[Congressional Record Volume 151, Number 39 (Thursday, April 7, 2005)]
[Extensions of Remarks]
[Pages E590-E594]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                 THE SAFETY OF SILICONE BREAST IMPLANTS

                                 ______
                                 

                          HON. CHARLIE NORWOOD

                               of georgia

                    in the house of representatives

                        Wednesday, April 6, 2005

  Mr. NORWOOD. Mr. Speaker, in addition to my remarks today, I am also 
submitting a letter written by Dr. Scott Spear to the Senate Health 
Education Labor and Pensions Committee and the House Energy and 
Commerce Committee. In it, Dr. Spear, who is the President of the 
American Society of Plastic Surgeons, brings to light an important 
health issue that the Food and Drug Administration (FDA) is currently 
debating: the safety of silicone gel-filled breast implants. The FDA's 
General and Plastic Surgery Devices Panel has scheduled an upcoming 
hearing that will focus primarily on the safety of these products for 
the American consumer. The information that Dr. Spear shares in his 
letter is important for us to take note of as this panel continues its 
work to make an informed, science-based decision on the safety of these 
implants. In addition, I am submitting for the Record a pamphlet 
entitled Safety of Silicone Breast Implants that reviews the long term 
studies that have been performed on silicone gel-filled breast 
implants. Taken along with Dr. Spear's letter, this brochure makes a 
compelling argument that in determining the very real and 
unquestionably important issue of determining the safety of these 
implants, we must set preconceived notions aside, and ensure that 
science dictates our actions. I urge my colleagues to review these two 
documents and I encourage you to join me in supporting the unbiased and 
open-minded work of the FDA panel as it determines the safety of 
silicone gel-filled breast implants for American consumers.
                                                    March 4, 2005.
     U.S. Senate Health, Education, Labor, and Pensions Committee, 
         U.S. House Energy and Commerce Committee, (Members and 
         Health Legislative Assistants).
       Dear Senators: The Food and Drug Administration (FDA) is 
     conducting an ongoing regulatory process regarding breast 
     implants, which the American Society of Plastic Surgeons 
     (ASPS) fully supports. As physicians and patient advocates, 
     we support sound science and have confidence that the FDA 
     will review valid scientific data and make its decisions 
     based on the best interests of patients. Moreover, we believe 
     a strong post-market surveillance process will serve the best 
     interests of our patients.
       As part of this process, the FDA's General and Plastic 
     Surgery Devices Panel will be conducting hearings on April 
     11-13 regarding the pre-market approval (PMA) applications of 
     two manufacturers' silicone gel-filled breast implants. The 
     FDA appointed panel represents areas of expertise and 
     judgment relevant to the product under review including 
     academicians in specific fields, such as from radiology, 
     oncology, biostatistics, ethics, plastic surgery, general 
     surgery and other disciplines. Each panelist is vigorously 
     screened and cleared by the FDA in advance of their 
     participation. Historically, panelists have been permitted to 
     engage in educational activities promoting patient care. 
     These activities have not been deemed conflicts of interest. 
     Anti-breast implant advocates continue to raise this issue to 
     discredit qualified and reputable clinicians.
       As a matter of background, the FDA's General and Plastic 
     Surgery Devices Panel conducted a similar hearing in October 
     2003. The

[[Page E591]]

     hearings were conducted in a highly open and transparent 
     process, with more than 20 hours of public testimony and 
     signification deliberation. Ultimately, the 2003 Advisory 
     Panel recommended approval of the device with a number of 
     conditions. The conditions outlined by the panel include 
     development of a model informed consent form, patient 
     education, surgeon education, patient follow-up and exams, 
     annual reports to FDA, implant retrieval testing, a breast 
     implant registry, and recommendation for removal of ruptured 
     implants. In January 2004, the FDA decided to postpone action 
     pending submission of additional manufacturer data outlined 
     in a revised draft guidance to be addressed at this 
     subsequent panel hearing.
       Given the level of interest in the FDA's review of silicone 
     breast implants, it is important that Members of Congress are 
     provided accurate and science-based information concerning 
     these medical devices.


                             PATIENT SAFETY

       The ASPS believes that the FDA's scrutiny of this product 
     is appropriate to ensure patient safety. We are not 
     interested in supporting any device that is not proven safe. 
     In 2000, the Institute of Medicine (IOM) issued an exhaustive 
     report that reviewed and analyzed the scientific literature 
     on silicone breast implants. The IOM concluded that there is 
     no link between silicone breast implants and systemic 
     disease. The primary safety issues for women who choose 
     breast implants are local in nature and include the following 
     complications: (1) Capsular contracture or tightening of 
     natural scar tissue around the implant (contracture is 
     unpredictable and, when severe, may require corrective 
     surgery); (2) Implant rupture, which carries risk of 
     additional surgery for replacement; and (3) Infections 
     associated with breast implants, which are generally not 
     common. The IOM report noted that while breast implants have 
     improved over time, patient safety issues associated with 
     local complications require additional research. The ASPS has 
     supported and is supporting continued research in these and 
     other areas.
       Our clinical experience over 35 years with breast 
     augmentation surgery shows an excellent track record and the 
     demand for breast augmentation surgery has grown steadily 
     with nearly 250,000 procedures performed in 2003. The ASPS 
     believes that an important component of patient safety and 
     satisfaction with breast augmentation depends on patients 
     being fully informed about both the benefits and risks of the 
     surgical procedure. Consequently, ASPS has developed a 
     comprehensive document that covers all of the risks and 
     potential complications in breast implant surgery for plastic 
     surgeons to use when discussing the procedure with their 
     patients.


                                 CHOICE

       Currently saline-filled breast implants, approved by the 
     FDA in 2000, are the only implants available for general use 
     in breast augmentation. Silicone gel-filled implants may only 
     be used in clinical trials for reconstructive breast surgery 
     and limited clinical trials for breast augmentation. The 
     FDA's device approval process will determine whether 
     requirements for safety and efficacy have been met and 
     whether women should have additional choices regarding the 
     type of implants they may select for breast surgery. The 
     implant type that provides the best aesthetic outcome depends 
     on a variety of individual patient factors. In all cases, 
     patient safety and informed decision making should be primary 
     considerations in selecting a particular type of implant.
       Like other implantable medical devices, breast implants may 
     not last a lifetime. Hundreds of thousands of women 
     understand this fact and still choose to undergo breast 
     implant surgery. Current research shows that an overwhelming 
     majority are happy with their decision.


                            hiSTORY/SCIENCE

       It is important to distinguish between anecdotal and 
     scientific evidence with regard to breast implants. Anecdotal 
     evidence and junk science do not provide valid contributions 
     to the review and analysis of this device. Plastic surgeons 
     actively support valid scientific research on the safety and 
     efficacy of breast implants, as well as the psychological 
     impact of breast augmentation. The following are select areas 
     of scientific research that Congress should be aware of in 
     relation to breast implants.
       The National Academy of Sciences' Institute of Medicine 
     report, issued in 2000, found no scientific evidence of an 
     association between silicone breast implants and disease; the 
     report represents a comprehensive and unbiased review of 
     breast implant safety by top experts in a variety of medical 
     fields. Safety of Silicone Breast Implants, Institute of 
     Medicine, National Academy Press, 2000.
       Recent studies about suicide among Scandinavian women who 
     have breast implants warrant further investigation. Suicide 
     is a very complicated problem with many contributing factors; 
     biological, genetic, social and cultural. It is important to 
     note that the recent studies do not show a ``cause and 
     effect'' relationship between breast implants and suicide. 
     Plastic surgeons and the medical community in the U.S. have 
     studied breast implants, breast augmentation patients, and 
     breast reconstruction patients for more than 30 years with no 
     indication of a relationship between breast implant surgery 
     and suicide. Further investigation of this issue is 
     appropriate. Mortality among augmentation mammoplasty 
     patients. Epidemiology. 2001; 12:321-326. Total and cause 
     specific mortality among Swedish women with cosmetic breast 
     implants: prospective study. Brit Med j. 326:527-528, 2003.
       The National Institutes of Health (NIH) issued a report to 
     Congress in May of 2003 on the status of its research on the 
     long-term health effects of breast implants. The report 
     stated that there was not sufficient evidence to support any 
     relationship between breast implants and connective tissue 
     disorders. The NIH report also cited a recent National Cancer 
     Institute (NCI) finding that women with breast implants 
     showed a slight decrease in the risk for breast cancer. 
     National Institutes of Health. Breast implants: status of 
     research at the National Institutes of Health, May 2003.
       Since the Institute of Medicine report in 2000, numerous 
     studies have been conducted which investigate the purported 
     connection of breast implants to cancer. However, researchers 
     have consistently found no persuasive evidence of causal 
     association between breast implants and any type of cancer. 
     Breast Implants and Cancer: Causation, Delayed Detection and 
     Survival, May, 2001 Plastic and Reconstructive Surgery.
       In 2000, the Plastic Surgery Educational Foundation 
     established the National Breast Implant Registry (NaBIR). It 
     was founded to collect and analyze data regarding breast 
     implant surgery to further understand the risks and benefits 
     of this procedure. To date more than 21,000 women have 
     registered with NaBIR and there are 316 surgical facilities 
     entering data. We believe that NaBIR is quickly becoming a 
     world standard for an electronic breast implant registry, as 
     it is being considered in a number of European and Latin 
     American countries. In December of 2002, the European Union 
     mandated that participating countries implement breast 
     implant registries by 2004; Denmark, England, Finland, and 
     Germany have already implemented programs. Australia and 
     Brazil have also implemented registries.
       The ASPS and its members support sound science and have 
     been leaders in the research on the safety and efficacy of 
     breast implant surgery. Our primary concern is the safety of 
     our patients and we are strongly interested in the collection 
     of accurate and reliable data pertaining to breast implants. 
     We recently launched the medically-grounded online resource 
     for women and other concerned parties, 
     www.reastimplantsafety.org. We encourage you to visit the 
     site for the latest information on breast implants and 
     patient safety. We believe that the upcoming hearing of the 
     FDA General and Plastic Survery Devices panel will again be 
     rigorous and the panel deliberations will be largely based on 
     the findings of science, rather than emotion and anecdote.
       The ASPS has offered to work with the FDA, public, and 
     manufacturer in order to address many of the conditions 
     attached to the panel's affirmative recommendation. 
     Specifically, the panel recommended that the manufacturer 
     work with professional organizations to create patient and 
     surgeon education materials, a model informed consent form, 
     and establish a breast implant registry and we are responding 
     to that call. We hear stories every day of women whose lives 
     have been dramatically improved with the use of this device. 
     We are hopeful that the FDA's regulatory review process can 
     continue moving toward a conclusion based on science.
           Sincerely,
                                               Scott L. Spear, MD,
     ASPS President.
                                  ____


                   Safety of Silicone Breast Implants


                               BACKGROUND

       In October, 2003, the General and Plastic Surgery Devices 
     Panel convened by the Food and Drug Administration (FDA) 
     concluded that there was a dearth of long-term safety data 
     related to silicone breast implants. Contrary to this 
     contention, there are in fact almost 100 published papers in 
     the peer-reviewed biomedical literature assessing long-term 
     effects of cosmetic breast implants, virtually all of which 
     are reassuring in their lack of evidence for adverse effects.
       Concerns about a link between silicone breast implants and 
     varlious adverse health outcomes were initially raised in the 
     1980's and early 1990's by anecdotal case reports. However, 
     as unanimously concluded by several independent expert review 
     committees by the late 1990's,1-5 these alleged 
     health risks have not been supported by the numerous analytic 
     epidemiologic studies of cosmetic breast implant recipients. 
     Since publication of these independent reviews from various 
     countries, including the United States, a large number of 
     long-term cohort studies of connective tissue diseases, 
     undefined connective tissue disease, cancer, neurologic 
     disorders, mother-offspring effects and mortality have been 
     published.6-38


                       CONNECTIVE TISSUE DISEASE

       More than 20 case-control and cohort investigations have 
     been conducted in in North America and Europe to evaluate the 
     potential association between cosmetic silicone breast 
     implants and the occurrence of CTDs. Initially, the primary 
     concern was the occurrence of systemic sclerosis, although 
     these epidemiologic studies have examined the occurrence of 
     numerous other CTDs. The published case-control 
     studies,39-49 and cohort 
     studies,6,18,35,37,50-59 many of which have been 
     large, long-term follow-up studies, have been remarkably 
     consistent in finding no evidence

[[Page E592]]

     of an association between silicone breast implants and any 
     individual CTD or all established CTDs combined. Moreover, 
     meta-analyses, weight-of-the-evidence, and critical reviews 
     have unanimously concluded that there is no evidence of an 
     association between breast implants and any of the CTDs 
     evaluated individually or combined.2-5,60-66


                ``ATYPICAL:'' CONNECTIVE TISSUE DISEASE

       An association has also been hypothesized between silicone 
     breast implants and some new ``atypical'' disease, which does 
     not fulfill established diagnostic criteria for any known CTD 
     and may bear some resemblance to fibromyalgia.67 
     Those studies which did include undefined CTD as an outcome, 
     many of which have been large, long-term follow-up studies, 
     have been strikingly consistent in finding no convincing 
     evidence of an association between silicone breast implants 
     and atypical connective tissue or rheumatic 
     disease.2,5,6,8,14,18.24,46,68


                              FIBROMYALGIA

       In 2001, Brown et al.\35\ reported an excess of self-
     reported fibromyalgia among women who had ruptured implants 
     with extracapsular silicone migration (extracapsular rupture) 
     diagnosed by magnetic resonance imaging (MRI). However, this 
     elevated risk ratio cannot be meaningfully interpreted, due 
     to the inappropriate use of a combined group of women with 
     intracapsular rupture and women with intact implants as the 
     comparison group.68-70 It is also noteworthy that 
     the rates of fibromyalgia reported among women with intact 
     implants or intracapsular ruptures in the study by Brown et 
     al.\36\ are remarkably high compared with the estimated 
     prevalence rate of 3.4% for U.S. women\71\ and with similar 
     or lower prevalence rates reported in many other 
     countries,6,55,72-76 indicating a biased selection 
     of women in that study.
       Most recently, Holmich et al.\18\ explicitly tested the 
     hypothesis of an increased risk of fibromyalgia by rupture 
     status among 238 unselected women with cosmetic silicone 
     breast implants. There was no excess of undefined CTD or 
     other chronic inflammatory condition, including fibromyalgia. 
     None of the women with extracapsular rupture reported 
     fibromyalgia. Thus, the finding by Brown et al.\35\ of a 
     greater than two-fold excess of self-reported fibromyalgia 
     among women with extracapsular rupture was not confirmed in 
     the study by Holmich et al.,\18\ who concluded that implant 
     rupture is not associated with fibromyalgia or other 
     rheumatic conditions.


                        BREAST AND OTHER CANCERS

       More than 10 epidemiologic studies, many of which have been 
     large and able to assess long-term risks, have been conducted 
     in Europe and North America to evaluate the potential 
     association between cosmetic breast implants and the 
     incidence of breast or other cancers, notably lung cancer, 
     cancers of the cervix and vulva, leukemia, and multiple 
     myeloma.17,23,24,32-34,77-83 Although the primary 
     concern has been breast cancer risk, epidemiologic studies 
     have been remarkably consistent in finding no evidence of 
     increased risk for breast or other cancers among women with 
     breast implants; in fact; in most studies the risk of breast 
     cancer was below expectation.1,2,84,85 The rare 
     reported excesses of lung and cervical cancer are likely due 
     to confounding by lifestyle factors and/or reproductive 
     characteristics. In fact only the cohort study by Brinton et 
     al.,\34\ which reported a significant excess of deaths from 
     brain cancer, has reported an association with a cancer that 
     is not a likely result of lifestyle factors such as smoking 
     or other activities that are unrelated to implants. The 
     extreme risk estimate for brain cancer reported in this 
     study, which suffers from several methodological 
     shortcomings, is inconsistent with the overwhelming weight of 
     the epidemiologic evidence and is biologically 
     implausible.\86\


                        BREAST CANCER DETECTION

       Concern has been raised that the ability to detect early 
     breast cancer is limited in women with breast implants. The 
     hypothesis that breast implants may interfere with physical 
     breast examination or mammographic visualization of breast 
     tumors, leading to delays in breast cancer diagnosis and 
     worse prognosis among women receiving implants, is based on 
     the findings of a few early clinical studies,87,88 
     many of them originating from the same clinic. However, the 
     interpretation of these clinical case series is hampered by 
     potential referral or ascertainment bias, small sample size 
     and absence of a control group. The results of numerous 
     analytic epidemiologic studies, which used control groups to 
     provide comparison data, consistently show that women with 
     breast implants do not in fact present with more advanced 
     stages of breast cancer or experience shorter survival (the 
     clinically relevant outcomes), thus indicating no delay in 
     breast cancer detection following breast 
     augmentation.19,32,71,89-97
       In a recently published large-scale study,98 
     women receiving silicone gel implants for breast 
     reconstruction after breast cancer had significantly lower 
     mortality rates than those women who did not receive breast 
     implants after cancer surgery. Thus, there is no evidence 
     that silicone gel implants adversely affect survival 
     following breast cancer.


                           NEUROLOGIC DISEASE

       With respect to other outcomes, during the past six years, 
     three large, population-based cohort studies have been 
     conducted to evaluate risk for neurologic disease among women 
     with cosmetic breast implants,9,}28,}99 and no 
     association has been found.


                  OFFSPRING EFFECTS AND BREASTFEEDING

       Similarly, three epidemiologic 
     investigations,10,15,100 all population-based 
     retrospective cohort studies, have examined health outcomes 
     among children born to mothers with silicone breast implants, 
     and none has found evidence of adverse health outcomes among 
     the children. Concerns about possible contamination of breast 
     milk with silicone compounds and of potential adverse health 
     effects to infants who are breastfed by mothers with silicone 
     breast implants are not supported by the scientific 
     literature. In fact, the American Academy of Pediatrics 
     101 policy statement on the transfer of drugs and 
     other chemicals into human milk concluded that ``The 
     Committee on Drugs does not feel that the evidence currently 
     justifies classifying silicone implants as a contraindication 
     to breastfeeding.'' Similarly, the Institute of Medicine of 
     the National Academy of Sciences 2 concluded that 
     ``convincing evidence is available that silicon 
     concentrations in breast milk are the same in mothers with 
     and without breast implants, and thus there are no data to 
     support transmission of silicone to infants in breast milk of 
     mothers with implants.''


                           RUPTURE INCIDENCE

       There has been only one published study to date that 
     directly examined the true incidence rate of breast implant 
     rupture by repeated MRI.\21\ In a follow-up to their rupture 
     prevalence study,12 in which 271 women study had a 
     baseline MRI in 1999, a repeat MRI was performed two years 
     later and a rupture incidence analysis was performed based on 
     317 implants (in 186 women). The authors found an overall 
     rupture incidence rate for definite ruptures of 5.3% per 
     year. The rupture rate increased significantly with implant 
     age. For ``third generation'' implants (barrier-coated, low 
     bleed implants available since 1988), the percentage of 
     implants that remained intact was estimated as 98% at 5 years 
     and 83%-85% at 10 years.\21\ Only one prospective study to 
     date has been conducted to address the possible health 
     implications of ruptured, in situ silicone breast implants.
       In this unique study, Holmich et al,\25\ examined the 
     possible health implications, including changes over time in 
     MRI findings, serological markers, or self-reported breast 
     symptoms, of untreated silicone breast implant ruptures. 
     Sixty-four women with implant rupture diagnosed by MRI were 
     followed for two years, and a second MRI was performed. A 
     control group of women with no evidence of rupture on either 
     MRI was used for comparison. The majority of women had no 
     visible MRI changes of their ruptured implants. There was no 
     increase in autoantibody levels, and no increase in reported 
     breast hardness. Women did report a significant increase in 
     non-specific breast changes compared with women in the 
     control group. The authors concluded that, for most women, 
     rupture is a harmless condition which does not appear to 
     progress or to produce significant clinical symptoms.


                          LONG-TERM FOLLOW-UP

       Over the past six years, the majority of the epidemiologic 
     cohort studies were performed in Scandinavia, where unique 
     nationwide databases and data-linking possibilities exist. 
     Table 1 presents the average years of follow-up and the 
     maximum years of follow-up for these cohort studies, by 
     country:

                                 TABLE 1
------------------------------------------------------------------------
                                     Ave. yrs. of        Max. yrs. of
             Country                   follow-up           follow-up
------------------------------------------------------------------------
Denmark.........................                  9                  23
Breiting et al.\24\.............                 19                  35
Finland.........................                 10                  30
Sweden..........................                 11                  29
------------------------------------------------------------------------

       These studies had, on average, a decade of follow-up and 
     almost three decades of follow-up for the longest term 
     implant recipients. In the recent Danish study by Breiting et 
     al.,\24\ the average years of follow-up was 19, with a 
     maximum of 35 years. Thus, the large body of nationwide 
     investigations originating in these populations belies the 
     assertion that there is a dearth of data on long-term effects 
     of silicone breast implants.


                                SUICIDE

       Four mortality studies have reported elevated risks of 
     suicide among women with cosmetic breast implants compared 
     with the general population.20,29,30,34 Recently, 
     however, the suicide excess has been shown to be related to 
     pre-implant psychiatric disorders.30


                                SUMMARY

       In summary, after almost a decade of extensive 
     epidemiologic research, the weight of the epidemiologic 
     evidence is overwhelmingly reassuring that there are no long-
     term adverse effects associated with silicone breast 
     implants.


                               REFERENCES

       1. International Agency for Research on Cancer. Surgical 
     implants and other foreign bodies. IARC Monograph on the 
     Evaluation of Carcinogenic Risks to Humans, Volume 74. Lyon: 
     IARC Press, 1999.
       2. Bondurant S, Ernster V, Herdman R. Safety of Silicone 
     Breast Implants, Report of the Committee on the Safety of 
     Silicone Breast Implants (IOM). Washington, D.C.: National 
     Academy Press, 1999.
       3. Independent Review Group, Rogers J, et al. Silicone gel 
     breast implants: The report

[[Page E593]]

     of the Independent Review Group. Cambridge, England: Crown, 
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       4. Janowsky EC, Kupper LL, Hulka BS. Meta-analyses of the 
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       5. Tugwell P, Wells G, Peterson J, et al. Do silicone 
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       6. Kjoller K, Friis S, Mellemkjaer L, et al. Connective 
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       7. Kjoller K, Holmich LR, Fryzek JP, et al. Self-reported 
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       8. Fryzek JP, Signorello LB, Hakelius L, et al. Self-
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       10. Signorello LB, Fryzek JP, Blot WJ, et al. Offspring 
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