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"Complications caused by permanent fillers in the face - alternatives"
Plastic Surgery 06/2010, Kaden-Verlag

Authors: Michaela Montanari, Andreas Arens, Jutta Liebau

Complications in the facial area caused by the injection of permanent fillers are often associated with disfiguring effects for the patient and a therapeutic challenge for the doctors treating them. The first treatments to alter the face were carried out as early as 1900. This certainly took place under different conditions, with different methods and different products than is the case today. Since then, the development of the product range has been in a constant state of flux. New products are launched on the market at regular intervals, so that there is now a large number of degradable and non-degradable filling substances. Although these materials are CE-certified medical products that are subject to the Medical Devices Act [1] in terms of their potential requirements, they are not prescription drugs. Users are therefore obliged to critically examine the products they use, particularly with regard to their health safety.

Late complications occur more frequently with the use of permanent fillers compared to non-permanent fillers

Indications for the use of filling materials include aesthetic aspects. The focus here is on treatments that aim to maintain youthfulness and attractiveness even in old age. The frequently held view that an attractive appearance helps to achieve success in professional life and can therefore be conducive to a professional career should also not be neglected these days. It is therefore not surprising that men are also increasingly undergoing such primarily aesthetic treatments. On the other hand, there are medical indications, for example to compensate for the formation of wrinkles after severe weight loss, for fat distribution disorders (lipodystrophies) or autoimmune diseases associated with tissue dystrophies (e.g. lupus profundus) as well as acquired or congenital facial asymmetries (e.g. facial nerve palsy).

Non-biodegradable filling materials, so-called permanent fillers, can be divided into three groups:

• Injectable silicone (PMS 350®, Bioplastique®)
• Preparations containing methacrylic (Artecoll®)
• Mixed products of absorbable and permanent substances (Dermalive®, Evolution®)

In contrast to non-permanent fillers, late complications occur more frequently with the use of permanent fillers. These often develop years after treatment and often lead to unforeseeable, permanent and dramatic problems for the patient. As a result, complex surgical measures are often required, involving multiple surgical steps and complex reconstructive procedures, particularly in the facial area. In our clinic, we regularly see patients with complications following the use of permanent filling materials in the face and other areas of the body. The following are some examples of pronounced consequences after injections of various permanent filling materials (Artecoll®, Dermalive® and DIY silicone) in the face.

Four years after the Artecoll treatment, disturbing hardenings and lumps developed

The first example shows a 50-year-old female patient after augmentation of her glabellar fold with Artecoll. This treatment was carried out ten years earlier for aesthetic reasons. It was not until four years later that disturbing hardening and lumps developed in the injected area. These granulomas were subsequently excised externally several times. With a pronounced tendency for these nodules to recur, the patient presented to our consultation with disturbing and painful granulomas. The patient was psychologically distressed. Soft tissue indurations were disturbing and prolapsed into the medial corner of the eyelid (Fig. 1a-c). The scars following excisions in the glabellar region were also disturbing. The current appearance caused the patient much more suffering than before the initial aesthetic treatment. Due to the multiple unsuccessful extirpations, we initially carried out conservative treatment with strictly intralesional cortisone therapy at six-week intervals. The course of a possible regression of the granulomas due to the cortisone therapy should be awaited before further interventions.

In a 47-year-old female patient, large, hard tumours were found on both sides of the cheekbone/cheek region

The next case study concerns a 47-year-old female patient who underwent augmentation of her zygomatic regions with Dermalive ten years ago. A few years after the treatment, she developed recurrent abscesses with persistent fistula on the left side (Fig. 2a-k). Furthermore, the patient complained of severe pain in the zygomatic region. The clinical examination revealed large, hard tumours on both sides of the zygomatic cheek region, which were not displaceable on the support. Surgical revision with a preauricular approach was performed to remove the soft tissue tumours. The surgical procedure revealed pronounced diffuse adhesions with infiltration of the zygomatic periosteum and the surrounding musculature, in particular the major and minor zygomatic muscles and surrounding vessels and nerves, so that we were unable to perform a complete extirpation. As the soft tissue trauma caused by the operation was already very pronounced, we initially limited the procedure to the removal of the largest foreign body conglomerates. Histological processing of the specimen revealed the suspected foreign body reaction. In the further course, there was a clear regression of the initially very pronounced soft tissue swelling and haematoma. The patient requested a repeat operation with the aim of further removing the infiltrating granulomas. The second operation was performed one year later with residual granuloma removal, lid edge elevation on the left by means of wedge excision on the lower eyelid and suspension of an entepithelialised tarsal strip on the bony orbital rim. The resulting contour asymmetry was corrected with an autologous fat transplant (45 ml) six months later.

The patient revealed that augmentation with a medical device had been too expensive for her

The medical history of a 46-year-old female patient who presented with redness, telangiectasia, multiple soft tissue indurations and pain in the face and chest following injection of liquid silicone five years ago was impressive (Fig. 3a-f). She also complained of progressive visual field loss. The patient told us that augmentation of the two body regions with a medical device had been too expensive for her. For this reason, she went to a DIY store and purchased a liquid silicone product. She had not thought about the possible differences between DIY products and medical products. Finally, a good acquaintance - after explicit enquiry, the woman explained that it was not a doctor - injected her with this product for beautification. Multiple foreign body granulomas were removed during an operation lasting several hours. Over the course of the operation, there was a significant improvement in the symptoms, in particular the visual field restriction and the telangiectasia. The last case example illustrates the need for a precise medical history in order to determine which products were used.

Hyaluronic acid can be used to achieve aesthetic results that are satisfactory for the patient

In contrast to resorbable fillers, the use of permanent materials generally requires a single treatment, which ideally produces a reaction-free result. Nevertheless, treatments with permanent filling materials are associated with a higher complication rate [2] and the risk of late effects [3] with irreversible soft tissue damage. For this reason, we believe that alternative procedures for volume augmentation should be considered. Autologous substances such as autologous fat or dermis grafts as well as heterologous biodegradable materials such as hyaluronic acid or collagen are available for this purpose and can lead to satisfactory results with few complications [4]. In our experience, hyaluronic acid can be used to achieve aesthetic results that are satisfactory for the patient. Possible side effects are essentially limited to reversible complications that can occur when using such products. These include redness, swelling, pain and haematomas. We have not observed any allergic reactions, skin necrosis, infections or discolouration in our patients.

If the malar fat body shrinks, the patient's own fat can be used to compensate for the volume deficit

Another option for levelling out contour irregularities is the use of autologous fat [5, 6]. HIV patients in particular suffer from stigmatisation due to the loss of the malar fat body - most likely in the context of antiviral medication. Here, autologous fat can be used to achieve good compensation of the volume deficit (Fig. 4a,b).

Another option for using autologous tissue as a filling material is the use of dermis grafts as a resorption-resistant filling material. In lupus panniculitis, a rare autoimmune disease that is often associated with systemic lupus erythematosus, scarring of the subcutaneous fat and the deep dermis leads to corresponding defects with predilection in the face and extremities, which can be easily compensated for with a dermis graft. In the case of any pre-existing scars, this provides a suitable approach for harvesting an appropriate graft. In the patient presented (Fig. 5- f), we were able to harvest a 12 x 8 cm graft from the lower abdomen via an existing section scar, deepithelialised and divided so that adequate volume augmentation was available for both halves of the face. Fixation was carried out with a knot using a preparation swab.

Complications should always be reported in filler portals

To summarise, permanent fillers carry the risk of pronounced late complications - often associated with irreversible soft tissue damage. Due to the variety of materials available today, we therefore do not recommend the use of permanent fillers. Instead, degradable substances or the body's own tissue should be used, which in our experience can only lead to reversible complications such as swelling, redness or haematomas.

Complications that are observed after the use of permanent and non-permanent filling materials should always be reported in so-called filler portals such as www.bfarm.de, www. zentralregister-filler.de, www.fillerwelt.de. In addition to the product manufacturers, doctors as users and aftercare providers of such complications as well as the patients themselves should feel addressed. Once the complications and filling substances have been registered, they will be analysed to provide users and patients with valuable information on the frequency of side effects, the type of complications following wrinkle injections in particular and information on treatment options. Due to the growing number of products available and the current increase in treatment numbers, the use of such reporting registers is an indispensable tool for carrying out reliable, low-complication and therefore patient-orientated treatments.

Literature

1. Medical Devices Act (in the version published on 7 August 2002 (Federal Law Gazette I, p. 3146), last amended by Article 6 of the Act of 29 July 2009 (Federal Law Gazette I, p. 2326). [http://bundesrecht.juris.de/ bundesrecht/mpg/gesamt.pdf]
2. Heinz BC, Ladhoff U, Kahl CH, et al (2008) Incident reports on injectable filling materials, evaluation of the medical device monitoring and reporting system in Germany. Bundesgesundheitsbl Gesundheitsforsch Gesundheitsschutz 51: 787-792 (Federal Institute for Drugs and Medical Devices, Bonn)
3. Wiest LG (2009) Spectrum of complications after treatment with injectable filling materials. J Aesthet Chir 2: 95-104
4. Lemperle G, Morhenn VB, Charrier U (2003) Human histology and persistence of various injectable filler substances for soft tissue augmentation. Aesth Plast Surg 27: 354
5. Coleman SR (1995) Long term survival of fat transplants: Controlled demonstrations. Aesth Plast Surg 19: 421-425
6. Coleman SR (1997) Facial recontouring with lipostructure. Clin Plast Surg 24: 347-367

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Source: Plastische Chirurgie 06/2010, Kaden-Verlag