Are Injectable Fillers Truly Safe for Off-Label Use?
A recent New York Times article suggests that the use of injectable fillers in non FDA-approved procedures could be a major reason for reported complications.
Chicago plastic surgeon Dr. Julius Few believes another possible reason could be "ancillary medical personnel and doctors who lack expertise in cosmetic treatments."
Speculation about filler safety has been a hot topic of discussion since the FDA panel on dermal fillers convened last month. Off-label uses for dermal fillers like Juvéderm or Restylane, such as injections under the eye or in the hands, might be more prone to complications.
Minneapolis plastic surgeon Bruce Cunningham says filler injections are incident free "99.5 percent of the time, but when a problem occurs, it does stick out in doctors’ minds because it is so different than what we usually expect."
Manhattan plastic surgeon Dr. Rene Rodriguez-Sains claims he has seen a rise in the number of patients with complications of the eye due to filler injections. He says, "certainly I wouldn’t do it myself or have it done on me."
The intended purpose of an under-eye injection is to correct a loss of volume that results in a dark indentation and baggy skin around the patient's eye. Rodriguez-Sains claims he has seen as many as 2 patients a month with eye complications.
However, other off-label uses are quite popular and relatively low rate of reported complications. Many doctors have found hyaluronic acid fillers to be safe and effective in plumping up lips, a use that isn't FDA approved for such fillers.
Doctors are allowed to use products however they see fit, but cannot market them for off-label procedures.
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1125 posts
1 Feb 2009
Patients should be very careful about who they let inject them. The dermal fillers can be very effective when used correctly and in the appropriate situations. Not every filler is appropriate for every patient and not every patient needs fillers.
8 posts
16 Jun 2009
How can I research/find a doctor in CT who does alot of injectible fillers under the eye. I know it is important to find someone who has alot of experience in this particular area.