Procedures

silicone breast implants

There are different filler types available in different types of implants. For many years, breast augmentation patients could choose between saline or silicone filled implants. A third option, the soy oil filled Trilucent implant, was available between 1995 and 1999, but was pulled off the shelves due to safety concerns.

In 1992 the FDA banned silicone implants for cosmetic purposes due to the unacceptable rate of illness and injury suffered by patients with silicone implants. These implants had a high rate of rupture, leakage, and other local complication. There was also significant concern about the risk of developing immune related diseases as a result of silicone implants.

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Implant Studies

Several studies were conducted after the silicone implant ban to determine the long and short term safety of both saline and silicone breast implants. A few large studies were conducted to investigate the risk of developing connective tissue disorders from silicone implants. While these studies found no correlation between connective tissue diseases and silicone implants, they have been criticized as being too limited in scope to determine the true risk. The risk of immune diseases from silicone implants remains unknown.

Rupture rates, silicone migration, capsular contracture, infection, and other local complications associated with silicone implants were also studied at this time. In 1995, medical testimony submitted to the FDA showed that rupture rates can be as high as 51 percent and that this risk increases as the implant ages. Studies have not produced any conclusive evidence about the risk of cancer associated with either type of implant filler.

It is generally accepted that silicone implants have a higher rate of capsular contracture and rupture than saline implants. Capsular contracture occurs when the scar around the implant squeezes and hardens the breast. Rupture is particularly dangerous with silicone implants because is it not always immediately noticeable, whereas saline ruptures are easily recognized. Silicone implants are also more difficult to replace than saline implants.

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Saline Implants
Saline implants may carry some of the risks associated with silicone implants but have been allowed to remain on the market. Saline implants have a silicone rubber shell and are available with fixed or adjustable volumes. Saline implants are considered easier to replace when replacement is desired or necessary than their silicone gel counterparts.

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Cohesive Silicone Implants
In 2003, two major implant manufacturers began to solicit the FDA for approval of cohesive silicone breast implants which have fallen under the silicone implant ban for over a decade. These manufacturers argue their new products are safe and do not pose the same risks associated with traditional silicone implants.

Mentor received conditional approval of their cohesive silicone gel implants in July 2005 and Inamed Corporation continues to seek the approval of their silicone implants. Because no study has examined the long term safety of these new implants, it is not possible to know the benefits and drawbacks of these silicone implants.