Permanent dermal filler : Common questions about permanent dermal filler treatments

<body> <h1>Frequently asked questions about Permanent dermal filler</h1><br><br> <h2>What is Permanent dermal filler?<br> <br> </h2><span class="faqa">Permanent dermal filler is a new generation of filler. It is a permanent filler where the volume of the implant is given by water not from a solid product. Permanent dermal filler is made of 2.5% polyacrylamide and 97.5% water. The cross-linked polyacrylamide forms a real gel, which does not contain any solid microparticles. This makes it soft and uniform. It is injected under the skin where it can't be seen or felt and remains in place permanently. Being mostly water, the body accepts the gel readily and only forms a thin membrane around the implant which helps to keep it in place; as the gel is very elastic it moves with all facial expressions.<br> <br> Polyacrylamide has now been used in cosmetic and plastic surgery for more than ten years. Studies demonstrate that Permanent dermal filler PERMANENT FILLER<br> <br> Permanent dermal filler is a transparent, injectable polyacrylamide gel for correction of soft tissue deficiencies and tissue augmentation. The sterile gel consists of sterile water bound to 2.5 % cross-linked polyacrylamide and does not contain microparticles.<br> <br> Permanent dermal filler is produced by Ferrosan A/S, a Danish pharmaceutical company founded in 1920. Ferrosan A/S [via their subsidiary Contura] has obtained full rights to manufacture, sell and market the gel internationally.<br> <br> <b>This unique gel is:</b><br> <ul> <li>Permanent<br><br></li> <li>Non absorbable<br><br></li> <li>Biocompatible<br><br></li> <li>Non toxic<br><br></li> <li>Non allergenic<br><br></li> <li>Does not migrate from the injection site.<br><br><br></li> </ul> </span> <span class="faqa">Permanent dermal filler<font size="-4"><sup>TM</sup></font> has been specially designed for correction of facial contour deformities due to ageing, acne, trauma, surgery and infection or due to congenital deformities, and can be used for:<br> <ul> <li>Cheekbones<br><br></li> <li>Smile lines<br><br></li> <li>Lip augmentation<br><br></li> <li>Frown lines<br><br></li> <li>Depressed corners of the mouth and marionette lines<br><br></li> <li>Chin<br><br></li> <li>Tissue reconstruction following lipodystrophy or surgery<br><br></li> <li>Other soft tissue deficiencies of the face such as scars etc<br><br></li> </ul> </span> <span class="faqa"><b>When not to use:</b><br> <ul> <li>Permanent dermal filler is not indicated for treatment of fine wrinkles.<br><br></li> <li>Permanent dermal filler should not be injected at a site already treated with another permanent filling product. It can be injected elsewhere in that patient.<br><br></li> <li>If other non permanent filling products have been used, injection of<br><br></li> <li>Permanent dermal filler should wait until the first product has disappeared (approx 6 months).<br><br></li> <li>Treatment should not be administered if there is Infection of any type on the skin.<br><br></li> </ul> </span> <span class="faqa">Permanent dermal filler is unique due to its stability and long lasting cosmetic results. After the injection of Permanent dermal filler a thin layer of the body's own connective tissue surrounds the gel, enabling Permanent dermal filler to become a stable part in the connective tissue. Permanent dermal filler can be removed shortly after the injection if necessary. If the gel has to be removed at a later stage, a minor surgical procedure might be necessary, the success rate of which is variable.<br> <br> </span> <h2>POLYACRYLAMIDES<br> <br> </h2><span class="faqa">Polyacrylamides are polymers formed from the polymerisation of acrylamide. Polyacrylamide itself is considered to be non-toxic because of the inability to pass biological membranes due to the large molecular size. Additionally, polyacrylamides are extremely resistant to biodegration. Polyacrylamides are used widely in biomedical research and in the biomedical industry. Permanent dermal filler is a cross linked polyacrylamide, which makes it stable and practically impossible for human body enzymes or bacterium to metabolise the polyacrylamide. Due to this and a high viscosity the gel remains in place at the site of injection and behaves as a natural part of the skin.<br> <br> <br> </span> <h2>THE Permanent dermal filler GEL ITSELF<br> <br> </h2> <span class="faqa">The Permanent dermal filler gel is homogeneous and does not contain any hard particles (microballs, microcrystals ). Permanent dermal filler effect is clearly linked to the volume injected, so the deeper the defect the more product will be required. Permanent dermal filler does not migrate; it is stable and inactive at the site of injection. Permanent dermal filler remains soft after injection and the implant is not distinguishable from the surrounding skin by palpation. The effect of the injection of Permanent dermal filler is permanent. Since the ageing of the skin continues, it may be necessary to carry out follow-up injections after a certain period of time, depending on a number of factors (skin structure, age, etc.)<br> <br> <br> </span> <h2>PAST Permanent dermal filler USE<br> <br> </h2> <span class="faqa">Permanent dermal filler has been used for aesthetic correction for more than ten years in 30,000 patients. Retrospective studies have not shown any long-term side effects, clinically and histologically. Numerous toxicological studies have been carried out on animals. They have shown that implants of polyacrylamide gel are tolerated for long periods of time without biodegradation. Preclinical studies have not shown any cytotoxic effects, any systemic or pyrogenic effect, or any effect on the blood or on enzyme activity. Polyacrylamides have been used for many years in the United States and Europe for treatment of drinking water.<br> <br> <br> </span> <h2>Permanent dermal filler SIDE EFFECTS<br> <br> </h2> <span class="faqa">Injection of Permanent dermal filler causes only mild reaction in the surrounding tissue which is minimal compared with reactions to other foreign bodies. This indicates that the polyacrylamide gel is well tolerated by the human body. There is no calcification, no Cancer causing effect, no inflammation and no local allergic reaction. The gel is not found in the lymph nodes. Permanent dermal filler does not Cause any allergic reaction or any other immunological effect either in animals or in humans. Permanent dermal filler does not migrate. Adverse effects are seen in relation to 1-2% of injections mostly infection which is easily treated. Temporary reactions typically connected with injection may appear, for example reddening, pain, oedema, itching at the site of injection. Within 1 -2 weeks after treatment 1 out of 1500 patients have a risk of developing transient swelling and tenderness near injection sites. If not caused by infection these reactions are self limiting and will resolve in a couple of weeks.<br> <br> <br> </span> <h2>Permanent dermal filler AFTERCARE<br> <br> </h2> <span class="faqa">The patient should not expose the treated zone to intense heat (sun bed, sunbathing) or extreme cold in the first days following treatment. The purpose of this is to avoid inflammation of the zone where the injection has been made. The area should be kept clean and touching of the area avoided for the first few days after treatment. Any discomfort should respond to paracetamol. Should any problem arise it is important to contact the treating physician, as most problems are easy to fix if caught early.<br> <br> it is a safe product. Interim reports from a clinical trial started in January 2001 involving 243 patients in Europe, report no serious adverse events.<br> <br> <br> </span> <h3>What is Permanent dermal filler used for?<br> </h3> <span class="faqa"> <ul> <li>Deep facial lines (such as the naso labial folds)<br><br></li> <li>Enhancing lips<br><br></li> <li>Replacing facial volume lost from age<br><br></li> <li>More prominent cheek bones<br><br></li> <li>Stronger jaw line<br><br></li> <li>Facial deformities<br><br></li> <li>Depressed scars<br><br></li> </ul> </span> <h3>Since when has Permanent dermal filler been used in Europe?<br> <br> </h3><span class="faqa">Permanent dermal filler obtained CE marking in March 2001. This marking, which is granted by an independent notified body, certifies that the production of Permanent dermal filler takes place in compliance with European norms and that the product has proved to be harmless and efficient in human beings.<br> <br> <br> </span> <h3>What does the Permanent dermal filler CE 0543 mark mean?<br> <br> </h3><span class="faqa">This is the number from the notifying body in Denmark (DGM) which is audited by MDA in London. A notified body is an institution that issues CE certificates, i.e. grants CE marking to products that have been approved for sale in the European Community. The CE mark indicates that Permanent dermal filler meets the requirements formulated in EU Directive 93/42.<br> <br> <br> </span> <h3>What is the difference between Permanent dermal filler and other products containing polyacrylamide?<br> <br> </h3> <span class="faqa">The difference lies in the origin and manufacture of the gel. Permanent dermal filler is a polyacrylamide gel that is made in Denmark in compliance with the ISO standards. Another difference is the structure of the gel. Permanent dermal filler is made on the basis of a new patented technology which makes it possible to control the viscosity and elasticity of the gel while preserving a watery, stable concentration. The monomer content is below 5 ppm (approx. equal to two day's consumption of drinking water). Permanent dermal filler is patented in the United States, Europe and Brazil.<br> <br> <br> </span> <h3>Why are certain polyacrylamide gels said to be non-permanent?<br> <br> </h3> <span class="faqa">We suggest that you submit this question directly to other manufacturers. Studies have shown that the polyacrylamide gel Permanent dermal filler is stable, that it does not migrate, and that Permanent dermal filler implants are well tolerated over long periods of time without biodegradation.<br> <br> </span> <h3><br>How is Permanent dermal filler made?<br> <br> </h3> <span class="faqa">Permanent dermal filler is made in Copenhagen, Denmark, at the pharmaceutical company Ferrosan NS. The production takes place in sterile surroundings. In addition the gel is sterilised by means of autoclave sterilisation in the syringe.<br> <br> <br> </span> <h3> How is Permanent dermal filler sterilised?<br> <br> </h3> <span class="faqa">The manufacture and processing of Permanent dermal filler take place under aseptic conditions. The filled syringes are then sterilised by means of autoclave sterilisation (moist heat).<br> <br> <br> </span> <h3> Why is Permanent dermal filler gel permanent?<br> <br> </h3> <span class="faqa">Because the polyacrylamide forms long chains that cannot be split by the human body. No enzyme or bacterium is able to metabolise the polyacrylamide. This is the reason why the gel remains in place at the site of injection and remains as a part of that tissue.<br> <br> <br> </span> <h3> What is Permanent dermal filler's mode of action?<br> <br> </h3> <span class="faqa">The Permanent dermal filler gel is homogeneous and does not contain any particles (microballs, microcrystals). Permanent dermal filler's effect is clearly linked to the volume injected. Permanent dermal filler does not migrate; it is stable and inactive at the site of injection.<br> <br> <br> </span> <h3> How long does treatment with Permanent dermal filler last?<br> <br> </h3> <span class="faqa">The effect of the injection of Permanent dermal filler is permanent. Since the ageing of the skin continues, it may be necessary to carry out follow-up injections after a certain period of time, depending on a number of factors (skin structure, age,...).<br> <br> <br> </span> <h3> For what Permanent dermal filler purposes is polyacrylamide used?<br> <br> </h3> <span class="faqa">Polyacrylamides are used in the production of drinking water. They are used as a floculant and coagulant to remove particles from the water. Polyacrylamides are used to wash fruits for peeling as well as certain vegetables. Polyacrylamides are also used as a floculant in the production of cane sugar. Polyacrylamides are used in medical products: soft contact lenses, implant materials,... They are also used in the cosmetics industry (hair colouring products, creams, lotions,...) and in paper production.<br> <br> <br> </span> <h3> How can you be sure that Permanent dermal filler is not harmful in the long term?<br> <br> </h3> <span class="faqa">Because it has been used for aesthetic correction for more than ten years in 30,000 patients. Retrospective studies have not shown any long-term side effects, clinically and histologically. Numerous toxicological studies have been carried out on animals. They have shown that implants of polyacrylamide gel are tolerated for long periods of time without biodegradation. Preclinical studies have not shown any cytotoxic effects, any systemic or pyrogenic effect, any effect on the blood or on enzyme activity. Polyacrylamides have been used for many years in the United States and Europe for treatment of drinking water. Injection of Permanent dermal filler causes only mild reaction in the surrounding tissue which is minimal com- pared with reactions to other foreign bodies. This indicates that the polyacrylamide gel is well tolerated by the human body. There is no calcification, no carcinogenic effect, no inflammation and no local allergic reaction. The gel is not found in the lymph nodes. Permanent dermal filler does not cause any allergic reaction or any other immunological effect either in animals or in humans. Permanent dermal filler does not migrate. In fact, its high molecular weight makes migration impossible.<br> <br> </span> <br> <h3>How deep into the tissue should Permanent dermal filler be injected?<br> <br> </h3><span class="faqa">Permanent dermal filler should be injected into the subcutaneous tissue.<br> <br> <br> </span><span class="faqq">What size of needle should be used?<br> <br> </span><span class="faqa">For injection of Permanent dermal filler a fine gauge 27G needle is recommended.<br> <br> <br> </span><span class="faqq"> Does the material grow in size after injection?<br> <br> </span><span class="faqa">The result obtained immediately after the injection is the visible, definitive result. Permanent dermal filler requires neither under correction nor overcorrection.<br> <br> <br> </span><h3> What will happen if Permanent dermal filler is not injected at the subcutaneous level?<br> <br> </h3><span class="faqa">The gel must be injected subcutaneously. It should not be injected into the superficial dermis or the intermediate dermis, since the consequences of such injections are not known. If an injection is too superficial, the aesthetic result may not be as desired, since the surface will not be smooth. If necessary, the gel can be withdrawn with a 19G needle inserted into the gel. The gel can be diluted by means of a solution of sodium chloride or anaesthesia, which will facilitate the removal of the gel.<br> <br> <br> </span><h3> Can Permanent dermal filler be injected to eliminate fine wrinkles?<br> <br> </h3><span class="faqa">Permanent dermal filler is not indicated for treatment of fine wrinkles.<br> <br> <br> </span><span class="faqq"> Are there any side effects or adverse reactions?<br> <br> </span><span class="faqa">Temporary reactions typically connected with injection may appear, for example reddening, pain, oedema, itching at the site of injection. Adverse effects are seen in relation to 1-2% of injections. They are mainly due to the quality of the injection and of hygienic standard and sterility.<br> <br> <br> </span><h3> Can Permanent dermal filler be associated with other types of injectable implants?<br> <br> </h3><span class="faqa">Permanent dermal filler should not be used in a site where a non-soluble filling product has previously been injected. In sites previously treated with a soluble filling product, an injection of Permanent dermal filler should not be made until the soluble product has disappeared completely.<br> <br> <br> </span><h3> Can Permanent dermal filler be injected if other filling products have already been used?<br> <br> </h3><span class="faqa">It is a contraindication for the use of Permanent dermal filler if the site in question has already been treated with injections of a permanent filling product. If other filling products have been used, injection of Permanent dermal filler should wait until the first product has disappeared.<br> <br> <br> </span><h3> Can Permanent dermal filler be used between the eyebrows?<br> <br> </h3><span class="faqa">Treatment of the area between the eyebrows is one of the indications for Permanent dermal filler.<br> <br> <br> </span><h4>Can a person suffering from an autoimmune disorder be treated with Permanent dermal filler?<br> <br> </h4><span class="faqa">Autoimmune disorders are not a contraindication for injection of Permanent dermal filler.<br> <br> <br> </span><h4>Can a person suffering from immune deficiency be treated with Permanent dermal filler?<br> <br> </h4><span class="faqa">Immune deficiency is not a contraindication for injection of Permanent dermal filler.<br> <br> <br> </span><h4> Can treatment of a patient with recurrent facial herpes with Permanent dermal filler provoke a new outbreak?<br> <br> </h4><span class="faqa">The very injection process constitutes a risk, since the injection of the needle into the skin may contribute to provoking an outbreak of facial herpes. Prevention of an outbreak of herpes by means of an oral antivirus drug is recommended. Never use Permanent dermal filler when having an outbreak of herpes labialis.<br> <br> <br> </span><h4> Should a prophylactic treatment be prescribed for patients suffering from recurrent herpes?<br> <br> </h4><span class="faqa">Prescription of a prophylactic treatment with an oral antivirus drug is recommended in the case of patients suffering from recurrent facial herpes.<br> <br> <br> </span><h4> Can Permanent dermal filler cause hyperpigmentation?<br> <br> </h4><span class="faqa">No hyperpigmentation reaction has been registered following injection of Permanent dermal filler.<br> <br> <br> </span><h4> How does the product react when the area is exposed to sunlight/UV rays?<br> <br> </h4><span class="faqa">The patient should not expose the treated zone to intense heat (sun bed, sunbathing) or extreme cold in the first days following treatment. The purpose of this is to avoid inflammation of the zone where the injection has been made.<br> <br> <br> </span><h4> Can Permanent dermal filler be used for pregnant or breastfeeding women?<br> <br> </h4><span class="faqa">Since there is no clinical evidence of Permanent dermal filler in pregnant and breastfeeding women it is advisable not to use Permanent dermal filler for pregnant or breastfeeding women.<br> <br> <br> </span><span class="faqq"> Are there any known interactions with systemic treatments (antibiotics, etc.)?<br> <br> </span><span class="faqa">There is no interaction between systemic treatment and Permanent dermal filler, since Permanent dermal filler is stable, inactive and bio- compatible and does not migrate.<br> <br> <br> </span><span class="faqq"> How long can the product be stored?<br> <br> </span><span class="faqa">At present Permanent dermal filler can be stored until the expiring date. Stability studies are being carried out with a view to prolonging the approved storage period.<br> <br> <br> </span><h3> Under what conditions should Permanent dermal filler be stored?<br> <br> </h3><span class="faqa">Permanent dermal filler should be stored at room temperature (25°C) protected from direct sunlight. Do not freeze Permanent dermal filler.<br> <br> <br> </span><h3>Permanent dermal filler and the ageing process<br> <br> </h3><span class="faqa">Permanent dermal filler is a polyacrylamide gel, which is a 3 dimensional-body composed of a skeleton of polymer in water environment. Permanent dermal filler<sup>TM</sup> contains about 2-3% of cross-linked polyacrylamide network and with the remaining part of 97-98% being water. Monomer chains are held together by covalent bindings, whereas water is attached to the polymer network with weaker bounds. The molecule is not dissolved in water, but "swollen" like a sponge. The gel is in dynamic equilibrium with the surrounding tissue, but still the polymer retains its ability to hold water and remains elastic over an extended time.<br> <br> The ageing process of the skin represents a combination of gravity effect and skin atrophy itself. Skin becomes thinner and loses its elasticity. Subcutaneous tissue flattens. Therefore attempts have been made to restore the volume and increase tissue elasticity. A large amount of different substances are currently used as volume fillers. Permanent dermal filler is used as a fat substitute. Once injected Permanent dermal filler becomes a stable part in the soft tissue. When palpating, Permanent dermal filler feels soft and elastic like normal tissue.<br> <br> Polyacrylamide gel has been used for aesthetic and reconstructive surgery for more than 10 years. Thousands of patients have been injected with the gel for various indications. Retrospective studies on patients having gel injected for 1-9 years showed no concerns with respect to product safety as well as aesthetic result. Histology samples taken from patients 1-9 years after gel injection reveal a high biocompatibility of the product. Polyacrylamide gel induces only very mild foreign body reaction with no strong fibrous reaction or calcifications common for other implants. There is no difference between tissue reactions over many years.<br> <br> With ageing Permanent dermal filler will follow the tissue movements, which could be more visible in lower parts of the face like mentolabial folds. This will result in an unsatisfactory aesthetic result and therefore additional injections may be necessary. It has to be remembered that Permanent dermal filler is not a substitute for a face-lift, since it only cures effects of gravity. Nevertheless, Permanent dermal filler can be used as a supplement to achieve "volumetric face lift".<br> Permanent dermal filler is elastic filler consisting mostly of water. In contrast to a number of various implants, Permanent dermal filler does not interfere with a natural growth/movement of the tissue. 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