Injectable dermal fillers
Injectable dermal fillers (cosmetic fillers, facial fillers) are fillers that are injected into the skin to help fill in facial wrinkles. But also to correct loss of facial volume, restoring a fuller, smoother and more youthful appearance.
Most of these injectable dermal 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 injectable dermal fillers that are lasting longer and are even considered permanent.
Types of injectable dermal Fillers
The most commonly used filler substance is Hyaluronic Acid (HA) – also called Hyaluronan. HA is actually a form of salt – not an acid. This is found in our own bodies. It also plays a significant role in many ways. It helps with 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 it is also a powerful hydrator, used also topically. Because the free, radical form of the HA is very easily dispersed, degraded and destroyed there are various binders. Therefore 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® injectable dermal fillers
Algeness® is the newest breakthrough in the filler industry. A biomaterial that consists of a purified agarose gel, derived from a sophisticated manufacturing process. Agarose gel is in the polysaccharide family like HAs. For the first time in the aesthetic medicine history, a 100% natural and injectable implant, is available on the market. It is even biocompatible and biodegradable with a durability profile comparable to the HA fillers. This is now available on the market, fulfilling the expectations and requirements of the most demanding practitioners.
Algeness ® is free from 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 proved 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. This makes it excellent for mid face, nose or chin correction.
Who is a candidate for injectable dermal Fillers and what can you expect?
If you look at HA fillers, nearly anyone can receive treatment meaning there are not really any exclusion factor as such. Treatment – and to a large degree outcomes – with dermal fillers are individual depending on the age, skin quality and type. But also 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 the health of the skin. But it also depends on 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:
- Patients who have facial asymmetry of some kind – either born that way or having had a disease or significant loss of weight. These patients are both male and female and can be of any age.
- Patients who show signs of aging in form of wrinkles and/or loss of volume. While aging is individual, most commonly the patients start showing age related symptoms at around 35-40 years of age.
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 An INJECTABLE DERMAL FILLER?
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 are falling 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 is regulating 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 also adverse event reporting on medical devices in class III (including fillers).
WHICH FILLER IS THE RIGHT ONE TO USE?
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 are usually injected by anyone licensed to do so by the respective local medical authorities. These are 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 they do require sufficient documentation. Not just on the production and quality, but also mechanism of action. Not to mention 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.
The main factors regarding product technology
- 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. They are also 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 also 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 so that 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. But also 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.
The new Agarose filler is very low on side effects and the types of adverse events. This is due to the lack of cross-linkers and 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 occur at similar frequencies. These are including redness at injection site, swelling and bruising. Much less frequent adverse events are including 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 is playing the role in deciding which fillers are used. Both in terms of the product properties/quality, injection comfort and ease as well as price.