In May, the FDA issued a report called: Unintentional Injection of Soft Tissue Filler into Blood Vessels in the Face: FDA Safety Communication. For our general audience, fillers are approved to reduce the appearance of wrinkles or augment hollowed-out areas, such as lips or cheeks. When injected by trained and experienced practitioners, the safety record is quite good. On rare occasion, complications can be horrific. I have seen pictures presented at plastic surgery conferences of skin slough. I have seen reports of patients becoming blind. In such circumstances, it is believed the filler can block blood vessels directly and/or embolize to distal vessels – including those of the eye or brain. If it happens to your patient, you’ll never forget it.
The FDA reasonably counsels:
Do not inject soft tissue fillers if you do not have the appropriate training or experience.
Make sure that you are familiar with the anatomy at and around the site of injection, keeping in mind that blood vessel anatomy can vary among patients.
Know the signs and symptoms associated with injection into blood vessels, and have an updated plan detailing how you plan to treat the patient if this should this occur. This may include on-site treatment and/or immediate referral to another health care provider for treatment.
Immediately stop the injection if a patient exhibits any signs or symptoms associated with injection into a blood vessel, such as changes in vision, signs of a stroke, white appearance (or blanching) of the skin, or unusual pain during or shortly after the procedure.
All good advice.
The FDA also advises:
Before injection, thoroughly inform the patient of all risks of the procedure and the specific product you intend to use.
Tell patients that they should seek immediate medical attention after the procedure if they experience signs and symptoms associated with injection into a blood vessel.
It’s easy to forget that cosmetic procedures are medical procedures; with risks and potential complications – some irreversible. I can imagine it’s difficult informing a patient who wants his/her appearance improved by fillers that there’s a risk of blindness, stroke, or death – albeit rare. And full informed consent would include educating patients on identifying complications as soon as possible to enable intervention, if possible.
For those who perform such cosmetic injections, do you explain these rare ischemic complications in advance of the patient saying “yes”? If so, how do you do it? Do some patients rethink their decision and go home?
Please weigh in using the comments box below.