"Complications caused by permanent fillers in the face - alternatives"
Face International magazine of orofacial esthetics, 3/2010, Oemus Verlag
Authors: Dr Michaela Montanari, Dr Andreas Arens, Prof. Dr Jutta Liebau, Düsseldorf
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 treating physicians.
The first treatments to change 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 wide range of degradable and non-degradable filling substances. Although these materials are CE-certified medical devices that are subject to the Medical Devices Act1 with regard to their potential requirements, they are not prescription drugs. Users are obliged to critically examine the products they use, particularly with regard to their health safety.
Indications for the use of filling materials include aesthetic aspects. The focus here is on treatments to maintain youthfulness and attractiveness even in old age. The frequent view that an attractive appearance can help to achieve success in professional life and thus promote a professional career should also not be ignored nowadays. It is therefore not surprising that men are also increasingly undergoing these treatments.
On the other hand, there is a medical indication, for example, in the compensation of wrinkle formation after severe weight loss, fat distribution disorders (lipodystrophies), 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, combined with multiple surgical steps and complex reconstructive procedures, particularly in the facial area.
We regularly see patients with complications following the application of permanent filling materials to the face and other areas of the body in our consultation hours.
In the following, examples with pronounced consequences after injections of permanent filling materials (Artecoll®, Dermalive® and DIY silicone) in the face are demonstrated.
Case study 1
Example 1 shows a 50-year-old female patient after augmentation of her glabellar fold with Artecoll®. This treatment was carried out ten years ago 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.
Case study 2
The other case study concerns a 47-year-old female patient who had her zygomatic regions augmented with Dermalive® ten years ago. A few years after the treatment, she developed recurrent abscesses with persistent fistula on the left side (Fig. 2a-c). Furthermore, the patient complained of severe pain in the zygomatic region. Clinical examination revealed large, hard tumours on both sides in the zygomatic cheek region, which were not displaceable on the underlying surface.
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 zygomatic major and minor muscles (Fig. 3), and surrounding vessels and nerves, so that we were unable to perform a complete extirpation. The soft tissue trauma caused by the operation was already very pronounced (Fig. 4), so we initially limited the procedure to removal of the largest foreign body conglomerate (Fig. 5). 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 haematomas. The patient requested a repeat operation with the aim of further possible removal of 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 (Fig. 6a, b).
The resulting contour asymmetry was equalised with an autologous fat graft (45 ml) six months later (Fig. 7a-c).
Case study 3
The medical history of a 46-year-old female patient who presented with redness, telangiectasia, multiple soft tissue indurations and pain in the face (Fig. 8a-c) and breast following injection of liquid silicone five years ago was impressive. She also complained of progressive visual field loss.
The patient told us that the augmentation of the two body regions with a medical product 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 (who was not a doctor after she expressly asked) injected her with this product for beautification.
Multiple foreign body granulomas were removed during an operation lasting several hours. In the further course (Fig. 9, 10) there was a significant improvement in the symptoms, in particular the visual field restriction and the telangiectasia (Fig. 11).
The last case study certainly clearly demonstrates the need for a precise medical history in order to determine which products were used.
Compared 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 effects3 with irreversible soft tissue damage.
Alternative procedures for volume augmentation
For this reason, we believe that alternative procedures for volume augmentation should be considered. Autologous substances such as autologous fat or dermis grafts or heterologous biodegradable materials (hyaluronic acid, collagen) are available for this purpose and can lead to satisfactory results with few complications.4
In our experience, good and satisfactory results can be achieved with hyaluronic acid. Possible complications are essentially limited to the general 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.
Another option for levelling out contour irregularities is the use of autologous fat.5, 6
Case study 4
HIV patients in particular suffer from stigmatisation due to the loss of the malar fat body, which is most likely to occur during antiviral medication. Here, the volume deficit can be well compensated for with autologous fat (Fig. 12a and b).
Case study 5
Another option for using autologous tissue as a filling material is to use 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 on 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 shown in the images (Fig. 13a and b), we were able to harvest a 12 x 8 cm graft from the lower abdomen by accessing an existing section scar, deepithelialising and dividing it so that adequate volume augmentation was available for both halves of the face (Fig. 14 a-c). Fixation was achieved by knotting using a dissection swab (Fig. 15).
Conclusion
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, we do not recommend the use of permanent fillers over the use of biodegradable substances and the body's own tissue.
Instead, degradable substances or the body's own tissue should be used, which in our opinion can only lead to reversible complications.
Complications that occur and are observed after the use of permanent and non-permanent filling materials should 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 should feel addressed as users and aftercare providers of corresponding complications as well as the patients themselves. Once the complications and filling substances have been registered, they are analysed to provide users and patients with valuable information on the frequency of side effects, the type of complications after wrinkle injections in particular and information on treatment options.
Due to the growing variety of available product ranges and the current increase in treatments, the use of such 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), status: revised by notification of 7.8.2002 I 3146; last amended by Art. 6 G of 29.7.2009 I 2326
[2] B. C. Heinz1 - U. Ladhoff1 - Ch. Kahl2 - B. Rzany2 - D. von Mallek1, Bundesgesundheitsbl - Gesundheitsforsch - Gesundheitsschutz 2008 - 51:787-792, 1Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, BRD - 2 dEBM, Klinik für Dermatologie, Venerologie und Allergologie, Charité Berlin, BRD Incident reports on injectable filling materials, evaluation of the medical device monitoring and reporting system in Germany
[3] Wiest, L.G. (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 sunstances for soft tissue augmentation, Aesth Plast Surg 27:354
[5] Coleman SR (1995) Long term survival of fat transplants: Controlled demonstrations. Aesthetic Plast Surg: 421-425
[6] Coleman SR (1997) Facial recontouring with lipostucture, Clin. Plast Surg. 24,2: 347-67
Source: face, 3_2010