Bariatric surgeries, including gastric bypass, gastric banding, and gastric balloon placement, are among the fastest growing surgical procedures. While the surgeries have proven successful in helping patients lose weight, complications are not uncommon and can be life threatening if not properly diagnosed and treated.
FDA Investigating Gastric Balloons
As San Diego injury attorneys, we are increasingly concerned about the safety of gastric balloons. The medical devices are currently linked to the deaths of five patients.
As described by the FDA, gastric balloons are temporary devices intended to help treat obesity. They typically include one, two, or three balloons that fill space in the stomach. They can be placed via a swallowable capsule attached to a thin catheter or via an endoscope (a long flexible tube with a small camera and light at the end). After the device is placed, it is filled with gas or saline. Balloons filled with saline are then sealed, and all balloons must be removed after six months.
Implanting a gastric balloon is touted as minimally invasive and effective weight-loss procedure. However, according to a recent alert by the U.S. Drug and Food Administration (FDA), the new medical devices may pose serious risks. The agency is currently investigating five reports of unanticipated deaths that occurred from 2016 to present in patients with liquid-filled intragastric balloon systems. Four reports involve the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery, and one report involves the ReShape Integrated Dual Balloon System, manufactured by ReShape Medical Inc.
According to the FDA, the patients all died within a month or less of balloon placement. In three reports, death occurred as soon as one to three days after balloon placement. The agency is investigating whether the medical devices are defective or whether the insertion procedures for the gastric balloons may have caused the patients’ deaths, such as gastric and esophageal perforation or intestinal obstruction.
The FDA disclosed that it has received two additional reports of patient death linked to potential complications associated with balloon treatment. In one case, a patient implanted with the Orbera balloon system suffered a gastric perforation. In the other, a patient with the ReShape balloon system implanted suffered an esophageal perforation.
Alarming, this is not the first time the FDA has raised concerns about the safety of gastric balloons. In February, the agency issued a letter to health care providers to recommend close monitoring of patients with liquid-filled intragastric balloon systems for the potential risks of acute pancreatitis and spontaneous over-inflation. In the wake of the letter, both device makers revised their product labeling to address these risks.
Medical Malpractice Suits Involving Elective Surgery
Unfortunately, gastric balloons are not the only gastric devices raising safety concerns. Surgeons are performing fewer gastric band surgeries, in large part because patients often suffer complications that require additional procedures. Complications can occur when the medical device erodes into the stomach or causes obstruction by slipping down. One recent study found that one in five patients needed additional surgeries within about five years of receiving a gastric band.
When something goes wrong with weight-loss procedures, patients often wonder if they can pursue a medical malpractice lawsuit for harm suffered in conjunction with an elective surgery. The short answer is yes. If a medical professional deviates from the accepted standard of care and injures a patient during an elective cosmetic procedure, he or she can be held accountable in a California medical malpractice lawsuit.
Of course, not all mistakes rise to the level of elective surgery malpractice. The threshold question is whether the medical professional acted in a way other medical professionals under the same or similar circumstances would have acted. In addition, dissatisfaction with the results of an elective surgery is generally not grounds for a malpractice lawsuit.
Patients whose bariatric surgery involved a medical device, such as a gastric balloon or lap band, may also have a claim against the manufacturer. In many cases, complications following weight loss surgeries are linked to device defects.