The Safety of Silicone



Health Canada approved

In 2006, Health Canada approved Natrelle gel-filled breast Implants for breast augmentation and breast reconstruction. This confirmation of the safety of the devices is based on preclinical testing, four years of data for 715 women from Allergan’s Core Clinical Study, three years of data from Allergan’s Natrelle 410 Study and a European study that evaluated Implant rupture prevalence rates beyond 10 years. For more information, please read the complete patient information.

One study looks at silicone gel-filled breast Implants and confirms findings.

In 1997, the U.S. Department of Health and Human Services began one of the most extensive research studies in medical history by appointing the Institute of Medicine of the National Academy of Science (IOM) to examine potential complications during or after surgery. The IOM consisted of a 13-member volunteer committee, including six women. The committee was composed of members of the medical, scientific and educational communities with experience in radiology, women's health, neurology, oncology, silicone chemistry, rheumatology, immunology, epidemiology, internal medicine and plastic surgery. No IOM members had on-going relationships or conflicts of interest related to any implant lawsuits.

The result: After reviewing years of evidence and research concerning silicone gel-filled breast implants, the IOM found that "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."

Furthermore, a review of research and medical studies shows:

  • Extensive studies, including a report by the Institute of Medicine, conclude that breast cancer is no more common in women with implants than in those without implants
  • The American Academy of Pediatrics concluded in September 2001 “The Committee on Drugs does not feel that the evidence currently justifies classifying silicone implants as a contraindication to breastfeeding.„
  • Epidemiological investigations have not found any increased risk of adverse health outcomes... in children born to women with breast implants

For more information, you can download two different versions of the IOM report. A good place to begin is the 17-page summary report, Information for Women About the Safety of Gel-Filled Breast Implants. For more technical data, read the entire 455-page IOM report which contains the history of breast implants and studies concerning their safety.

Silicone gel-filled breast implants are arguably the most studied medical devices and decades of research have evaluated their safety and effectiveness.

The Allergan Core Clinical Study

Allergan's Core Clinical Study is an ongoing 10 year study of 940 women who had breast augmentation, reconstruction or revision of a previous surgery between 1999 and 2000. Safety and effectiveness is evaluated through patient follow-up at zero to four weeks, six months, 12 months, 24 months, and annually through 10 years. Safety is assessed by complications, such as implant rupture, capsular contracture and re-operation. Benefit (effectiveness) is assessed by patient satisfaction and measures of body image/esteem and self-esteem.

The result: Health Canada has evaluated Allergan's Core Clinical Study data at seven years and determined that Natrelle™ Gel-Filled Breast Implants are safe and effective for use in breast augmentation and breast reconstruction.

The Allergan Adjunct Clinical Study

The Allergan Adjunct Clinical Study enrollment was limited to reconstruction and revision surgery patients who met certain inclusion criteria. Between the years of 1998 and 2006, when enrollment in this study was terminated, over 80 000 silicone gel-filled breast implants were implanted in more than 50 000 women. Safety data is collected at one, three and five years and is used as supplemental data to support the safety of Natrelle™ Gel-Filled Breast Implants.

The Allergan Natrelle 410 Study

Allergan's Natrelle 410 Study is an ongoing 10-year study of 941 women to assess safety and effectiveness in augmentation, reconstruction and revision (revision-augmentation and revision-reconstruction) patients. Patient follow-up is at zero to four weeks, six months, 12 months, 24 months and annually through 10 years. Safety is assessed by complications, such as implant rupture, capsular contracture, and reoperation. Benefit (effectiveness) is assessed by patient satisfaction and measures of body image/esteem and self-esteem.

Studies show silicone gel-filled breast implants are safe, but that doesn't make them right for everybody.

Silicone gel-filled breast implants are not lifetime devices. It is possible at some point in your lifetime that the implant(s) would need to be removed or replaced. To ensure that you achieve your optimal results safely, patients should be aware that you should not have breast implant surgery if you:

  • Have existing cancer or pre-cancer of the breast and have not had adequate treatment for those conditions
  • Have an active infection anywhere in the body
  • Are currently pregnant or nursing

You should also know that silicone gel-filled breast implants have not been clinically tested in women with:

  • Autoimmune diseases like lupus or scleroderma
  • Conditions that could interfere with wound healing and blood clotting
  • A weakened immune system (such as women receiving immunosuppressive therapy)
  • Reduced blood supply to the breast tissue
  • Radiation to the breast following implantation
  • Clinical diagnosis of depression or other mental health disorders, including body dysmorphic disorder and eating disorders. Please discuss any history of mental health disorders prior to surgery

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