Only Two Types of Breast Implants Carry FDA Approval

Last Updated: December 05, 2012

Even with the widespread popularity of breast implant surgery, there are still many real and cautionary stories told about implant leakage that necessitates removal of the devices and poses tangible health risks to the patient. It is important, therefore, to understand what kind of material is being put in your body and whether or not it is, indeed, a safe and regulated product.

What are the Two FDA Approved Types of Breast Implants?

The Food and Drug Administration (FDA) has approved two types of breast implants for use with patients in the United States: saline-filled breast implants and silicone gel-filled breast implants. The outer shell of each is made with silicone, but the form factor, in terms of size, thickness of the shell, and contour depend on the manufacturer and the purpose of the surgery.

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There are two types of breast implants approved for sale in the United States: saline-filled and silicone gel-filled. Both types have a silicone outer shell. They vary in size, shell thickness, and shape.

While often regarded as a vanity procedure, it is also important to remember that many implant surgeries are reconstructive in nature following mastectomies in breast cancer patients. These individuals are even more aware and cautious of introducing foreign substances into their systems.

The current use of saline versus gel-filled implants is roughly 50/50 in the United States. Extensive information about studies with and testing of these implants is available on the the FDA website at fda.gov

The information on the page includes the regulatory history of breast implants in the U.S. and how labeling should be handled for properly approved implants. Currently no other materials have been approved by the FDA for filler in implants and thus cannot be considered safe.

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