User's Manual

Indications, Contraindications, Warnings, Cautions
Benefits and Risks—PillCam Capsule Endoscopy 9
• PillCam capsule endoscopy offers a simple, safe and non-invasive alternative to traditional
imaging procedures.
• The PillCam patency capsule provides a simple and convenient means to verify functional patency
of the GI tract in patients with known or suspected strictures.
Risks
• A normal or negative capsule endoscopy examination does not exclude the possibility of colon
polyps or colon cancer.
• PillCam capsule endoscopy is not for everyone. PillCam video capsules are contraindicated in
patients with known or suspected gastrointestinal obstruction, strictures or fistulas, in patients with
cardiac pacemakers or other implantable electromedical devices and in patients with swallowing
disorders.
• Capsule retention has been reported in less than two percent of all capsule endoscopy and patency
procedures. Capsule retention is defined as having a capsule remain in the digestive tract for more
than two weeks.
• Causes of retention cited in the literature include: NSAID strictures, Crohn's disease, small bowel
tumors, intestinal adhesions, ulcerations, and radiation enteritis. Summaries in published literature
identify the overall risk of retention for capsule endoscopy to be 1.4%. The risk of retention for
obscure bleeding is estimated to be 1.2%, for suspected Crohn's disease to be 2.6%, for known
Crohn's the risk is higher at 5% and for neoplastic lesions the rate of retention is 2.1% as compared
to healthy volunteers [1]. To verify passage of the capsule from the GI tract, an abdominal X-ray
may be obtained at the discretion of the physician. The capsule can be removed using medical,
endoscopic or surgical intervention.
• There is an extremely rare risk of capsule aspiration while patients are attempting to swallow a
PillCam video capsule or Patency capsule.
• There is also a low risk of skin irritation from the sensor array sleeve adhesive or silicone exposure.
• The PillCam SB video capsule may be administered by using transendoscopic delivery in patients
who are either unable to ingest the capsule or are known to have slow gastric emptying time. If
using transendoscopic delivery potential complications include, but are not limited to: perforation,
hemorrhage, aspiration, fever, infection, hypertension, respiratory arrest, cardiac arrhythmia or
arrest, due to the transendoscopic procedure.
• PillCam patency capsules are contraindicated in patients with swallowing disorders. The PillCam
patency scanner is contraindicated in patients with cardiac pacemakers or other implanted
electromedical devices.
• All medical procedures carry some risks. Information on this site should not be used as a substitute
for talking with your doctor about diagnosis and treatment.
References:
[1] Liao et al., Indications and detection, completion, and retention rates of small-bowel capsule
endoscopy: a systematic review, Gastrointestinal Endoscopy, 2010; 71:280-286