Five deaths reportedly involving gastric weight-loss balloons

Regulators report that at least five people have died not long after receiving a gastric balloon fitted into their stomachs to help them lose weight. While authorities have not confirmed that the weight-loss balloons are the final cause of death, all five died within a month of having the Intragastric Balloon System inserted, and three of the patients died between one and three days after the procedure took place.

Given the trend, regulators will need to carefully examine what has happened and whether the cause of death is the devices being used. If it is, action needs to be taken without delay to avoid any further loss of life.

About the weight-loss balloons

Four of the balloons involved were manufactured by Apollo Endosurgery and were approved by regulators in 2015. The last balloon was made by ReShape Medical Inc, receiving approval from the same authority in July 2015.

The weight-loss balloons are inserted into the patient’s mouth and though the oesophagus and into the stomach, and then filled with saline or purified water. When filled up, the balloons take up space inside the stomach, making the patient feel like they’re full, or less hungry. Clinics who offer the balloon products boast of their success stories; such as clients who have lost several stones in just a matter of months.

Unfortunately, if there is a risk of death, this praised-procedure is in need of further assessment.

Statement from regulators

Regulators have released a statement, admitting they cannot “definitively attribute the deaths to the devices or the insertion procedures for these devices.”

The authority will therefore be conducting thorough investigations to see if the balloons carry a fatality risk, or perhaps whether the procedure was carried out incorrectly. For now, regulators suspect  patients may have suffered a tear in the stomach and/or the oesophagus whilst the balloon was being inserted, or an intestinal blockage during or after the procedure was carried out.

Further deaths reported

Since 2016, regulators have received reports of another two deaths involving the balloon treatments.

One patient died after sustaining a gastric perforation, and the other suffered a tear in their oesophagus.

The deaths may not come as a huge shock given that regulators were alerted to potential problems with the balloons earlier this year that lead to early removal of some devices. A number of patients experienced ‘spontaneous hyperinflation’ where the balloon over-inflated with air or liquid, and other reports noted patients developing acute pancreatitis.

Manufacturers deny wrongdoing

Manufacturer Apollo Endosurgery maintains that it has “not received any communication or indication from the attending physicians or hospitals that the deaths have been due” to their Orbera devices. The company also noted that no compensation claims have been made in respect of the five deaths either.

The other manufacturer, ReShape Medical Inc, has yet to make a statement over the deaths, but its website it still up and running and they’re assumedly still taking patients on.

Former president of the American Society for Metabolic and Bariatric Surgery, John Morton, suspects that the fault lies in the technique of inserting the devices. He notes that:

“…if you’re an experienced endoscopist and surgeon, you recognise the signs of perforation, which is important because they’re treatable.”

Morton also advises that clinics who offer the procedure must implement adequate follow-up procedures so any adverse complications can be quickly caught and rectified.