Five patients who were treated for obesity passed away, allegedly, after they were treated with intragastric silicone balloons. According to the US Food and Drug Administration (FDA), the organisation which approved this procedure, the deaths were recorded from the year 2016. Earlier this year, FDA has issued a letter to caution healthcare providers pertaining the potential risks with liquid-filled intragastric balloons.

What is the science behind the silicone balloons?

The main premise of this technology is the fact that the balloons occupy physical space within the stomach after being filled with a solution. Therefore, since there is less volume available in the stomach for food, the balloons could potentially have an appetite lowering effect.

This technology only lasts for six months; in which during this duration, patients need to complement their treatment with a healthy diet and regular physical exercise—in order to achieve optimum weight loss. As with any surgical procedure, insertion of these silicone balloons via an endoscope into the stomach has associated risks primarily related to over-inflation of the balloon. Over-inflation may result in abdominal distension, resulting in pain and shortness of breath.

Patients are typically administered mild sedation, after which the balloon is directed towards the stomach via the throat. Plausible reasons stipulated for the fatal complications include oesophageal perforation or intestinal obstruction. Both reasons could be very severe if not immediately recognised and treated.

Root cause yet to be determined

In a safety alert released by FDA, five reports of unanticipated deaths occurred (from 2016) within a month or less of balloon placement. Four reports involve the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery, and one report involves the ReShape Integrated Dual Balloon System, manufactured by ReShape Medical Inc. Despite the heated speculation circling these deaths, no concrete evidence is yet to be found to link the deaths to the procedure or medical device.

According to Apollo Endosurgery, its Orbera balloon has a mortality rate of less than 0.01%. Since obtaining FDA approval in 2015, five patients have died with the Orbera balloon, and “Apollo self-reported all five cases to FDA,” remarked Apollo Endosurgery CEO Todd Newton, in a press release issued by the device manufacturer. He also noted that while the cause of death has not been provided or determined in all five cases, “Apollo has not received any indication from the physicians or hospitals that the deaths were caused by the Orbera device. That company has not received any product liability-related claims in connection with these cases either,” he emphasised.

Health authorities weighed in

Despite these deaths occurring within a short timeframe of patients undergoing the procedure, the FDA claims "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.”

Dr Christopher Gostout, chief medical officer of Apollo Endosurgery, stresses the importance of informing patients about the anticipated risks associated with these silicone balloons. “Each patient must be appropriately evaluated prior to the decision to place the balloon, especially the potential risks of anaesthesia and an endoscopic procedure.”

Gostout underscores the value of regularly monitoring the patient’s health and promptly managing any deteriorations. Patients should also be equipped to understand which symptoms require professional assistance. In the event of any unusual symptoms, patients should contact healthcare professionals in a timely manner to prevent complications.

The FDA is currently in discussion with the responsible firms to determine exactly what transpired. It is essential to determine whether the method of administration of the balloons have caused these deaths, or the balloons themselves. This will determine their potential for future use as a reliable alternative for the treatment of obese patients. MIMS

[Editor's Note: 18/8/2017: We have updated this article to clarify the presentation of the FDA's comments concerning patient deaths in paragraph five.]

Read more:
4 top health technology hazards in 2017
5 wearable technologies for the hospital
5 of the worst medical malpractice cases