Breast implant

Breast implant

A prosthesis used to alter the size, shape, and feel of a woman’s breasts for aesthetic enhancement.

Industry: Beauty

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Breast implant

Extracapsular rupture

Beauty; Breast implant

Rupture of silicone gel-filled breast implant in which the silicone gel is outside of the fibrous scar capsule that forms around the implant.

Premarket approval (PMA)

Beauty; Breast implant

Application for marketing a device. FDA must approve the PMA for the device to be sold on the market in the U. S.

Extrusion

Beauty; Breast implant

Skin breakdown with the implant appearing through the skin.

Prospective study

Beauty; Breast implant

Study in which people are exposed to a medical intervention, such as breast implants, and then observed over time to determine how effective and safe the intervention is. The outcome is not known ...

Capsular contracture

Beauty; Breast implant

Scar tissue or capsule that normally forms around the implant, which tightens or squeezes the implant. There are four grades of capsular contracture ranging from grade I (breast is normally soft ...

Adjunct study

Beauty; Breast implant

Clinical study for silicone gel-filled breast implant to address a public health need for reconstruction and revision patients. The status of the implants in an adjunct study is investigational.

Calcification

Beauty; Breast implant

Hard lumps under the skin around the implant. These can be mistaken for cancer during mammography, resulting in additional surgery, either to biopsy the lumps or to remove the implant.