by the IOM to include expertise in preventive and internal medicine, nursing, family and women's health, rheumatology, clinical and basic research, epidemiology, immunology, neurology, silicone chemistry, toxicology, breast and other cancer, plastic surgery, and radiology or mammography. Committee members are listed at the front of this report.
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From page 16... ...
The committee's plastic surgery expert, on the other hand, does not perform breast implant surgery in her practice of pediatric plastic surgery. In addition to the first committee meeting in April and the scientific workshop and public meeting (summarized in the appendixes)
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From page 17... ...
Although individual reports of personal experiences cannot be confirmed and are anecdotal and therefore not scientifically definitive, this human element, which is after all a part of medical care and medical science, provided an important context to the committee's deliberations. A review of the reference lists at the end of this report indicates that much of the literature available to and considered relevant by the committee, did not consist of full, peer-reviewed, published scientific reports but was in the form of letters, position papers, abstracts, industry reports,
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From page 18... ...
These have allowed the committee to take firm conclusions on many of the important issues. To communicate this firmness, the committee adopted a ranking of evidence or data as: conclusive or convincing of an association or of no association; limited or suggestive of an association or of no association; or, in the committee's judgment, insufficient, flawed in terms of methodology, or lacking in support of the various evaluations of the safety of silicone breast implants.
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From page 19... ...
. Case reports from individual women can be used to generate hypotheses about disease and symptoms that may be associated with silicone breast implants.
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From page 20... ...
These powerful motivations may explain the continuing acceptance by many women and health professionals of evolving cosmetic surgical breast procedures despite complications, high incidence of hardness, and often globular or otherwise less than natural-looking breasts. Autogenous Tissue The modern history of cosmetic breast surgery began in the late 1800s.
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From page 21... ...
in a chronological listing of surgical advances with citations to the literature and in 1995 by Wickman. About one-third of modern breast reconstructions are performed using autogenous tissue.
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From page 22... ...
fluid with a stannous octoate catalyst to form a silicone rubber within the breast tissue were also used for breast augmentation and other plastic surgical purposes with positive early reports (Ashley et al., 1967; Conway and Goulian, 1963; Freeman et al., 1966; Harris, 1965~. Substantial amounts of these substances were injected on occasion, as much as 2 liters for breast augmentation and body contouring in a single patient (Kagan, 1963)
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From page 23... ...
Among the more clear-cut effects associated with silicone breast injection (as noted, not an FDAapproved use as part of the Dow Corning IND) have been pain, skin discoloration, edema, ulceration and necrosis, calcification, granulomas, migration of the fluid, infection, cysts, axillary adenopathy, disfigurement and loss of the breast, liver granulomas and dysfunction, acute pneumonitis or adult respiratory distress syndrome, pulmonary embolism, coma, and death (Baker, 1992; Boo-Chai, 1969; Brozena et al., 1988; Celli et al., 1978; Chastre et al., 1983a, 1987; Chen, 1995; Chen et al., 1993; Cruz et al., 1985; Edgerton and Wells, 1976; Ellenbogen and Rubin, 1975; Inoue et al., 1983; Ko et al., 1995; Koide and Katayama, 1979; Lai et al., 1994; McCurdy and Solomons, 1977; Parsons and Thering, 1977; Perry et al., 1985; Piechotta, 1979; Rodriguez et al., 1989; Solomons and Tones, 1975; Symmers, 1968; Truong et al., 1988; Vinnik, 1978; Winer et al., 1964~.
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From page 24... ...
Nevertheless, "FDA has not approved the marketing of liquid silicone for injection for any cosmetic purpose, including the treatment of facial defects or wrinkles..." (FDA, 1991~. The history of silicone injection is relevant to the safety of silicone breast implants because of the possible analogy to silicone gel fluid diffusion through implant shells into breast tissue or the deposition of silicone gel (and gel fluid)
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From page 25... ...
The response to this need was the introduction of the silicone breast implant in 1962 and its continued development through the 1990s, as described in Chapter 3. The specific experimental basis for the clinical introduction of this device was the work reported by Cronin and Gerow (1963)
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From page 26... ...
Similarly, the Karolinska group (Sweden) has consistently found that, up to seven years after surgery, women were satisfied with, or tolerant of, severe (Class III or IV; see breast augmentation classification in Appendix D)
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From page 27... ...
(1996a) reported 84% of augmented women satisfied to very satisfied, as were 91% of implant-reconstructed women in a survey carried out at least one to ten years postoperatively by plastic surgeons.
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From page 28... ...
women with breast implants in the early 1990s. Although they constitute the only national source, and provide expanded details on patient satisfaction from a some
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From page 29... ...
staff with some collaborators reported a follow-up in 1994 of 1,167 of these reports of local or systemic problems with implants with a survey requesting information on physician diagnoses. Of the original cohort, 820 completed the interview; 28% of these reported a physician diagnosis of a connective tissue disease and 43% reported multiple implant surgery.
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From page 30... ...
Concerns surfaced that silicones might be associated with cancer, and reports of connective tissue diseases and less well defined systemic complications, perhaps of an immune nature, in women with silicone injections and implants began to appear (see Chapters 6, 7, and 8~. As a result, in 1982, the FDA proposed and, on June 24, 1988, formally implemented a classification of silicone breast implants in a category (Class III)
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From page 31... ...
Prevalence of Silicone Breast Implants Implantation of silicone shell devices began from a small base, gradually replacing other breast alloplastic devices listed earlier in this chapter and slowly increasing in numbers. Early reports estimated that somewhat more than 50,000 women received implants between 1962 and 1970, and 98% of these were for augmentation (de Cholnoky, 1970; Braley, 1972; Robertson and Braley, 1973~.
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From page 32... ...
It is not possible to be sure of the division between augmentation and reconstruction at any given time in the total cohort of U.S. women receiving breast implants.
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From page 33... ...
An analysis of data from the 1988 National Health Interview Survey, which reported 11 million persons in the United States with implants of all kinds (Moss et al., 1991; see Chapter 2 for a partial list of silicone containing devices) suggested 304,000 women at least 18 years of age with silicone breast implants (95% confidence interval [CI]
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From page 34... ...
(see also August et al., 1994; Birtchnell and Lacey, 1988; Cook et al., 1995; Gabriel et al., 1997; McGhan Medical Corporation, undated; Shipley et al., 1977; Wickman and furell, 1997; Winer et al., 1993~. All of the reported estimates of breast implant prevalence suffer from problems that affect their accuracy, as the authors themselves often point out.
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From page 35... ...
The AACS surveys a different group of medical specialists with practices limited to cosmetic procedures, including general surgeons, dermatologists, facial plastic and reconstructive surgeons, some plastic surgeons, family practitioners, and obstetricians or gynecologists (Atwood et al., 1994~. These specialists perform about 30% of augmentations with breast implants in the United States.
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From page 36... ...
The committee judges there to have been 1 million to 1.27 million U.S. women with silicone breast implants in 1988.
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From page 37... ...
The English language, peer-reviewed, scientific literature supplemented with some data from industry and other technical reports comprised the primary information base for the description of the background, context and prevalence of silicone breast implantation and for the subsequent chapters of this report. An enormous amount of material generated from U.S.
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From page 38... ...
A number of important issues emerged from the committee's reviews of available information. These issues are the ones that make up the committee's charge and they are the scientific and medical questions that are suggested or explicit in the reports concerning associations between silicone breast implants and human health conditions that have appeared in increasing numbers in the world's medical and scientific literature.
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