What's New in the Plastic Surgery Industry
Allergan® Silicone-Filled Breast Implants are FDA approved.
With the recent approval of silicone gel-filled breast implants for breast augmentation and breast reconstruction, physicians and patients can be assured of the safety of silicone. This confirmation is based on extensive preclinical testing, four years of data on 715 women from Allergan's Core Clinical Study and a European study that evaluated implant rupture prevalence rates beyond 10 years. In addition, countless published, peer-reviewed studies and research support the safety of silicone gel-filled breast implants.
A study by the US Government looks at silicone gel-filled breast implants and confirms findings.
In 1997, the 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 Silicone-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: The FDA has evaluated Allergan's Core Clinical Study data at four years and determined that INAMED® Silicone-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 INAMED® Silicone-Filled Breast Implants.
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 malignant or pre-malignant cancer of the breast and have not been successfully treated
- 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
Read more about the re-introduction of silicone breast implants with these links - silicone breast implants - cohesive breast implants - surgery and you - planning your surgery - silicone breast implant placement and incision site - breast augmentation considerations