Reports that serious patient injuries and death can be caused by improper injection procedures, Boston Scientific Corporation has recalled all ENTERYX® Procedure Kits and ENTERYX® Single Pack Injectors.
Prescribed for gastroesophageal reflux disease (GERD), ENTERYX® is injected by a physician into the inside muscle wall of the patient’s esophagus.
The liquid then thickens into a sponge-like substance helping to block stomach acids and prevent them from entering the esophagus and throat.
There have been reports that in rare cases, physicians may have mistakenly injected the drug into areas close to the esophagus, including other vital organs, resulting in serious health complications for the patient, including reduced kidney function, internal bleeding, and even death.
Despite extreme care by doctors to avoid such incidents, it is difficult to discern whether or not the liquid has been injected improperly.
Patients who have been given an inaccurate injection may experience the following symptoms:
· Pain in the chest or side
· Shortness of breath
· Difficulty swallowing
· Significant weight loss
· “Flu-like” symptoms
Even when ENTERYX® is injected properly, it is still possible that long-term complications will occur.
In at least two of the reported cases, patients experienced some of the above symptoms up to a month and a half after their procedure and even though ENTERYX® was injected properly.
The FDA advised patients who have had the ENTERYX® procedure within the last seven weeks, to contact their physicians immediately in the event that they experience any of the above symptoms, even if they have already been treated in the emergency room.
Doctors may order a follow-up procedure to confirm or rule out improper injection of the ENTERYX® product.
FDA and Boston Scientific are working to make sure that physicians treating patients with ENTERYX® products 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.