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General| Product Type | Breast Implant |
|---|---|
| Material | Silicone |
| Shell Surface | Smooth or Textured |
| Filling | Silicone Gel |
| Shape | Round or Anatomical |
| Manufacturer | Allergan |
| Device Type | Implantable medical device |
Details on the physical attributes and construction of Natrelle implants.
Conditions and reasons for which Natrelle implants are recommended.
Situations or conditions where Natrelle implants should not be used.
Potential failure modes of implants leading to gel leakage or volume loss.
Formation of scar tissue around the implant causing firmness or pain.
Risks and signs of infection associated with breast implants.
Tissue death that may occur, requiring surgical intervention.
Collection of blood or fluid around the implant, potentially needing surgery.
Body's response to implant material, possibly causing inflammation.
The implant becoming visible or protruding through the skin.
Potential causes and management of pain post-implantation.
Prohibition of using non-approved or contaminated filling materials.
Risk of insufficient skin coverage after tissue expansion.
Potential for implant shape distortion during insertion or handling.
Guidelines for surgeons on implant selection and surgical technique.
Procedures and considerations for correctly positioning implants.
Specific steps for placing and filling the Natrelle 150 implant.
Procedure for filling the expandable mammary implant.
Method for filling and managing saline implants with a diaphragm valve.
Correct procedure for inserting the fill tube into the implant valve.
Aseptic technique for inflating the implant with saline.
Guide for using tissue expanders with integrated injection sites.
Correct placement procedure for Natrelle tissue expanders.
Using the MAGNA-FINDER™ to locate the injection site.
Procedure for filling Natrelle tissue expanders.
