INJECTABLE DERMAL FILLERS
Injectable filler (injectable cosmetic filler, injectable facial filler) is a filler injected into the skin to help fill in facial wrinkles and loss of facial volume, restoring a fuller, smoother and more youthful appearance. Most of these fillers are temporary because they are eventually absorbed by the body – usually within 6-12 months depending on the substance concentration, patient profile and mechanism of action but there are some that last longer and are even considered permanent.
Types of Fillers
The most commonly used filler substance is Hyaluronic Acid (HA) also called Hyaluronan (as the HA really is a form of salt – not an acid) that is found in our own bodies and plays a significant role in many ways such as cartilage/joint hydration, tissue regeneration and wound healing due to its incredible imbibing capabilities.
As HA can withhold water 1000 of its weight, it is not only excellent as volume and smoothing agent but also a powerful hydrator, used also topically. Because the free, radical form of the HA is very easily dispersed, degraded and destroyed, various binders such as BDDE (most commonly used in HA fillers) are usually used to delay the degradation and to provide more localized structure and thus allow 6-12 months benefits as injected and intended.
Algeness® is the newest breakthrough in the filler industry. A biomaterial consisting of a purified agarose gel (in the polysaccharide family like HAs), derived from a sophisticated manufacturing process. For the first time in the aesthetic medicine history, a 100% natural, biocompatible and biodegradable injectable implant, with a durability profile comparable to the HA fillers, is available on the market, fulfilling the expectations and requirements of the most demanding practitioners. Algeness ®does not contain cross-linked synthetic chemicals (BBDE) associated with Hyaluronic Acid (HA) fillers. It gives you immediate results, provides excellent duration of the result and has a very safe and tolerated safety profile – all of which are proven by clinical studies. Furthermore, it is extremely low in migration which allows you to form and shape the face like no other dermal filler does today – excellent for mid face, nose or chin correction!
Other non-permanent or temporary types of injectable fillers are collagen fillers – of either bovine (cow) or human origin. These are not so much more used as they tend to last from 6 weeks to 6 months and are likelier to have allergic reactions and other Adverse Events than HA based fillers.
Substances such as hydroxylapatite (bone crystals) and polylactic acids (lactic acid) are used as dermal fillers but are usually considered more permanent as they are so called bio-stimulators some delivering immediate volume others not but all causing skin regeneration via fibroblast stimulation leading to collagen synthesis that greatly improves the skin thickness and quality over longer term rather than actually helping to fill.
These can be difficult to administer and utilize as there is no antidote if having an adverse reaction or unintended results as there is for HA or Agarose fillers. Also, the longer term results can be unpredictable and more side effects have also been seen in form of inflammation and infection some even months post injection but in the hands of well trained experienced injector, these types of products can be very beneficial to some patients.
Finally, autologous tissue – particularly fat tissue harvested from areas of ones own body and re-injected into other areas, including face and treating volume loss and wrinkles have been used over the years. It has proven to work well for some and not so well for others and often require multiple rounds of harvesting and injection as some of the cells die in the process of relocation. However, the ability to contour and precision in terms of results are not nearly as great as with HA fillers.
Who is a candidate for treatment and what to expect
If looking at HA fillers, nearly anyone can receive treatment meaning there are not really any exclusion factors as such. Treatment and to a large degree outcomes with dermal fillers are individual depending on the age, skin quality and type as well as external factors such as sun exposure, smoking, etc.
Some people and areas of treatment may need more than one injection to achieve the intended effect. Successful results depend – as stated above – on health of the skin but also the skill of the health care provider and the type of filler used. In general, the effect lasts for about 6-12 months but for some this will be shorter and for some longer.
Typically, the most common types of patients are:
With polysaccharid fillers, there are no limitations as to the number of treatments the patients are able to receive nor age or gender limitations as such.
How to choose a treatment and which product is the right one to use?
The first point is to check whether the product is properly documented and produced. In the US, fillers are approved as medical devices by the Food and Drug Administration (FDA) and fall under prescription practices. in Europe and the UK, HA fillers need CE marking from the health authorities and are non-prescription medical devices.
CE mark, which regulates adherence to production standards, does not require demonstration of medical efficacy the same way FDA approval does. As a result, there are many more injectable fillers in the UK/ European market originating from all over the world compared to a handful available in the US. However, nowadays EU regulating body and local health authorities require post marketing authorization surveillance and adverse event reporting on medical devices in class III (including fillers).
MediNordic sells its injection products only to healthcare professionals.
Who treats you matters too! In the US the injection is prescribed and performed by a health care provider, usually a doctor. In the EU fillers can usually be injected by anyone licensed to do so by the respective local medical authorities – usually doctors and nurses. In some EU countries, however, there are no regulations around this and in principle anyone could treat whether they are qualified or not.
Most of the European and certainly Nordic healthcare professionals (doctors and nurses) treating patients with fillers are careful and do require sufficient documentation not just on the production quality but also mechanism of action, product properties, clinical evidence and proven results. They are trained and experienced in injection techniques and facial physiology including nerves and vessels that represent high-risk areas when being treated. Patients really should not allow other than registered injectors/healthcare professionals to treat them.
Closing in on the product technology, the main factors that are of interest are
The amount of active ingredient (HA, Agarose, Collagen, Hydroxylapatite, etc.) in the product – in principle different concentrations are suited for different indications.
- The size of particles/molecules in the product as smaller molecules integrate with own tissue better/more naturally
- Variation of the particles sizes in the product where monophasic products have homogeneous particle sizes showing more cohesivity and staying in place vs. biphasic/varying particle sizes that are less cohesive and may migrate/spread out post injection
- Technology (cross-linking) used to construct and bind the free HA – ensuring that the product lasts as long as possible post injection. Cross-linkers used to manufacture HA fillers include 1,4-butanediol diglycidyl ether (BDDE) and divinyl sulfone. More concentrated products with a greater degree of cross-linking provide increased longevity, but they can be associated with a higher risk for inflammation and nodule formation particularly if the gel has cross-linker residue in it.
- Rheological properties, such as gel consistency, hardness, viscosity and degree of water solubility play an important role in terms of how easy the product is to work with (extrusion force, precision) and the HA gel injected comes to lay in its place, stays in its place, shapes and molds. All of these factors influence the possibilities of product usage, the ease and comfort in injecting the products and the aesthetic outcomes and their durability.
The higher the concentration, the larger the particle size and the more cross-linking used the deeper they have to be injected (volume giving effect) and the longer they will last while the lower end of the range will allow more superficial injection and is used at more visible, superficial wrinkles and lines as well as lip contouring but typically lasting less than the volume giving, stiffer gel products.
Finally, most of the fillers sold today have local anaesthesia ingredient – lidocaine – in them. This is to reduce the patient discomfort associated with the injection itself. It is particularly helpful in the more sensitive, superficial areas such as lips.
While the new Agarose filler is very low on side effects and the types of adverse events due to the lack of cross-linkers, most of the monophasic HA filler products are very similar to each other with slight variations as described above. Thus the adverse reactions across the board are very similar and occuring at similar frequencies. These include, redness at injection site, swelling and bruising. Much less frequent adverse events include hematomas, nodules, granulomas and infections.
Hygiene in general, disinfection of the injection sites and no re-usage of needles are crucial elements in avoiding adverse events.
Given all of the above, often it is the preferences of the injector that play role in deciding which fillers are used – both in terms of the product properties/quality, injection comfort and ease as well as price.