There's certainly no shortage of discussion about silicone gel-filled breast implants. In fact, they are one of the most studied medical devices in history. Here's a closer look at the evolution of silicone gel-filled breast implants, and why they might be an option you wish to consider.

An extensive 30-year history worldwide

For more than 30 years, silicone gel-filled breast implants have been used consistently in more than 60 countries. This includes continuous use in the United States for breast reconstruction surgery since 1992 under clinical study protocols. Today, when given a choice, 9 out of 10 women worldwide, outside of the U.S., choose silicone gel filler.

U.S. FDA approval

Following extensive review of relevant background information and clinical studies, the U.S. FDA recently approved silicone gel-filled implants for breast augmentation for women 22 years of age and for reconstruction in November 2006.

Further study

Allergan is committed to the long term safety of our breast implants. Our Breast Implant Follow-up Studies (BIFS) allow us to track the long-term safety of our products. When complete, over 40,000 women will have participated in this far-reaching study over the course of 10 years.
 

A brief history of silicone gel-filled breast implants

1970s-1992
Silicone gel-filled breast implants are used extensively in the United States and over 60 countries around the world for breast augmentation and reconstruction.
1992
In 1992, the U.S. FDA calls for a voluntary moratorium (delay) on the use of silicone gel-filled breast implants until the FDA's advisory panel could review new safety information. That same year, the FDA lifted the moratorium and allowed access to silicone gel-filled breast implants for reconstruction patients under controlled clinical studies. Silicone gel-filled breast implants continue to be available outside of the United States during this time.
1999
In 1999, the FDA allowed the use of silicone gel-filled breast implants for augmentation and reconstruction in Allergan's Core Clinical Study to assess the safety and effectiveness of these devices.

While these studies are collecting information specific to Natrelle™ silicone-filled breast implants, the National Institutes 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 of silicone concluded, "There is insufficient evidence to support an association of silicone breast implants with defined connective tissue disease." Further, it concluded that there was no higher incidence of specific health conditions (CTD, cancer, autoimmune diseases, etc.) for women with implants than those without.
2006
The FDA re-approves silicone gel-filled breast implants for use in the U.S. after reviewing a vast amount of scientific data. These data consisted of results from extensive preclinical testing and clinical data from Allergan's Core Clinical Study and a European study that evaluated implant rupture prevalence rates beyond 10 years.