Gastric Balloon Perforations Lead to FatalitiesSeptember 19, 2017
For many patients suffering from obesity and the range of health conditions that go along with it, surgical procedures like gastric bypass and gastric balloon implants have resulted in significant weight loss and improved health. However, patients, physicians, and surgeons should be aware that there may be serious health risks associated with these procedures and medical devices. The U.S. Food and Drug Administration (FDA) issued an alert recently, warning that there were five fatalities between 2016 and the present that were connected to gastric balloon procedures.
According to FDA officials, five patients passed away unexpectedly within a month after having a liquid-filled gastric balloon system implanted in their stomach. Three of the patients died between one and three days following the surgical procedure. The FDA said they are still investigating the exact cause of the fatalities. At the time of the alert, the FDA could not say definitively whether the fatalities were directly linked to the device or the insertion procedure.
Risk of Perforation During Device implantation
One of the risks associated with these procedures is the potential for gastric, esophageal, or intestinal perforation, either while the device is being implanted or during the recovery process. One of the reported fatalities involved a patient who suffered a gastric perforation while having an Orbera Intragastric Balloon System implanted. One of the other five fatalities involved a patient who suffered an esophageal perforation from the ReShape balloon system. The company that manufactures the Orbera Balloon System, Apollo Endosurgery of Austin, Texas, reported the cases to the FDA, but they were not contacted by any physicians or hospitals suggesting that they were liable for the deaths.
This recent scrutiny of surgical weight loss procedures comes after the FDA received reports that there were instances of the liquid-filled gastric balloons becoming over inflated with air or liquid while in patients’ stomachs. As a result, devices had to be removed ahead of schedule. According to John Morton, a bariatric surgeon at Stanford University and former president of the American Society for Metabolic and Bariatric Surgery, placement of these balloons requires the skill of an experienced surgeon who can recognize the signs of perforation. If detected in time, it is possible to repair a perforation.
Morton said that it is important that these procedures be performed at accredited facilities that have the resources to follow up with patients and the experience to recognize potential problems. The FDA continues to work with manufacturers like Apollo Endo-Surgery and ReShape Medical Inc. to better understand what could have caused these fatalities, and how to prepare for unexpected complications, including acute pancreatitis and spontaneous over inflation.
Baltimore Medical Malpractice Lawyers at LeViness, Tolzman & Hamilton Seek Justice for Victims of Medical Negligence
If you or a loved one has become seriously ill or suffered any harm after a surgical gastric balloon procedure, do not hesitate to contact the Baltimore medical malpractice lawyers at LeViness, Tolzman & Hamilton. If the device was not implanted properly, was defective, or you did not receive the proper postoperative care, we will ensure that the medical professional responsible for your care is held liable for your injuries. We are committed to protecting your rights and obtaining the maximum financial compensation you deserve. To schedule a free consultation, call us today at 800-547-4LAW (4529) or contact us online.
Our offices are located in Baltimore, Columbia, Glen Burnie, and Towson, allowing us to represent medical malpractice victims in Maryland, including those in Anne Arundel County, Carroll County, Harford County, Howard County, Montgomery County, Maryland’s Western Counties, Southern Maryland, and the Eastern Shore, as well as the communities of Catonsville, Essex, Halethorpe, Middle River, rosedale, Gwynn Oak, Brooklandville, Dundalk, Pikesville, Nottingham, Windsor Mill, Lutherville, Timonium, Sparrows Point, Ridgewood, and Elkridge.