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Be Careful! Fillers and Regulation.

Writer's picture: NataliaNatalia




There is much current debate with regard to the qualifications and regulations with regard to the use of dermal fillers. The article I found below demonstrates how and why this is a real issue. Anyone considering dermal fillers must make sure that the person you go to is fully qualified. I cannot emphasise this enough. The article is not my own work and the citation is shown below the article. The italics in the article are mine, where I have "translated" some of the medical terms.



Soft tissue filler injections remains in the top five minimal invasive cosmetic procedures, performed in 2.70 million cases in 2019 alone. Compared to neurotoxins, filler complications occur more commonly and are often more severe. A total of 3,782 adverse events were reported on the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience from 1993 – 2014.2 The true incidence is unknown due to the lack of universal reporting and minor complications that patients do not address. The most severe filler complications include vascular necrosis (8.5%), anaphylactic reaction (5.5%), autoimmune reactivation (0.7%), strokes (0.1%) and even death (0.1%).


Defining “safe zones” and “danger zones” for injections can be challenging as the vascular anatomy of patients is highly variable with multiple anastomoses (basically, we are not all quite "wired" in exactly the same way). The arterial blood supply of the face arises from the external carotid artery (facial artery, transverse facial artery, and superficial temporary artery) while the arterial blood supply of the orbit arises from the internal carotid artery (ophthalmic artery).6 Within one-fifth of the population, the cilioretinal artery occurs off a branch of the posterior ciliary artery instead of the ophthalmic artery that allows for an alternate mode of perfusion of the optic nerve and macula (part of the retina) This accounts for preserved vision in cases of central retinal artery occlusion.


Intravascular occlusion resulting in vision loss is related to retrograde flow of a small particle from the facial vasculature to the orbital vasculature. This may occur from direct arterial wall perforation or vascular cannulation. The injection force must be greater than the systolic blood pressure to push the resulting embolus. The risk of vascular occlusion is low, occurring in 1 per 5,000 syringes used, with lower occlusion rates associated with microcannulas


Certain injection techniques can be utilized to avoid intravascular occlusion. Anatomical studies have shown the ability of a cannula to penetrate an artery. Insertion of needles should be placed perpendicularly to avoid contact with a vessel, as any angle can allow penetration. Smaller gauge needles may easily penetrate a vessel. Aspiration can be performed to ensure no blood is seen through the syringe. However, even small movements of the syringe may change the position in the needle.


The glabella (the area of skin between the eyebrows and above the nose) is one of the highest risks of skin necrosis and vascular blindness. Given the delicate region, hyaluronic acid fillers are recommended, as they are reversible and have excellent integration. Superficial injections should be performed in the glabella as the neurovascular bundles are deep in this region.


Specific considerations should be taken when injecting within the temporal region. The superficial temporal artery can be palpated. Injections should occur deep on the periosteum (membrane that covers the bones), superomedial to the temporal line of fusion and posterior to the hairline.


In the tear troughs, injections should be placed deep on the periosteum. Care should be taken to avoid the infraorbital foramen, in line with the medial limbus (outer bit of the inner eye). Injections should be placed laterally deep on the periosteum.


Along the midface, injections should be placed deep on the periosteum. The needle should be positioned perpendicular to the periosteum along the zygoma


In the nasolabial region, both deep dermal and superficial subcutaneous injections can be performed on the inferior two-thirds. Injections in the upper third of this region should occur in a pre-periosteal plane and 2-3 mm above the alar groove to avoid cannulation of the facial artery or vein. At the nasal labial folds, the use of retrograde linear threading, fanning and serial puncture can be used.


No reported cases of blindness have resulted from lip augmentation, but theoretically can occur with anastomosis of the superior labial artery. A small injection with a cannula or needle, parallel to the lip margin allows for a safe technique. Care should be taken at the medial third of the lip where the superior labial artery courses more superficially at the wet-dry mucosal junction of the upper lip. Deep injections should be avoided within the oral mucosa and deep in the oral commissures.


Hyaluronic acid filler can be depolymerized by an endogenous enzyme hyaluronidase. In any office where injectables are to be performed, hyaluronidase should be readily available to allow for immediate reversible of soft tissue filler application. Case reports and animal models of hyaluronidase to restore vision loss have not demonstrated the ability to reverse vision loss.


Soft tissue fillers can be utilised to combat facial aging and volume. Appropriate understanding of facial anatomy and injection technique is key to avoid rare and devastating ophthalmic complications. Many of these cases result in irreversible vision loss with no effective treatment for intravascular occlusion. Providers must be aware of early signs of complications and provide prompt treatment.


The above may sound extreme though please do read the full article for further information. The point, though, is made. Any injections of fillers or neurotoxins (e.g. Botox) must be only carried out by fully qualified (and regulated) therapists or medical professionals.


NOT MY OWN WORK - Taken from:


Vision Loss and Blindness Following Fillers Ann Q. Tran, MD (1), (2), Wendy W. Lee, MD, MS1 (1) Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL (2) Manhattan Eye Ear Throat Hospital, Northwell Health, New York, NY




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