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Breast Implants and the FDA

Saline and silicone gel-filled breast implants are the most widely used for breast augmentation throughout the world. In 1976, the Food and Drug Administration (FDA) was tasked by Congress to regulate medical devices. Silicone implants were removed from the market in 1992, but were reintroduced in 2005. In November 2006 the FDA lifted restrictions for cosmetic surgery and approved the use of silicone breast implants for women who are at least 22 years old.

This article will help you understand the FDA's process and their reasons for scrutinizing breast implants.

Approval Process

FDA approval for marketing a medical device in the United States involves a two-step process.

The first step is for the company to convince the FDA that the new device has merit and warrants further investigation. In some cases, the FDA does not approve further investigation if the preliminary data shows that the risks associated with the device are too great.

Once a device has been approved for investigation, then a company performs studies to determine how well the device works and if it is safe. The results of the study are presented to an advisory panel of experts who review the data and make recommendations to the FDA. If the FDA feels the data is positive and substantial enough, then the FDA approves the distribution of the device.

Once approved by the FDA, the device can be marketed commercially. For example, 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.

History of Silicone Approvals

Between 1976 and 1991 saline and silicone breast implants could be marketed in the United States if they were on the market prior to 1976 and had a good safety record, or if they were substantially equivalent to other breast implants that were already on the market.

In other words, before 1991, the designs of the silicone breast implants were assumed to be safe and effective.

In 1991, the FDA required PMA (or premarket approval) for the silicone breast implants to be sold in the United States. PMA means that the companies who market the implants had to provide data, before the implants were sold commercially, to show that the implants were safe. 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.

Removal from the Market

In April 1992, the FDA determined that the data submitted by the implant companies was not sufficient to demonstrate the safety of silicone breast implants. (It is important to note that the FDA did not determine that silicone implants were unsafe, but that the data was insufficient to demonstrate their safety.) The silicone breast implants were removed from the general market at that time.

Continued Research

The FDA believed that there was a public need for silicone breast implants and allowed companies, who had not withdrawn their PMA submissions (Mentor Corporation and McGhan — now Inamed Corporation), to perform adjunct studies. These adjunct studies allowed these companies to continue research on the use of silicone implants for breast reconstruction and revision patients. Between 1992 and 2005, silicone breast implants were used for patients enrolled in investigational studies, reconstructive patients, and could not be marketed commercially to the general public. The United States was one of the few countries during this time period in which silicone breast implants could not be marketed commercially.

Reintroduction into the Market

In April 2005, third-generation silicone breast implants received a preliminary letter of approval by the FDA for use in certain patients, primarily reconstructive patients. Then in November 2006 the FDA lifted restrictions and approved the use of silicone breast implants for cosmetic purposes, for women who are 22 or older.

About the Reviewer of This Article

Michael Olding, MD, FACS, of Washington, D.C. is board-certified in plastic and reconstructive surgery by the American Board of Plastic Surgery and is a member of the American Society of Plastic Surgeons, the Northeastern Society of Plastic Surgery and the National Capital Society of Plastic Surgeons, where he was elected president. Dr. Olding specializes in cosmetic plastic surgery procedures and clinically related activities in cosmetic surgery, cosmetic facial surgery, breast augmentation and reduction, rhinoplasty, body contouring, liposuction and melanoma. He is also one of the area experts on soft-tissue fillers (Restylane, Sculptra and Botox). He received his doctorate in medicine from the University of Kentucky in 1980 and completed his internship at Cornell Medical Center. He completed his fellowship in plastic and reconstructive surgery at McGill University in Montreal. Dr. Olding maintains hospital staff privileges at George Washington University Medical Center, Sibley Hospital and Children's Hospital in Washington, D.C. More about Dr. Michael Olding