- Branża: Government
- Number of terms: 2516
- Number of blossaries: 0
- Company Profile:
The FDA is responsible for pprotecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, the US food supply, cosmetics, dietary supplements, and products that give off radiation.
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.
Industry:Beauty
Not approved, in general terms. For breast implants, this means not PMA-approved.
Industry:Beauty
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.
Industry:Beauty
Application for marketing a device. FDA must approve the PMA for the device to be sold on the market in the U. S.
Industry:Beauty
Rupture of silicone gel-filled breast implant in which the silicone gel is outside of the fibrous scar capsule that forms around the implant.
Industry:Beauty
An increase or a decrease in the sensation in the nipple or breast. This change can vary in degree and may be temporary or permanent. It may affect comfort while nursing or sexual response.
Industry:Beauty
An increase or a decrease in the sensation in the nipple or breast. This change can vary in degree and may be temporary or permanent. It may affect comfort while nursing or sexual response.
Industry:Beauty
