Weight Loss Balloons Lawsuit

ReShape and Orbera gastric balloons for weight-loss have been linked to pancreatitis and other potentially life-threatening complications such as balloon deflation, gastrointestinal obstruction, ulceration, and gastric and esophageal perforation.  Gastric balloons physically fill up the stomach, making a person feel full and limiting the amount of food they can eat. Patients also have to exercise, follow a strict diet, and remove the balloon after six months.

About Weight Loss Balloons

Intragastric weight-loss balloons, also known as “stomach balloons”, are non-surgical devices that treat obesity. A doctor inserts the silicone balloon down the throat with an endoscope. Once in the stomach, they are filled with air or salt-water (saline) to about the size of a grapefruit. Gastric balloons physically fill up the stomach, making a person feel full and limiting the amount of food they can eat. Patients also have to exercise, follow a strict diet, and remove the balloon after six months.

In August 2015, the FDA approved the Orbera Intragastric Balloon System made by the Texas-based medical device company Apollo Endosurgery Inc. The system is a single silicone balloon filled with 400-700 cc saline.

In July 2015, the FDA approved the ReShape Integrated Dual Balloon System made by the California-based device company ReShape Medical Inc. The system is two silicone balloons attached to each other. The balloons are filled with saline and methylene blue, which is a dye that causes the patient’s urine to turn blue if the balloon pops.

Weight Loss Balloons Risk

Acute pancreatitis and over-inflation of gastric balloons are very serious side effects that may require emergency removal of the balloon. Neither dangerous side effect is on the label for ReShape or Orbera. Therefore, doctors may not realize they are causing a patient’s symptoms. This could delay diagnosis and lead to life-threatening complications. It could also lead to misdiagnosis and inappropriate treatments.

Symptoms of Pancreatitis

Acute pancreatitis occurs when the pancreas (a digestive gland behind the stomach) suddenly becomes inflamed. This could cause the following symptoms:

  • Severe stomach pain
  • Back pain
  • Nausea, vomiting
  • Fever
  • Rapid heartbeat

Symptoms of an Over-Filled Stomach Balloon

Gastric balloons are made of silicone, so they do not “stretch” like a toy balloon made of rubber. Too much fluid increases the risk of a stomach balloon popping. Even if it does not pop, an over-filled balloon is dangerous and it may need to be removed. The symptoms may include:

  • Intense abdominal pain
  • Swelling of the abdomen
  • Abdominal distention
  • Discomfort
  • Difficulty breathing
  • Vomiting

FDA Warnings for Weight Loss Balloons

On February 9, 2017, the FDA warned doctors to closely monitor patients for symptoms of pancreatitis and over-filled gastric balloons after dozens of serious injuries were linked to Orbera and Re-Shape. Dozens of people have been injured from spontaneous hyperinflation as soon as 9 days after implantation. Then, four others went to the hospital after contracting pancreatitis as soon as 3 days after implantation. Doctors suspect the balloon compressed the pancreas or other organs.

There Have Been 12 Deaths Since 2016

The FDA in June 2018 warned that a total of 12 patients have died since 2016 from weight loss balloons surgery.  All of the patients died within a month from surgery. Then, three died within three days of balloon placement. The FDA is also investigating two additional people who died after their stomach balloon perforated their stomach.

We Want to Help Weight Loss Balloons Victims

Furthermore, it is your right for manufacturers to inform you about the long-term risks associated with the medical devices, and it is the responsibility of manufacturers to provide this information. Of course, we want to help send a message that this is not acceptable. We are advocates for consumers who have been harmed by dangerous products, and likewise, we have the experience necessary to successfully litigate these cases.

Contact the Michael Brady Lynch Firm today for a free consultation to learn more about seeking justice. Compensation may be available for any medical expenses associated with this ordeal, as well as for your physical and emotional suffering. There is no obligation.

How We Can Help

When you experience side effects from a dangerous drug, it can have devastating effects on your entire life. A verdict or settlement could also provide compensation for your injuries and damages. The types of recoverable losses are:

  • Past and future medical expenses
  • Lost wages
  • Loss of an ability to work; and
  • Pain and suffering

If a person dies from complications from a drug, family members may be able to recover damages for the wrongful death of their loved one, including:

  • Funeral expenses
  • Medical expenses prior to death
  • Loss of economic support; and
  • Loss of companionship

If the conduct of a company is found to be highly reckless, punitive damages may be awarded to punish the company and deter similar conduct in the future. If you or a loved one suffered from weight loss balloon surgery, please speak to us to learn more about your rights.

The Michael Brady Lynch Firm is currently accepting cases in all 50 states. Please use the form on this page or call toll-free 24 hours a day at 877-513-9517.

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