Intragastric Balloon Lawsuit | 2025 Latest Updates

Intragastric Balloon Lawsuit Overview

The intragastric balloon lawsuit involves legal claims against manufacturers of fluid-filled weight loss balloons that have been linked to serious complications and deaths.

The primary allegations center on Apollo Endosurgery’s Orbera Balloon System and ReShape Medical’s ReShape Balloon System, which have been associated with at least 5 deaths and dozens of adverse event reports.

According to FDA warnings, these devices have caused complications including acute pancreatitis and spontaneous over-inflation requiring premature device removal.

All reported deaths occurred within 1 month of gastric balloon placement, with several deaths occurring as quickly as 1 to 3 days after surgery.

The FDA has issued multiple safety alerts warning healthcare providers about these serious complications with fluid-filled intragastric balloon systems.

Latest Intragastric Balloon Lawsuit Updates

• August 10, 2017 – The FDA issued a Safety Alert revealing that intragastric balloons for weight loss made by Apollo Endosurgery and ReShape Medical Inc. have been linked to at least 5 deaths from 2016 to the present. All deaths occurred within 1 month of gastric balloon placement, with several deaths occurring in as little as 1 to 3 days after surgery [1].
• February 9, 2017 – The FDA sent a letter to healthcare professionals after receiving dozens of adverse event reports associated with fluid-filled intragastric balloons used to treat obesity. The agency identified two primary types of adverse events: spontaneous hyperinflation and acute pancreatitis, both requiring premature device removal [2].
• 2015 – The FDA approved the ReShape Integrated Dual Balloon System and Apollo’s Orbera Intragastric Balloon System for weight loss treatment in obese patients [3].

FDA Reports and Statistics

The FDA has received dozens of adverse event reports associated with fluid-filled intragastric balloons, with at least 5 confirmed deaths linked to these devices between 2016 and 2017.

Most complications were reported in patients who received the Orbera Balloon System made by Apollo Endosurgery, but similar problems have been linked to ReShape Medical’s ReShape Balloon System.

The FDA’s Medical Device Reporting (MDR) database shows that the most common adverse events include spontaneous hyperinflation and acute pancreatitis.

All reported deaths occurred within 1 month of balloon placement, with several occurring within 1 to 3 days post-surgery.

The FDA has issued multiple safety communications and warnings to healthcare providers about these serious complications.

Intragastric Balloon Injuries & Side Effects

Intragastric balloons have been associated with serious complications that can develop shortly after implantation, sometimes requiring emergency medical intervention or resulting in death.

• Acute Pancreatitis: Severe inflammation of the pancreas that can be life-threatening and requires immediate medical treatment.
• Spontaneous Hyperinflation: Over-inflation of the balloon with air or fluid, causing dangerous pressure and requiring emergency removal.
• Premature Device Removal: Emergency surgical removal of the balloon due to serious complications.
• Death: Fatal complications occurring within days to weeks after balloon placement.

Do You Qualify for an Intragastric Balloon Lawsuit?

You may qualify for an intragastric balloon lawsuit if:

• You received an intragastric balloon between 2015 and 2017 (particularly Orbera or ReShape systems)
• You experienced serious side effects including acute pancreatitis, device over-inflation, premature removal, or death of a loved one
• The injuries required medical treatment or hospitalization
• You can provide medical documentation linking your injuries to the intragastric balloon device

Evidence Required for an Intragastric Balloon Lawsuit

To pursue a successful intragastric balloon lawsuit, you will need to gather comprehensive documentation and evidence:

• Medical Documentation: Complete medical records from your balloon placement procedure, complication treatment, and any emergency interventions
• Device Information: Specific details about your intragastric balloon, including manufacturer, model, lot number, and implantation date
• Complication Records: Medical documentation of adverse events, including diagnostic tests, imaging results, and treatment records
• Expert Medical Testimony: Medical experts who can establish the connection between the device and your injuries
• Device Removal Records: If applicable, complete records of premature device removal and the reasons for removal

Damages You Can Recover

Successful intragastric balloon lawsuits may result in compensation for:

• Medical Expenses: Past and future medical costs for treatment of complications, emergency procedures, and ongoing care
• Lost Wages: Income lost due to inability to work during recovery and treatment
• Pain and Suffering: Compensation for physical pain, emotional distress, and reduced quality of life
• Punitive Damages: Additional compensation intended to punish manufacturers for negligent conduct

Intragastric Balloon Recall Information

While no formal recalls have been issued for intragastric balloons, the FDA has issued multiple safety alerts and warnings about serious complications associated with these devices.

In August 2017, the FDA issued a Safety Alert specifically warning about deaths linked to Apollo Endosurgery’s Orbera and ReShape Medical’s ReShape balloon systems.

The FDA has advised healthcare providers to closely monitor patients for signs of complications and to follow manufacturer instructions for device returns or evaluations if removal is necessary.

Statute of Limitations for Intragastric Balloon Lawsuits

The statute of limitations for filing an intragastric balloon lawsuit varies by state, typically ranging from 2 to 3 years from the date of injury discovery or when you reasonably should have known about the connection between your injuries and the device.

Because many complications develop quickly after implantation, the statute of limitations often begins from the date of the adverse event.

It’s crucial to consult with an experienced attorney as soon as possible after experiencing complications to ensure your rights are protected and to avoid missing critical filing deadlines.

FAQs

1. Can I file a lawsuit if I suffered complications from an intragastric balloon?

Yes, if you suffered complications from an intragastric balloon, you may be eligible to file a lawsuit. A lawyer experienced in medical device litigation can help you explore your legal options and seek compensation for your injuries, medical expenses, and other damages.

2. What compensation might be available in an Intragastric Balloon lawsuit?

Compensation may include medical expenses, lost wages, pain and suffering, and compensation for long-term health issues or permanent damage caused by complications. In cases of death, families may also pursue wrongful death claims.

3. How can I prove that the intragastric balloon caused my injuries?

To prove that the balloon caused your injuries, you’ll need medical records, expert testimony, and evidence of the device’s implantation and complications. A lawyer can assist in gathering and presenting the necessary documentation.

4. Which intragastric balloon systems are linked to the most complications?

The Orbera Balloon System by Apollo Endosurgery and the ReShape Balloon System by ReShape Medical Inc. are linked to the most complications. The Obalon system has not been associated with adverse events.

5. How quickly do complications typically develop after balloon placement?

Complications often develop rapidly, with some occurring as quickly as 1 to 3 days after surgery. According to FDA reports, all deaths occurred within 1 month of balloon placement, with several occurring very quickly.

6. What should I do if I’m experiencing complications from my intragastric balloon?

Seek immediate medical attention if you experience severe abdominal pain, nausea, vomiting, or other concerning symptoms. Contact your healthcare provider and consider consulting with an attorney about your legal options.

7. Are there any intragastric balloon systems that are considered safer?

The Obalon Balloon System has not been associated with adverse events, unlike fluid-filled systems that have been linked to complications and deaths.

8. How long does an intragastric balloon lawsuit typically take?

Lawsuits can take anywhere from 18 months to several years, depending on your case’s complexity, the manufacturer, and whether the case goes to trial or settles.

9. Do I need to pay attorney fees upfront for an intragastric balloon lawsuit?

Most product liability lawyers work on a contingency fee basis, meaning no upfront costs, and attorney fees are only collected if your case is successful.

10. Can family members file wrongful death claims for intragastric balloon deaths?

Yes, family members may file wrongful death claims if their loved one died due to complications from intragastric balloon devices

See the other medical device lawsuits we’ve taken on.

Get a Free Intragastric Balloon Lawsuit Evaluation With Our Lawyers

Time is limited to pursue legal action for intragastric balloon injuries. With statute of limitations periods varying by state – typically only 2 to 3 years from the date of injury – it’s crucial to act quickly to protect your rights.

Schmidt & Clark offers:

• Free, confidential consultations to evaluate your case
• No upfront costs or fees – you pay nothing unless we win
• Payment only if we win your case through our contingency fee structure
• Experienced legal representation in medical device and product liability cases

If you suffered an injury after intragastric balloon surgery, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.

FDA Recommendation: The FDA is advising healthcare providers to watch for symptoms of complications in patients who received fluid-filled intragastric balloons. If abnormalities are found, physicians should perform any confirmatory diagnostic studies. If the device is removed, follow the manufacturer’s instructions for device returns or evaluations.

References

1. https://www.medscape.com/viewarticle/884089
2. https://www.fda.gov/medical-devices/letters-health-care-providers/fda-alerts-health-care-providers-about-potential-risks-liquid-filled-intragastric-balloons
3. https://secure.medicalletter.org/TML-article-1476c