Silicone Breast Implants

Helping consumers learn about breast augmentation and find the best breast augmentation surgeons.

Breast Augmentation Surgery

Are you facing surgery? You are not alone. Millions of Americans have breast augmentation surgery each year. Most operations are not emergencies. This means you have time to ask your breast augmentation surgeon questions about the operation and time to decide whether to have it,. The information does not apply to emergency surgery.

What is are Silicone Breast Implants?
The three types of silicone gel-filled breast implants are as follows:

One type is a single lumen implant that is prefilled by the manufacturer with a fixed volume of silicone gel.

A second type is a double lumen implant with (1) an inner lumen prefilled by the manufacturer with a fixed volume of silicone gel and (2) an outer lumen that is filled during the operation with a fixed volume of saline through a valve.

A third type is a double lumen implant with (1) an outer lumen prefilled by the manufacturer with a fixed volume of silicone gel and (2) an inner lumen that is filled during the operation with saline through a valve. This type of implant allows for adjustments of the saline volume after the operation.

A silicone gel-filled breast implant has a silicone rubber shell with the same general composition as shown in the Saline-Filled Breast Implants section above.

The filler is silicone gel that has the general composition of:

silicone oil
cured polymeric (large) silicones
small amounts of uncured large and smaller silicones
minute amounts (parts per million) of metals, including a metal catalyst (usually platinum). (A catalyst is something that causes a change in material.)

Prior to 1991, silicone gel-filled breast implants were sold on the market as either preamendments devices (they were on the market prior to May 1976) or as 510(k)-cleared devices. In April 1991, FDA issued a regulation that required that all silicone gel-filled breast implants be PMA-approved to be sold on the market. However, those companies that had a preamendments or 510(k)-cleared silicone gel-filled breast implants and submitted their PMA within 90 days of the April 1991 regulation were allowed to keep their device on the market until the final decision/actions were made in April 1992. Since April 1992, a silicone gel-filled breast implant must be PMA-approved to be sold on the market.

As of the date of this handbook, no company has PMA approval for a silicone gel-filled breast implant. Therefore, all silicone gel-filled breast implants are considered investigational. For a woman to receive a silicone gel-filled breast implant in the U.S., she must enroll in an IDE study or an adjunct study.

An adjunct study is different from the IDE study in terms of its purpose and study design. In April 1992, FDA determined that the silicone gel-filled breast implant PMAs submitted in 1991 did not include adequate safety data to support PMA approval. However, FDA believed that there was a public health need to have breast implants available for reconstruction and revision patients. Therefore, companies that had not withdrawn their PMAs prior to the April 1992 decision were given the opportunity to submit an adjunct study protocol, for FDA approval, to address the public health need. Only Mentor Corporation and Inamed Corporation received approvals for their adjunct studies.

Adjunct studies are limited to reconstruction and revision patients. Women who want silicone gel-filled implants for augmentation (cosmetic reasons) cannot be enrolled in an adjunct study. New reconstruction and revision patients are continuously being enrolled in the adjunct studies because there is no limit on the number of patients or the number of sites. Each woman who participates in an adjunct study must give informed consent.5 The safety data collected in an adjunct study are used as supplemental data to support a future PMA.

Additional Liposuction Research:

Breast Augmentation Information

If you or a loved one are thinking about having breast augmentation, you need to speak with an experienced doctor or surgeon as soon as posisble. You probably have alot of questions, and chances are you may be nervous or afraid. Good breast augmentation surgeons in your area can help relieve this anxiety and stress.

Disclaimer: The breast augmentation surgery and all other information presented on this website should not be construed to be formal medical advice, nor the formation of a doctor or surgeon client relationship. The information is not intended in any way to be, or replace, in person medical advice offered by a doctor, breast augmentation surgeon, or other healthcare professional. Please contact a doctor, surgeon, specialist, or other healthcare professional for a breast augmentation consultation This web site is not intended to solicit clients.