COOK Medical Biodesign Instrucciones De Uso página 3

BIODESIGN® NIPPLE RECONSTRUCTION CYLINDER
DESCRIPTION
The Biodesign® Nipple Reconstruction Cylinder is a rolled cylinder of
extracellular collagen matrix derived from porcine small intestinal submucosa.
The Biodesign® Nipple Reconstruction Cylinder is implanted by a trained
physician to support weakened soft tissue during surgery of the nipple. The
template provides the physician with suggested surgical flap designs to
correspond with each cylinder size. The nipple shield provides the patient
with post-operative protection of the reconstructed nipple.
INTENDED USE
The Biodesign® Nipple Reconstruction Cylinder is intended for implantation
to reinforce soft tissue, where weakness exists, in plastic and reconstructive
surgery of the nipple. The cylinder is supplied sterile and is intended for
one-time use.
Rx ONLY
This symbol means the following:
CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the
order of a physician.
NIPPLE RECONSTRUCTION CYLINDER
Reconstruction Cylinder
This product is intended for use by trained medical professionals.
CONTRAINDICATIONS
• The cylinder is derived from a porcine source and should not be used in
patients with known sensitivity to porcine material.
• The cylinder should not be used in patients with thin or irradiated skin
who do not have pectoralis fascia.
PRECAUTIONS
• This device is designed for single use only. Attempts to reprocess,
resterilize, and/or reuse may lead to device failure and/or transmission of
disease.
• The cylinder is not for vascular use.
• Do not resterilize. Discard all open and unused portions of the cylinder.
• The cylinder is sterile if the package is dry, unopened and undamaged. Do
not use if the package seal is broken.
• Discard the cylinder if mishandling has caused possible damage or
contamination, or if the cylinder is past its expiration date.
• Users should be familiar with the surgical technique for nipple
reconstruction.
• Ensure that the cylinder is rehydrated prior to implanting.
• The cylinder should be placed in maximum possible contact with healthy,
well-vascularized tissue to encourage cellular in-growth and tissue
remodeling.
• The cylinder should not be implanted in infected or potentially infected
tissue beds, or over open cavities, because infection, migration, or
extrusion may result.
• Compromised patients (such as those with autoimmune disease, diabetes,
or undergoing chemotherapy or radiation therapy) may not experience
normal wound healing.
• Extended rehydration or excessive handling could lead to partial
delamination of the cylinder.
• Excessive internal pressure within the reconstructed nipple may increase
the risk of extrusion, ischemia, or premature flattening.
• Trimming the cylinder to a length less than 1.0 cm may reduce long-term
projection.
• No studies have been conducted to evaluate the performance of the
cylinder in patients who are pregnant, may become pregnant, or are breast
feeding.
• For irradiated patients, consider waiting to implant the cylinder for at least
6 months following their final treatment.
• Smokers should abstain from smoking for at least 6 weeks prior to
cylinder implantation and should remain smoke free for 6 to 8 weeks after
implantation.
• Tissue at the implant site should demonstrate an ability to elastically recoil
before implanting the cylinder. Ensure preoperatively that the patient
has adequate skin elasticity by performing a pinch test and watching for
elastic recoil.
• Timing of tattoo placement, quality of tattooing instruments, and
tattooing technique can affect nipple projection.
• Failure to wear the nipple shield according to post-op care guidelines may
increase the risk of projection loss.
• Selecting an improper flap size can compromise long-term nipple
reconstruction success. The product kit contains a flap template with sizing
options that can be consulted as a general guideline for use with different
sized cylinders.
This symbol means the following: Nipple
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ENGLISH