Food & Drug Administration Warns of Gastric Balloon Deaths

by Kristina Fiore

7 reports of death tied to gastric balloon obesity treatment since 2016

The FDA sent a letter to healthcare providers warning of reports of seven deaths with liquid-filled intragastric balloon systems used to treat obesity.

In five cases, the cause of death was unclear, but all occurred within a month or less of balloon placement, the agency said. In three of those cases, the patient died within one to three days of having the balloon inserted.

Four of these reports involved the Orbera Intragastric Balloon System from Apollo Endo Surgery, and one involved the ReShape Integrated Dual Balloon System by ReShape Medical.

The FDA noted that for these five cases it doesn’t know “the root cause” of the problem. It also can’t determine the incidence rate of patient death, nor could it “definitively attribute the deaths to the devices or the insertion procedures for these devices” — meaning they couldn’t tell if death was due to gastric or esophageal perforation, or to intestinal obstruction, or to some other cause.

Two additional reports of deaths in the same time period — since 2016 — were also noted in the FDA letter. One was related to gastric perforation with the Orbera Intragastric Balloon System and one to esophageal perforation with the ReShape device.

The FDA said it’s working with both companies to better understand what’s causing these issues, and to monitor potential complications of acute pancreatitis and spontaneous overinflation. It also emphasized that it had mandated ongoing post-approval studies for the devices.

Article originally appeared in MedPage Today

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Study Boosts Case for Over-the-Counter Hearing Aids

OTC hearing aids performed nearly as well as prescription devices, but not yet legal for sale

In a highly controlled comparison study, several over-the-counter hearing assistance devices performed almost as well as a conventional hearing aid that cost thousands of dollars more.

Three of five selected personal sound amplification products (PSAP) were found to improve speech understanding among participants with mild-to-moderate hearing loss to a degree that was comparable to results obtained with a hearing aid, Nicholas Reed, AuD, of Johns Hopkins School of Medicine, and colleagues wrote in the July 4 issue of JAMA

Hearing aids for both ears typically cost around $4,500, while PSAPs cost several hundred dollars or less.

The Over-the-Counter Hearing Aid Act of 2017 is being sponsored in the Senate by Elizabeth Warren (D-Mass.) and Charles Grassley (R-Iowa) and in the House by Joseph Kennedy (D-Mass.) and Marsha Blackburn (R-Tenn.).

Reed told MedPage Today that the study findings lend support to the creation of the new regulatory classification for hearing aids.

“Some of these devices did about as well as the hearing aid in our controlled environment, suggesting that some PSAPs are pretty good,” he said. “Perhaps we should support the movement to get these in the hands of more people and to regulate them to improve the quality of the products.”

Click here to read entire article published in MedPage Today