Clinical surgery–AmericanEmerging endoluminal therapies for gastroesophageal reflux disease: adverse events
Section snippets
Materials and Methods
The Manufacturer and User Facility Device Experience (MAUDE) Database from the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health Web site was used for this study [13]. This database consists of all user facility reports, voluntary reports, distributor reports, and manufacturer reports. The search was performed in April of 2005.
The MAUDE database was searched to examine all adverse events reported for the 4 specific emerging endoluminal therapies listed in
Results
There were a total of 50 adverse events reported for the 4 therapies. Half of the complications were found in the injection-based therapy. Table 2 lists the complications and classifies them as major or minor.
There were 8 deaths reported (3 in the radiofrequency ablation–based group and 5 in the injection-based group). Most (64%) of these adverse events resulted in hospitalizations and 10% of these patients required surgery. Postprocedure hemorrhage required 2 patients to receive a transfusion
Conclusions
These data show that adverse events do occur after endoluminal therapies for GERD; both major complications and death have occurred with these devices. Unfortunately, a true incidence of these complications is not calculated from these numbers. The denominator is difficult to obtain because even the manufacturers usually only keep sales data and not necessarily patient-use data. It has been estimated that approximately 3150 EndoCinch (C. R. Bard, Inc., Billerica, MA), 6000 Stretta, and 1700
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