6
NOTE: The strap closure protects the valve after implantation, and the valve
must be properly closed first to prevent leakage.
NATRELLE
®
133 TISSUE EXPANDERS
TECHNIQUE FOR USING NATRELLE
®
TISSUE EXPANDERS
WITH MAGNA-SITE™ INTEGRATED INJECTION SITES
Natrelle
®
133 tissue expanders are temporary devices, and are not intended to
be used for permanent implantation. Tissue expanders should be removed once
adequate tissue has developed. Tissue expansion in breast reconstruction typically
requires four to six months. The total expansion period will vary depending on
patient tolerance and desired flap size.
1. Natrelle
®
Tissue Expander Placement
Ensure incision is sufficiently large to facilitate insertion and avoid damage
to the device. Inadequate pocket dissection increases the risk of deflation and
tissue expander malposition. If the pocket is too small, the tissue expander
may not have adequate room to unfold, increasing the risk of tissue erosion.
Place the tissue expander flat end in the exact desired location, as the
BIOCELL™ textured surface promotes tissue adherence to help immobilise the
device. The MAGNA-SITE™ should be situated anteriorly, adjacent to the skin
surface.
2. MAGNA-SITE™ Location
The MAGNA-FINDER™ is designed to assist with the location of the
MAGNA-SITE™ injection site. While the injection site can be generally
identified by palpation, always verify the location and orientation of the
injection site with the MAGNA-FINDER™, as described below, before each
filling.
a) DO NOT store or use the MAGNA-FINDER™ near any loose metal
particles, as they may attach themselves to the magnet.
b) Be sure the magnet inside the MAGNA-FINDER™ moves freely without
obstruction.
c) Place the MAGNA-FINDER™ on the tissue overlying the implanted
MAGNA-SITE™ contained in the
Natrelle
®
133 tissue expander.
d) Following the direction of the arrow on the device, slowly move the base of
the MAGNA-FINDER™ back and forth over the tissue surface, as shown in
Figure 7. The magnet of the MAGNA-FINDER™ will indicate the location
of the injection site on one plane.
e) When the magnet on the MAGNA-FINDER™ is perpendicular to the base
of the MAGNA-FINDER™, mark the tissue with a surgical marker at the
two notches on the base of the MAGNA-FINDER™. The line between these
two marks indicates location of one plane, as shown in Figure 8. The
MAGNA-SITE™ will be at one point along this plane.
f) To determine the exact location of the MAGNA-SITE™, turn the MAGNA-
FINDER™ 90° and again, slowly move the MAGNA-FINDER™ back and
forth. When the magnet locator is again perpendicular, make two more
marks, as shown in Figure 9.
g) Repeat this location process on several different axes to ensure the precise
location of the injection site. The point at which all the marked lines
intersect is the location of the MAGNA-SITE™. DO NOT re-sterilise or
re-use the MAGNA-FINDER™.
3. Natrelle® Tissue Expander Filling
If the incision site is remote from the site of expansion, the tissue expander
may be filled to tissue tolerance at the time of surgery. If the incision site is
not remote from 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.
a) Insert a new, sterile 21-gauge (or smaller) standard 12° bevel hypodermic
needle into injection site. Ideally, the needle should enter perpendicular to
the top of the injection site as shown in Figure 10.
DO NOT penetrate the injection site at an angle.
b) Penetrate the injection site until the needle is stopped by the needle guard.
c) Fill the tissue expander only with sterile saline for injection, and only
through the injection site after precise location of the MAGNA-SITE™
with the MAGNA-FINDER™. Fill carefully to a volume within the
recommended fill range specified on the device package labelling and only
to patient and tissue tolerance. The suggested fill volume is located on the
patch of the tissue expander and is also listed on the device data sheet.
Filling is typically performed at weekly intervals. A
Natrelle
®
Expander Fill
Volume Record is provided with each device for recording fill volumes and
monitoring the expansion process (see back of this book).
INSTRUCTIONS AND PRECAUTIONS FOR REMOVAL
In case that removal of the product is necessary, the device should be removed
from the patient without harming or breaking the outer shell of the product, if
possible. If breakage of the outer shell occurs in an expander or implant filled
with saline solution, no further action needs to be taken. If the outer shell of a
silicone gel-filled implant is harmed or broken, all remnants of the silicone gel
filling that might have exited the device must be removed from the patient’s body
mechanically or washed out. The wound and former implant pocket should then
FIGURE 7
FIGURE 8
FIGURE 9
FIGURE 10
Injection site
Release Date: 29 Sep 2015 00:07:57 GMT -07:00
Expires one day from 21 Dec 2015
Effective