Silicone Implants

Silicone Implants

As of November 2006, the U.S. Food and Drug Administration (FDA) approved the marketing of silicone gel-filled breast implants made by two companies for breast augmentation in women ages 22 and older.

"FDA has reviewed an extensive amount of data from clinical trials of women studied for up to four years, as well as a wealth of other information to determine the benefits and risks of these products," said Daniel Schultz, M.D., Director, Center for Devices and Radiological Health, FDA.

According to the FDA, Silicone gel filled implants have been determined to be safe and effective. The decision by the FDA to approve these implants was based on a thorough review of clinical and preclinical studies, a review of studies by independent scientific bodies and deliberations of advisory panels of outside consultans that heard public comment from hundreds of stakeholders.

In the past decade, a number of independent studies have examined whether silicone gel-filled breast implants are associated with connective tissue disease or cancer. The studies, including a report by the Institute of Medicine, have concluded there is no convincing evidence that breast implants are associated with either of these diseases. Some of the complications reported in the core studies included hardening of the area around the implant, breast pain, change in nipple sensation, implant rupture and the need for additional surgery. However, the majority of women in these studies reported being satisfied with their implants.

Full information about the risks and benefits of silicone gel filled implants can be found in the package and patient labeling mandated by FDA. The patient labeling outlines some of the important factors women should consider when deciding whether to get silicone gel-filled breast implants. Some of these factors are: breast implants are not lifetime devices and a woman will likely need additional surgeries on her breast at least once over her lifetime; many of the changes to a woman's breast following implantation are irreversible; rupture of a silicone gel-filled breast implant is most often silent, which means that usually neither the woman nor her surgeon will know that her implants have ruptured; and a woman will need regular screening MRI examinations over her lifetime to determine if silent rupture has occurred. The device labeling states that a woman should have her first MRI three years after her initial implant surgery and then every two years thereafter. The cost of MRI screening over a woman's lifetime may exceed the cost of her initial surgery and may not be covered by medical insurance. The labeling also states that if implant rupture is noted on an MRI, the implant should be removed and replaced, if needed.

Silicone Implants

Breast implants are man-made devices used to enhance the appearance of the breasts. All implants whether filled with saline or silicone gel have a silicone shell on the outside. Silicone is a complex polymer made of smaller particles of silicon. Silicon is a naturally occurring molecule which can be arranged using chemical reactions to obtain silicone molecules of various lengths and sizes. The shell (hard plastic) and gel (liquid) form of silicone found in breast implants are a few examples of the types of silicone polymers which can be created. Silicon is the most common element on Earth. Beach sand is made from silicon and so is the glass used in making windows and spectacles. Silicon is extremely versatile and is used to make computer chips, medical devices and is used as a food stabilizer. Additionally, silicon occurs naturally in the human body in relatively large quantities. Silicon is one of the most inert elements known to man and is an ideal substance from which to make medical devices such as implantable joint prosthesis, heart pacers, catheters for intravenous access and breast implants. The human body naturally resists any foreign material implantation, but silicone implants are some of the best tolerated. Several technological advances have been made over the past two decades in the design and manufacture of silicone implants. Newer silicone shells and gels are much better than those used in the 1970s.

Statement on Silicone Implants from the American College of Rheumatology

In this statement, the American College of Rheumatology (ACR) acknowledged that many women who have received silicone implants complained of muscle aches and bony pains. Many of these women had been diagnosed with scleroderma, lupus, fibromyalgia, and other rheumatologic disorders. They emphasized that the basis for their conclusions was based on two large scientific studies which were published in the New England Journal of Medicine. The ACR believes that these studies provide compelling evidence that silicone implants expose patients to no demonstrable additional risk for connective tissue or rheumatic disease. In other words, having silicone breast implants does not increase the risk of coming down with some form of rheumatologic disease later on in life.9-10

Safety Studies from the Institute of Medicine

The Institute of Medicine (IOM) was commissioned through the Department of Health and Human Services by the United States House of Representatives to sort out safety issues associated with breast implants in 1997. The IOM panel reviewed scientific studies in the U.S., Canada and Europe. The panel concluded that silicone breast implants do not cause cancer, connective tissue disorders, or autoimmune diseases like lupus or rheumatoid arthritis. 10-14 Also, no new diseases were discovered among the studies that would be specifically related to silicon exposure. And, breast milk of women with breast implants was analyzed and found to be perfectly safe for babies. Silicon is found in human breast milk, but at much lower levels than silicon found in cow's milk or even baby formula. No increased level of silicon was found in the bloodstream of pregnant women with silicone implants. Additionally, there was no increase in the number of birth defects after silicone breast implantation.

Studies by Modern Implant Manufactures

There are two major implant manufacturers operating in the United States. These companies have submitted their results of studies regarding silicone implants to the FDA for pre-market approval of their products. These studies demonstrate that silicone implants are comparable to saline implants in rupture rate and safety.15

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