5
remote valve pocket should be generally positioned lateral (not inferior)
to the Breast in the mid-axillary line. Subcutaneous sutures may be used
to maintain the position of the pocket.
c) Ensure that the injection site connector tubing is not kinked, as this may
restrict fluid flow during expansion.
2. Remote Injection Site Preparation
Always verify the location and orientation of the injection site prior to filling.
Ensure that the base of the injection site is properly oriented for needle entry.
3. Expandable Mammary Implant Filling
If the incision site is remote from and radial to the site of the expansion, the
internal bladder of the expandable implant may be filled to tissue tolerance
at the time of surgery.
If the incision site is not remote from, and radial to, the site of expansion,
the wound should be stable before tissue expansion begins. However, a slight
amount of inflation to fill the pocket space without tension to the tissue may
be possible initially. Ensure that the expander/implant can be percutaneously
filled and that there is no kink in the tube.
a) Insert a new, sterile, 21-gauge needle (or smaller) into the injection site.
Ideally, the needle should enter perpendicularly to the top of the injection
site as shown in Figure 3.
b) Penetrate the injection site until the needle is stopped by the needle
guard, as shown in Figure 4.
c) Air Aspiration: Initially remove as much air as possible. Fill the implant
with 50cm
3
sterile saline for injection, and then remove all remaining air.
d) Fill the implant only with sterile saline for injection and only through the
injection site. Fill carefully and only to patient and tissue tolerance.
DO NOT underfill or overfill the implant beyond the range specified.
Filling is typically performed at weekly intervals. A Patient Fill Volume
Record card is provided with each implant for recording fill volumes and
monitoring the expansion process (see back of this book).
NOTE: The suggested total fill volume is listed on the product labelling.
4. Removal of Remote Injection Site
After satisfactory tissue expansion, the remote injection port may be
removed and the remaining fill tube sealed using the Fill Tube Plug Kit,
available separately.
SALINE IMPLANTS
TECHNIQUE FOR USING IMPLANTS WITH DIAPHRAGM
VALVE
1. Fill tube insertion
Holding the implant, push the secondary strap closure to one side of the valve
entrance. Figure 5 shows the secondary closure in place and diaphragm valve
seal closed.
Wet the tip of the fill tube in sterile saline for injection. Insert the fill tube by
gently pushing the tip into the valve entrance as far as the tube flange permits.
Figure 6 shows the diaphragm valve held open by the fill tube, for filling or
emptying.
When the flange on the fill tube meets the periphery of the valve with a snap,
the tube is in position for filling.
2. Air aspiration
After the fill tube is properly inserted, remove any air from the implant by
aspiration with an empty sterile syringe attached to the fill tube.
3. Placement
Ensure incision is sufficiently large (particularly for textured implants)
to facilitate insertion and avoid damage to the device. Inadequate pocket
dissection increases the risk of deflation and implant malposition.
4. Filling
Use aseptic technique when adding/removing sterile saline, to prevent risk of
contamination. Using a syringe filled with sterile saline for injection, inflate
the implant. Fill only with sterile saline for injection, and fill to a volume
within the recommended fill range specified on the product package labelling.
DO NOT underfill or overfill the implant beyond the range specified.
5. Residual Air
After filling is completed, aspirate any residual air bubbles. Then use gentle
traction to remove the fill tube from the valve, taking care to avoid damage to
the shell or valve.
6. Diaphragm Valve Closure
Verify that the diaphragm valve is clear of particulates, and sealed. To help
retard tissue ingrowth or fluid accumulation in the valve entrance, engage the
strap closure as follows: using the thumb and forefinger, compress the valve
seat and the strap to snap the valve plug into place as shown in Figure 5.
FIGURE 3
Silicone Injection Dome
RTV Silicone
Adhesive
Reinforced Silicone Base Flange
FIGURE 4
Puncture Proof Titanium
Needle Guard Plate
Reinforced Silicone
Base Flange
Sealing Septum
Silicone Injection Dome
RTV Silicone
Adhesive
Titanium Needle
Guard Cup
FIGURE 5
Secondary Closure
Diaphragm Valve Seal
FIGURE 6
Fill Tube
Diaphragm Valve
Tubing Flange
Strap Closure
Implant Shell
Release Date: 29 Sep 2015 00:07:57 GMT -07:00
Expires one day from 21 Dec 2015
Effective