The Food and Drug Administration did not regulate medical devices until 1976. Under the 1976 law, devices already in use such as saline-filled breast implants and silicone gel-filled breast implants were "grandfathered". The manufacturers did not have to demonstrate to the F.D.A. that the devices were safe at that time.

Saline-filled breast implants were on the market for nearly three decades in the U.S. before the FDA approved them in May 2000. Mentor and Allergan (formerly Inamed) saline-filled breast implants are approved for augmentation in women who are 18 and older. There is no age restriction for saline implants used for reconstruction.

Silicone gel-filled breast implants were removed from the U.S. market in April 1992. Since then the FDA has permitted a small number of women, who wanted silicone gel-filled breast implants for cosmetic purposes and women undergoing mastectomies, to receive the implants in a long-term study. On October 14th and 15th in 2003, the F.D.A. sought input from an Advisory Panel of experts on the data contained in the Inamed pre-market approval (PMA) for silicone gel-filled breast implants during an open public meeting. In a 9-6 vote, the Panel recommended approval of the Inamed PMA with conditions. Ultimately in January 2004, the Food and Drug Administration rejected Inamed Corp.'s bid to bring silicone gel-filled breast implants back on to the market.

Mentor Corporation submitted their silicone gel-filled breast implant PMA in December 2003. The General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee reviewed applications submitted by Inamed Corp. and Mentor Corp. for marketing silicone gel-filled breast implants in April 2005. The advisory panel rejected U.S. sales of Inamed Corp.'s silicone gel-filled breast implants by a 5-4 vote. The following day, the Panel voted 7-2 in favor of allowing Mentor's application to be approved.

On Thursday, July 28,2005, the F.D.A. issued an approvable letter for Mentor’s application for silicone gel-filled breast implants. Inamed Corporation received an approvable letter from the Food and Drug Administration (FDA) for its silicone gel-filled breast implants on Sept. 21, 2005. The letters contained information regarding conditions that the companies needed to meet to obtain final FDA approval for marketing the implants in the U.S.

On September 23, 2005 the FDA Commissioner, Lester Crawford, resigned. In October 2006, he pleaded guilty to conflict of interest and falsely reporting information about stocks he owned in food,  beverage and medical device companies that he was in charge of regulating.

On November 17, 2006, the Food and Drug Administration (FDA) issued final approval to manufacturers Allergen Corporation (formerly Inamed) and Mentor Corp. for general marketing of silicone gel-filled breast implants to women of all ages for reconstruction purposes (e.g. cancer & trauma victims or those with breast abnormalities) and women 22 and older for augmentation purposes. The FDA has imposed a minumum age requirement for augmentation because breasts can continue to develop through a woman’s late teens and early twenties and because a young woman may not be mature enough to make a decision about potential risks. The FDA is requiring that Allergen Corporation and Mentor Corp. study 40,000 women for the next 10 years to assess potential health problems. The FDA has also recommended that silicone implant recipients have MRIs at regular intervals to detect ruptures that may be silent.