Silicone Implants Approved
by the FDA

On November 17, 2006, the FDA lifted a 14-year ban on silicone implants. Silicone-filled implants are generally considered softer than the saline implants currently in use, and therefore are expected to soon be the implant of choice for the 300,000 women who elect to have breast augmentation surgery each year.

The majority of implants being used today are saline-filled implants. These have a silicon rubber shell and are filled with sterile salt water. In the unlikely event that a saline implant leaks, salt water is harmlessly absorbed by the body.

Safety Studies

Each year, thousands of women undergo breast augmentation surgery and experience no major complications. However, one must fully understand the risks as well as the benefits of this procedure. A recent study with a follow-up of at least ten years showed that nearly 96 percent of women with saline-filled breast implants who were surveyed would make the same choice again. This study was performed at the University of Minnesota in consultation with the Food and Drug Administration (FDA). Of 450 patients, 93 percent reported they were satisfied or very satisfied with their breast implants, and 71 percent rated their breast implants as soft and natural.

After a comprehensive evaluation of the evidence for the Association of Silicon Breast Implants with human health conditions, the Institute of Medicine concluded in June that there is "no definitive evidence linking breast implants to cancer, neurological diseases, neurological problems or other systemic diseases."

Many of the changes to the breast following implantation should be considered irreversible. If it is necessary or one chooses to have the implants removed, there may be dimpling, puckering or wrinkling, or other changes to the breast. Breast implants may affect the ability to produce milk for breast feeding. Breast implants may not prevent your breasts from sagging after pregnancy.

Long-Term Effects

There are millions of women who have had this surgery done since the 1970s who continue to live in harmony with their implants.

Breast augmentation may not be a one-time surgery. It is possible that there will be a need for additional surgery and doctor visits over the course of your life.

Breast implants should not be considered lifetime devices. It is possible that a woman will undergo implant removal with or without replacement over the course of her life.