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Clinical data on injectable tissue fillers: a review

Claudette GJCA de VriesCentre for Health Protection, National Institute for Public Health and the Environment (RIVM), P.O. Box 1, NL-3720 BA Bilthoven, The NetherlandsCorrespondence[email protected]
&
Robert E GeertsmaCentre for Health Protection, National Institute for Public Health and the Environment (RIVM), P.O. Box 1, NL-3720 BA Bilthoven, The Netherlands
Pages 835-853 | Published online: 09 Jan 2014

Abstract

Treatment with injectable tissue fillers for aesthetic purposes is increasingly popular. In parallel with this success, questions related to the safety of these treatments and the products involved are being raised more prominently. To gain insight in the safety aspects of injectable tissue fillers, we performed a literature review to collect studies reporting clinical data of injectable tissue fillers. We found several case reports where serious complications after more than three years are described. However, there are only a limited number of well-defined prospective clinical studies available with follow-up periods longer than three years. Furthermore, causes of complications, that is, treatment or product related, are often not specified in literature. Considering the intended functional period of fillers in combination with the known occurrence of long-term complications, there is a need for well-defined prospective clinical studies. In order to be able to discriminate between product failure (a product safety issue) or application methodology (a physician expertise or training issue), better identification of observed complications and whether they are product or treatment related, is needed. For the safe use of the fillers it is important that treatment with injectable tissue fillers is performed by a trained physician, who knows the product specifications and its applications.

Injectable tissue fillers are increasingly popular for the treatment of facial wrinkles. According to the American Society for Dermatologic Surgery, soft tissue augmentation treatments showed a 130% increase between 2005 and 2007 Citation[1]. Moreover, it is expected that due to increase in life expectancy, the demand for anti-aging treatments, like tissue augmentation with injectable tissue fillers, will grow Citation[2]. Their success has been attributed to the fact that treatments with injectable tissue fillers are fast and appear to be relatively easy Citation[2]. Only a relatively ‘simple’ subcutaneous injection is needed. Today, various injectable tissue fillers with different characteristics are available, for example, duration of the effect, material type and intended anatomical location.

Although the application of an injectable tissue filler seems to be relatively simple and safe, reports of serious adverse effects have appeared in the literature Citation[2–8]. Estimates of the occurrence of severe complications after treatment with various types of injectable tissue fillers range between 1:80 and 1:50,000 patients Citation[9,10]. Adverse side effects can be caused by incorrect injection techniques (treatment related) or by the characteristics of the products (product related) Citation[11,12]. Short-, mid- and long-term complications can be discerned Citation[2,13–15]. Short-term complications like pain, swelling, fever, immediate hypersensitivity reactions, occur immediately or within several days past treatment and disappear after several weeks. A more severe short-term complication is necrosis Citation[5,16]. Necrosis occurs immediately or within a few days if blood vessels are obstructed by the filler material or if they are injured during the treatment Citation[17]. Mid-term complications such as delayed inflammatory reactions, ulceration and granuloma reaction may occur after 2–12 months. If they do not disappear spontaneously, they can be treated with anti-inflammatory drugs (e.g., corticosteroids). Nodule formation, chronic inflammatory or delayed hypersensitivity reactions, and migration of the injected product are categorized as long-term complications, which occur after several years and can only be removed surgically. Delayed hypersensitivity reactions are related to a triggering event, such as another operation or additional injection Citation[16,18,19]. To gain insight in the safety aspects of injectable tissue fillers, we performed a literature review to collect studies reporting clinical data of injectable tissue fillers.

Table 1. Overview of the most frequently observed types of complications.

Literature review

Literature was identified through searches in electronic databases Scopus™ (Elsevier BV), Medline/PubMed (US National Library of Medicine) and the Food and Drug Administration (FDA) website, and supplemented with cross-references. Search strings, which were used, were ‘skin filler,’ ‘injectable skin fillers,’ ‘facial tissue augmentation,’ ‘injectable filler skin effects,’ ‘complications of tissue fillers,’ ‘safety of tissue fillers’ and product names. Only peer-reviewed articles and reports reviewed by the FDA were used for this literature review. Literature of the past decade, 2000–2012, with information on tissue fillers still used today on a large scale for facial tissue augmentation were reviewed. In additions, illustrative older and newer studies on facial application of permanent and semi-permanent injectable fillers were included. Studies on combination treatments with other products such as Botox were not included. Studies on biodegradable fillers, like collagen and non-cross-linked hyaluronic acid, were not included, because biodegradable fillers have a limited and waning role in the filler market due to their lack of longevity in the skin Citation[20,21]. New and improved collagen and hyaluronic acid injectable tissue fillers, with a lasting result of more than six months, were included as semi-permanent injectable fillers. For this study, we reviewed available literature with clinical safety data for semi-permanent and permanent fillers. We distinguished prospective studies, retrospective studies and case reports. As prospective studies are most suitable to detect safety issues before products are used on a large scale, the focus of this review lies on prospective studies. From each study, we extracted the following data: filler material, study type, number of participants of the study, follow-up period, complications and cause of complication. Furthermore, we checked literature on duplicates by examining the content of the articles and the first author’s name. Publications on follow-up studies of injectable fillers were indicated as such in the table.

Clinical data for semi-permanent & permanent tissue fillers

Injectable tissue fillers can be categorized according to the duration of their effect . Examples of permanent filler materials are non-degradable fragments/microspheres in a resorbable matrix solution like collagen or hyaluronic acid, aqueous polymer solutions and silicone oil. Examples of semi-permanent filler materials are cross-linked hyaluronic acid or porcine collagen gel, polyvinyl alcohol 8%, carboxymethylcellulose and polyethylene oxide, non-animal derived poly-L-lactic acid (PLLA), and synthetic calcium hydroxyapatite suspension in a gel carrier. Permanent fillers will have a long-lasting effect, while semi-permanent and biodegradable fillers will be absorbed by the body after a certain period. To maintain the effects of the fillers, retreatment is needed for semi-permanent fillers after 7–24 months depending on the product, and for biodegradable fillers within approximately six months. Permanent fillers aim to provide a long lasting (>24 months) effect without the need for repeated treatment.

Table 2. Type of injectable tissue fillers.

Semi-permanent tissue fillers

Semi-permanent tissue fillers are all relatively recent products, most of which have been evaluated in prospective studies with defined follow-up periods, varying from 6 to 38 months . The number of studies and the size of the respective study populations vary considerably, when products are compared. Complications such as bruising or local hypersensitivity are usually transient or curable with minor treatment, for example, topical treatments with antibiotics and steroids Citation[7,22]. However, there are also cases in which persistent inflammatory reactions after 24–60 months past treatment were observed Citation[23,24]. We observed very large differences in the occurrence rate of complications with semi-permanent tissue fillers, between 0 and 56% . Some authors did not specify the number of complications observed Citation[25–28,201]. Moreover, in some cases the complications were described per injection site instead of per participant Citation[29,202,203]. Although product as well as treatment related complications have been described in more than one-third of the studies, no specifications of the causes of the complications were given. Although this category of products is associated with an apparently minimal or low incidence of severe complications, knowledge of the product characteristics and training in specific injection techniques are necessary for the safe use of the products Citation[2,15,30,204].

Table 3. Type of studies and complications of semi-permanent tissue fillers.

Most studies have a follow-up period ranging from six months to two years, which generally seems to correspond with the period that these products are intended to be present in the skin. However, there are cases known in which cross-linked hyaluronic acid fillers particles were found after two years Citation[31]. Also, aesthetic effects up to four years with injectable PLLA have been observed, while the claimed aesthetic effect is approximately two years Citation[32]. Between 2008 and 2012, some studies have been published with longer follow-up periods, that is, three to four years Citation[32–36]. The need for this development is illustrated by two studies Citation[37,38] in which it was found that semi-permanent injectable fillers remain in the skin longer than the period claimed by the manufacturer: 18 and 23 months, respectively, while the claims were 12 months. Experiences in the past with PLLA, also a biodegradable material, have already shown that late adverse effects may occur depending on the amount of material used, for example, PLLA bone plates and screws used in fixation of cheekbone fractures were found to be able to lead to swelling after about three to five years Citation[39]. In this study, the total amount of PLLA was considered essential for the occurrence of the local persistent inflammation. Therefore, studies with a more extended follow-up period are needed for all semi-permanent fillers. A theoretical explanation for these late reactions possibly lies in that the cross-linked hyaluronic acid filler contain varying amounts of the hyaluronan-associated proteins Citation[23].

Permanent tissue fillers

With regard to the safety and frequency of complications of permanent tissue fillers, a number of prospective studies, retrospective studies and various case reports were identified . Silicone has been applied for over 50 years, and for a long time it was the only material used. Only since the late 1990s, products based on other materials have been developed. Four of the retrospective studies on silicone Citation[40–43] are in fact just providing a set of anecdotal case reports without information on the period between injection and complication, or on possible causes of the complication. Therefore, they are only useful as an indicator for the occurrence of complications like severe granulomatous reaction and facial ulceration Citation[44]. Only one relatively small prospective pilot study in which a silicone filler is used, with just six months follow-up, is available Citation[45]. Descriptions of unpublished FDA approved studies for silicone fillers Citation[10,46] are insufficiently detailed to draw conclusions.

Table 4. Type of studies and complications of permanent tissue fillers.

For the more recent filler materials such as polymethyl methacrylate micro spheres in collagen, polyethyl methacrylate (copolymer of hydroxyethylmethacrylate and ethylmethacrylate) in hyaluronic acid, polyacrylamid solution, polyalkylimide solution, more data from prospective studies are available, with varying sizes of the study populations and follow-up periods for each product . In the early 2000s, prospective studies stopped after 12 months or less Citation[47–53]. Therefore, mainly short- or mid-term reactions, like immediate sensitivity reactions, formation of granulomas and swelling, could be picked up in these studies. In a number of case reports, long-term complications occurring after more than 12 months and even more than three years were described Citation[8,16,19,44,54–60]. These case reports indicate that more extended follow-up periods are needed to determine long-term effects of permanent fillers.

In 2003, an advisory committee already provided advice to the FDA on a permanent tissue filler in which they formulated specific conditions for approval, including a post-marketing approval study for safety of not less than five years, a contraindication for lip augmentation, physician training and a patient educational brochure Citation[205]. Results of this study were published by Cohen et al. Citation[61,62].

Today, more and more prospective studies are published with follow-up periods exceeding three years Citation[63–65]. In addition to the short term, often transient reactions, in these studies long-term complications, such as nodules, gel migration or accumulation, persistent redness or pain, swelling, infection and chronic inflammatory reactions are observed . Similar to the situation with semi-permanent tissue fillers, very large differences in the reported occurrence rate of complications were found, while some authors did not specify the number of complications observed. Furthermore, in the various types of studies, both product- and treatment-related complications have been described, although the causes of complications were unfortunately not always specified. Knowledge of different characteristics and limitations of injectable permanent tissue fillers, as well as training in specific injection techniques, have been reported; a necessary requirement to help a plastic surgeon to reduce the risk of complications and to increase the safe use of the product Citation[2,15,30,206].

US soft-tissue fillers conference

Recently, the outcomes of a large conference on facial soft tissue fillers in the USA were published Citation[66–69]. The conference was a joint effort of seven American professional societies, spanning the variety of clinicians applying these products. Issues of patient safety, efficacy and effectiveness were discussed, based on a literature review of data on details of the treatments. One of the key points was that there are major gaps in evidence related to the safety of soft-tissue fillers, and therefore more organized and systematic collection of safety data is needed. This key point on the need for greater availability of safety data correlates very well with our findings.

Expert commentary

In recent years the awareness of the need for well-defined prospective clinical studies with prolonged follow-up period before and after injectable fillers are placed on the market is growing. However, at the moment only a limited number of well-defined prospective clinical studies with sufficiently long follow-up periods are available for these products. Especially when the intended functional period is considered in combination with the known occurrence of long-term complications, such studies are clearly warranted. The various injectable tissue fillers have different characteristics, intended uses and limitations. Moreover, they each require specific injection techniques. Therefore, it is important that treatment with injectable tissue fillers is performed by a trained physician, preferably with a specialization in plastic surgery, who knows the product specifications and its applications. Observed complications can either be product-related or may be attributed to incorrect use. Therefore, it is important that both the safety of injectable tissue fillers and the way to apply these products are thoroughly evaluated by the manufacturer before they are placed on the market. Also afterwards post-marketing surveillance is needed including long-term clinical follow up. When describing results of such evaluations, it is necessary to specify the causes of observed complications as well as their frequency of occurrence. Before deciding on a treatment with injectable tissue fillers, the patient has to be informed on possible risks of such complications. In this context, it should be noted that risks cannot be excluded completely, not even when a product is injected in the right way by a trained doctor.

Five-year view

Because of the different characteristics of the various tissue augmentation treatments, a diverse range of injectable tissue fillers with different characteristics is available. Variations in characteristics lie in duration of the effect, material type and intended anatomical location. It is expected that due to the increasing life expectancy, the demand for anti-aging treatments like tissue augmentation with injectable tissue fillers will grow. As a result of this, manufacturers will place new or improved types of injectable tissue fillers on the market. According to Glogau et al., currently more than 200 commercial products are available outside the United States Citation[70]. Many of these products are variations on existing materials, for example, hyaluronic acid fillers with a higher degree of cross-linking. Also new products have recently emerged, containing a mix of different materials such as hyaluronic acid in combination with hypromellose and particles of cross-linked dextran Citation[70]. Kablik et al. reported that, in recent years, hyaluronic acid-based tissue fillers have become the material of choice for use in soft tissue augmentation Citation[71]. However, the request for permanent correction by consumers is also likely to continue, leading to an expected market for permanent tissue fillers. The use of permanent tissue fillers is controversial. On the one hand, there is the consumer’s pursuit of a lasting youthful appearance. On the other hand, there are important issues such as the nonreversible effects and problems like immune responses and delayed infections. No easy solutions for these issues are available. Semi-permanent tissue fillers hold promises to be safer alternatives for permanent fillers, however, they have their disadvantages too. For example, the enzyme hyaluronidase can be used to degrade hyaluronic acid fillers in the skin if overcorrection is performed or a strong immune response occurs. However, several cases have been reported where it seemed to be impossible to degrade the filler completely with the enzyme Citation[72]. A possible explanation could be that the hyaluronic acid material is modified to such an extent that the enzyme does not recognize the hyaluronic acid filler Citation[72]. If product safety and application methodology are not evaluated sufficiently thorough before as well as after introduction on the market, or if the products are injected by insufficiently trained physicians, an increase in the occurrence of complications with injectable fillers can be expected, especially in view of the expected increase in the number of treatments with a wider range of available products.

Key issues

  • • All semi-permanent and permanent injectable tissue fillers may cause complications.

  • • Complications can occur long after the first treatment. Complications can be product- or treatment-related.

  • • Tissue filler products need to be thoroughly evaluated in clinical studies with sufficient long-term follow-up before and after they are placed on the market.

  • • Only trained physicians with knowledge of products and the intended use, who have evaluated the risks and benefits with the consumer, should perform treatment with tissue fillers.

Acknowledgement

The authors would like to thank WH de Jong for critically reviewing the manuscript.

Financial & competing interests disclosure

This investigation has been performed by order and for the account of the Health Care Inspectorate of The Netherlands, within the framework of project V/360050 Supporting the Health Care Inspectorate on Medical Technology. The author have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

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