- October 2011 Co-Sponsored Workshop
- May 2012 Panel Meeting
- Patient Risk Tolerance Survey
- Benefit-Risk Assessment Model for Clinical Trial Design of Obesity Treatment Devices
- Warning Letters
On October 16-18, 2011, the FDA, Dartmouth Device Development/GI at Dartmouth Medical School, and the Obesity, Metabolism and Nutrition Institute at Massachusetts General Hospital co-sponsored a two day workshop, “Device Development in Obesity and Metabolic Disease (DDOMD).”
The DDOMD workshop consisted of lectures and panel discussions addressing the following key topics:
- Overview - The Epidemic of Obesity and Metabolic Disease
- Optimization of Clinical Trial Design: Controls and Blinding
- Case Presentations - Previous Device Trials
- Inclusion Criteria and Outcome Targets
- Device Development Strategies and Regulatory Considerations
- Clinical Perspective
- Industry Perspective
- Payer Perspective
- Looking to the Future
Additional information about the DDOMD workshop is available at http://www.obesitydevices.org.
On May 10-11, 2012, the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee discussed general issues related to obesity treatment devices and provided clinical study design recommendations to better evaluate the safety and effectiveness of obesity treatment devices. The FDA presented background information to the Panel on the following topics:
- FDA-approved obesity treatment devices
- Published literature regarding benefits of weight loss
- Options for control arms in clinical studies
In addition, the FDA discussed current efforts to explore ways to incorporate patient preferences in the decision making process that leads to approval of new medical devices. The FDA also presented a benefit-risk assessment method for categorizing and quantifying risk for the purposes of identifying an acceptable effectiveness target.
For more information about this panel meeting click the following link: May 10-11, 2012: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee.
FDA’s Center for Devices and Radiological Health (CDRH) has worked with the Research Triangle Institute Health Solutions (RTI‐HS) to carry out the first national benefit‐risk preference study to provide information on patient risk tolerance. The study surveyed 654 obese patients to assess how much risk they would tolerate in order to lose weight. In order to assess benefit-risk preferences before and after having a procedure, the survey included 23 patients who had previously undergone gastric bypass or banding procedures. In addition, the preferences of those patients who underwent gastric bypass or banding procedures were compared with those who did not. The results of this survey provide significant information on patient benefit-risk preferences, and will help the FDA evaluate the applicability of a patient risk tolerance survey as a tool in FDA’s decision making process.
The FDA proposed a new benefit-risk assessment model to help manufacturers in developing clinical studies that can provide valid scientific data on the safety of obesity treatment devices. These studies will help the FDA to make well-informed regulatory decisions. The new benefit-risk assessment model includes 11 categories of expected and unexpected events that could occur following device placement, collected from available clinical data and real-world use of the devices. Based on the percentages of patients experiencing events in each category in the year following device placement, a new medical device could be assigned to one of four risk levels. The FDA also proposed different effectiveness targets for the different risk levels.
The proposed new model includes many of the important concepts of benefit-risk assessment, such as:
- Type of benefit
- Level and duration of benefit
- Probability of a patient experiencing benefit
- Number, severity, and types of harmful events associated with the use of the device
- Probability of a harmful event
FDA’s proposal is outlined in a journal article featured in the March 2013 print issue of the Journal of Surgical Endoscopy.
The FDA issued warning letters to several California-based surgical centers and a marketing company for failing to include appropriate use and risk information, such as warnings, precautions, side effects, and contraindications that are required in advertising certain devices.
- 1 800 Get Thin LLC 12/12/11
- San Diego Ambulatory Surgery Center, LLC 12/9/11
- Palmdale Ambulatory Surgery Center 12/9/11
- Valencia Ambulatory Surgery Center, LLC 12/9/11
- Beverly Hills Surgery Center, LLC 12/9/11