MEDICAL DEVICES

After patient deaths, Austin’s Apollo Endosurgery involved in FDA investigation

Posted August 17th, 2017

After five people died since January 2016 following surgery to insert an inflatable balloon into their stomachs to treat obesity, the U.S. Food and Drug Administration is investigating whether that medical device is to blame for their deaths. 

Included in the investigation is Austin-based Apollo Endosurgery, which manufactures an inflatable balloon called Orbera that was used on some of the patients who died, according to the FDA.

There have been seven total deaths reported following the placement of an Orbera or ReShape balloon, according to the FDA. 

Apollo Endosurgery’s stock plunged 38 percent after the FDA issued a letter alerting health care providers about the deaths

The FDA said in a written statement that it does not know if any of these deaths were caused by the balloon itself. The agency is investigating to determine what role, if any, the medical devices played in the death of these patients.

Three of the deaths occurred within one to three days of the surgery. “We are continuing to monitor the use of these devices in clinical settings to learn more about any risks and will communicate publicly when we have new information to share,” the FDA said. 

An Apollo Endosurgery spokeswoman said Thursday that the company has not been told by the FDA that its products are part of an ongoing investigation.

But Deborah Kotz, an FDA spokeswoman, said Thursday that the agency is "still investigating this issue."

According to Apollo Endosurgery, the company is aware of five instances in which a patient has died after having an Orbera balloon inserted into their stomach. The company self-reported the deaths to the FDA. Four of these surgical procedures happened outside of the United States. 

“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,” CEO Todd Newton said in a written statement. 

The company said from Jan. 1, 2006 to March 31, 2017, the “incident rate” for patients that have had an Orbera is “less than one-hundredth of 1 percent.” More than 277,000 balloons have been distributed in that time period, the company says. 

Apollo provided details to the American-Statesman about what happened in the five cases in which a patient died after having an Orbera balloon implanted and issued a news release last week that included information on the deaths. 

Two patients died in Brazil, one of a heart attack and the other after reporting a “gastric perforation” surgical complication, according to the company. The cause of death is unknown in the other three cases, which happened in Great Britain, the United States and Mexico.

“In each of these cases,” the company said in a statement, “Apollo was not aware of any evidence that suggest a device malfunction or failure.”

Apollo Endosurgery was founded in 2006 and employs about 200 people worldwide, with its headquarters in Austin. The company specializes in developing less invasive surgical devices to treat obesity and other gastrointestinal disorders.

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