• 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 US 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.

For full risk information, please see approved packaging in our Safety information page.