People are dying after getting these weight-loss implants
People are dying after getting these weight-loss implants
Apollo Endosurgery Provides Update and Clarity to FDA Letter to Health Care Providers Related to Potential Risks of Intragastric Balloons
13 August, 2017, 01:10
The weight loss system, which the FDA first issued a safety warning for in February, involves the inflation of balloons in patients' stomachs via a micro-catheter.
The FDA issued an update to alert healthcare providers of 5 deaths that occurred since 2016 in patients with liquid-filled stomach balloons. 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 are left in the stomach for up to six months with the idea being they leave less room for food. The agency said two more death reports it received happened within the same time frame and are potentially related to complications from the balloon treatment.
But three of the five patients died within three days of their supposedly low-risk operation.
"At this time, we do not know the root cause or incidence per rate of patient death", the FDA said, adding that it is working with the companies that manufacture the devices.
"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. The agency recommends that doctors closely monitor patients who are using these devices.
Last year America expended $2.5 billion on commercial weight-loss balloons. The company confirmed that only 21 devices from 277,000 distributed all over the world had been linked to deaths between January 1, 2006, and March 31, 2017.
'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'.
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