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Patient 1
MEDWATCH SENT TO THE FDA. A REVIEW OF THE DEVICE LABELING NOTES THE FOLLOWING: THE CURRENT ORBERA? INTRAGASTRIC BALLOON SYSTEM DIRECTIONS FOR USE (DFU) ADDRESSES THE KNOWN AND ANTICIPATED POTENTIAL EVENT OF "DEFLATION", "NAUSEA", "VOMITING" AND "EARLY REMOVAL" AS FOLLOWS: PRECAUTIONS: ANTIEMETICS, ANTISPASMODIC, AND ANTICHOLINERGIC DRUGS MAY BE PRESCRIBED TO LESSEN THE EARLY PLACEMENT SYMPTOMS SUCH AS NAUSEA, VOMITING, AND ABDOMINAL PAIN. PATIENTS WILL NEED TO IMMEDIATELY CONTACT THEIR PHYSICIAN FOR ANY SEVERE OR UNUSUAL SYMPTOMS. PLACEMENT OF THE BALLOON WITHIN THE STOMACH PRODUCES AN EXPECTED AND PREDICTABLE REACTION CHARACTERIZED MOST COMMONLY BY A FEELING OF HEAVINESS IN THE ABDOMEN, NAUSEA AND VOMITING, GASTROESOPHAGEAL REFLUX, BELCHING, ESOPHAGITIS, HEARTBURN, DIARRHEA AND, AT TIMES, ABDOMINAL, BACK OR EPIGASTRIC PAIN AND CRAMPING. FOOD DIGESTION MAY BE SLOWED DURING THIS ADJUSTMENT PERIOD. THESE SYMPTOMS CAN BE TREATED WITH ANTIEMETIC, ANTISPASMODIC, AND ANTICHOLINERGIC MEDICATIONS. TYPICALLY THE STOMACH ACCLIMATES TO THE PRESENCE OF THE DEVICE WITHIN THE FIRST 2 WEEKS. IN ORDER TO PREVENT OR AMELIORATE THE SYMPTOMS MOST FREQUENTLY EXPERIENCED DURING THE ADJUSTMENT PERIOD, IT IS RECOMMENDED THAT THE PHYSICIAN USE PROTON PUMP INHIBITORS (PPIS), ANTIEMETICS, ANTISPASMODICS, AND ANTICHOLINERGIC MEDICATIONS PROPHYLACTICALLY (BEFORE ORBERA? PLACEMENT). PATIENTS SHOULD BE ADVISED TO IMMEDIATELY CONTACT THEIR PHYSICIAN FOR ANY UNUSUALLY SEVERE OR WORSENING SYMPTOMS. WARNINGS AND PRECAUTIONS: THE RISK OF BALLOON DEFLATION AND INTESTINAL OBSTRUCTION (AND THEREFORE POSSIBLE DEATH RELATED TO INTESTINAL OBSTRUCTION) MAY BE HIGHER WHEN BALLOONS ARE LEFT IN PLACE LONGER THAN 6 MONTHS OR USED AT LARGER VOLUMES (GREATER THAN 700 CC). THE PHYSIOLOGICAL RESPONSE OF THE PATIENT TO THE PRESENCE OF THE ORBERA? SYSTEM BALLOON MAY VARY DEPENDING UPON THE PATIENT'S GENERAL CONDITION AND THE LEVEL AND TYPE OF ACTIVITY. THE TYPES AND FREQUENCY OF ADMINISTRATION OF DRUGS OR DIET SUPPLEMENTS AND THE OVERALL DIET OF THE PATIENT MAY ALSO AFFECT THE RESPONSE. EACH PATIENT MUST BE MONITORED CLOSELY DURING THE ENTIRE TERM OF TREATMENT IN ORDER TO DETECT THE DEVELOPMENT OF POSSIBLE COMPLICATIONS. EACH PATIENT SHOULD BE INSTRUCTED REGARDING SYMPTOMS OF DEFLATION, GASTROINTESTINAL OBSTRUCTION, ACUTE PANCREATITIS, SPONTANEOUS INFLATION, ULCERATION AND OTHER COMPLICATIONS WHICH MIGHT OCCUR, AND SHOULD BE ADVISED TO CONTACT HIS/HER PHYSICIAN IMMEDIATELY UPON THE ONSET OF SUCH SYMPTOMS. COMPLICATIONS- POSSIBLE COMPLICATIONS OF THE USE OF THE ORBERA? SYSTEM INCLUDE: BALLOON DEFLATION AND SUBSEQUENT REPLACEMENT. POSSIBLE COMPLICATIONS - POSSIBLE COMPLICATIONS OF THE USE OF ORBERA? INCLUDE: GASTRIC DISCOMFORT, FEELINGS OF NAUSEA AND VOMITING FOLLOWING BALLOON PLACEMENT AS THE DIGESTIVE SYSTEM ADJUSTS TO THE PRESENCE OF THE BALLOON. CONTINUING NAUSEA AND VOMITING. THIS COULD RESULT FROM DIRECT IRRITATION OF THE LINING OF THE STOMACH, DELAYED GASTRIC EMPTYING AND/OR THE BALLOON BLOCKING THE OUTLET OF THE STOMACH. IT IS EVEN THEORETICALLY POSSIBLE THAT THE BALLOON COULD PREVENT VOMITING (NOT NAUSEA OR RETCHING) BY BLOCKING THE INLET TO THE STOMACH FROM THE ESOPHAGUS.