Potential Complications; Required Materials - COOK Medical Biodesign Instrucciones De Uso

POTENTIAL COMPLICATIONS

Complications that can occur during nipple reconstruction include, but are
not limited to:
• Inflammation
• Seroma formation
• Paresthesia
• Localized necrosis
• Induration
• Excessive bleeding
If any of the following conditions occur and cannot be resolved, cylinder
removal should be considered:
• Infection
• Acute or chronic inflammation (initial application of surgical graft materials
may be associated with transient, mild, localized inflammation)
• Allergic reaction
STORAGE
The cylinder, nipple shield, and flap template should be stored in a clean, dry
location at room temperature.
STERILIZATION
The cylinder, nipple shield, and flap template have been sterilized with
ethylene oxide.
INSTRUCTIONS FOR USE
These recommendations are designed to serve only as a general guideline.
They are not intended to supersede the institutional protocols or professional
clinical judgment concerning patient care.
NOTE: Always handle the cylinder using aseptic technique, minimizing
contact with latex gloves.

REQUIRED MATERIALS

• A sterile dish (kidney dish or other bowl)
• Sterile forceps
• Rehydration fluid: room temperature sterile saline or sterile lactated
Ringer's solution
• Surgical marker or pen (3mm tip or smaller)
PROCEDURE
1. Determine the proper cylinder diameter (A):
a. If a contralateral nipple is present, measure its diameter to determine
the cylinder size that most closely matches, taking into account post-
operative contraction and tissue thickness.
b. If a contralateral nipple is not present, the following factors should be
considered when determining the proper cylinder diameter: overall size
of the reconstructed breast, presence or absence of a well-vascularized
skin flap, thickness of skin flap(s), and/or the patient's desired final
appearance.
2. Aseptically prepare the patient and surgical site.
3. Aseptically remove all components from their pouches and place them
in the sterile field. Avoid dumping any component out of its pouch as it
may bounce out of the sterile field. Discard any component that falls out
of the sterile field.
4. Obtain the flap template and place it on the breast mound at the site of
the intended reconstruction.
5. Choose a flap stencil that corresponds to the desired level of projection
and does not exceed the length of the cylinder provided in the kit.
Position the flap stencil at the desired location while looking through the
template as it rests on the breast mound.
6. Position the flap to optimize the blood supply. For best outcomes, orient
the pedicle (blood supply) of the flap away from the mastectomy scar
line. If possible, position the flap to avoid intersecting the scar line.
7. Using a fine-tipped surgical marker and the selected stencil, trace the
edge of the flap pattern from the stencil onto the patient's breast mound
to guide the creation of the skin flap.
NOTE: If the surgeon's preference is to use a flap not included on the
template, ensure:
• The flap is drawn large enough to create a silo for the selected cylinder
without having to stretch the flap.
• The flap is drawn to avoid additional trimming of the flap.
• The flap is drawn to maintain a good blood supply. If possible, orient the
pedicle (blood supply) of the flap away from the mastectomy scar line.
8. Dissect along the nipple flap pattern to create a free-moving skin
flap. Ensure that bleeding is observed from the flap. In patients with
insufficient subcutaneous tissue (<5mm), pectoralis muscle fascia can be
mobilized if there is adequate underlying muscle to provide blood supply
and support.
9. Grasp the nipple flap by the flap cover and raise the entire flap until it is
completely free of the donor site except at the pedicle (blood supply), as
shown in Figure 1A.
• Migration
• Hematoma
• Infection
• Epidermolysis
• Implant Exposure
• Insufficient or excessive augmentation
4
• Extrusion
• Numbness
• Tissue Ischemia
• Discoloration
• Wound dehiscence