Five people have died after have anti-obesity devices surgically inserted into their stomachs, US regulators have revealed.
The patients all went under the knife earlier this year to get FDA-approved liquid-filled balloons fitted in a bid to lose weight.
But three of the five patients died within three days of their supposedly low-risk operation. The other two died within a month.
The FDA said it is not clear whether the deaths were caused by the devices – which were approved in 2015 – or the surgical process.
However, the agency has issued a warning to doctors treating patients with similar devices to monitor them closely.
Four of the patients were using the Orbera Intragastric Balloon System, made by Apollo Endo Surgery. The fifth was using the ReShape Integrated Dual Balloon System, made my ReShape Medical Inc.
The Orbera balloon, approved in August 2015, is filled with saline and inserted in an obese patient’s stomach to help them with portion control.
Apollo Endo Surgery said there have been more than 220,000 cases of successful Orbera placements across 80 countries.
The company said the product can help overweight people lose more than three times the weight that diet and exercise alone can.
The ReShape balloon, approved by the FDA in June 2015, is inserted into a patient’s stomach via their mouth to prevent surgical scarring.
The FDA warned that someone who has already had gastrointestinal surgery or who is ‘unwilling or unable to participate in a medically-supervised diet and behavior modification program’ should not try either of the devices.
Apollo said in a press release that the deaths of the patients using their weight-loss balloon were not necessarily caused by their products.
‘The FDA’s letter to health care providers does not indicate that the patient deaths were related to the Orbera device or the insertion procedures.
‘While the cause of death has not been provided or determined in all cases, Apollo has not received any communication or indication from the attending physicians or hospitals that the deaths have been due to the Orbera device.’
The company has not received product-liability claims as a result of any of the deaths, it said.
They said that from January 2006 to March 2017, 21 patients using the Orbera device died.
This is less than 0.01 percent of the more than 277,000 Orbera balloons distributed during that time period, their statement said.
Apollo’s CEO Todd Newton said many of the patients who use the device as a weight-loss tool have other obesity-related health problems.
‘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.’