The US Food and Drug Administration (FDA) has issued a safety alert after 5 people who had undergone an obesity procedure have died since 2016. We talked about this procedure in our post titled “Can a Balloon in Your Belly Help You Lose Weight?“.
The procedure, as you might have guessed, involves placing a deflated balloon (or two) made of silicone in your stomach through your mouth while under general anesthesia. The balloon is then inflating with saline.
The inflated balloon takes up room in your tummy, so you get full sooner and therefore eat less. Of course, this is expected to help you lose weight. The balloon is meant to remain in your stomach for six months.
According to reports on the web, all five deaths occurred within a month or less of the balloon placement. In three reports, death occurred in one to three days of insertion of the balloon(s). The FDA potential risk waring reads in part;
FDA is issuing an update to alert health care providers of five reports of unanticipated deaths that occurred from 2016 to present in patients with liquid-filled intragastric balloon systems used to treat obesity. 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. (See full text on the FDA website).
The FDA adverse report system is not proof of device or drug complication, rather it is meant to gather information about anything that happens while someone is using a device or drug. In other words, the FDA is suggesting that the device is cause of the deaths just yet, but that there may be a link.
This shows that even seemingly safe procedures that don’t involve going under the knife can potentially be risky, or even deadly. Unfortunately, sometimes we learn about the risks after the drug or device has been on the market for a while. And, again unfortunately, some people pay the (sometimes ultimate) price for it.