Updated on May 11, 2022
MBSAQIP-Accredited centers must receive approval from an Institutional Review Board (IRB) in order to perform primary procedures that are not endorsed by the ASMBS. ASMBS endorsed procedures and FDA approved medical devices DO NOT require IRB approval. The IRB approval must be for performing the procedures, and not solely for data collection of outcomes from these procedures. In the event that an IRB determines a study protocol unnecessary for a primary procedure that is not endorsed by the ASMBS, a letter of exemption from the IRB is required to demonstrate compliance with MBSAQIP standards. Procedures and devices used for re-operative purposes do not require IRB approval or IRB exemption. However, the ASMBS recommends conforming to the endorsed procedure list when selecting procedures and devices for re-operative purposes whenever possible.
Procedures and devices not listed in these tables are either not endorsed or have not been reviewed and approved by following the ASMBS Pathway for Approval of New Devices and Procedures. A member can submit a procedure or device for review.
ASMBS Endorsed Procedures
- Adjustable Gastric Banding (FDA approved)
- Sleeve Gastrectomy
- Roux-en-Y Gastric Bypass
- BPD/Duodenal Switch
- Single Anastomosis Duodeno-ileostomy with Sleeve
- Bariatric Re-operative Procedures
- Intragastric Balloons (FDA approved)
- One Anastomosis Gastric Bypass
FDA Approved Bariatric Devices
- Adjustable Gastric Band (Lap-Band®)
- Intragastric Balloons (Orbera®, Reshape®, Obalon®)
- Transpyloric bulb (TransPyloric Shuttle®)
- Vagal Nerve Blocking Therapy (Vbloc®)
- Endoscopic Sleeve Gastroplasty (Apollo ESG™, Apollo ESG Sx™ Endoscopic Suturing System)
- Transoral Outlet Reduction (TORe) (Apollo Revise™ and Apollo Revise Sx™ Endoscopic Suturing System)
Originally posted October 18, 2016
Updated December 5, 2022