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Intragastric Balloon Surgery Lawsuits


Intragastric balloon lawsuits are now taking shape after a dozen deaths were attributed to the recently-approved form of weight-loss surgery. As of June 2018, the Food and Drug Administration linked 12 deaths to the implantation of what appears to be a defective medical device. The most recent reports implicate the Orbera Intragastric Balloon, manufactured by Apollo Endosurgery Inc. and the Integrated Dual Balloon, which is manufactured by ReShape Lifesciences. Similar devices are manufactured by Obalon Therapeutics and Spatz Medical.

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How Intragastric Balloons Work

This is a rapidly developing situation. Some of the more popular devices were approved for use in the United States only as recently as 2015. Since 2017, deaths and injuries have been reported with greater frequency. The FDA issued new warnings in June 2018.

As defective medical product lawsuits typically develop, these are still early days. Class action lawsuits, multidistrict litigation and settlements offers may lie ahead. By mid-2018, the process seems to be under way.

How Intragastric Balloons Work

Gastric balloon systems are designed to treat obesity by taking up space in a patient’s stomach. The Obera Intragastric Balloon and the Integrated Dual Balloon are inserted into the patient's stomach endoscopically through the mouth. Once in place, the balloon is then filled with a saline solution. The balloons are designed to be removed after six months and may facilitate weight loss of five to ten percent loss of an individual’s total body weight.

Other intragastric balloon systems function in a similar way but are swallowed in a capsule. Some are inflated with gas rather than liquid. Either way, they must be deflated and removed some months after implantation. The treatment is time-limited, and the benefit may also be temporary. Sometimes the intragastric balloon procedure is used in preparation for more permanent gastric bypass or gastric sleeve surgery.

Intragastric Balloon Complications

Patients report considerable misery following intragastric balloon surgery. Symptoms include nausea, vomiting, diarrhea, fatigue and tenderness. Reports have also indicated concerns about substandard medical treatment and opportunistic bacterial infections apparently contracted at the treatment center.

Sometimes, however, these side effects are more than uncomfortable; they warn of potentially deadly conditions such as:

  • acute pancreatitis;
  • esophageal perforation;
  • stomach perforation;
  • stomach leakage and stretching;
  • rupture of the stomach resulting from hyperinflation of the balloon; and
  • stomach or intestinal blockages

Death can come quickly. Patients and their families should watch for severe abdominal and back pain, difficulty in breathing, fever and rapid heartbeat. Several recent fatalities occurred within three days of surgery.

Intragastric Balloon FDA Warnings

In February 2017, the FDA sent a letter to health care providers to recommend close monitoring of patients with liquid-filled intragastric balloon systems. The warning specifically outlined the risk of acute pancreatitis and spontaneous over-inflation.

In August 2017, the FDA issued an additional update, citing the need to alert health care providers to five reports of unanticipated deaths between 2016 to August 2017 in patients with liquid-filled intragastric balloon systems. The update noted that four reports involved the Orbera Intragastric Balloon System, and one report involved the ReShape Integrated Dual Balloon System. The warning noted that, “All five reports indicate that patient deaths occurred within a month or less of balloon placement.” In three reports, death occurred within three days of balloon placement.

In June 2018, the FDA issued another warning, writing that: “We have been carefully tracking adverse events, including a total of 12 deaths over the past two years that have been reported in patients with two balloon devices [Obera and ReShape] used to treat obesity.”

At the time the FDA noted that the manufacturers are cooperating with its investigation.

Developing Defective Medical Device Lawsuits

Defective medical device lawsuits can be daunting for individuals to initiate. But for the lawyers who specialize in these kinds of legal actions, there is a predictable rhythm. The first step is for government watchdog agencies like the FDA to begin investigations and issue warnings. The second step is for people who have been injured or families of those who have died to come forward. This is where the situation stood in June 2018.

The usual process would then be for individual lawsuits begin, often followed by consolidation in one form or another. Confronted with growing evidence of wrongdoing, manufacturers may offer to settle with plaintiffs. Early settlement offers tend to be low. That is why people who have been hurt by defective medical products often seek the expertise of lawyers who specialize in this area.

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