Gastric Balloons Linked to a Dozen Deaths, FDA Warns
According to the United States Food and Drug Administration, a popular weight-loss remedy has been tied to the deaths of twelve patients.
The procedure is the insertion of a gastric balloon, which is a balloon filled with liquid that is inserted into the stomach. The purpose of the balloon is to make the patient feel fuller and eat less. According to the FDA, most of the deaths occurred within one month of the surgery.
The gastric balloons are not new. Two different types emerged onto the market in 2015. The Orbera Intragastric Balloon System and the ReShape Integrated Dual Balloon System have been used in many procedures. During the surgery, a physician uses an endoscopic method to place the balloon into the stomach. Once set, it is then filled with saline solution.
After the surgery, patients are supposed to undergo counseling on implementing and maintaining a healthy lifestyle. The patients receive counseling on diet and exercise. The counseling is supposed to last several months. The results of the surgeries looked promising at first. Clinical trials concluded that patients lost double the weight as compared to those who implemented exercise and diet only.
However, in August of 2017, the FDA published a warning, stating that seven deaths were linked to the balloons. At that time, the FDA acknowledged that it was not clear if the gastric balloons caused the deaths, but it stated it would be launching an investigation.
In June of 2018, the FDA released another statement about the gastric balloons. The FDA explained that five additional deaths had been linked to the devices. In these patients, the stomach wall was perforated after the balloons were placed. Other complications were also reported, such as the balloon filling up with air or liquid and becoming too big. Inflammation of the pancreas was also reported.
In light of the additional five deaths, the FDA has approved new labeling for the gastric balloons. The agency has also encouraged physicians to carefully observe patients who have been implanted with these balloons to watch for complications. Additionally, physicians should make their patients aware of the signs of complications and encourage them to seek medical assistance immediately if they experience these symptoms.
At this time, the FDA has not advised against implanting the ReShape or the Orbera gastric balloons. Dr. William Maisel, who serves in the FDA’s Center for Devices and Radiological Health as the director of the Office of Device Evaluation stated, “While these devices remain an appropriate treatment option for some patients with obesity, patients should always discuss with their doctors which treatment option is best for them.”
Dr. Aurora Pryor, the director of the Bariatric and Metabolic Weight Loss Center of Stony Brook University, said that she uses both brands of gastric balloons in her practice. She commented that the FDA’s warnings should be acknowledged by both patients and physicians, but that the big picture shows that complications caused by these medical devices is pretty low.
Dr. Pryor said, “Any death in a patient raises red flags and concern, but you also have to consider the large number of people who are using these balloons and look at that proportionately.” Thousands of gastric balloons have been implanted in patients across the globe. Orbera reports that its mortality rate is less than 0.01 percent, and ReShape states that its mortality rate is less than 0.06 percent.
Dr. Pryor added, “You can’t say that this is a completely safe operation—there are definitely some risks involved. And for a fair consent process, you have to discuss these things with your patients. But I do think if you’re aware of these complications, and you’re looking out for pain and other symptoms, these things can be managed if identified early.”
For those who are seeking weight loss recovery options, there are several to choose from. Those who meet the criteria for weight loss surgeries may look into sleeve gastrectomies or gastric bypass procedures. Generally, to be eligible, the patients must have a body mass index (BMI) or 40 or higher. If health problems are present, the BMI threshold is 35.
Dr. Pryor stated, “If people meet the parameters, I will strongly encourage them to have either a sleeve or gastric bypass procedure, as those are the most studied to be effective for weight loss. If somebody has a lower BMI or they don’t qualify for surgery or aren’t interested in surgery, that’s where other options, such as balloons, come in.”
The American Society for Metabolic and Bariatric Surgery reports a mortality rate of 0.13 percent after bariatric procedures.
A relatively new balloon device, called Obalon, is also an option. The patient swallows this balloon. After it is swallowed, the balloon is filled with gas. Thus far, Obalon has not been linked to any serious complications or deaths.
Of course, Dr. Pryor explains it is important for patients to discuss all of their options with their physicians. She said, “Despite the FDA’s warning, I think the balloons are still an excellent procedure and an important option for many patients struggling with their weight.”
What happens if a medical device causes injuries or death?
Medical device manufacturers, pharmaceutical companies, and other types of manufacturers have a duty to provide safe products to consumers. If an item is defective and injures a consumer, the consumer may be able to file a products liability claim against the manufacturer. In a products liability case, the consumer must show:
- The consumer was using the product as directed or as anticipated by the manufacturer
- The product was defective
- The consumer was injured
- The consumer’s injuries were linked to the defect in the item
Each element must be supported with evidence for the consumer to prevail and receive damages. If the consumer cannot prove one of the elements, the claim may be dismissed—meaning that the consumer would be responsible for all financial losses he or she has endured.
There are three primary types of product defects.
- Design defects
- Manufacturing defects
- Marketing defects
Design defects occur when there is a problem with the product’s “blueprints.” Designing a product with a dangerous ingredient or material would be an example of a design defect.
Manufacturing defects may occur in a factory as a product is being assembled or during transport to retailers. If the wrong type of material is used to assemble a product, which makes the product dangerous, the issue is a manufacturing defect.
Marketing defects occur when a manufacturer does not include proper warnings or instructions with a certain product. Consider a medical device that should not be implanted in patients with diabetes. If a diabetic patient receives the device and suffers complications, that patient may have a claim against the manufacturer.
An experienced products liability attorney is able to pursue all avenues of recovery against a manufacturer to ensure claimants receive the compensation they deserve.
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If a medical device or other product have injured you, let Parker Waichman LLP help you. To schedule your free Gastric Balloon lawsuit consultation with our experienced legal team, call 1-800-YOURLAWYER (1-800-968-7529) 24 hours a day, 7 days a week.
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