Breast Implants and the FDA

There are two types of bust implants that are widely used for breast augmentation in the USA and around the world. These are saline-filled and silicone gel-filled bust implants. The Food and Drug Administration (FDA) has regulated medical devices in the USA since 1976.

In 1992, silicone implants were removed from the American market but were reintroduced in 2005. As of November 2006, the FDA has lifted restrictions on cosmetic surgery, and silicone breast implants are FDA approved for women of 22 years or more.

Approval Process

A two-step process is required for a medical device to become approved for marketing and sale in the USA. First, the company must convince the FDA that the product has merit and warrants further investigation. If the preliminary data shows the risks to be too great, the product won’t clear this hurdle.

After the product has been approved for investigation, studies are done to determine if the product works and how safe it is. The results are presented to a panel of experts who then make a recommendation to the FDA.

If the FDA then approve the device, it can be marketed and sold in the United States of America.

Approval from 1976 to 1991

Silicone and saline implants were approved in the USA from 1976 to 1991, if they were on the market as of 1976 (or if they were similar to ones on the market) and had a good safety record. Before 1991, they were assumed to be safe and effective.

In 1991, however, the FDA required premarket approval for the implants. That means the companies who made them had to provide data to show they were safe. They were allowed to continue marketing the devices if they could back up their presumed safety with data.

Removal from the Market in 1992

The FDA decided that the data submitted by implant companies was insufficient to demonstrate the safety of silicone implants in April 1992. They did not determine that silicone implants were unsafe, merely that the data was insufficient. They were then removed from the American market.

Lifting of Restrictions in 2006

Further studies done between 1992 and 1995 showed no major health risks from silicone implants, and they were given preliminary approval as of April 2005. In November 2006 the FDA lifted all restrictions and approved silicone implants for women 22 or older.

You can get all the information you need to make an informed decision about breast implants by consulting with a plastic surgeon near you today.