The Food and Drug Administration issued a warning Friday to medical providers to closely monitor patients undergoing a specific gastric-bypass procedure, following the deaths of five people shortly after they underwent the operation. In addition to saline, the balloon that is made from silicone may contain some radio-opaque material as a radiographic marker and a dye such as methylene blue to alert the patient when the balloon would leak. Studies have suggested that fluid is superior to air for distending gastric balloons. Inflated balloons reduce the operative volume capacity of the stomach. The balloons remain in the stomach for six months to help facilitate weight loss before being removed during an outpatient endoscopy.
Each of the five dead died within a month or less of receiving the balloon treatment. Three patients died 1 to 3 days afterward.
"At this time, we do not know the root cause or incidence rate of patient death, nor have we been able to definitively attribute the deaths to the devices or the insertion procedures for these devices", the agency said.More news: Flight-to-Safety Buying Drives Gold to a Two-month High
The FDA's adverse report system is very broad and is not created to immediately prove a device or drug caused a complication. One case involves ReShape Medical Inc's ReShape Integrated Dual Balloon System. Four reports involve Apollo-Endo Surgery's Orbera Intragarstric Balloon System, and one report involves ReShape Medical Inc.'s ReShape Integrated Dual Balloon System. The use of the balloon is complemented with counseling and nutritional support or advice.
Still, the company said it has not received product-liability claims in connection to those five cases, and it has not received information from physicians and hospitals indicating that its Orbera device had caused those deaths.
A spokeswoman for Apollo said the reports were from around the world and did not necessarily involve US patients.More news: Trump declares opioid crisis 'national emergency'
Apollo Endosurgery also said that 21 deaths have been reported in the last 11 years, from January 2006 to last March, out of more than 277,000 Orbera balloons distributed during that time period.
"Each patient must be appropriately evaluated prior to the decision to place the balloon, especially the potential risks of anesthesia and an endoscopic procedure", Gostout said in the statement. The FDA letter is an important reminder to the physician community that obesity is a serious disease and many obese patients are affected by one or more co-morbid conditions due to their obesity.
The agency is investigating two more deaths that may be linked to the so-called gastric balloons, including one patient who had a ReShape product implanted. Symptoms include intense abdominal pain, swelling of the abdomen, difficulty breathing and vomiting.More news: European shares fall on Paris incident, North Korea worries