FDA investigating intragastric obesity treatment linked to five deaths
pharmafile | August 14, 2017 | News story | Medical Communications, Sales and Marketing | life sciences, medicine, obesity, pharma, pharmaceutical
The FDA has launched an investigation after five deaths thought to be caused by an obesity treatment surgery in which a silicone balloon device is fitted within the patient’s stomach.
Two Californian firms are implicated in the investigation: Apollo Endosurgery, which provided its Orbera Intragastric Balloon System to four of the deceased patients, and ReShape Medical, whose Integrated Dual Balloon System was fitted in the remaining patient.
“All five reports indicate that patient deaths occurred within a month or less of balloon placement,” the FDA said in a letter to healthcare providers. “In three reports, death occurred as soon as one to three days after balloon placement. 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.”
Intragastric balloons are nothing new and have been employed to assist in weight loss since their inception in the 1980s. Now, designs of the technology utilise a liquid-filled balloon rather than air has seen their uptake rise, but concerns raised over their risks are still widespread; just in February, the FDA released a warnings that the devices could present “potential risks of acute pancreatitis and spontaneous over-inflation.”
ReShape Medical commented: “There is no responsibility that we take more seriously than patient safety. ReShape is committed to supporting the continued safe and effective use of the dual balloon and is proactively communicating with physicians about this FDA update. Patients with questions about this FDA update should contact their physicians directly.”
The agency also remarked: “The FDA continues to work with Apollo Endo-Surgery and ReShape Medical to better understand the issue of unanticipated death, and to monitor the potential complications of acute pancreatitis and spontaneous over-inflation.”
Matt Fellows
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