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DISCOMFORTS AND RISKS
Potential discomforts and risks, originating from the surgical procedure or the TIES device itself.
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Redness at the operation site
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Pain
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Allergic reaction (including to medications, anaesthesia or device materials)
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Infection
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Device misplacement or migration
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Enterocutaneous fistula
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Perforation of the intestine during insertion of ileum through implant
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Contamination of implant with intestinal content during surgery
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Narrow passage or constipation caused by irritated or swollen intestine
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External violence -skin or body injuries caused by the protruding part of the implant getting
caught or by violent accidents
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In patients with Crohn’s disease or determined colitis, there is a risk of recurrence. However, this
risk is in line with the one patients with conventional ileostomies face. A recurrence may cause
a partial or complete obstruction of the implant. The implant may have to be removed. Should a
recurrence of Crohn’s disease occur it is not advised to replace the implant. It should be removed
and a conventional ileostomy should be done.
SURGICAL AND DEVICE RISKS
FUNCTIONAL RISKS
REMEDIES IN CASE OF LEAKAGE
Potential discomforts and risks regarding the functional performance of the device related to the embedding
of the implant into the soft tissue of the abdomen during the healing period after surgery.
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Leakage of intestinal liquid between the device and the skin due to
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Ileum retraction
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Too early use of Lid
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Trauma
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Other factors
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Insufficient ingrowth of soft tissue into the device to ensure a leak-free system
Should the system show incomplete ingrowth inside or outside or being harmed in a way or another over
time, it should be “put to rest”. The usage of the Lid should be stopped for a few weeks to give the biological
system time to adjust to the situation and come to a new balance; the ingrowth of the skin and the intestine
tends to adjust by itself.
MANUFACTURER
ADDRESS
