Japanese literature in 1984 was the first to report the possible association of silicone prostheses with autoimmune diseases, but in these sporadic reports, women used mostly liquid silicone and had other oils mixed in, such as paraffin oil, and autoimmune or related tissue diseases included rheumatoid arthritis, systemic lupus erythematosus, Sjogren (Scheglin) syndrome, dermatomyositis, and Raynaud’s disease. In 1988, a case of scleroderma was reported in a patient who had received a prosthetic implant, and the U.S. medical community became generally aware that silicone exposure could cause disease in some patients, and sporadic reports of similar diseases prompted the Food and Drug Administration (FDA) to seek more conclusive data that could demonstrate the safety of silicone gel breast implants. In the late 1980s, the FDA did not issue warnings about the dangers of silicone gel breast implants. Nevertheless, in 1990, the FDA required manufacturers to provide additional data on their silicone gel breast implant products, particularly information on diseases, including autoimmune diseases and effects on the fetus. Historical Review It has been suggested that the detection of anti-silicone antibodies in women applying silicone gel breast implants suggests that implant leakage is a causative factor. However, antibodies are also found in non-pathogenic foreign body reactions. In a 1994 study by the UK Department of Health summarizing breast cancer predisposition factors, it was noted that anti-silicone antibodies were also seen in women who did not receive silicone gel prostheses, so their clinical significance is questionable. Radiologists, at the request of the FDA, answered this question by applying a special mammography technique (Eklund) to screen for breast cancer in augmented and unaugmented breast patients with approximately equal efficiency. Although studies denying a relevant association have yielded convincing results prior to 1995, more information continues to accumulate. The National Institute of Medicine (IOM) issued a statement on June 21, 1999, that silicone gel prostheses do not cause many major diseases and new autoimmune disorders. In another 1995 report in the New England Journal of Medicine, researchers studied 87,501 caregivers (1,183 of whom had breast augmentation) for 41 related tissue diseases and again found no association between silicone gel breast implants and autoimmune or related tissue diseases. Interestingly, the incidence appears to be even lower after breast augmentation. Anti-silicone antibodies A study by Dowcoring did find silicon in breast milk, but silicon is ubiquitous in our daily surroundings and levels of silicon are quite high in unaugmented individuals. Nearly 11,000 women in Albert, Canada, participated in a study comparing the incidence of breast cancer in augmented versus unaugmented breast surgeons. The results showed no significant difference between the two groups. In a 1995 summary, the UK Department of Health stated that there was no causal link between silicone gel breast implants and associated tissue disease. The report also noted that, unfortunately, despite all the scientific evidence, public perceptions had not changed due to the FDA’s restrictions on silicone gel breast implants and the overblown media lawsuit decisions. In January 1992, the FDA urged manufacturers of silicone gel breast implants to provide additional information about the product, and in April of that year, the FDA effectively banned its use: silicone gel implants were allowed only for patients undergoing breast reconstruction after mastectomy and for women volunteering for breast augmentation studies. Since 1992, however, numerous studies have reported refuting claims that silicone gel breast implants cause cancer or lead to immune disorders. More recently, the IOM has made it even clearer that there is no risk of breastfeeding in women after breast augmentation, that milk and infant food formulas contain much higher levels of silicon than breast milk, and that women after breast augmentation should breastfeed whenever possible. Large samples of animal studies and human trials have helped to confirm the relationship between silicone exposure and associated tissue or autoimmune diseases. The UK Department of Health, after reviewing nearly 270 papers, noted that there is no evidence from animal studies that silicone gel in prostheses causes immune disorders. A widely circulated JAMA report suggested that women breastfeeding after applying silicone gel breast implants could transmit autoimmune diseases to their children, but the report’s methodology was widely questioned and the report was later deemed untrustworthy because one of the authors had legal entanglements with the implant manufacturer. It was claimed that the placement of silicone gel breast implants could delay the diagnosis of breast cancer because they blocked x-ray penetration in mammography. However, in 1991 the American College of Radiology noted that physicians are able to make a thorough examination and diagnosis under existing conditions. In fact, women tend to be more aware of breast cancer screening after breast augmentation, thus reducing the risk of delayed diagnosis. Breastfeeding Anti-silicone antibodies may arise as a result of the body’s immune response to everyday foods, vegetables, cosmetics, and everyday medical devices. 1998 Wienzwieg et al. conducted a phase II study to see if there was a link between silicone levels in tissues and tissue disease in patients who received silicone gel breast implants. The study included both silicone gel and saline implant recipients, and the researchers examined silicone levels in the implant envelope and breast tissue. The results showed that the level of silicone gel in the tissue had no statistically significant effect on the development of autoimmune or tissue disease in women who received silicone gel prostheses. These findings provide strong evidence that there is no correlation between silicone gel breast prostheses and autoimmune disease. Although the debate about the safety of silicone gel breast implants has continued for more than eight years, scientific studies have confirmed their safety. Silicone gel breast implants are a model for the future of implant science, and plastic surgeons should be aware of the debate regarding silicone gel breast implants and must be familiar with the epidemiologic and basic science focused research on these arguments. Only then can he or she answer patient inquiries and help them make decisions in a comprehensive manner. Nevertheless, the mammography diagnosis is complicated by the impermeability of the prosthesis to X-rays. Furthermore, in some patients, a thin layer of calcification may develop in the peri-implant envelope after 10 years or more of implant placement. However, these calcified tissues do not always obscure small lesions or overlap precisely with the tumor, leading to false negatives or false positives. The point of calcification may affect the diagnosis of lesions in the adjacent envelope. The patient must tell the mammographer that she has applied a breast prosthesis and additional imaging must be added. If the Eklund technique is applied, the breast tissue can be pushed forward and the prosthesis correspondingly posterior to facilitate maximum detection of substantial breast disease, and posterior pectoralis major augmentation is more conducive to the examination. In conclusion, breast implants do not increase the rate of carcinogenesis. For a long time, the biggest concern of physicians and health policy makers about silicone gel implants was their potential carcinogenicity. However, early studies have shown that many types of silicone and other material implants do not pose this risk. More recently, epidemiological studies of large samples of post-augmentation women have confirmed the conclusions of earlier studies that silicone gel breast implants are not carcinogenic. In 1993, the American Medical Association’s Committee on Scientific Affairs stated that women who undergo breast augmentation or breast reconstruction surgery have the right to make a personal choice about which implant to use after a detailed understanding of the advantages and disadvantages of silicone gel and saline implants. The American College of Rheumatology has also issued a statement that there is no clear evidence that silicone gel breast implants cause rheumatologic disease, and on June 21, 1999 the NIH reported the results of a two-year study of the safety of silicone gel breast implants, funded by the National Institute of Skeletal, Musculoskeletal, and Articular Disorders and supervised by 13 scientific research groups: silicone gel breast implants were not associated with cancer, autoimmune diseases, or other systemic diseases. diseases and other systemic disorders, and that infants and fetuses are not affected. However, the FDA ban has not been lifted. Plastic surgeons should be aware of the scientific basis for health issues related to the safety of silicone gel breast implants in the media and medical lawsuits so that they can answer patient inquiries with certainty. The largest study of related tissue disease was published by Mayo Clinics in 1994. This study addressed 12 associated tissue diseases that may be associated with silicone gel breast implants. The results showed no correlation between silicone gel breast prostheses and them. Breast Cancer 1994 University of Maryland, University of Pittsburgh and Johns? Hopkins University conducted a study on the relationship between silicone gel breast prostheses and scleroderma. Eight hundred and sixty-nine women with scleroderma and 2,061 normal women from three clinical research centers for immune diseases participated in the study. 12 cases (1.4%) had breast augmentation prior to the diagnosis of scleroderma, while 23 cases (1.1%) in the control group developed scleroderma, with no statistical difference between the two, further confirming that augmentation was not associated with the development of scleroderma. Before the advent of breast augmentation, silicone had been widely used in medical clinical practice. As early as the 1950s, clinicians began using silicone tubes as ventricular access in the treatment of cerebral edema. Over the next 50 years, silicone has been used to create artificial bronchial tubes, prosthetic eyes, artificial heart valves, prostheses for congenital facial deformities or postoperative defects, and even the syringes and intravenous catheters we use every day are made of silicone. To date, more than two million people have used medical materials made partially or entirely of silicone. Also in 1995, the American College of Rheumatology stated that recent epidemiological studies were conclusive and confirmed that silicone gel breast implants were not associated with related tissue diseases or rheumatologic conditions. The Society also called for anecdotes such as “silicone gel implants cause disease” to no longer be cited or referenced by courts and the FDA. Epidemiological studies have never found a higher than normal incidence of breast cancer in women after breast augmentation, and a study in 1986?1995 showed that 21 of 3112 cosmetic breast augmentation patients in Los Angeles in 1959?1981 developed breast cancer, indicating that the incidence of breast cancer after breast augmentation is not increased and is actually lower than expected. Before the application of silicone gel breast implants, a large amount of medical literature and research has been conducted to extensively and thoroughly discuss the safety of silicone gel applied to the human body. As early as the 1950s, there were reports of successful repair of deformities with silicone, and Edgerton’s textbook on implant surgery clearly stated that silicone was an important substance in various implants. In 1965?1968, seven better animal studies also showed no serious adverse reactions to silicone placement. Research on the safety of silicone gel implants in humans reached a peak in the 1990s, when researchers conducted numerous human epidemiological studies, and in 1991, at the request of the FDA, a manufacturer seeking scientific support to continue marketing its own brand of silicone gel breast implants submitted the results of more than 230 studies to confirm the safety of the product. In total, more than 2,000 studies have confirmed the safety of silicone or silicone implants over the past half century. The IOM published in 1999 that silicone gel implants do not cause systemic disease, that there is no increase in the incidence of initial or recurrent breast cancer in breast augmentation patients, and that the incidence of breast cancer in augmentation patients is slightly lower in some studies. Conclusion In the debate about silicone gel breast implants, the debate has involved not only patients and clinicians, but also the media, legal professionals, social activists, and the FDA, and the debate has centered on whether the application of silicone gel breast implants is safe, especially since it has been claimed that the application of silicone gel breast implants may lead to autoimmune disease, breast cancer, and may be detrimental to the health of the infant when breastfeeding. Numerous epidemiological studies have thoroughly debunked and refuted the claims of pathogenicity of silicone gel breast implants on a case-by-case basis. The American Medical Association urges physicians to provide patients with the latest scientific data to allay the public’s anxiety about not understanding the advances in science. In a 1994 summary of clinical studies on factors related to the impact on breast health, the British Department of Health stated that women breastfeeding after augmentation did not make their babies sick, that there was no evidence that women should avoid breastfeeding after augmentation, and that the benefits of breastfeeding far outweighed the possible, undeserved risks posed by silicone gel breast implants. In March 2000 Janowsky et al. published the results of their analysis of variables associated with silicone gel breast implants and associated tissue diseases in the New England Journal of Medicine, the researchers analyzed nearly 20 major diseases and found no evidence that breast implants in general, and silicone gel breast implants in particular, were associated with any one or more of the associated tissue diseases and other autoimmune diseases or rheumatoid factors There was an association.