In der medizinischen Fachpresse wird ein Verschluss der Zentralarterie im Auge nach kosmetischen Fillerinjektionen im Stirnbereich berichtet. In drei Fällen trat irreversible Blindheit auf.
Abgesehen davon, dass es keine Indikation für Filler in der oberen Gesichtshälfte gibt, muss diese schwerwiegende Nebenwirkung zu Umdenken in der ästhetischen Medizin führen. Fillermaterial kann also wandern und über den Blutstrom zu Verschlüssen von kleinen Gefäßen und Kapillaren führen. Das gilt nicht nur für das Auge, sondern und vor allem für das Gehirn mit der Folge von Mikroembolien und Schlaganfällen.
Bei der Implantation von Fillern – besonders bei flächigem Volumenersatz – kann nicht ausgeschlossen werden, dass kleine Gefäße verletzt werden, auch nicht mit stumpfen Kanülen.
Daher ist eine schriftliche Aufklärung auch über diese – sehr seltenen – Komplikationen eine notwendige Voraussetzung, um einer Beweislastumkehr im Schadensfall zu vermeiden.
Die Fillerimplantation in der Ästhetischen Medizin ist eine invasive, ärztliche und keine kosmetische Behandlung!
Irreversible vision loss should be added to the list of potential complications associated with injection of cosmetic facial fillers.
Michelle V. Carle, MD, from Retina-Vitreous Associates Medical Group, Los Angeles, California, and colleagues report 3 such cases of blindness or near-complete vision loss in an article published online March 6 in JAMA Ophthalmology. All 3 patients had central retinal artery occlusion shortly after receiving an injection of 1 of 3 different dermal fillers. The injections were in the forehead area, which is not an approved site for dermal fillers but is a common off-label use, the researchers write.
In 1 case, a healthy man in his late 30s noticed field vision loss the day after getting an injection of hyaluronic acid. Using fluorescein angiography, clinicians found blockage of retinal circulation in the left eye. He continued to experience left-eye visual field defect a year later.
In the second case, a healthy woman in her early 60s presented with severe vision loss the same day she had an injection of autologous fat into the high forehead. Fluorescein angiography revealed patchy choroidal filling and incomplete filling of the retinal arterioles.
In the third case, a healthy woman in her mid-40s also presented on the same day she had an injection of bovine collagen and polymethylmethylacrylate microspheres (Artefill, Suneva) in her forehead creases. She reported that after the procedure, she could not see with her right eye. Fluorescein angiography revealed delayed and patchy filling of some proximal arteries in the right eye. She still had minimal reaction to light 2 days later, despite aggressive therapy by Dr. Carle and colleagues shortly after the injection.
The cases presented over a time frame of „a year or so“ and to different physicians in a large practice, Dr. Carle told Medscape Medical News. She said there have been reports of ocular complications from injections in other areas but that this is the first report about forehead injection complications.
„This is a very rare event. The risk is very, very low, but the risk is not zero,“ she added. „I just worry that often risks are minimized, and when something bad happens, it catches everybody by surprise. You don’t want to be a fear monger, but at the same time, these areas of the face that we manipulate for a lot of cosmetic procedures are highly vascularized, and now the whole area around the eye has been reported to cause this.“
She said the proposed mechanism for this complication is retrograde flow. When an injection is made under a higher force, the injected substance gets into the external carotid vessel at a high enough force that it flows backward into the internal carotid and into the eye.
„Any substance injected at high pressure into the oculofacial area, including the forehead, can result in occlusion of the central or branch retinal artery or the posterior ciliary circulation, both of which branch from the ophthalmic artery,“ the researchers write. „All 3 of our patients had both choroidal filling defects and retinal arterial involvement.“
Regulations Vary by State
The absence of information in the paper about who performed the injections „is a reason to take pause,“ Robert X. Murphy Jr, MD, a cosmetic and reconstructive surgeon at Lehigh Valley Health Network, Bethlehem, Pennsylvania, and president of the American Society of Plastic Surgeons, told Medscape Medical News. „If you take those of us who are plastic surgeons, who are board-certified, and then you add up all the other people who aren’t, 3 cases are rare.“ State-to-state differences exist on who can perform these cosmetic procedures, he said.
„The tendency of people is to say, ‚injections are kind of minor. Anybody can do it.‘ You’ve seen evidence that as minor [as] they may be considered, there are still people who have bad outcomes,“ he added. „As popular as these procedures have become, it’s really important for people to understand that they are procedures and every procedure carries a risk. To mitigate the risk, try to make sure you have it performed in the appropriate circumstances.“
Data from the American Society of Plastic Surgeons show that more than 2.2 million soft tissue filler injections were performed in 2013, up from about 1.9 million in 2012 and almost 683,000 in 2000. Of the 2.2 million 2013 injections, almost 1.7 million were of hyaluronic acid.
„Complications may be 1 in a hundred million, but if you’re that 1, it’s 100%,“ Dr. Murphy said. He said providers should understand that certain areas carry a higher risk and that understanding the anatomy, balanced with patients‘ wishes and safe procedures, is important.
Still, informed patients are the ones who have to decide, he added, „with the hope that the practitioner is providing them with good and valuable and valid information, and guidance when asked.“
The researchers write, „The indication for fillers are limited to the nasolabial folds and lips by the manufacturers, yet they are often used in other areas. A review of the product and safety information from the manufacturers for many fillers indicates that safety has been established only in specific facial regions (varying by product, but generally the nasolabial folds or lips).“
They conclude, „Ocular arterial occlusion is an uncommon adverse effect of these treatments, but it can be a devastating consequence of injection into areas of rich anastomoses (much of the periocular region).We recommend that blindness or significant visual loss be added as a risk when discussing these procedures with patients, because these are devastating consequences.“
Suneva declined to comment for this story.
The authors and Dr. Murphy have disclosed no relevant financial relationships.
JAMA Ophthalmol. Published online March 6, 2014. Abstract