In-Depth Scientific Studies and Reviews on Silicone and Silicone Gel-filled Breast Implants
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National Institute of Medicine (IOM), under the charter of the National Academy of Sciences, Safety of Silicone Breast Implants, a 400-page report. 1999.
The Research:
Investigating the concerns related to silicone gel-filled breast implants that arose in the late 1980s and 1990s. -
Independent Review Panel Reports:
- The National Science Panel formed by Federal Judge Sam Pointer (November 1998)
- The British Independent Review Group (July 1998)
- The European Committee on Quality Assurance and Medical Devices in Plastic Surgery (June 2000)
The Research:
Each of these independent groups reviewed a broad range of scientific information regarding the potential risks associated with silicone gel-filled breast implants, and concluded there is no link between silicone gel-filled breast implants and medical conditions such as connective tissue diseases (CTDs), rheumatologic disorders, abnormalities of the immune system or increased toxicity in the body. Several panels also evaluated the risk of cancer and other malignant disorders, as well as the health effects on children of women with silicone gel-filled breast implants.- The National Science Panel formed by Federal Judge Sam Pointer (November 1998)
Read this report - The European Committee on Quality Assurance and Medical Devices in Plastic Surgery (June 2000)
Read this report - The British Independent Review Group (BIRG)
Read this report
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McLaughlin, K, et. al. The safety of silicone gel-filled breast implants: a review of the epidemiologic evidence. In press. Annals of Plastic Surgery. 2007.
The Research:
This review summarizes the epidemiologic evidence related to the safety of breast implants, drawing primarily from large studies with long-term follow up. The paper addresses cancer, breast cancer detection, connective tissue disease, suicide, offspring effects, neurologic disease, implant rupture, and local perioperative complications and additional surgery.Lipworth, L., et. al. Excess mortality from suicide and other external causes of death among women with cosmetic breast implants. Annals of Plastic Surgery. August 2007.
The Research:
This paper reports updated findings of long-term, additional follow up (up to 38 years) from an original study of 3,527 Swedish women with cosmetic breast implants. The study was designed to examine mortality from specific causes among women with breast implants compared with the general population. -
Villeneuve PJ, et al. Mortality among Canadian women with cosmetic breast implants. American Journal of Epidemiology. 2006.
The Research:
This study compared the mortality of women who received breast implants with that of the general population. -
Spear, SL and Heden, P. Allergan’s silicone gel breast implants. Expert Review of Medical Devices. 2007
The Research:
This review assesses the data related to the safety and effectiveness of Allergan’s Style 410 (round and anatomical) breast implants, as well as the health implications of silicone gel-filled breast implants more broadly.Heden, et. al. Style 410 cohesive silicone breast implants: safety and effectiveness at 5 to 9 years after implantation. Plastic and Reconstructive Surgery. 2006
The Research:
This Swedish study evaluated the safety and effectiveness of silicone gel-filled breast implants in 144 women with a mean implantation time of six years.
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American Academy of Pediatrics, Committee on Drugs. The Transfer of Drugs and Other Chemicals into Human Milk. Pediatrics. 2001.
The Research:
This study updated the American Academy of Pediatrics (AAP) Committee on Drugs list of substances transferred into human milk, including silicone from silicone gel-filled breast implants. The study described these substances' possible side effects on infants and on the production of milk during breastfeeding. -
Kjoller, K, et al. Health Outcomes in Offspring of Mothers with Breast Implants. Pediatrics. 1998.
The Research:
The study was designed to examine esophageal disorders, connective tissue disease (CTD), and congenital malformations in children of mothers with silicone gel-filled breast implants. Researchers looked at children born to 1,135 women with silicone gel-filled breast implants for cosmetic reasons against a comparison group of 7,071 women who underwent breast reduction surgery.
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Lipworth L, et al. Breast Implants and Fibromyalgia: A Review of the Epidemiologic Evidence. Annals of Plastic Surgery. 2004.
The Research:
This review of the results from six studies explored the possible relationship between silicone gel-filled breast implants and fibromyalgia, a connective tissue disease (CTD) similar to rheumatism that is characterized by bone and joint discomfort, stiffness and fatigue. -
Janowsky EC, et al. Meta-analyses of the relation between silicone breast implants and the risk of connective-tissue diseases. New England Journal of Medicine, 2000.
The Research:
Researchers analyzed the results of 20 different studies that reviewed the relationship between silicone gel-filled breast implants and the risk of connective tissue disease (CTD), such as rheumatoid arthritis and lupus. -
Lipworth L, et. al. Silicone breast implants and connective tissue disease: an updated review of the epidemiologic evidence. Annals of Plastic Surgery. 2004.
The Research:
Numerous analyses and studies conducted up to 1999 evaluated the potential association between cosmetic silicone breast implants and the occurrence of well-defined connective tissue diseases, as well as a hypothesized new atypical disease. This paper provides an updated review of the results of epidemiologic studies published since 1999.Brinton LA, et. al. Risk of connective tissue disorders among breast implant patients. American Journal of Epidemiology. 2004
The Research:
This study comprises a re-analysis of records from a United States retrospective study completed in 1996, which evaluated the risks of developing rheumatoid arthritis (RA), scleroderma, systemic lupus erythematosus, or Sjögren’s syndrome among women with breast implants.Fryzek JP, et al. A nationwide study of connective tissue disease and other rheumatic conditions among Danish women with long term cosmetic breast implantation. In press. Annals of Epidemiology. 2007
The Research:
An extended follow-up of an earlier study of Danish women with cosmetic breast implants and women with other types of cosmetic surgery, looking at the incidence of CTD and other rheumatic conditions in these women as compared with those in the general Danish population.
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National Cancer Institute (NCI) of the National Institutes of Health (NIH). A Long-Term Study of the Health Effects of Silicone Gel-Filled Breast Implants. 2006.
The Research:
As the principal federal agency for cancer research and training, the NCI studied 13,500 women who had breast implant surgery for aesthetic reasons. For comparison, the study also included 4,000 women similar in age who had some other type of plastic surgery. This is one of the largest studies on the long-term health effects of silicone gel-filled breast implants. -
Brisson, J., et al. Cancer incidence in a cohort of Ontario and Quebec women having bilateral breast augmentation. International Journal of Cancer. 2006.
The Research:
This study is considered to be one of the largest epidemiologic studies investigating the long-term health effects of breast implants. Researchers conducted the study in two Canadian provinces. -
Friis S., et al. Cancer risk among Danish women with cosmetic breast implants. International Journal of Cancer. 2006.
The Research:
This Danish study evaluated the relationship between silicone gel-filled breast implants and breast cancer, or other cancers. It also examined whether breast implants interfere with the interpretation of routine mammography examinations, thus delaying the diagnosis of breast cancer. -
McLaughlin JK, et al. Long-term cancer risk among Swedish women with cosmetic breast implants: an update of a nationwide study. Journal of the National Cancer Institute. 2006.
The Research:
This 2006 report includes results from the longest large-scale follow-up study of women with implants to date, evaluating the risk of breast cancer and other cancers. -
Miglioretti DL, et al. Effect of breast augmentation on the accuracy of mammography and cancer characteristics. Journal of the American Medical Association. 2004.
The Research:
This study examined whether breast implants interfere with routine mammography procedures, causing delays in cancer detection in women with breast augmentation. -
Holmich, LR, et al. Stage of breast cancer at diagnosis among women with cosmetic breast implants. British Journal of Cancer. 2003.
The Research:
This study examined the potential delay in breast cancer diagnosis in women with breast implants. -
Hoshaw, SJ, et al. Breast implants and cancer: causation, delayed detection and survival. Plastic and Reconstructive Surgery. 2001.
The Research:
This is a qualitative review of all of the existing literature on cancer (breast cancer and other cancers), the delayed detection of breast cancer, increased breast cancer recurrence, or decreased length of survival in women with breast implants. -
Deapen, D, et al. Breast cancer stage at diagnosis and survival among patients with prior breast implants. Plastic and Reconstructive Surgery. 2000.
The Research:
Examined breast cancer diagnosis and survival in women with breast implants living in Los Angeles County. The researchers paid particular attention to whether or not implant patients experienced an unusual delay in breast cancer diagnosis or have a poor rate of survival. -
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: International Agency for Research on Cancer Press. 1999.
The Research:
This study, released by the International Agency for Research on Cancer (part of the World Health Organization) examined the link between the presence of a solid metallic or non-metallic object in the body (specifically medical devices) and the development of cancers. -
Park AJ, et al. Silicone breast implants and breast cancer. Breast. 1998.
The Research:
Evaluated whether women with silicone gel-filled breast implants were at increased risk of developing breast cancer, or developing a recurrence of their disease. -
Deapen DM, et al. Are breast implants anticarcinogenic? A 14-year follow-up of the Los Angeles study. Plastic and Reconstructive Surgery. 1997.
The Research:
This study followed more than 3,000 women with cosmetic breast implants for an average of 14 years, exploring the relationship between breast implants and breast cancer risk. The researchers also looked at detection issues, due to concerns that implants may delay tumor detection. -
Bryant, H., et al. Breast Implants and Breast Cancer - Reanalysis of a Linkage Study. New England Journal of Medicine. 1995.
The Research:
The researchers conducted a second analysis of data from Alberta Health Care linked to the Alberta Cancer Registry. The re-analysis was conducted in response to concerns that the original study included a number of potential errors in the study methods used. -
Pukkala E, et al. Incidence of breast and other cancers among Finnish women with cosmetic breast implants, 1970-1999. Journal of Long-Term Effects of Medical Implants. 2002.
The Research:
To examine the cancer risk among women with cosmetic silicone gel-filled breast implants, researchers studied Finnish women with cosmetic silicone gel-filled breast implants.
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Two Studies by Lisbet R. Holmrich, M.D., (known as The Danish Studies):
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Holmrich, LR, et al. Untreated Silicone Breast Implant Rupture. Plastic and Reconstructive Surgery. 2004.
The Research:
This study was the first and only time that untreated implant rupture has ever been evaluated, making the results significant in the realm of silicone gel-filled breast implant safety. -
Holmrich, LR, et al. Self-Reported Diseases and Symptoms by Rupture Status among Unselected Danish Women with Cosmetic Silicone Breast Implants. Plastic and Reconstructive Surgery. 2003.
The Research:
This study examined women with intact breast implants, as well as those with ruptured implants, and looked specifically at any potential association between breast implant rupture and disease. -
Brook, MA. Platinum in Silicone Breast Implants. Biomaterials. 2006.
The Research:
Authored by platinum expert and BIRT member Dr. Michael Brook, this study summarized the scientific literature on platinum as it applies to silicone materials used in biomedical devices, especially silicone gel-filled breast implants.
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Sarwer, David B. Mental Health Histories and Psychiatric Medication Usage Among Persons Who Sought Cosmetic Surgery. Plastic and Reconstructive Surgery. 2003.
The Research:
This study examined the mental health histories and psychiatric medication usage of persons who sought cosmetic surgery. -
Cash TF, et al. Women's Psychosocial Outcomes of Breast Augmentation with Silicone Gel-Filled Implants: A 2-Year Prospective Study. Plastic and Reconstructive Surgery. 2002.
The Research:
This two-year study examined the experiences of 360 women receiving bilateral breast augmentation (augmentation of both breasts) with different types of breast implants. -
Sarwer, DB, et al. Cosmetic breast augmentation surgery: A critical overview. Journal of Women's Health and Gender-Based Medicine. 2000.
The Research:
This report provided an in-depth overview of the medical and psychological literature on cosmetic breast augmentation. -
Sarwer DB, et al. Changes in body image following cosmetic surgery. Paper presented at the annual meeting of the Society of Behavioral Medicine. March 25-28, 1998.
The Research:
This study analyzed the motivations behind women who decide to seek cosmetic surgery, as well as their psychological and social outcomes post-surgery. -
Rankin M, et al. Quality of life outcomes after cosmetic surgery. Plastic and Reconstructive Surgery. 1998.
The Research:
In this study of 105 patients undergoing elective cosmetic surgery, researchers analyzed quality-of-life index, depression, social support and overall coping.
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