Alerte De Sécurité sur Intragastric balloon systems

Safety alert

2018-07-18

2018-07-18

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20180718b.html

Medical device safety alert: intragastric balloon systems the therapeutic goods administration (tga) of australian government has conducted a product safety review of two intragastric balloon systems on the australian register of therapeutic goods, including orbera intragastric balloon system (manufactured by apollo endosurgery) and reshape integrated dual balloon system (manufactured by reshape lifesciences). tga's review follows information published by food and drug administration (fda) of the united states about deaths and serious injuries to patients associated with use of intragastric balloons to treat obesity. tga has received 19 adverse event reports since 2009 regarding the intragastric balloon systems that are currently being supplied in australia. these reports include three patient deaths. tga is working with sponsors and manufacturers to ensure clinicians and patients are fully informed of the risks with this type of device. information for health professionals and patients as below: if doctors are treating a patient who has an intragastric balloon, be alert to symptoms that might indicate there is an issue associated with the device. adverse events associated with these devices include: obstruction; ulceration; necrosis; ischaemia (gastric or intestinal); spontaneous hyperinflation of the balloon; perforation (oesophageal, gastric or intestinal); gastritis/ gastric erosions; acute pancreatitis. where relevant, patients should be advised to take the necessary precautions to prevent pregnancy prior to placement and throughout the duration of treatment, and be instructed to inform doctors as soon as possible if pregnancy is confirmed during treatment, so that removal of the device can be arranged. tga recommends that doctors monitor patients closely during the entire term of treatment with intragastric balloon systems for possible complications. in particular, be aware that patients with an intragastric balloon who present with severe abdominal pain and have a negative endoscopy and x-ray, may still require a ct scan to definitively rule out a perforation. an intragastric balloon should not be used in patients who: are under 18 years of age; have had previous upper gastrointestinal surgery; regularly take aspirin, non-steroidal anti-inflammatory agents, cox-2 inhibitors, anti-coagulants or anti-platelet agents; are pregnant; have a clinically significant hiatus hernia; have a history of inflammatory disease of the gastrointestinal tract. there are other conditions that may also preclude use of an intragastric balloon, and so it is important that patients discuss complete medical history with doctors. if they or someone they provide care for has an intragastric balloon system in place, be alert to potential issues. complications (mentioned in the adverse events), although rare, may require abdominal surgery, or have serious consequences including death. symptoms to watch out for include persistent or recurrent abdominal pain, swelling of the abdomen, vomiting, difficulty breathing or back pain. do not ignore these symptoms and seek medical attention as soon as possible. for detailed information, please refer to tga website https://www.Tga.Gov.Au/alert/intragastric-balloon-systems. posted on 18 july 2018.