Other Systemic Disease Very few published studies have medically evaluated enough women with implants for enough years to determine whether implants cause other systemic diseases in the long-term. Two recent federally funded studies by scientists from the NCI have demonstrated a link between implants and cancer, lung diseases, and suicide. One of the studies found that women with breast implants are more likely to die from brain tumors, lung cancer, and suicide compared with other plastic surgery patients.[33] The other study found a 21% overall increased risk of cancer for women with implants, compared with women of the same age in the general population.[34] The increase was primarily due to an increase in brain cancer, respiratory tract cancers, cervical cancer, leukemia, and vulvar cancer. The dramatic findings regarding lung disease and brain cancer were described as "unexpected" by the authors, but the findings are consistent with other newly published research. For example, the previously described FDA study of women with ruptured breast implants reported an increase in pulmonary fibrosis for women with ruptured and leaking implants,[11] and another recent NCI study reported an increase in fatal lung diseases.[33] A recent case report, published by the Royal Academy of Medicine in Scotland, found that a woman with a broken silicone gel implant in her calf was coughing up silicone that was identical to the kind in her implant.[35] The physicians involved believe that this case report suggests that silicone from a ruptured gel implant can migrate to the lungs. Unlike many other studies of women with implants, the federally funded epidemiologic studies controlled for potentially confounding variables such as smoking and social class and included 2 comparison samples: the general population of women in the same age range, and a population of other plastic surgery patients. The results of the 2 NCI studies indicated that women with breast implants, like other plastic surgery patients, tend to live longer than other women, apparently because women who will undergo plastic surgery tend to have relatively good baseline health and can afford adequate healthcare. However, implant patients were more likely to die from the diseases mentioned above than other plastic surgery patients. Therefore, a recent article in Medscape (April 26) titled "Augmentation Mammoplasty Associated with Reduced Mortality" was misleading. Alternatives to Silicone Gel Breast Implants When silicone gel breast implants were allowed to remain on the market in 1992 as a "public health need," the main concern was to keep this option for mastectomy patients. However, since that time, the number of women getting mastectomies rather than breast-conserving surgery has decreased dramatically, and the number of women choosing autologous tissue transfer instead of implants has increased exponentially.[36] And, in 2000, saline-filled breast implants were approved by the FDA; saline implants became a popular alternative to silicone gel after silicone gel implants were restricted in the early 1990s. The Importance of Empirical Research Many plastic surgeons and implant patients believe that silicone gel breast implants are safe. Medical opinion is not the standard for selling medical products in the United States, however. A recent example involving a different kind of breast implant illustrates the importance of empirical research. Trilucent breast implants, which have a soybean oil-based filler, were designed to interfere less with mammograms than saline or silicone implants. In recent years, these products were widely praised by the doctors who used them (mostly in the United Kingdom) and were embraced as the safe alternative to silicone implants by women and the media. The manufacturers had not sought FDA approval, however, and some plastic surgeons and patients criticized the FDA because the implants were not widely available in the United States. In 2000, Trilucent implants were removed from the market when serious problems were reported. The soya oil implants were found to cause swelling and, in some cases, leaking soybean oil had emulsified and turned rancid.[37] Moreover, the Trilucent implant filler was found to break down into aldehydes, which are genotoxic, raising concerns that the implants could increase cancer risk or reproductive toxicity. Because implant leakage or rupture would lead to increased exposure, the British Medical Device Agency advised women to avoid pregnancy until their Trilucent breast implants were removed. They also recommended that breastfeeding be avoided because the toxic chemical could migrate from the implants to the milk.[38]The removal of Trilucent implants from the market, after doctors and patients involved had enthusiastically praised them, serves as a reminder that the long-term risks of implants are not always obvious during the first few years of use. That is why studies of the risks of long-term use are essential to establish the safety of implants, and why it is important to refrain from drawing conclusions until objective, comprehensive, long-term research is completed. In summary, some of the most recent research raises serious questions about the long-term safety of breast implants, and most of the conclusions of the Medscape editorial are based on shorter-term studies that examined relatively few women and relatively few diseases. The fact that silicone gel implants can rupture without warning, and the silicone can migrate to organs where it can't be removed, raises concerns. Since the health risks of broken implants have been evaluated in only 1 study -- which found a statistically significant link to disease -- this should raise the threshold when the FDA finally reconsiders whether to approve silicone gel implants. The bottom line, however, is that the studies that have been published thus far are not the basis for approval or disapproval of silicone gel implants. The law requires that the review of silicone gel implants must be based only on studies of the specific types of implants that are seeking approval -- not of implants no longer on the market, or studies of women with implants made by a variety of manufacturers. Since the currently used implants have been on the market for more than a decade, the FDA review should include long-term data, and an assessment of the health of women with ruptured implants, to examine whether systemic diseases are linked to long-term implant use. References 1.ASAPS 2000 Statistics on Cosmetic Surgery. American Society for Aesthetic Plastic Surgery (ASAPS), Inc.; 2001. Available at: http://www.surgery.org/. Accessed October 18, 2001. 2.1999 Reconstructive Procedures: American Society of Plastic Surgeons (ASPS); 1999. Available at: http://www.plasticsurgery.org/. Accessed October 18, 2001. 3.Janowsky EC, Kupper LL, Hulka BS. Meta-analyses of the relation between silicone breast implants and the risk of connective-tissue diseases. N Engl J Med. 2000;342:781-790. 4.Bondurant S, Ernster V, Herdman R, eds. Safety of Silicone Breast Implants. Washington, DC: Institute of Medicine; 1999. 5.Sims S, Lundberg GD. Maybe now is the time to lift the ban on silicone breast implants. MedGenMed. 2001;3. Available at: http://www.medscape.com/Medscape/GeneralMedicine/journal/2001/v03.n02/mgm0402.sims/mgm0402.sims-01.html. Accessed October 18, 2001. 6.Staff Report, The FDA's Regulation of Silicone Breast Implants: Human Resources and Intergovernmental Relations Subcommittee of the Committee on Government Operations, US House of Representatives; 1992. 7.Flanders L. Is it real... Or is it Astroturf? PR firm finds "grassroots" support for breast implants. Extra Magazine. July/August 1996. Available at: http://www.fair.org/extra/9608/breast-implants.html. Accessed October 18, 2001. 8.Poblete JV, Rodgers JA, Wolfort FG. Toxic shock syndrome as a complication of breast prostheses. Plast Reconstr Surg. 1995;96:1702-1708. 9.FDA's Analysis of the Study of Mentor Saline Breast Implants. FDA Meeting March 1-3, 2000. Washington, DC; 2000. Available at: http://www.center4policy.org/. Accessed October 18, 2001. 10.US Food and Drug Administration. Saline-Filled Breast Implant Surgery: Making an Informed Decision (Mentor Corporation). Available at: http://www.fda.gov/cdrh/breastimplants/labeling/mentor_patient_labeling_5900.html. Accessed October 18, 2001. 11.Brown SL, Pennello G, Berg WA, Soo MS, Middleton MS. Silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women. J Rheumatol. 2001;28:996-1003. 12.Brown SL, Middleton MS, Berg WA, Soo MS, Pennello G. Prevalence of rupture of silicone gel breast implants revealed on MR imaging in a population of women in Birmingham, Alabama. AJR Am J Roentgenol. 2000;175:1057-1064. 13.Wolfe F. Silicone breast implants and the risk of fibromyalgia and rheumatoid arthritis. Arthritis Rheum. 1995;38:S265. 14.Teel WB. A Population-Based Case-Control Study of Risk Factors for Connective Tissue Diseases. Seattle, Wash: University of Washington; 1997. 15.Laing TJ, Gillespie BW, Lacey JV, Other E. The association between silicone exposure and undifferentiated connective tissue disease among women in Michigan and Ohio. Arthritis Rheum. 1996;39:S150. 16.Lacey JV, Laing TJ, Gillespie BW, Other E. Reply to letter: Epidemiology of scleroderma among women: assessment of risk from exposure to silicone and silica. J Rheumatol. 1997;24:1854-1855. 17.Dugowson CE, Daling J, Koepsell TD, Other E. Silicone breast implants and risk for rheumatoid arthritis. Arthritis Rheum. 1992;35:S66. 18.Park AJ, Black RJ, Sarhadi NS, Chetty U, Watson AC. Silicone gel-filled breast implants and connective tissue diseases. Plast Reconstr Surg. 1998;101:261-268. 19.Hennekens CH, Lee IM, Cook NR, et al. Self-reported breast implants and connective-tissue diseases in female health professionals. A retrospective cohort study. JAMA. 1996;275:616-621. 20.Edworthy SM, Martin L, Barr SG, Birdsell DC, Brant RF, Fritzler MJ. A clinical study of the relationship between silicone breast implants and connective tissue disease. J Rheumatol. 1998;25:254-260. 21.Wells KE, Cruse CW, Baker JL Jr, et al. The health status of women following cosmetic surgery. Plast Reconstr Surg. 1994;93:907-912. 22.Friis S, Mellemkjaer L, McLaughlin JK, et al. Connective tissue disease and other rheumatic conditions following breast implants in Denmark. Ann Plast Surg. 1997;39:1-8. 23.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. 24.Nyren O, Yin L, Josefsson S, et al. Risk of connective tissue disease and related disorders among women with breast implants: a nation-wide retrospective cohort study in Sweden. BMJ. 1998;316:417-422. 25.Schusterman MA, Kroll SS, Reece GP, et al. Incidence of autoimmune disease in patients after breast reconstruction with silicone gel implants versus autogenous tissue: a preliminary report. Ann Plast Surg. 1993;31:1-6. 26.Gabriel SE, O'Fallon WM, Kurland LT, Beard CM, Woods JE, Melton LJ 3rd. Risk of connective-tissue diseases and other disorders after breast implantation. N Engl J Med. 1994;330:1697-1702. 27.Aziz NM, Vasey FB, P.E. L, Other E. Comparison of clinical status among women retaining or removing gel breast implants. American College of Epidemiology Annual Scientific Session. Boston, MA; 1998. 28.Zuckerman D, Lieberman P. FDA Advisory Panel Reviews Safety of Saline Breast Implants. Available at: www.center4policy.org/implant.html. Accessed October 18, 2001. 29.Handel N, Silverstein MJ, Gamagami P, Jensen JA, Collins A. Factors affecting mammographic visualization of the breast after augmentation mammaplasty. JAMA. 1992;268:1913-1917. 30.Silverstein MJ, Handel N, Gamagami P, Waisman E, Gierson ED. Mammographic measurements before and after augmentation mammaplasty. Plast Reconstr Surg. 1990;86:1126-1130. 31.Hoshaw SJ, Klein PJ, Clark BD, Cook RR, Perkins LL. Breast implants and cancer: causation, delayed detection, and survival. Plast Reconstr Surg. 2001;107:1393-1407. 32.Brinton LA, Lubin JH, Burich MC, Colton T, Brown SL, Hoover RN. Breast cancer following augmentation mammoplasty (United States). Cancer Causes Control. 2000;11:819-827. 33.Brinton LA, Lubin JH, Burich MC, Colton T, Hoover RN. Mortality among augmentation mammoplasty patients. Epidemiology. 2001;12:321-326. 34.Brinton LA, Lubin JH, Burich MC, Colton T, Brown SL, Hoover RN. Cancer risk at sites other than the breast following augmentation mammoplasty. Ann Epidemiol. 2001;11:248-256. 35.James SE, Tarr G, Butterworth MS, McCarthy J, Butler PE. Silicone in the sputum after rupture of a calf implant. J R Soc Med. 2001;94:133-134. 36.Zuckerman DM. The need to improve informed consent for breast cancer patients. J Am Med Womens Assoc. 2000;55:285-289. 37.Laurance J. Agonizing wait for 5,000 women told that their breast implants might leak and cause cancer. The Independent. June 7, 2000. Available at: http://www.independent.co.uk/story.jsp?story=5864. Accessed October 18, 2001. 38.Statement on the Safety of Trilucent Breast Implants: UK Medical Devices Agency. Available at: http://www.medical-devices.gov.uk/. Accessed October 18, 2001. Acknowledgements The author thanks Rachael Flynn, MPH, and Jae Hong Lee, MD, MPH, for their comments, suggestions, and research assistance. Diana Zuckerman, PhD, is trained in epidemiology and psychology, and is President of the National Center for Policy Research (CPR) for Women & Families in Washington, DC. Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. 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