Breast Cancer and Silicone Implants Psychological Consequences

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					                                                                   stantial amounts of TDA were produced by the chemical
                                                                   breakup of the polyurethane covering of the breast implant
                                                                   and then released into the blood during or after pha-
Breast Cancer and Silicone                                         gocytosis, the result might be an increased risk of cancer for
                                                                   women with implants. Subsequent tests of this possibility
Implants: Psychological                                            have not provided support for such an increased risk for
                                                                   malignancy due to TDA release (77,72). However, after
Consequences for Women                                             April 1991, these polyurethane-covered implants were no
                                                                   longer marketed.
                                                                      It has been demonstrated, however, that, when silicone
                                                                   elastomer is used as the breast implant envelope, the silicone
Chris Hatcher, Loren Brooks,                                       gel does bleed through the breast implant elastomer and can
Candace Love*                                                      migrate away from the implant site through a lymphatic or
                                                                   hematogenous pathway (75). No teratogenic effects have
                                                                   been noted with silicone fluid migration or bleeding through
                                                                   the elastomer (6), but concern has been expressed about the
   One of every nine women in the United States is expected        effect of silicones on the immune system. Over the last 14
to develop breast cancer at some point in her lifetime. An         years, a limited, but continuing, series of reports on clinical
estimated 180000 women are diagnosed with breast cancer            studies of breast reconstruction and augmentation have noted
each year (7-5). For many of these women, excision of the          immune system reactions associated with the following
tumor, resulting in surgical modification of the breast, is the    procedures: silicone injection (14,15), combined silicone and
primary component of the treatment response. The U.S. Food         paraffin injections (76), silicone gel implants (77), or saline-
and Drug Administration (FDA) (4) estimates that approx-           filled implants (15,18). Scleroderma has been cited as the
imately 20% of these women elect breast implant surgery            most frequent clinical diagnosis, but approximately half of
following mastectomy. The use of breast implants, par-             the patients' symptoms are suggestive but not diagnostic of a

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ticularly silicone implants, has generated considerable            known clinical diagnosis. These symptoms often receive the
discussion in scientific forums, clinical treatment settings,      general diagnosis of "human adjuvant disease," a term first
lay consumer groups, legislatures, and regulatory agencies.        applied in 1964 in two case reports (79) describing breast
   Surgical insertion of breast implants dates back to the         cancer patients who developed rheumatoid arthritis-like
initial use of polyvinyl alcohol sponges (5). However,             symptoms subsequent to paraffin injections for breast
relatively few implant procedures were performed until the         augmentation after mastectomy (20,21). Yet, studies of the
introduction of implants constructed of silicone in 1963 (6).      immune system in animals have not provided evidence to
Silicone breast implants contain silicone materials in three       support the hypothesis that silicone produces negative effects
forms: 1) silicone fluid (polydimethylsiloxane), which is the      on the immune system (22-24). While some clinical reports
fluid component of the silicone gel; 2) silicone gel, which is     have indicated a reduction in immune system symptoms
the actual gelatin form that fills the implant envelope; and 3)    following breast implant removal (19,25-30), the silicone
silicone elastomer, which comprises the envelope that              particles that have already passed through the silicone
contains the fluid and the gel (7). In the original silicone       elastomer of the implant should logically still be present in
implant device, the gel and fluid were enclosed in a thick,        the body. In summary, the events that may involve the
smooth-surfaced silicone envelope, which was subsequently          interaction of silicone with the human immune system
altered over time (6).                                             remain unclear and continue to be the subject of substantial
   From a scientific and clinical standpoint, silicone breast      scientific and clinical discussion.
implants have been a topic of considerable discussion. One             More recently, women have reported physical symptoms
concern involved capsular contraction, a known side effect         and problems associated with silicone breast implants.
of breast implantation, and the subsequent use of poly-            Acting as consumers, they have sought to focus attention on
urethane foam implant coverings in an effort to reduce             this issue through the media, litigation, support/advocacy
capsular contraction rates. Capsular contraction results from      groups, and legislation and by seeking increased control by
the formation of a capsule-like layer of scar tissue in the        regulatory agencies. Popular media reports of women with
surgical pocket created for the implant. Such scar tissue then     serious autoimmune disease symptoms have evoked com-
squeezes the implant to varying degrees of firmness (6).           mentaries from both physicians and attorneys stating
When polyurethane-covered implants were observed to have           alternative views as to whether such symptoms were causally
a lowered capsular contraction rate, their use became              related to silicone breast implants. Civil litigation against
frequent (8). This lowered rate was believed to be due to the      implant manufacturers has also been pursued, resulting in
peripheral breakup of fragments of the polyurethane foam           two nationally visible judgments against manufacturers (the
and the subsequent phagocytosis of the fragments (9).              Mariann Hopkins case in San Francisco, Calif., for $7.3
Although the polyurethane itself has not been shown to be a
carcinogen in either animals or humans (70), in vivo
hydrolysis of the foam produces an end product known to be
an animal carcinogen (2,4-toluenediamine [TDA]). If sub-             *See "Notes" section following "References."

Journal of the National Cancer Institute, Vol. 85, No. 17, September 1, 1993                                         EDITORIALS       1361
     million and the Pamela Jean Johnson case in Houston, Tex.,       A small number of these women sounded angry. The most
     for $25 million) and one judgment against a plaintiff (the       commonly asked questions were: What should I do if I
     Tammy Turner McCartney case in Denver, Colo., for $7             already have implants? What symptoms should I be
     million denied). Popular media coverage of the silicone          concerned with? Should patients without symptoms be
     implant controversy in general and of civil litigation awards    routinely checked by a physician? Are saline implants safe?
     in particular has raised awareness of potential health           Am I eligible for implants and how can I get them? Callers
     concerns for women with implants.                                to the Line were provided additional information by mail
        From a statutory standpoint, state and Federal legislators    about breast implants (32). In summary, the FDA Breast
     have also responded to the silicone breast implant issue. At     Implant Information Line experience is supportive of the
     the state level, Maryland in 1987 and New York in 1991           broadly based existence of concerns about emotional distress
     both passed measures requiring physicians to provide printed     and health care among women with implants.
     risk information to all women considering breast augmenta-          Furthermore, during the deliberation period of the FDA's
     tion or reconstruction (57). At the Federal level, involvement   regulation of silicone gel breast implants in 1991 and 1992,
     of regulatory agencies in regulation of silicone breast          the FDA received thousands of letters from women with
     implants began with the 1976 Medical Device Amendments           breast implants. The majority were from women "satisfied"
     to the Federal Food, Drug, and Cosmetic Act. The                 with their implant results, but a small group of women
     responsibility for classifying medical devices as to safety      reported "dissatisfaction" with their implant results. A
     and effectiveness was then assigned to the FDA Center for        qualitative analysis of the experiences of these "dissatis-
     Devices and Radiological Health. Silicone breast implants        fied" women as well as a descriptive analysis of these
     were designated as class III (devices requiring proof of         women's physical complaints was undertaken by the FDA.
     safety and effectiveness). After an extended period of           The qualitative analysis reviewed all letters (112) received
    review, the FDA General and Plastic Surgical Devices              during January 1992 for their psychosocial content from
    Advisory Panel recommended against assigning implant              women who had silicone gel implants for cosmetic
    devices to a less regulated class, so implants continued to be    augmentation or reconstruction after mastectomy. Four
    categorized as a class III device.                                patterns of these women's experiences were revealed: 1)

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        However, Congressional concern with medical devices,          Women did not receive adequate information prior to
    including implants, continued to grow. This concern resulted      surgery, 2) women were not taken seriously by their
    in the 1990 Safe Devices Act, which mandates that health          physicians when they complained of pain or other symp-
    care providers report serious complications or fatalities         toms, 3) women had difficulty maintaining their normal
    involving medical devices to the Department of Health and         activities, and 4) women had concerns about the future and
    Human Services and to the device manufacturer who, in             about not being able to get information (32). The descriptive
    turn, must notify the FDA. Most significantly, on April 16,       analysis reviewed all letters (271) received in the FDA
     1992, the FDA issued a regulation limiting further use of        Office of the Commissioner during the period of January
    silicone implants to experimental studies and to individual       1992—July 1992 from a group of women who described
    urgent-need exemptions. In January 1993, the FDA placed           health problems they believed to be associated with their
    new benefit/risk assessment requirements on manufacturers         silicone implants. The most commonly cited complaints were
    of saline breast implants as well.                                breast pain (40%), rupture (31%), capsular contracture
        The FDA Breast Implant Information Line was established       (29%), joint pain (39%), and fatigue (35%). The diagnoses
    in February 1992 to provide current information on silicone       most commonly described were arthritis (19%), autoimmune
    gel breast implants following announcement of the FDA's           disease (7%), Raynaud's disease (5%), and connective tissue
    advisory panel that met February 18-20. Additional informa-       disorder (4%). The physical complaints from the descriptive
    tion was provided as it developed including the conditions of     analysis were then used as keywords for a computerized
    FDA's final decision, announced in April 1992 on the              search of two FDA systems for reporting problems with
    availability of silicone gel implants.                            silicone gel breast implants (the mandatory Medical Device
        The Information Line, which was in operation until July       Reporting [MDR] and the voluntary Product and Reporting
    1992, was accessed by an 800-telephone number. It                 Program [PRP] systems) in order to identify any similarities
    responded to 41000 callers, most of whom spoke directly to        among the three. The search yielded a consistency in physi-
    information specialists. According to a summary report            cal complaints and problems from these three sources (33).
    provided by the FDA and based on information logs                    From January 1, 1992, until July 1, 1992, the FDA
    maintained by the information specialists to record informa-      received 7191 MDR unfavorable reports from manufacturers
    tion volunteered by subjects (specific information was not        and 1136 PRP reports from users of silicone breast implants
    requested), more than 90% of the callers were women. Of           representing a significant increase in reporting as compared
    these, more than 70% already had breast implants. Over half       with similar reports from 1988 through 1992. Media
    of these women reported on a variety of physical problems         attention of the silicone breast implant controversy and
    including symptoms often associated with autoimmune               product liability court verdicts may have contributed to this
    disorders, implant ruptures, capsular contracture, infection,     increased reporting. Also, possible variations in manufacturer
    and other conditions. According to subjective assessments         implant problem reporting criteria may account for the lower
    made by the information specialists, about half of the            reporting prior to 1992. The authors of the FDA descriptive
    women they spoke to sounded upset, sad, fearful, or worried.      analysis suggest that information from the letters received by

1362 EDITORIALS                                           Journal of the National Cancer Institute, Vol. 85, No. 17, September 1, 1993
the FDA, MDR reports, and PRP reports may raise questions           the silicone implant controversy, being satisified with the
 about the assertion that the small number of breast implant        implant reconstruction, and currently being in good physical
 complaints during the previous 30 years means that the             health. This finding is consistent with other limited existing
 implants are safe. While the FDA analyses indicate that self-      sources of self-report or clinical data (e.g., FDA Breast
 reporting does not constitute scientific evidence of a             Implant Information Line, anecdotal accounts by plastic
 relationship between silicone breast implants and subsequent       surgeons, and a number of clinical literature reports of
physical complaints, it is noted that more women have               women with implant problems or potential problems related
 reported problems than had previously been recognized (33).        to implants) (13-18,20,21). These sources indicate that it is a
    In providing information for women making health care           minority of the 2 million women with implants (reconstruc-
decisions about breast cancer, scientists and clinicians have       tion and cosmetic combined) who have reported to their
 long recognized the importance of understanding psychologi-        physicians physical symptoms possibly related to the
cal issues. Breast cancer involves many of the most feared          implants. This limited rate of symptoms reported to
aspects of illness, including disfiguring surgery, radiation        physicians could be accounted for by one (or a combination)
and/or chemotherapy with marked side effects, and the real          of five explanations: 1) Some women may be asymptomatic
potential that the disease may be fatal (34). It is appropriate     at this point in time. 2) Some women are unaware that
then that psychological processes associated with breast            certain physical symptoms may be associated with implants.
cancer diagnosis and treatment have received substantial            3) Some women have symptoms and have not sought health
attention. Across this extensive literature, decreased survival     care. 4) There is a latency before implant-associated
rates have been found for women with 1) an inactive                 symptoms appear. 5) Such symptoms appear in a subsample
approach to breast cancer marked by unexpressed anger,              of women who have a particular physical, immune system,
stoic acceptance, and helplessness as contrasted with better        and psychological profile.
outcome for an active approach of unexpressed anger or                 Second, while women participants had a high level of
dential; 2) decreases in physical activity level, sexual            awareness about the silicone implant controversy, over half
activity level, and marital intimacy; 3) fears of loss of           had vague or inaccurate recollections about the types of
female identity, cancer recurrence, and death; and 4) poor          problems that had been attributed to silicone implants,

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marital and/or social support, regrets about the past, and past     including the type of implant filler.
depression (35-39). Less attention, however, has been given            Third, almost half of the women did not contact their
to the psychological effects of breast reconstruction in            physicians, and only a few woman contacted a hotline or the
women following mastectomy. The limited studies have                FDA for information. These two findings may indicate a
shown the following: 1) increased observed and reported             need to re-evaluate health education outreach efforts for
satisfaction with psychological, social, and sexual functions;      women in these circumstances.
2) reduced emotional distress with breast reconstruction               Fourth, while over half of the women worried about their
within 1 year versus a delay greater than 1 year; 3) greater        implants, only slightly more than one fifth had even
patient satisfaction than surgeon satisfaction with outcome;        considered implant removal.
and 4) increased depression and/or suppression of anger and            Fifth, more than one fifth of the women were willing to
unmarried status as predictors of poor outcome (40-44).             accept a one in four risk for implant leakage and the
Finally, despite the substantial number of women seeking            potential health problems attributed to such leakage.
breast augmentation in the 1980s and early 1990s, combined             These final two findings by Winer et al. indicate a
with the increasing public discussion of potential health           multidimensional interaction in the health care decision-
issues with silicone implants, psychological reports of any         making process, involving emotion, risk assessment, and risk
kind were almost nonexistent, with only occasional studies          taking. For a significant number of the women participants
(45,46). Therefore, at present, there are no reliable empirical     in the Winer et al. study, this multidimensional interaction
data on the characteristics of women who receive or seek            process was characterized by an absence of accurate
implants or on the psychological benefit and cost of such a         information and individualized medical consultation.
health care decision.                                                  While Winer et al. are appropriately conservative about
   In this issue of the Journal, Winer et al. (47) open an          the limitations in an initial study of this new area, their
important window to our understanding of the psychological          results are thought provoking for scientists, clinicians, and
consequences for women with breast cancer who have                  health policy makers alike. Women with breast cancer and
received silicone breast implants after mastecomy and who           silicone breast implants are faced with difficult decisions but
now are faced with implant-related health care decisions. In        have both limited information and limited individualized
their survey of 174 such women, Winer et al. assessed the           medical consultation. Enhanced understanding and assistance
following issues: the patients' satisfaction with implant-          in the health care decision-making process for women with
based reconstruction, physical and/or emotional problems            silicone implants are likely to involve interactions among
reported by the patients, how the implant recipients dealt          three separate, but related, disciplines of study: 1) cognitive
with the implant controversy, and how much risk they would          beliefs and health care decision models (both perceived
be willing to accept to have the silicone implants. The             health consequences, such as probability/severity of negative
results of the study by Winer et al. included five findings of      health effects, and perceived psychosocial effects, such as
special note.                                                       body image and interpersonal relationships) (48,49); 2)
   First, the vast majority of women reported knowing about         coping styles and affective responses (50-53); and 3)

Journal of the National Cancer Institute, Vol. 85, No. 17, September 1, 1993                                         EDITORIALS 1363
       physical health status (including immune system status)                            (23) MAEKAWA     A,   OGIU   T, ONODERA    H,   ET AL: Malignant   fibrous
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                                          = A   = = • *   = • • • .= • * .   =

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                                                                                                    Kathleen M. Foley, M.D., editor

                                                                                                    Management of Intermediate and High Grade Lymphomas
                                                                                                    Joseph M. Connors, M.D., editor
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                                                                                                    Management of Primary Bone Tumors
                                                                                                    Michael P. Link, M.D., editor

                                                                                                    Adverse Neurological Effects of Cancer Therapy
                                                                                                    Jerome B. Posner, M.D., editor
                 I              D       017-042-00292-3                          $10.00             The Use of Growth Factors in Cancer Therapy
                                                                                                    Karen Antman, M.D., and
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Journal of the National Cancer Institute, Vol. 85, No. 17, September 1, 1993                                                                                                     EDITORIALS 1365

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