Important Clinical Studies Evaluating the Safety of Silicone and Silicone Gel-Filled Breast Implants

Silicone gel-filled breast implants represent one of the most widely studied medical devices approved by the FDA in history. This section will help you understand the different types of scientific studies conducted to evaluate the safety of silicone and silicone gel-filled breast implants.

Key Safety Studies and Data on Silicone and Silicone Gel-Filled Breast Implants

In addition to the Core Clinical Studies sponsored by manufacturers of silicone gel-filled breast implants, hundreds of scientific studies have been completed to evaluate the effectiveness and safety of silicone and silicone gel-filled breast implants. The FDA considered data from many of these studies during their review of silicone gel-filled breast implants.

  • "Non-clinical" reviews conducted by independent governmental bodies, such as the Institute of Medicine (IOM): The IOM evaluated specific safety concerns related to silicone gel-filled breast implants. These included cancer, connective tissue disease, neurological disease, the effects on pregnancy, lactation, and the children of women with silicone gel-filled breast implants.
  • Independent Panel Reviews: Various governments, third-party organizations and professional associations have also convened advisory groups to examine existing data from a wide range of studies, and make determinations about the safety of particular medical devices. Following review of study protocols and results, individual panels usually issue a final, unbiased and objective determination regarding the safety of the device at hand. In the instance of silicone gel-filled breast implants, experts scrutinized the wealth of existing safety data, and also closely reviewed how researchers conducted the studies and collected data. It is important to note that independent panels have no interest in the outcome of their conclusions.
  • Toxicology and biocompatibility testing indicated that the silicone materials used in breast implants do not cause toxic reactions, even when large amounts were administered to test animals. In addition, studies have demonstrated that the type of platinum found in silicone gel-filled breast implants in very small quantities is metallic platinum, similar to that found in approved medical devices, rather than the form of platinum that is more active in the body, platinum salts.
  • Independent epidemiologic studies published in medical journals: These studies evaluate if there is any relationship between silicone gel-filled breast implants and potential safety complications or health concerns.
  • FDA Panel Reviews: These advisory groups are put together by the United States Food and Drug Administration (FDA) to provide independent, professional expertise and technical assistance on the development, safety and effectiveness, and regulation of medical devices. Each panel consists of experts with recognized expertise and judgement in a specific field. Members have the training and experience necessary to evaluate information objectively and to interpret its significance. These persons are not regular employees of the FDA, but are paid as "special government employees" for the days they participate as members of a panel. The purpose of these panels is to examine existing data from a wide range of studies and make an overall determination of the safety of a particular medical device. Following the panel's review of the data and information, it makes a final, unbiased and objective determination regarding the safety and effectiveness of the device under consideration. In the instance of silicone gel-filled breast implants, experts on the panel scrutinized the abundance of existing safety and effectiveness data, closely reviewed how the studies were conducted and how the data were collected, and listened to public testimony from patients, advocates, physicians, scientists and special interest groups. It is important to note that the panels are advisory – they provide their expertise and recommendations – but final decisions are made by the FDA.

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Results of Key Safety Studies Conducted on Silicone and Silicone Gel-Filled Breast Implants

National Academy of Sciences' Institute of Medicine (IOM) Report

Established in 1970 under the charter of the National Academy of Sciences, the Institute of Medicine (IOM) provides independent, objective, evidence-based advice to policy makers, health professionals, the private sector and the public. In the 1990s, the IOM convened an independent committee of 13 scientists to launch a comprehensive examination into the safety of silicone gel-filled breast implants. In 1999, the committee released a 400-page report summarizing its conclusions, based on review of the evidence reported in peer-reviewed, published scientific literature, for the association of silicone gel-filled breast implants with human health conditions.

In its report, the IOM committee stated, "A review of the toxicology studies of silicone and other substances known to be in breast implants does not provide a basis for health concerns." The report also noted, "evidence suggests diseases or conditions such as connective tissue diseases, cancer, neurological diseases or other systemic complaints or conditions are no more common in women with breast implants than in women without implants."

Read the IOM report

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Independent Third-Party Research

In addition to data derived from the Core Clinical Studies provided by the manufacturers of breast implants, the FDA examined literature reviews of scientific data published by independent experts. This is significant, because independent data are collected and analyzed with no input or oversight from the device manufacturers. Therefore, these data might be considered to be the most objective available. Several highly respected groups of medical experts have conducted studies or analyzed data assessing the safety of breast implants, including:

Each of these independent groups reviewed a broad range of scientific information regarding the potential risks associated with silicone gel-filled breast implants. Collectively, these independent panels and review groups reached individual, but ultimately similar, conclusions about the safety of silicone gel-filled breast implants. The consensus among these groups, as described by the National Science Panel, was that there is "no link between silicone breast implants and any established connective tissue diseases, rheumatologic disorders, abnormalities of the immune system or increased toxicity in the body."

In addition, independent groups issued the following conclusions that further reinforce the safety of silicone gel-filled breast implants:

  • The European Committee on Quality Assurance and Medical Devices in Plastic Surgery (EQUAM) concluded that "the additional medical studies have not demonstrated any association between silicone breast implants and ... cancer, nor any other malignant diseases." The committee also found that "silicone breast implants do not adversely affect pregnancy, fetal development, breast feeding or the health of breast fed children. EQUAM believes that "in all fields of medicine and surgery, implants and medical devices made of silicone remain essential not only for aesthetics, but also for reconstructive procedures and to support survival." Download this report
  • The British Independent Review Group (BIRG) also examined risks to children of women with breast implants and concluded that "there is no evidence that children of women with breast implants are at increased risk of connective tissue disease."

For a library of other important safety studies, click here

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