Information on Silicone Breast Implants

Silicone is a class of synthetic compounds derived from silicon, an element that is found in the earth's crust. It should not be confused with either silica, the main ingredient in most beach sand, or the element silicon. Silicone is found in a wide variety of consumer and industrial products and was first used in breast implants in the early 1960s. It is also widely used in many different products made for implantation in the body.

Both silicone and saline breast implants have a flexible outer shell made of silicone elastomer, but the term "silicone implants" refers to the type filled with silicone gel. Silicone implants are filled with a fixed amount of silicone gel at the factory, and each implant has a patch over the manufacturing port so it cannot be modified. They are available in a variety of shell surfaces, shapes, profiles, volumes, and shell thickness. The silicone gel used today is a very thick liquid, thicker than that used in implants in the past. A type of implant called a "gummy bear" is under development that contains an almost solid silicone gel. Some implants are "double lumen" which means they have one shell inside another shell.

Silicone gel-filled implants were taken off the U.S. market in 1992 by the FDA because of reports of women developing autoimmune diseases and other problems. In 1997, the federal government asked the Institute of Medicine of the National Academy of Science to examine the complications of silicone breast implant surgery. The institute concluded that "evidence suggests diseases or conditions such as connective tissue diseases, cancer, neurological diseases or other systemic complaints or conditions are no more common in women with breast implants than in women without implants." Following a rigorous review process, the FDA approved the use of silicone gel-filled breast implants in 2006 for reconstructive breast surgery on women of any age, and for cosmetic augmentation surgery on women 22 years old and older. That age requirement is different from that for saline-filled implants and is based on the fact that a woman's natural breast can continue to develop until she is in her early 20s. It is also based on concern that younger women may not be mature enough to make an informed decision about cosmetic breast augmentation.

The FDA also recommends that women who have silicone gel-filled implants have magnetic resonance imaging (MRI) done on their breasts every few years to check for leakage of silicone gel. This imaging may not be covered by health insurance and is an important consideration when choosing between silicone gel-filled or saline-filled implants.

Implant Warranty

Like other important investments in your life, breast implants come with a manufacturer's warranty that covers problems that may crop up as a result of implant failure. Allergan (Inamed) and Mentor, the two breast implant manufacturers in the United States, assign lot and serial numbers to all their implants, and you will receive a device card with this information after your surgery. This card should be kept in a safe place with your other important papers.

The manufacturers are also supplied with data about the patient who received the implants (information about the surgery and the patient's Social Security number), which is used for warranty purposes. If a problem with the implants arises, the manufacturer can then get in touch with both the surgeon and the patient to inform them.

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