Patient safety is the highest priority for both Dr. Islam and the manufacturer of the ReShape Medical Weight Loss Balloon. We take any potential risks to our patients very seriously, and Dr. Islam is known for his transparency with patients.
Earlier this year, the FDA issued a warning about pancreatitis as a complication of the ReShape balloon procedure. You can read our blog post about this initial statement in our blog archives. When this statement was released, we added pancreatic monitoring to all ReShape protocol.
Earlier this month, the FDA posted an updated letter about ReShape. This update indicated that following balloon insertion, five patients died within 30 days. In all five deaths, the FDA acknowledged that they had insufficient information as to the specific cause of death. There is no indication from the health care providers that the deaths are linked to either the balloon itself or the insertion procedure. There is also no mention in the release referencing what type of doctor performed the procedure.
If you have already had the ReShape balloon insertion or are considering the procedure, it is important for you to know why Dr. Islam and his team always made your safety their first priority.
First, being a specially trained gastroenterologist, Dr. Islam performs endoscopes regularly. In our practice, we have successfully inserted and monitored many ReShape patients. We take each patient’s long term health very seriously and care deeply for you to meet your goals and to gain control of your weight and your life. Consider us your partner in your pursuit of better health. Dr. Islam personally monitors your journey and treats every patient individually.
If more information becomes available from the FDA, you can trust us to keep you informed.