Important Safety Alerts

The Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom posted a medical device alert concerning Easy Life Balloon (reference number: ELB/800-KT3.0/70 and serial numbers: all), manufactured by Life Partners.

Some users have informed the manufacturer of partial deflation cases. There may be potential complications related to a balloon deflation: partial deflation can lead to a total deflation, causing balloon migration. The balloon could remain blocked in the digestive system and cause an obstruction which could prove to be fatal for the patient. The obstruction would need to be removed, either endoscopically or surgically.

The manufacturer has decided to stop marketing the affected intragastric balloon (since June 2013) and it is currently working on a solution to improve the levels of air tightness. It also recommends the followings:

• Any remaining stock of affected products should be returned.
• Physicians should not proceed with any new implantation of the affected products
• Patients should be informed on all the risks and complications related with a medical device as well as the potential additional complications which are may arise.
• A regular monthly follow-up of patients should be performed and it is necessary for physicians to urgently meet the patients who currently have a balloon implanted in order to perform a radiological or endoscopic review of the balloon. Each physician should judge the actions to be taken according to each patient: i.e. balloon to be maintained implanted, adjustment of balloon volume, or retrieval of balloon.

For details, please refer to MHRA website
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON394666

If you are in possession of the product, please contact your supplier for necessary actions.

Posted on 28 Mar 2014