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Medical Justice

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Patient Safety

Informed Consent and Facial Fillers: Risk versus Reward 

03/10/18 11:23 AM

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. 


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Posted by Medical Justice | in Patient Safety | 6 Comments »

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Robert Lucas MPAS, PA-CDavid ApplebaumPatti FlintEasyEReginald D Rice, MD Recent comment authors
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Stacy J. Childs, M.D.
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Stacy J. Childs, M.D.

Do you have information on Medical Justice specifically designed for medical malpractice insurance companies and lawyers. My company and lawyer do not seem to understand what you do.

Reginald D Rice, MD
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Please use cannulas….yes, it is possible to inject intravascularly with a cannula, however, I know of no cases of such cases documented in literature. The technique is a little different, but any experienced injector will find the switch easy. If you haven’t started injecting, start with cannulas. They are best practice and defensible.

EasyE
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EasyE

I’m happy this dirty little secret about temporary gel-fillers has been brought to light. There is controversy around microdroplet Silikon-1000 treatments, but the size of a polydimethyl-siloxane molecule is smaller than a RBC, and blindness and necrosis NEVER happens with microdroplet Silikon-1000. Temporary gel fillers like HA (Juvey, Resty), and CaHydroxyappetite (Radiesse) may lead to blood vessel occlusion and frank necrosis unless discovered and treated early. One prominent FPS who developed the protocol for recognizing and treating vascular occlusion from temporary gel fillers stated at an AAFPRS lecture many years ago that he receives phone calls from other doctors on… Read more »

Patti Flint
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According to Drs. DiLorenzi and Swift, who are true experts on filler complications, there are an equal number of patients who suffered blindness who were injected with cannulae and needles. According to them, large bolus injections under high pressure injected rapidly is the most common denominator.

David Applebaum
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David Applebaum

Don’t be misguided that “microdroplet” silicon is a “good “alternative to HA fillers. There are long term problems with permanent injectibles as continued dermal,fat, and boney atrophy occur. I don’t think this complication is a “dirty little secret” rather a known complication which should be disclosed to patients as rare but possible with long term complications. I feel that every good instructional course should include as discussion of complication detection and suggested treatment options. This discussion is just as or more important than the discussed product or technique. Understand that almost everything in life has its risks & benefits. We… Read more »

Robert Lucas MPAS, PA-C
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We train physician assistant students, plastic surgeon fellows and plastic surgery residents in all facets of plastic surgery, including neuromodulators and all fillers. We emphasize preparedness for, and recognition of complications such as vascular occlusion/vascular compression and resultant ischemia. Being prepared with nitro-bid, warm compresses, hyaluronidase and HBOT is great but but without a high level of suspicion which leads to the recognition of complications, disasters can result. As an additional level of preparedness, we have relationships with local occuloplastic surgeons nearby in case large dose retrobulbar hyaluronidase is indicated. Technique wise, we warn against moderate or high volume, high… Read more »