PR Newswire06.05.18
ReShape Lifesciences Inc., a developer of minimally invasive medical devices to treat obesity and metabolic diseases, provided an explanation and clarifying details to a letter dated June 4, 2018 that the U.S. Food and Drug Administration (FDA) posted on their website addressed to Health Care Providers. The FDA letter updates the agency's August 10, 2017 letter regarding the potential risks of death associated with liquid-filled intragastric balloons manufactured by Apollo Endosurgery and ReShape Lifesciences.
FDA's most recent communication updates the healthcare community regarding additional reports of deaths they have received since August 2017 and discusses the collaborative effort taken with industry to understand these occurrences and enhance product labeling accordingly. In relation to the ReShape Balloon, the facts are:
"Patient safety is our highest priority at ReShape Lifesciences, and safety was the main driver behind the unique dual balloon design of our ReShape Balloon," stated Dan Gladney, Chairman and CEO of ReShape Lifesciences. "We worked closely with FDA to review and enhance our Instructions for Use (IFU), patient information and physician training materials and we will continue to work with the FDA to mitigate patient risk and optimize outcomes so that we can continue to safely and effectively change lives with our obesity solutions."
"Unfortunately, all health care procedures have a certain amount of associated risk, especially when they are dealing with a patient population that often has many associated difficult medical conditions," commented Scott A. Shikora, MD, FACS; Professor of Surgery, Harvard Medical School; Director, Center for Metabolic and Bariatric Surgery, Brigham and Women's Hospital. "It is important to note that FDA's recommendation to providers remains the same: Intragastric balloon patients should be closely monitored during the entire term of their treatment."
FDA's most recent communication updates the healthcare community regarding additional reports of deaths they have received since August 2017 and discusses the collaborative effort taken with industry to understand these occurrences and enhance product labeling accordingly. In relation to the ReShape Balloon, the facts are:
- ReShape Balloon is approved by the FDA as safe and effective for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 – 40 kg/m2 and one or more obesity-related comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.
- There has been one (1) reported death of a patient implanted with a ReShape Balloon since the August 10, 2017 letter from FDA
- The patient death was due to a pulmonary embolization secondary to a surgical repair of a gastric perforation
- ReShape has received no product liability-related claims in connection with this case
"Patient safety is our highest priority at ReShape Lifesciences, and safety was the main driver behind the unique dual balloon design of our ReShape Balloon," stated Dan Gladney, Chairman and CEO of ReShape Lifesciences. "We worked closely with FDA to review and enhance our Instructions for Use (IFU), patient information and physician training materials and we will continue to work with the FDA to mitigate patient risk and optimize outcomes so that we can continue to safely and effectively change lives with our obesity solutions."
"Unfortunately, all health care procedures have a certain amount of associated risk, especially when they are dealing with a patient population that often has many associated difficult medical conditions," commented Scott A. Shikora, MD, FACS; Professor of Surgery, Harvard Medical School; Director, Center for Metabolic and Bariatric Surgery, Brigham and Women's Hospital. "It is important to note that FDA's recommendation to providers remains the same: Intragastric balloon patients should be closely monitored during the entire term of their treatment."