Safety Issues

Endoscopic devices to treat GERD have been associated with complications. Postmarketing surveillance data was obtained on 1,200 patients undergoing Stretta RF treatment (Zagorodnyuk et al, 2001). A total of 15 significant com plications occurred in the first 6 months after FDA approval. These complications included five esophageal perforations and two deaths. The number of complications following Stretta RF procedure may have decreased, but there continues to be morbidity associated with this endoscopic GERD therapy. A 2002 report of 118 patients who were treated with the Stretta procedure recorded 13 patients with chest distress for 2 to 5 days, 7 patients with mild transient unobstructive dysphagia, and 2 patients with delayed bleeding (1 to 3 weeks) who did not require transfusions. The morbidity rate in this study was 1.7% (Noar et al, 2002).

The EndoCinch procedure is also associated with morbidity. In the 1-year EndoCinch study, "minor" adverse effects of sore throat, vomiting, abdominal pain, chest soreness, dysphagia, and bloating, described as "transient" and resolving spontaneously within 72 hours, were reported. Two patients had significant postprocedure bleeding and one of the patients required transfusion. A "gastric mucosal tear" was observed in one patient (Mahmood et al, 2003).

The Enteryx procedure can cause significant morbidity. In the report on 85 patients treated by injection therapy, 92% experienced retrosternal pain (rated as "mild to moderate") that resolved in 2 weeks requiring prescribed analgesics in 70% of patients. Dysphagia occurred in 17 patients and lasted for 2 to 12 weeks. Ten patients experienced low grade fever for 1 to 3 days. Overall, the rate of adverse effects was 34% in this series of Enteryx-treated GERD patients (Johnson et al, 2003).

A pharyngeal perforation related to introduction of the overtube was reported in the Gatekeeper study while chronic nausea prompted the endoscopic removal of the prostheses after 3 weeks (Fockens et al, 2003).

The long term complications associated with the current array of endoscopic devices to treat GERD are unknown.

A complete 46-item bibliography is available from [email protected]

Constipation Prescription

Constipation Prescription

Did you ever think feeling angry and irritable could be a symptom of constipation? A horrible fullness and pressing sharp pains against the bladders can’t help but affect your mood. Sometimes you just want everyone to leave you alone and sleep to escape the pain. It is virtually impossible to be constipated and keep a sunny disposition. Follow the steps in this guide to alleviate constipation and lead a happier healthy life.

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