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Journal of Gastrointestinal Surgery

, Volume 22, Issue 8, pp 1442–1447 | Cite as

Worldwide Experience with Erosion of the Magnetic Sphincter Augmentation Device

  • Evan T. Alicuben
  • Reginald C. W. Bell
  • Blair A. Jobe
  • F. P. BuckleyIII
  • C. Daniel Smith
  • Casey J. Graybeal
  • John C. Lipham
Original Article
  • 173 Downloads

Abstract

Background

The magnetic sphincter augmentation device continues to become a more common antireflux surgical option with low complication rates. Erosion into the esophagus is an important complication to recognize and is reported to occur at very low incidences (0.1–0.15%). Characterization of this complication remains limited. We aim to describe the worldwide experience with erosion of the magnetic sphincter augmentation device including presentation, techniques for removal, and possible risk factors.

Materials and Methods

We reviewed data obtained from the device manufacturer Torax Medical, Inc., as well as the Manufacturer and User Facility Device Experience (MAUDE) database. The study period was from February 2007 through July 2017 and included all devices placed worldwide.

Results

In total, 9453 devices were placed and there were 29 reported cases of erosions. The median time to presentation of an erosion was 26 months with most occurring between 1 and 4 years after placement. The risk of erosion was 0.3% at 4 years after device implantation. Most patients experienced new-onset dysphagia prompting evaluation. Devices were successfully removed in all patients most commonly via an endoscopic removal of the eroded portion followed by a delayed laparoscopic removal of the remaining beads. At a median follow-up of 58 days post-removal, there were no complications and 24 patients have returned to baseline. Four patients reported ongoing mild dysphagia.

Conclusions

Erosion of the LINX device is an important but rare complication to recognize that has been safely managed via minimally invasive approaches without long-term consequences.

Keywords

Magnetic sphincter augmentation device Gastroesophageal reflux disease Esophageal erosion 

Notes

Author Contributions

Study conception and design: Lipham.

Acquisition, analysis, or interpretation of data: Alicuben, Bell, Jobe, Buckley, Smith, Graybeal, Lipham.

Drafting or critically revising: Alicuben, Bell, Jobe, Buckley, Smith, Graybeal, Lipham.

Final approval: Alicuben, Bell, Jobe, Buckley, Smith, Graybeal, Lipham.

Compliance with Ethical Standards

Grant Support

This work was completed without financial assistance.

Meeting Presentation

This work was not presented at a meeting.

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Copyright information

© The Society for Surgery of the Alimentary Tract 2018

Authors and Affiliations

  • Evan T. Alicuben
    • 1
  • Reginald C. W. Bell
    • 2
  • Blair A. Jobe
    • 3
    • 4
  • F. P. BuckleyIII
    • 5
  • C. Daniel Smith
    • 6
  • Casey J. Graybeal
    • 7
  • John C. Lipham
    • 1
  1. 1.Department of Surgery, Keck Medicine of USCUniversity of Southern CaliforniaLos AngelesUSA
  2. 2.SurgOne Foregut InstituteEnglewoodUSA
  3. 3.Esophageal and Lung Institute, Allegheny Health NetworkPittsburghUSA
  4. 4.Temple University School of MedicinePhiladelphiaUSA
  5. 5.Foregut & Reflux Surgery, Dell Medical SchoolThe University of Texas-AustinAustinUSA
  6. 6.Esophageal Institute of AtlantaAtlantaUSA
  7. 7.The Heartburn and Swallowing Center, Northeast Georgia Physicians GroupGainesvilleUSA

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