Five people have died after have anti-obesity devices surgically inserted into their stomachs, USA regulators have revealed.
Since the FDA's OK, there have been five reported deaths in patients who received the ORBERA intragastric balloon in four countries, one in the U.S. The company reported all five cases under its Global Product Surveillance program.
The patients all went under the knife earlier this year to get FDA-approved liquid-filled balloons fitted in a bid to lose weight. All five deaths occurred within a month of the procedure, and three of them happened within three days of the procedure.
"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 U.S. Food and Drug Administration said on Thursday. In the other death, there was an esophageal perforation with the ReShape Integrated Dual Balloon System.
"Patient safety is a key priority in everything we do at Apollo Endosurgery and we take adverse event reporting obligations related to our products very seriously", said Apollo Endosurgery CEO Todd Newton in a statement.
A spokeswoman for Apollo said the reports were from around the world and did not necessarily involve USA patients.
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.
Two additional deaths since 2016 were related to potential complications - one stomach perforation due to Orbera, and one esophageal perforation with the ReShape weight-loss balloon. Symptoms include intense abdominal pain, swelling of the abdomen, difficulty breathing and vomiting. Pancreatitis and balloon over-inflation were not listed as potential side effects until February 2017, so doctors might not be aware of the risk.