Fw: BREAST IMPLANTS: The Risks Are Not Widely Known

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Sent: Thursday, October 17, 2002 2:07 AM

Subject: BREAST IMPLANTS: The Risks Are Not Widely Known

BREAST IMPLANTS: The Risks Are Not Widely Known

IMPORTANT FACTS ABOUT BREAST IMPLANTS

BY DIANA ZUCKERMAN, PH.D. AND RACHAEL FLYNN, MPH

More women are getting breast implants than ever before. In 2000, 203,310 women underwent breast implant surgery for augmentation 1, and 82,975 women underwent breast implant surgery for reconstruction after mastectomy in 1999 (the most recent statistics available).2 Those numbers have been increasing each year; in fact, the number of women and teenage girls who underwent augmentation surgery more than doubled between 1997 and 2000 (101,176 in 1997 vs. 203,310 in 2000).3The dramatic increase in breast implant surgery does not necessarily reflect a similarly dramatic increase in the number of women with breast implants, however. Many women who undergo surgery are replacing old implants that have broken or caused problems; some women report as many as ten or more surgeries as their implants are replaced over the years. There are no available statistics on how many women undergo their first breast implant surgery every year.Breast implants are widely advertised, but the risks are controversial and not widely known. The purpose of this summary is to provide information about what is known and not known about the risks of breast implants.The Role of the Food and Drug Administration (FDA)Breast implants were first sold in the 1960's, but sales were relatively slow until the 1980's. By 1990, almost one million women had breast implants, but there were no published studies about their safety, and the FDA had never approved them. Finally, in 1991, the FDA required the manufacturers of breast implants to submit safety studies. Unfortunately, the studies were inadequate, and the FDA could not conclude whether or not the implants were safe or effective. In 2000, the FDA reviewed the safety of saline-filled breast implants for the first time. Saline implants have a silicone outer envelope and are filled with salt water. The FDA required studies of local complications, such as pain, infection, hardening, and the need for additional surgery. They did not require studies of other health problems. Despite extremely high complication rates during the first three years (approximately three out of four reconstruction patients and almost half of first-time augmentation patients), the FDA approved saline implants. As part of the approval process, the FDA has made information about the risks of breast implants more available. A consumer handbook and a brochure with photographs of common complications are available for free at 1-888-INFO-FDA or online.Silicone gel-filled breast implants have never been approved as safe or effective by the FDA. In 1992, the FDA limited their availability to clinical trials, primarily for women who have mastectomies, breast deformities, or who want to replace a gel implant that was put in for augmentation prior to these restrictions. Currently, women can also receive gel implants for first-time augmentation as part of clinical trials. Any woman who has had implant surgery with silicone gel implants since 1992 is required to be regularly evaluated by her plastic surgeon as part of the study, in order to provide safety data that will help all women with gel implants. Types of ImplantsIn addition to silicone and saline implants, three other kinds of implants were available in recent years, primarily outside the U.S.: Trilucent implants, and Novagold and PIP hydrogel implants. Although never approved as safe in the U.S., these implants were vigorously promoted by plastic surgeons and in women's magazines as a "natural" and safer alternative to silicone or saline implants. Clinical trials, however, were apparently never conducted on humans with these implants.4, 5, 6 Trilucent breast implants, which have a soybean oil-based filler, were designed to interfere less with mammograms than saline or silicone implants. However, in 2000 they were removed from the market when serious problems were reported. The soya oil implants were found to cause serious infections, with breasts sometimes becoming very red and painful. In some cases, leaking soybean oil had emulsified and turned rancid.6 Moreover, the Trilucent implant filler was found to break down into chemicals known as aldehydes. Aldehydes are genotoxic, which means that they can alter DNA and potentially cause increased cancer risk or reproductive toxicity. Because implant leakage or rupture would lead to increased exposure to these genotoxic products, women were advised to avoid pregnancy until their Trilucent breast implants were removed. It was also recommended that breastfeeding be avoided because the toxic chemical could migrate from the implants to the milk.7Novagold and PIP Hydrogel implants were also removed from the market in 2000. Hydrogel, a plastic material that swells in water, is used in other products, such as contact lenses, medicines, surgical dressings, and food. These implants were banned as a precautionary measure because of inadequacies in the manufacturers’ safety assessments of the hydrogel fillings. Specifically, government investigators found a lack of long-term toxicity data or clinical follow-up, methodological flaws in some of the pre-clinical tests, and pathological changes in a study of rabbits.4, 5The removal of these three kinds of implants from the market, after they had been enthusiastically praised by doctors and patients, 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. Health and Cosmetic RisksAll surgery for breast implants, and all breast implants currently for sale, have certain risks, regardless of what they are made of. This fact sheet includes information that women should be aware of if they are considering breast implants, or considering removing or replacing older implants.Surgical Risks: Surgical risks include the risk of infection, hematoma (blood or tissue fluid collecting around an implant), the risk that one or both of the implants will have to be removed (requiring additional surgery), and the costs of repeated surgeries if the implants are replaced.Breast Implants Rupture: All breast implants will eventually break, but it is not known how many years the breast implants that are currently on the market will last. Studies of silicone breast implants suggest that most implants last 7-12 years, but some break during the first few months or years, and some last more than 15 years. In a study conducted by researchers at the FDA, most women had at least one broken implant within 15 years, and the likelihood of rupture tends to increase over time.8 Silicone migrated outside of the breast capsule for 21% of the women who had broken implants, even though most women were unaware that this had happened. Short-term studies of today’s saline implants suggest that between 3-9% break within the first 3 years.9 Local Complications: There are other well-documented "local complications" that can result from breast implants. For example, some women lose sensitivity in their breasts, and others become overly sensitive; these problems can interfere with sexual intimacy. The cosmetic outcome is sometimes very disappointing, with breasts looking or feeling unnatural or asymmetrical, or the saline making a "sloshing sound." All implants are "foreign bodies" and the woman’s body reacts by forming a capsule of scar tissue around the implants that can become too tight for the implant. If that occurs, the breasts can become very hard, misshapen, and cause mild discomfort or severe pain. Some women who have breastfed compare the feeling to being overly full of milk and unable to nurse for many, many hours. Autoimmune Disease: Although the epidemiological studies have not proved that autoimmune disease is caused by breast implants, several European studies have indicated that breast surgery (whether for breast implants or to reduce the size of breasts) may be associated with an increased risk of neurological or autoimmune disease.10,11 If those diseases (such as scleroderma and rheumatoid arthritis) were related to breast surgery, they would be a risk associated with all breast implants, regardless of what they are made of. Most research has focused on autoimmune or connective-tissue diseases studied women who have had implants for a relatively short period of time, ranging from a few months to a few years. These studies are the basis for statements regarding the lack of evidence that implants cause systemic disease, which have been made by the Institute of Medicine, Judge Pointer’s scientific panel, and in the New England Journal of Medicine.12,13,14 Since connective-tissue and auto-immune diseases may take years to develop and to be diagnosed, studies that include women who had implants for just a few months or years can not determine whether or not breast implants increase the long-term risks of getting these diseases. For that reason, any conclusions about the safety of implants in terms of systemic disease are premature.Almost two years after the widely-cited Institute of Medicine report was published, a new study conducted by FDA scientists found a statistically significant link between implants and fibromyalgia and several connective-tissue diseases.15 The study of patients who had silicone breast implants for at least 8 years found that women with ruptured silicone implants may be at risk for several painful and debilitating diseases. When the silicone had migrated outside of the scar tissue surrounding the implant, women were significantly more likely to report a diagnosis of disease such as fibromyalgia, dermatomyositis, polymyositis, Hashimoto’s thyroiditis, mixed connective-tissue disease, pulmonary fibrosis, eosinophilic fasciitis, and polymyalgia. The association with fibromyalgia remained even after controlling for patient’s age, implant age, location, and implant manufacturer. Another study, which examined 95 women who had silicone gel-filled breast implants and rheumatologic symptoms, found that the symptoms improved in 42 (97%) of the 43 women who had their breast implants removed.16 In contrast, rheumatologic symptoms worsened in 50 (96%) of the 52 women who did not have their implants removed.Breast Cancer: Breast implants interfere with the detection of breast cancer, because implants can obscure the mammography image of a tumor. Implants therefore have the potential to delay the diagnosis of breast cancer. Although mammography can be performed in ways that minimize the interference of the implants, approximately 30 percent of the breast tissue will still be obscured.17 Mammograms tend to be less accurate if the woman has capsular contracture. The accuracy of mammograms tends to decrease as the size of the implants increase proportionally to the size of the woman’s natural breast. There is no research evidence that implants cause breast cancer, but the delay in diagnosis can necessitate more radical surgery or can be fatal.Other Systemic Disease: There are very few published studies that have medically evaluated enough women with implants for enough years to evaluate whether or not implants cause other systemic diseases in the long-term. Two recent federally-funded studies by scientists from the National Cancer Institute (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, other respiratory diseases, and suicide compared to other plastic surgery patients.18 The other study found a 21% overall increased risk of cancer for women with implants, compared to women of the same age in the general population.19 The increase was primarily due to an increase in brain cancer, respiratory tract cancers, cervical cancer, and vulvar cancer. The health risks associated with broken implants are unclear, although concerns have been raised about the risks if liquid silicone migrates to the lungs, liver, or other organs. As described previously, the one study to investigate the health of women with ruptured breast implants focused on fibromyalgia and connective-tissue diseases, although it reported an increase in pulmonary fibrosis, which could be related to the increase in fatal lung diseases reported by NCI. Another recent study, 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 identical to the kind in her implant.20 This has potentially serious implications for women with breast implants, since silicone gel breast implants are considerably larger and closer to the lungs than calf implants. Concerns about cognitive problems have been raised by women with implants, but have not been studied in epidemiological research. Breastfeeding: According to the Institute of Medicine (IOM), women with any kind of breast surgery, including breast implant surgery, are at least three times more likely to have an inadequate milk supply for breastfeeding.12 Concerns about the safety of breastfeeding have also been raised, but there is insufficient research information available.Bacteria: Several researchers have shown that bacteria can grow in saline implants,21 and have expressed concerns about those bacteria being released into the body if the implant breaks. The effect of the bacteria on the woman, or a nursing baby, has never been studied. Financial RisksThe initial surgery for breast implants is the first, but not the greatest expense of implants. On average, implants last 7-12 years, and each replacement has considerable costs. Even if the implant itself is replaced for free, which is sometimes the case, the surgical costs are not free. In fact, even if the surgeon offers his or her services for free, the cost of the medical facility, anesthesiology, and other expenses will still be substantial. These expenses may be affordable if they are every 7-12 years, but for those women whose implant breaks after just a few months or years, they may be formidable. If a woman buys implants "on the installment plan" she probably does not have the financial resources to deal with any problems that arise.Health insurance can also be a considerable expense. Cosmetic surgery is not covered by health insurance, and problems resulting from cosmetic surgery are also excluded from coverage. In some states, major health insurance providers do not insure women with breast implants. Some insurers will sell health insurance to women with implants, but charge them more, and some insurers will not cover certain kinds of illnesses, or not cover any problems in the breast area. Obviously, this can be a terrible problem for women who are diagnosed with breast cancer or other illnesses that are excluded; it will not matter if those diseases are unrelated to the implants.What if a woman no longer wants breast implants?Women who have implants sometimes decide they no longer want them, either because they have problems, are dissatisfied with the cosmetic result, or do not want to worry about the long-term health risks. Some surgeons discourage patients from removing their implants, because they believe that implants are safe, or because they are concerned that the patient will be very unhappy with their appearance after the implant is removed. For example, the breast tissue stretches from the implant, and the breast is unlikely to be as attractive as it was before the implant surgery. Women with ruptured silicone implants often lose breast tissue as part of the removal surgery; in some cases, this may result in surgery that is similar to a mastectomy. The plastic surgeon that performed the original surgery is not necessarily the best choice for removing the implant. Removal can be much more complicated and expensive than the original surgery, especially if an implant has broken. Some plastic surgeons are very experienced at removal and are especially skilled at getting the best possible cosmetic result. Most surgeons who specialize in removal recommend removing the implants "en bloc" which means that the entire implant and the natural scar tissue capsule surrounding it are all removed together. This helps remove any silicone that may have leaked from a broken gel implant, and also helps remove silicone or other chemicals that may have "bled" from the silicone outer envelope.The National Center for Policy Research (CPR) for Women & Families is a nonprofit, nonpartisan organization that is dedicated to improving the lives of women and families by using objective, research-based information to encourage new, more effective programs and policies. CPR has research analyses, information about FDA’s regulation of implants, and information about other experts and implant patients’ experiences available upon request. For more information please contact Dr. Zuckerman, or see our website, www.breastimplantinfo.org. gigi*

http://www.redflagsweekly.com/storm_warnings.htmlReferences: 1 ASAPS 2000 Statistics on Cosmetic Surgery. American Society for Aesthetic Plastic Surgery (ASAPS), Inc., 2001. Available: www.surgery.org. 2 1999 Reconstructive Procedures. American Society of Plastic Surgeons (ASPS). Available: www.plasticsurgery.org. 3 ASAPS 2000 Statistics on Cosmetic Surgery. American Society for Aesthetic Plastic Surgery (ASAPS), inc., 2001. Available: www.surgery.org. 4 "Device Alert - Breast Implants: NovaGold." UK: Medical Devices Agency. Available: www.medical-devices.gov.uk/da2000(08).htm. 5 "Device Alert - Breast Implants: PIP Hydrogel R." UK: Medical Devices Agency. Available: www.medical-devices.gov.uk/da2000(07).htm. 6 nce, , "Agonizing wait for 5,000 women told that their breast implants might leak and cause cancer." The Independent, 7 June 2000. Available: www.independent.co.uk/story.jsp?story=5864. 7 "Statement on the Safety of Trilucent Breast Implants." UK: Medical Devices Agency. Available: http://www.medical-devices.gov.uk/tbi-state.htm. 8 Brown SL, Middleton MS, Berg WA, et al. Prevalence of Rupture of Silicone Gel Breast Implants Revealed on MR Imaging in a Population of Women in Birmingham, Alabama. Am J Roentgenol. 2000; 175: 1057-1064. 9 Local Complications of Saline Breast Implants. Available: www.center4policy.org/implant.html. 10 Friis S, Mellemkjaer L, McLaughlin JK, et al. Connective Tissue Disease and Other Rheumatic Conditions Following Breast Implants in Denmark. ls of Plastic Surgery. 1997; 39: 1-8. 11 Nyren O, Yin L, fsson S, et al. Risk of Connective Tissue Disease and Related Disorders Among Women with Breast Implants: A Nation-Wide Retrospective Cohort Study in Sweden. British Medical Journal. 1998; 316: 417-422. 12 Bondurant S, Ernster V, Herdman, R, eds. Safety of Silicone Breast Implants. Washington, DC: Institute of Medicine; 1999. 13 "Silicone Breast Implants in Relation to Connective Tissue Diseases and Immunologic Dysfunction" Summary of Report of National Science Panel. Available: www.fjc.gov/BREIMLIT/SCIENCE/summary.htm. 14 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. 15 Brown SL, Pennello G, Berg WA, et al. Silicone Gel Breast Implant Rupture, Extracapsular Silicone, and Health Status in a Population of Women. Journal of Rheumatology. 2001; 28:996-1003. For summary click Fibromyalgia and Ruptured Silicone Gel Breast Implants 16 Aziz NM, Vasey FB, Leaverton PE, et al. Comparison of clinical status among women retaining or removing gel breast implants. Presented at the American College of Epidemiology, 1998. 17 Zuckerman D, Lieberman P. FDA Advisory Panel Reviews Safety of Saline Breast Implants. Available: www.center4policy.org/implant.html. 18 Brinton LA, Lubin, JH, Burich MC, et al. Mortality among Augmentation Mammoplasty Patients. Epidemiology. 2001; 12: 321-326. 19 Brinton, LA, Lubin JH, Burich MC, et al. Cancer Risk at Sites Other than the Breast Following Augmentation Mammoplasty. ls of Epidemiology. 2001; 11: 248-256. 20 SE, Tarr G, Butterworth MS, et al. Silicone in the sputum after rupture of a calf implant. J R Soc Med 2001;94:133-134. 21 Young VL, Hertl, CH, Murray PR, et al. Microbial Growth Inside Saline-Filled Breast Implants. Plastic and Reconstructive Surgery. 1997; 100: 182-196.

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