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United States Food and Drug Administration
行业: 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 performed to collect clinical data on a device to support approval of a marketing application. Approval of an IDE study does not mean approval to market the implant. The status of a device in an IDE study is investigational.
Industry:Beauty
Formation of dead tissue around the implant. Factors associated with increased necrosis include infection, use of steroids in the surgical breast pocket, smoking, chemotherapy/radiation, and excessive heat or cold therapy.
Industry:Beauty
Collection of the watery portion of the blood around the implant or around the incision. Swelling, pain, and bruising may result. While the body absorbs small seromas, large ones will require the placement of surgical drains for proper healing. A small scar can result from surgical draining.
Industry:Beauty
When the implant is placed incorrectly during the initial surgery or when the implant has moved/shifted from its original position. Shifting can be caused by many factors, such as gravity, trauma, poor initial placement, and capsular contracture.
Industry:Beauty
Within the inframammary fold or breast fold.
Industry:Beauty
Collection of blood inside a body cavity. Swelling, pain, and bruising may result. If a hematoma occurs, it will usually be soon after surgery; however, it can also occur at any time after injury to the breast. While the body absorbs small hematomas, large ones may require the placement of surgical drains for proper healing. A small scar can result from surgical draining.
Industry:Beauty
Accumulo di sangue all'interno di una cavità del corpo. Possono insorgere gonfiore, dolore e livido. Se un ematoma di verifica,questo avviene di solito appena dopo l'intervento; comunque possono anche comparire in qualsiasi momento dopo un intervento al seno. Il corpo assorbe gli ematomi minori ma quelli di maggiori dimensioni possono richiedere l'inserimento di drenaggi chirurgici per guarire in maniera adeguata. Una piccola cicatrice può essere provocata dall'applicazione del drenaggio.
Industry:Beauty
Pain in the nipple or breast area.
Industry:Beauty
Can occur with any surgery when wounds are contaminated with micro-organisms such as bacteria or fungi. Most infections resulting from surgery appear within a few days to weeks after the operation. However, infection is possible at any time after surgery. Infections with an implant present are harder to treat than infections in normal body tissues. If an infection does not respond to antibiotics, the implant may have to be removed. Another implant may be placed after the infection is gone.
Industry:Beauty
Rupture of a silicone gel-filled breast implant that happens without a visible change or feel by the woman and is not evident by a physical examination by the doctor.
Industry:Beauty