Smart Plugs: Report complications to the FDA
I posted about this to my blog recently and am adding it here so newcomers will see it.
The reason for my urgency on this topic is:
- the excessively high complications rates associated with Smart Plugs emerging in the medical literature and
- the seriousness of those complications and
- the frequent requirement for surgery to correct the complications and
- the potential for failure to resolve the ensuing symptoms even with surgical intervention.
Click here to read more.
I encourage you to report complications your or your patient has experienced with ANY punctal or intracanalicular plug. This post focuses on Smart Plugs because their complications are documented in the medical literature.
If you have had a Smartplug complication of any kind, ask your doctor to report it to the FDA via MAUDE and to tell it to the manufacturer. If they are reluctant, do it yourself. Come to think of it, do it yourself anyway - if it's a duplication they'll figure it out and deal with it. See links below:
If you have a patient who had canaliculitis or another complication from a SmartPlug, report it to the FDA on the MAUDE database.
Here's the link to MAUDE.
And while you're at it, make sure you report it to Medennium too on their Contact page. Device manufacturers are required to notify the FDA of post market complications they become aware of.
I just had a look and there are only 14 reports of SmartPlug complications on MAUDE - on this device that has been on the market almost a decade and which has been studied extensively. (To find them, search first under SmartPlug and separately under Smart Plug.)
14, seriously? How about the 19 in the Hill study, or the 41 in the study group, or the ones in the Chou study, Burgess study, Mazow study? Let alone the ones in all the other hundreds of cities (and not a few countries) where none of these study authors practice? Why isn't anybody reporting these things? How is the FDA supposed to monitor stuff if nobody ever tells them anything?
I feel that Smart Plugs are following the unfortunate pattern of some other medical devices: Released to the market on the basis if studies with VERY SHORT follow-up periods (like 6 months) and it takes years to discover that there really are more frequent and more serious complications associated with the device. The information about the complications needs to not go unnoticed. It must be fed back in to the manufacturer and the FDA so that devices which do not meet safety standards can be removed from the market.
The Dry Eye Zone