Roux-en-Y gastric bypass (RYGB) is a popular surgical procedure to
treat morbid obesity [1]. StomaphyX (endoGastric
Solutions Inc., Redmond, Washington, USA) is designed for incisionless
transoral endoscopic plication and revision of the gastric pouch (EPRGP) in
case of pouch dilation with weight gain [2]
[3]. Nonresorbable polypropylene fasteners create
full-thickness plications of the pouch wall, reducing its volume. StomaphyX was
cleared by the Food and Drug Administration (FDA) in April 2007
[4] and clinical results are becoming available, with
only 3 % early complications [5].
We present the case of a 38-year-old woman who underwent StomaphyX
EPRGP in 2007, after RYGB in 2000. The procedure was carried out in a
peripheral hospital by a surgeon and was not planned within the regulations
governing ongoing clinical trials. After 3 days, the patient was referred to
our hospital with fever and thoracic pain. Thoracic X-ray showed left lung
empyema ([Fig. 1]). Antibiotics were started and
she underwent two thoracic surgical procedures to drain the left hemithorax and
to remove the pleural membranes ([Fig. 2]). Upper
gastrointestinal endoscopy showed three StomaphyX fasteners through the distal
oesophageal wall and a dilated gastric pouch with another three fasteners
around the gastrojejunostomy ([Fig. 3]). Because
of persistent empyema, a third draining thoracotomy was carried out 14 days
later, which revealed adhesions at the distal esophagus. Streptococcus viridans and non-aureus Staphylococcus were cultured and antibiotics started.
After a 28-day stay in the hospital, the patient was fit enough to be
discharged. At present, 4 years after the complicated StomaphyX procedure, the
patient is still under treatment for postoperative neuralgic pain of the left
hemithorax. She was not covered by a clinical trial insurance. This case report
illustrates the risk of serious complications of StomaphyX and the ethical
implications of using new devices outside the control of regulated clinical
trials.
Fig. 1 Chest X-ray showing left
lung empyema with a thoracic drain.
Fig. 2 Thoracic computed
tomography (CT) scan showing empyema and mediastinitis with a surgical thoracic
drain.
Fig. 3 Endoscopic image of the
gastric pouch showing inadequate placement of fasteners around the
gastrojejunostomy.
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