Silicone Breast Implants: The Safety of Silicone

A New Day in silicone, a preferred option in breast aesthetic surgery.

Silicones are a family of chemical compounds. They are made from silicon, a naturally occurring element found in sand, quartz and rock. Next to oxygen, silicon is the most common element in the earth's crust and becomes silicone when it is combined with oxygen, carbon and hydrogen. Depending on the arrangement of the molecules, silicones can be manufactured in a variety of forms including oils, gels and solids.

Silicones have been part of the consumer industry for over 50 years. Because they can be manufactured in various ways, silicones appear in a wide variety of products that most of us use everyday. Hairsprays, suntan lotions and moisturizing creams are just some of the consumer products that contain one form of silicone called dimethicone.

Medical devices utilizing silicone include artificial joints, catheters, drainage systems, facial implants, tissue expanders and breast implants. Silicone products have been shown to be biocompatible, reliable, flexible and easy to sterilize, making them an ideal choice for both implantable and non-implantable medical devices.

What makes today's silicone a safe option?

In 1992, the FDA called for a voluntary moratorium (delay) on the use of silicone gel-filled breast implants until new safety information could be thoroughly reviewed by the FDA's advisory panel. That same year, the FDA lifted this moratorium and announced its decision to allow access to silicone breast implants for reconstruction patients under controlled clinical studies, called Adjunct Studies. In 1999, the FDA allowed the use of silicone gel-filled implants in Allergan's Core Clinical Study to assess the safety and effectiveness of these devices.

While these studies are collecting information specific to INAMEDs Silicone-Filled Breast Implants, the National Institute of Health's Institute of Medicine (IOM) released a landmark 400-page report entitled "Safety of Silicone Breast Implants." This 1999 report on the safety ofsilicone concluded "There is insufficient evidence to support an association of silicone breast implants with defined connective tissue disease." The IOM also stated "There is no convincing evidence for atypical connective tissue disease or rheumatic disease or a novel constellation of signs and symptoms in women with silicone breast implants."??

The unique qualities of today's silicone gel-filled breast implants help make it the filler of choice for patients in countries where both saline-filled and silicone gel-filled breast implants are widely available.

With the recent approval of silicone 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 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 these 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
Silicone 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 INAMEDs 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 filled 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 INAMEDs 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:

1. Have existing malignant or pre-malignant cancer of the breast and have not been successfully treated

2. Have an active infection anywhere in the body

3. Are currently pregnant or nursing

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

1. Autoimmune diseases like lupus or scleroderma

2. Conditions that could interfere with wound healing and blood clotting

3. A weakened immune system (such as women receiving immunosuppressive therapy)

4. Reduced blood supply to the breast tissue

5. Radiation to the breast following implantation

6. 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