Just listing some of the SAFETY concerns (not effectiveness) people have/had regarding the LINX. I don't know what the status is on each of these. Appreciate if anyone can dump their info.
- Erosion - I think SpineQueen mentioned that Titanium is inert, so erosion should not be a problem. Some old silicon based implants around GE junction did create serious problems with erosion into stomach/esophagus.
- Migration from optimal
location - We don't have sufficient data yet, but the theory is that the scar tissue prevents migration?
- MRI restriction - Is there any plan around this at all?
- Long term safety/efficacy - According to the approval order for LINX
www.accessdata.fda.gov/cdrh_docs/pdf10/P100049a.pdf it is mandatory for Torax to
(a) keep track of every device installation
(b) start another new 5 year study
(c) report to the FDA every year (next report due in March 2013)
- Surgical complications - It does seem like it is a relatively straightforward surgery with no known vagus nerve or other complications.
- Device integrity - I don't know what the ring that holds together the magnets is made up of. Is there any cause to believe that that ring can break ? Also the locking mechanism to "close the loop" is based on magnets as shown in
www.youtube.com/watch?v=GiLtbQWLfA0. I wasn't sure if it is actually foolproof although it does seem like it is.