- Industry: 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.
Includes cosmetic uses, such as to increase breast size or for ptosis (sagging or drooping of the breast) or asymmetry. Augmentation is one of three indications (clinical uses) for breast implants.
Industry:Beauty
Rupture of silicone gel-filled breast implant in which the silicone gel remains contained within the fibrous capsule.
Industry:Beauty
Damage to the tissue or implant due to surgical instruments either during the operation, during a reoperation, during implant removal, or during breast procedures while the implant is in place (e.g., cyst aspiration or hematoma drainage).
Industry:Beauty
Rare, but life-threatening bacterial infection that may occur after surgery. Symptoms include sudden fever, vomiting, diarrhea, fainting, dizziness, and sunburn-like rash. A doctor should be seen immediately for diagnosis and treatment if toxic shock syndrome is suspected.
Industry:Beauty
Application for marketing a device. In the past, breast implants were reviewed under the 510(k) process. However, they are now reviewed under the PMA process.
Industry:Beauty
Patient or doctor is not satisfied with the overall look based on the style or size of implant used.
Industry:Beauty
