Advice
for Patients
with ENTERYX® for Gastroesophageal Reflux Disease
Boston Scientific Corporation has recalled all ENTERYX® Procedure Kits
and ENTERYX® Single Pack Injectors, because of reports that improper injection
procedures can lead to serious patient injury and death.
ENTERYX® is used to treat patients with gastroesophageal reflux disease
(GERD). A physician injects the ENTERYX® liquid into the inside muscle
wall of the esophagus, close to where it joins the stomach (i.e., the lower
esophageal sphincter). The liquid then thickens into a sponge-like substance
within the muscle where it helps the sphincter act as a barrier to stomach
acids, preventing the acids from entering the esophagus and eventually the
throat.
The company has received reports that in rare cases, physicians may inadvertently
inject the ENTERYX® liquid into areas close to the esophagus, including
other vital organs. This can result in serious health complications for the
patient, including internal bleeding, reduced kidney function, and death.
Even though doctors monitor patients during and immediately after the procedure
to make sure they inject ENTERYX® in the right location, they may not
detect some cases of improper injection right away.
Symptoms that patients may experience if ENTERYX® is improperly injected
include:
- Pain in the chest or side
- Cough
- Shortness of breath
- Difficulty swallowing
- Significant weight loss
- Fever
- “Flu-like” symptoms
- Fainting
- Weakness
- Fatigue
To date, all known cases of improper injection of ENTERYX® were discovered
within three weeks of the procedure in patients experiencing these symptoms.
It is important for patients to know that even when ENTERYX® is injected
properly, long-term complications are still possible. In at least two cases,
patients experienced some of the above symptoms up to seven weeks after their
procedure, even though ENTERYX® was injected properly.
Advice for Patients
- Go to the nearest emergency room if you experience chest pain or fainting.
- If you have had the ENTERYX® procedure within the last seven weeks,
contact your doctor immediately if you experience any of the following symptoms,
even if you have already been treated in the emergency room:
- Pain in chest or side
- Shortness of breath
- Difficulty swallowing
- Significant weight loss
- Cough
- Fever
- “Flu-like” symptoms
- Fainting
- Weakness
- Fatigue
Your doctor may order a follow-up procedure such as chest x-rays, barium swallows
or chest and abdominal scans to confirm or rule out improper injection of
the ENTERYX® product.
- Continue to see your doctor for regularly-scheduled follow-up appointments,
even if you experience no symptoms.
Your doctor has been notified of the problems associated with ENTERYX®,
and has received specific information about how to monitor patients who have
had this procedure. FDA will continue to monitor reported problems with ENTERYX®,
and we will update this notice as more information becomes available.
FDA and Boston Scientific are working together to see that all physicians are
notified of the reported problems and receive accurate, up-to-date information.
Additional information on this recall is available at http://www.fda.gov/cdrh/safety/101405-enteryx.html.
Updated October 17, 2005
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