Injectable cosmetic fillers have become a cornerstone treatment in the field of aesthetics over the last few decades. Soft tissue augmentation has existed since the early 20th century, when industrial-grade silicone was used, followed by injectable cosmetic fillers formulated with bovine collagen in the 1980s. In the 1990s, these products become the second-most popular minimally invasive aesthetic procedure in North America, focused mainly on volumizing and recontouring the facial region. In 2013, more than 2.2 million soft tissue dermal filler procedures were done.
Practitioners and patients alike attribute the rising popularity of this treatment to its ability to provide solutions to the axiom of an aging face, where dermal, subcutaneous, and even osseous atrophic changes can be seen. It replaces the lost volume seen from these changes and restores a level of youthfulness back to the patient; overall, it is part of a foundation that supports facial rejuvenation.
In 2010, over 200 fillers from 60 different manufacturers were available worldwide. Although many seem to be similar to one another, there are crucial distinctions between the products that medical professionals must be aware of for optimal use. Inexperienced practitioners that inappropriately substitute one product for another invite complications that ultimately lead to reduced patient satisfaction and patient safety.
The ideal dermal filler is effective, easy to inject, nonreactive, has low incidence of side effects, and is, most importantly, long-lasting. The need to fulfil the last criterion has propelled the advancement of cosmetic fillers into categories based on longevity; these categories include temporary, semi-permanent, and permanent.
Permanent fillers provide excellent long-term results but carry more potential for adverse events and generally require a higher level of expertise for their administration. Furthermore, the complications, if they do occur, tend to be less forgiving than temporary or semi-permanent fillers because of the lack of degradation of these fillers, meaning they tend to remain intact inside the skin for a significantly longer time than other, less permanent fillers.
As such, it is therefore vital that every aesthetic practitioner know the potential complications that can occur with treatment from permanent fillers and how to deal with them.
Issues with permanent fillers
To help increase aspects of patient safety, rigorous clinical trials are required, as per the standards set by the Food and Drug Administration (FDA), to scrutinize all potential complications of a drug/treatment prior to its release to the general public. Due to the stringent requirements for approval, permanent fillers are less likely to be found in North America. Bellafill is only one such permanent filler that has undergone this process to gain acceptance in the United States.
In Europe, the standards for the European Union differ insomuch as they require a CE certificate. This certificate concerns only the technical aspects of the manufacturing process, which means that the biological safety of the permanent filler is not taken into consideration. As you can imagine, the identification of dermal filler complications can then only be done in a retrospective manner, through anecdotal evidence. This difference explains why most reported permanent dermal filler complications come from Europe.
The increase in demand for long-lasting cosmetic fillers has made patient education an essential part of treatment plans. Temporary cosmetic fillers are capable of being broken down and resorbed into the surrounding tissues in a relatively short amount of time, while permanent cosmetic fillers resist being broken down. Permanent fillers are characterized by their irreversibility, even as the facial shape changes with age. They are able to achieve full and long-lasting correction but carry the risk of more severe and even permanent adverse effects. In addition, infection rates have been reported to be up to 19% for one particular permanent filler.
Complications of cosmetic fillers
However, all cosmetic fillers have adverse effects regardless of their duration of action. Generally, complications can be divided into early (immediate post-treatment to 14 days), late (14 days to one year), and delayed (more than one year) reactions.
Early reactions common to injections are erythema, pain, edema, bruising, and bleeding. They are transient in nature, usually mild to moderate in severity, and last less than 14 days as mentioned above. They can be avoided with good injection technique and skilled maneuvering.
More serious early complications are under- or over-correction, implant visibility, wrong tissue plane filler placement, infection, intravascular injection, and embolism resulting in blindness. While most of these can be mitigated with the administration of hyaluronidase if hyaluronic acid cosmetic fillers are used, permanent cosmetic fillers can result in permanence with any of these complications.
Below is a list of additional adverse effects associated with permanent dermal fillers:
This is an iatrogenic complication that arises when too much permanent dermal filler has been placed in a particular area and when the degree of fibroplasia that will occur over time has been underestimated. These are common mistakes most inexperienced practitioners will make, as they may not know that permanent fillers depend mainly on volume replacement by fibroplasia over time. The soft tissue will be augmented beyond what is appropriate if permanent fillers are not placed in small amounts over multiple sessions where the intervals allow adequate time for tissue augmentation to occur.
Direct arterial embolization
This is a deadly consequence that occurs particularly in areas such as the glabellar supratrochlear arterial branches, labial artery, nasal dorsal artery, and angular vessels along the nasolabial folds. Early manifestations are blanching and excessive pain. This complication is typically treated aggressively with vasodilating agents, such as nitroglycerin paste, applied topically.
Compromise of the venous circulation
If large quantities of filler are deposited, it may displace and compromise blood vessels, such as the angular vessels. Symptoms such as dull aching pain, swelling, and a patchy violaceous discoloration of the skin can occur.
It should go without saying that care must be taken to ensure that both sides of, for example, the face or lips, are augmented equally. However, in the case of permanent cosmetic fillers, this may be exceptionally challenging because they do not show immediate volume correction. As such, awareness during product placement is essential. Aadequate time must pass between injection sessions to avoid placing too much in one area.
This is a concern for all permanent cosmetic fillers where large injected volumes are concerned. The large volume increases the risk of the product tracking along tissue planes and ending up in distant body sites.
Contour and textural irregularities
Permanent fillers best function when they are placed deeply into the deep reticular dermis, subcutaneous tissue, or deeper. The particulate component of a few permanent cosmetic fillers, such as polymethylmethacrylate (PMMA) and acrylic hydrogels, is not suitable for the smooth, soft, and pliable nature of superficial placement.
Foreign body granulomas and late-onset granulomas
These are the most challenging complications to treat, and they are more likely to occur with permanent cosmetic fillers. They are manifestations of the host’s natural immunologic response to a foreign body. It is characterized by macrophages and the formation of foreign body giant cells that arrive to both phagocytose the foreign material and deposit fibroblastic collagenous materials. In normal circumstances, it creates a controlled fibrous area around the filler material, and augmentation occurs in a controlled manner. If the fibroblastic response does not stop, however, it will manifest as a foreign body granulomatous complication.
These are persistent subclinical infections of the surface of the permanent filler material. They are living colonies of bacteria that adhere to the foreign body surface (i.e. bolus of permanent filler) and are encapsulated by a protective matrix that avoids host immune response and antibiotics. These have also been involved in granuloma formation. They remain quiescent for months or years and can produce inflammatory and infectious processes.
Removing permanent fillers
In the case of permanent filler removal, consider minimally invasive techniques, such as needle aspiration, extrusion after incision, and liposuction, first. Surgical removal and laser destruction will be necessary if these prior modalities have been exhausted and the problematic area is still persistent. Keep in mind that complete removal of all filler particles may not be possible and that the best option is to reduce the incidence of recurrent biofilm infection.
Permanent fillers are produced in discrete collections with capsule formation; removal is easier in this regard, but there have been cases where removal can cause permanent damage to nearby structures. Also, introduction of infection during the removal process can lead to permanent scarring.
Depending on the area injected, removing through the complex anatomical regions of the face can be a daunting challenge for many practitioners. Extensive knowledge of the craniofacial region is essential.
Preoperative MRI with contrast can help determine the exact site to be removed and the method of removal (e.g. open or surgical needle, stab incision expression). An experienced radiologist can help guide incisions into the filler targets and can demonstrate that a complete-as-possible filler removal was performed.
All cosmetic fillers are not created equal and treating the aging face requires tactful management so that you deliver the desired outcomes to your patients. Any dermal filler may cause the complications mentioned above. The increasing use of these fillers and their expansion into the cosmetic industry has demanded that practitioners be versatile and knowledgeable.
Indeed, the modern aesthetic practitioner must be aware of these possibilities and recognize the products, complications, and treatment strategies. The surgical costs of removing the fillers are higher than the costs of the initial injection procedure. Most patients are not aware of these implications; therefore, it becomes the responsibility of the medical professional to inform them.