Worldwide Experience with Erosion of the Magnetic Sphincter Augmentation Device
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.
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.
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.
KeywordsMagnetic sphincter augmentation device Gastroesophageal reflux disease Esophageal erosion
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
This work was completed without financial assistance.
This work was not presented at a meeting.
- 3.Ganz RA, Edmundowicz SA, Taiganides PA, Lipham JC, Smith CD, DeVault KR et al. Long-term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux. Clin Gastroenterol Hepatol. 2016;14(5):671–7. https://doi.org/10.1016/j.cgh.2015.05.028.CrossRefPubMedGoogle Scholar
- 4.Bonavina L, Saino G, Bona D, Sironi A, Lazzari V. One hundred consecutive patients treated with magnetic sphincter augmentation for gastroesophageal reflux disease: 6 years of clinical experience from a single center. J Am Coll Surg. 2013;217(4):577–85. https://doi.org/10.1016/j.jamcollsurg.2013.04.039.CrossRefPubMedGoogle Scholar
- 5.Warren HF, Reynolds JL, Lipham JC, Zehetner J, Bildzukewicz NA, Taiganides PA et al. Multi-institutional outcomes using magnetic sphincter augmentation versus Nissen fundoplication for chronic gastroesophageal reflux disease. Surg Endosc. 2016;30(8):3289–96. https://doi.org/10.1007/s00464-015-4659-y.CrossRefPubMedGoogle Scholar