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Breast Implants and the FDA

Reviewed by Walter Erhardt, MD

Saline and silicone gel-filled breast implants are the two main implant options for breast augmentation, both in the United States and abroad.

Silicone implants were the No. 1 choice among women seeking breast augmentation prior to the 1990s in the U.S., but their popularity waned due to allegations that their use was linked to certain autoimmune and connective tissue diseases, such as lupus. The Food and Drug Administration (FDA) imposed a voluntary moratorium on the use of silicone breast implants in the U.S. in 1992. Fourteen years later, after extensive research, the FDA re-approved their use for women seeking cosmetic breast enhancement who are at least 22 years old. In 2011, the FDA stated that ongoing studies continue to show that silicone gel-filled breast implants are relatively safe, but not meant to last a lifetime. The FDA is still tracking safety information on the implants.

This article explains the FDA's process for approving medical devices and provides an abridged history of the regulatory hurdles faced by silicone breast implants.

Approval Process

In 1976, the FDA was tasked by Congress to regulate medical devices. In response, the FDA established a two-step process for gaining FDA approval to market a medical device.

First, the company must convince the FDA that the new device has merit and warrants further investigation.

Once a device has been FDA-approved for such investigation, the company performs studies to determine how well it works and if it is safe. The results of the studies are presented to an advisory panel of experts for review. The FDA is not obligated to follow the advice of its advisory panels, but it usually does. Once approved by the FDA, a device can be marketed commercially.

History of Silicone Breast Implants

Silicone-filled implants were first developed in 1961 and initially marketed in 1963. This means that they were grandfathered in and did not have to follow the approval steps outlined in 1976.

Specifically, silicone breast implants could be marketed in the U.S. if they were on the market prior to 1976 and had a good safety record, or if they were equivalent to other breast implants that were already on the market.

Trouble began to brew in the 1980s. Researchers discovered that when silicone implants ruptured, the silicone gel migrated into the pocket containing the implant and other areas of the body. Many women with these implants seemed to develop systemic diseases such as lupus and arthritis, and several class action lawsuits followed. Silicone breast implant manufacturers paid out millions in damages as a result of these lawsuits.

In 1991, the FDA began to require premarket approval (PMA) for silicone breast implants to be sold in the U.S. This meant that the companies who marketed the implants had to provide data that the implants were safe before they were sold commercially. If implants had already been on the market before 1991, then the companies could submit safety data for the FDA to review. These companies were allowed to continue marketing and distributing their silicone implants during this FDA review process.

Voluntary Moratorium

This all changed in January 1992, when the FDA called for a voluntary ban on the sale and use of silicone breast implants. Later that year, the FDA stated that silicone gel-filled breast implants should be available only for women seeking breast reconstruction after breast cancer surgery or revision breast augmentation. Breast implant makers were told to study the implants in women who received the devices under these restrictions.

Learn more about breast implants

In 1999, the prestigious Institute of Medicine concluded that silicone breast implants may be responsible for localized problems such as hardening or scarring, but do not increase risk for systemic diseases. These findings were supported by several other studies from independent organizations that also showed no such risk. However, the FDA left the moratorium in effect despite the IOM's findings.

In April 2005, third-generation silicone breast implants received a preliminary letter of approval by the FDA for use in certain patients, primarily reconstructive breast surgery patients. In November 2006, the FDA lifted its ban on silicone implants for breast reconstruction patients of all ages and cosmetic surgery breast augmentation patients who are 22 or older.

During the 14-year moratorium, silicone breast implants were readily available in other countries. However, saline-filled breast implants were the only type of implant available in the U.S. for primary breast augmentation during the ban.

Current Status and Developments

Now, once again, silicone breast implants are the most popular choice for women seeking breast augmentation with implants.

In addition, the FDA is currently investigating the safety and efficacy of gummy bear breast implants, which are filled with a highly cohesive silicone gel that will not leak if the implant shell ruptures. Other breast augmentation procedures — fat grafting breast augmentation and breast auto augmentation — are not regulated by the FDA because they do not involve the implantation of a medical device such as a breast implant.

If you are considering silicone gel implants for your breast augmentation, make sure you choose a board-certified plastic surgeon who has extensive experience with this implant type. Many surgeons lack this experience due to the 14-year ban. Others were still using these implants during the moratorium as part of clinical trials and/or in approved patients.

Start your search for the right surgeon now.

The Fall and Rise of Silicone Breast Implants


The FDA reaffirms the safety of silicone breast implants but states that the implants often require removal within 10 years.


They're back. FDA re-approves silicone breast implants. They are now available outside of clinical trials after a 14-year hiatus.


The FDA deferred action and determined that the PMA for Inamed Corp.'s silicone gel-filled breast implant is "not approvable," calling for additional information.


FDA reviews Inamed Corp.'s silicone breast implant pre-market application (PMA).


Saline breast implants receive formal FDA market approval.


FDA issues breast implant risk info booklet.


Global Settlement talks begin with manufacturers.


FDA issues moratorium on silicone gel breast implants; use of silicone implants restricted to breast reconstruction and clinical studies.


Congress gives FDA authority to regulate medical devices; pre-existing devices grandfathered pending further evaluation.


Breast implants introduced.

Adapted with permission from the American Society for Aesthetic Plastic Surgery and the American Society of Plastic Surgeons