“All five reports indicate that patient deaths occurred within a month or less of balloon placement. 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. The Agency has also received two additional reports of deaths in the same time period related to potential complications associated with balloon treatment," an FDA statement said.
The FDA-approved, liquid-filled balloons were designed to induce weight loss by surgically inserting them into the stomach, thus coaxing the body into feeling fuller and prompting lower food intake among users.
Four of the patients used Apollo Endo Surgery's Orbera balloon. The saline-filled device was approved in 2015 and was touted to help obese patients shed more than three times the weight lost through diet and exercise. According to the company, there have been more than 220,000 cases of successful implants across 80 countries.
On the other hand, the fifth patient was found to have used ReShape Medical Inc.'s ReShape Integrated Dual Balloon System. The device, approved in June 15, was inserted into a patient's stomach through the mouth in order to avoid surgical scarring. (Related: FDA-approved 'assisted bulimia' device pumps food from your stomach, allowing you to overeat while still losing weight.)
The FDA remains uncertain whether the devices or the required surgery to implant them caused the deaths, but issued a warning that physicians should closely monitor patients who receive the gastric balloons. The federal agency also cautioned that the devices should not be used by patients who already had gastrointestinal surgery and those who were unwilling or unable to undergo a medically-supervised diet and behavior modification program.
Device maker responds to recent reports
In response to the recent reports, Apollo has released a company statement indicating that the deaths were not necessarily caused by their device.
"The FDA’s letter to health care providers does not indicate that the patient deaths were related to the Orbera device or the insertion procedures. While the cause of death has not been provided or determined in all cases, Apollo has not received any communication or indication from the attending physicians or hospitals that the deaths have been due to the Orbera device," an Apollo statement read.
Apollo also noted that it did not receive liability claims as a result of any of the deaths. Likewise, the company noted that while 21 patients using the Orbera device died between January 2006 to March 2017, the rate was a minuscule 0.01 percent of the more than 277,000 units distributed during the said period.
According to Apollo's CEO Todd Newton, many of the patients who used the weight-loss devices also had other preexisting conditions associated with excess weight. "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," Newton said.
The FDA said it will examine two other deaths associated with the gastric balloons in question. Apollo subsequently countered, stating that on the first case, the Brazilian patient's cause of death was ruled out as heart attack. The company also noted that on the second case, non-device related gastric perforation lead to complications and eventual death in yet another Brazilian patient.
Sources include:
Please contact us for more information.
