Treating Permanent Dermal Filler Complications

By Mr Niall Kirkpatrick and Mr Pericles Foroglou / 17 Nov 2016

Mr Niall Kirkpatrick and Mr Pericles Foroglou discuss the complications that can arise from permanent filler injections and explain how they are removed

Patient demand for aesthetic procedures, which appear simple and relatively cheap compared to surgical interventions, has significantly increased. Following this trend, there has been a remarkable rise in the use of soft tissue or dermal fillers over the last decade or so, used predominantly for volumetric augmentation of facial features or wrinkle levelling. Patients are also seeking longer lasting or indeed ‘permanent’ results requiring fewer injections to achieve their desired aesthetic goals. Manufacturers have tried to meet this demand with the introduction of longer-lasting or permanent filler materials. However, some practitioners, and certainly many patients, do not understand the risks associated with these types of fillers. We believe it is essential for any aesthetic practitioner to know the complications that can arise from the treatment, how the complications must be dealt with and what they need to advise their patients when it comes to permanent or long-term dermal filler injections.

Issues with permanent fillers

All filler materials have risks associated with their use and their rapid expansion in the cosmetic industry is unavoidably associated with what we have noticed as a rising number of complications related to both the products and their forms of administration.

Whilst some complications may be tempered by the use of filler materials that will resorb relatively quickly within around six months, the use of fillers that are permanent or long lasting, which can last up to two to four years, inevitably leads to complications that patients may have to live with over a long period of time. As well as this, infection rates of up to 19% have been reported following the use of one particular permanent filler,2 and complication rates for all types of fillers are as high as 27%.3

There seems to be significant public ignorance about dermal fillers and their properties, and generally, from our experience, patients do not understand the difference between permanent and temporary fillers. Temporary fillers are made from materials that the body is capable of breaking down and resorbing – many are related to natural molecules found in the body. Permanent fillers are made from materials that the body cannot resorb and therefore tends to try and ward off as foreign bodies. We have noticed an increased demand for longer lasting fillers. This growth is what could be prompting companies to increasingly cross-link the resorbable filler molecules to delay resorption. The longer the resorption period the more ‘permanent’ the filler becomes, and as a consequence, the greater the risk of complications such as chronic infections and biofilm formation.2,3,4,10

Complications of dermal fillers

‘Normal’ transient and predictable complications of all dermal filler injections, both permanent and temporary include: post-injection pain, redness, ecchymosis, swelling, hyaluronic acid (HA) hydroscopic effect (for non-permanent fillers only), mild nodularity and palpability and transient visibility.4,10 Immediate complications can include under or over-correction, implant visibility, placement of the filler in the wrong tissue plane, infection, vascular compromise4 and blindness from retinal artery occlusion.7,8,9 Many complications are sequelae that should not occur after treatment and some may be avoidable with proper technique, appropriate anatomical knowledge and material selection. Whilst most of these complications can be mitigated to an extent if resorbable temporary fillers have been used, particularly when hyaluronidase can be administered for HA fillers, these complications can be permanent if permanent fillers are injected. Detailed below are some examples of complications that can arise from all dermal fillers, however these complications may be more problematic with permanent fillers as surgical intervention for removal may be necessary because they cannot be absorbed by the body.

Acute infections: usually due to skin commensals, but later infections are often due to atypical organisms and mycobacterium. Reactivation of herpes virus may be experienced. Infections should be treated empirically with macrolides or tetracycline, pending culture and sensitivity. Infections, whether they are acute or chronic, remain a lifetime risk for all patients injected with permanent fillers, as there is no method of ensuring complete removal of all material.3,4,10

Direct arterial embolisation: can lead to tissue necrosis, especially in the glabellar supratrochlear arterial branches, the labial artery, the nasal dorsal artery and the angular vessels along the line of the nasolabial folds. Direct arterial embolisation leads to immediate skin blanching and pain.

Compromise of the venous circulation: can be seen from compression due to large filler quantities, and this causes a persistent dull aching, swelling and a patchy violaceous discolouration of the skin. This is most commonly seen in the region of the angular vessels along the line of the nasolabial fold. A lack of anatomical knowledge in non-professional injectors will inevitably lead to a higher risk of these complications.3,4,10

Vascular compromise: commonly seen in the glabellar area, particularly in relation to a glutaraldehyde cross-linked bovine collagen filler that has since been restricted.4,3,10 It can however, occur with any filler and can be minimised with the use of small gauge needles (30-32G) and injecting with a needle withdrawal technique, where you inject as you withdraw the needle. Immediate treatment of vascular compromise is to stop injection, attempt aspiration, vigorous massage to distribute the filler widely, the use of warm compresses, and 2% nitroglycerin paste to increase local vasodilatation, and the use of hyaluronidase for HA fillers.4

Permanent fillers are often difficult to remove and cause permanent damage to structures, and chronic infections can lead to significant and permanent scarring 

Chronic pain: we are increasingly witnessing patients with chronic pain in the distribution of the infraorbital and zygomaticofacial nerve territories from injections in the region of the tear trough, a common site for injection. Whilst at present the exact mechanism for such pain is not understood, the use of permanent rather than temporary fillers may be more difficult to resolve.

Early onset complications: include non-inflammatory nodules, and are usually localised accumulations of filler, especially seen with bovine or human collagen or HA derivatives. Treatment of these is generally conservative with gentle massage and, if persistent, the use of hyaluronidase. Stab incisions into the nodules can be considered. Whilst over-augmentation with HA fillers can be reduced with the use of hyaluronidase, this is not a possible treatment for patients treated with permanent filler nodules.

Early inflammatory nodules: are red, painful and tender. These should be treated as infections and empirically treated with macrolides or tetracycline, pending culture and sensitivity. Fluctuance or impending skin erosion requires incision and drainage. Antibiotic treatment should be continued for at least four to six weeks. If inflammation continues, the judicious use of intralesional corticosteroids can be considered.

Delayed onset complications: include persistent erythema and telangiectasia and may require treatment with 532 nm or 1064 nm lasers. Other delayed onset complications include inflammatory nodules, granulomas and sterile abscesses. These represent a heightened peri-implant cellular activity. Treatment should commence with macrolides or tetracycline antibiotics for four to six weeks. If there is no response within one to two weeks, intralesional corticosteroids can be considered. If there is no further improvement, tissue biopsy for culture may be required and guided antibiotic treatment accordingly.

Granulomas: all dermal fillers can produce late granulomas and abscesses. We have seen granulomas occurring in patients with both permanent and temporary fillers even up to ten years post injection.

Biofilms: a quiescent infection by bacteria, probably introduced at the time of initial injection and a particular problem for patients with permanent fillers. They result in the formation of a structured community of microorganisms adherent to an inert surface and encapsulated by a protective self-developed polymer matrix such as polysaccharides, protecting them from phagocytosis.11 These organisms are able to maintain integrity against the host immune system by reduced metabolism and growth rates. The use of antibiotics often leads to resistance.

Removing permanent fillers

When these complications occur, surgical removal of the permanent filler may be required to resolve the issues associated with it. However complete removal of all filler particles is not possible and whilst reducing the ‘filler load’ may reduce the risk of recurrent biofilm infection, there is also the risk of introducing infective organisms at surgery, which should be considered. Permanent fillers are frequently described by manufacturers as producing discrete collections with capsule formation and therefore easy to remove in the future, if unwanted. This has not been our experience in patients with complications of their permanent fillers, where the fillers are often found not to be encapsulated and indeed be distributed widely, having migrated in the tissues. Permanent fillers are often difficult to remove and can cause permanent damage to structures, and chronic infections can lead to significant and permanent scarring (Figure 1).3,4,10

Figure 1: Left image shows extensive scarring of right cheek from chronic infection secondary to permanent filler injection. Right image shows post treatment with excision of affected tissue, interpolation of a superficial temporal fascia flap and secondary fat grafting. 

Removing permanent fillers from the complex anatomical regions of the face can be a difficult procedure, and requires extensive knowledge of the craniofacial region. In managing the complications of permanent fillers, preoperative radiological MR imaging with contrast – where a contrast medium is injected into the patient at the time of the scan to enhance visualisation of certain tissues – will help determine the anatomical site and whether the filler is sufficiently encapsulated to be able to be removed by open or surgical needle and stab incision expression. Other procedures include approaches to the mid-face via the lower eyelid, rhytidectomy approaches to the lateral cheek element, and bicoronal approaches to the upper third of the face, as well as open rhinoplasty approaches.

Intraoperatively, the use of an experienced radiologist in ultrasonography will help guide needles and incisions into the filler targets (Figures 2 & 3). It is important if considering open approaches at the same time that the ultrasound-guidance removal is performed first, as open approaches introduce air into the tissues, making the ultrasound impossible to interpret. Ultrasound is particularly useful following needle and stab incision expression, to demonstrate a complete as possible filler removal.

Figure 2: Ultrasound guidance to direct stab expression of filler material also allows confirmation of filler removal post expression 

Conclusion

Avoiding complications from the use of permanent dermal fillers requires thorough training in medical and anatomical knowledge as well as aesthetic common sense. However, the use of permanent fillers may lead to permanent complications. Surgical costs for removal of fillers are very high compared to the initial costs of injection. Most patients appear unaware that they would have to meet the costs of medical treatment to correct complications themselves. We suspect that complications are significantly higher than those often quoted. 

References

  1. Lim LM, Dang JM, et al. ‘Dermal Filler Devices Executive Summary,’ FDA, (2018) <http://www.fda.gov/ohrms/dockets/ ac/08/briefing/2008-4391b1-01%20-%20fda%20executive%20 summary%20dermal%20fillers.pdf>
  2. Nadarajah JT, Collins M, Raboud J, Su D, et al., ‘Infectious Complications of Bio-Alcamid Filler Used for HIV-related Facial Lipoatrophy’, Clin Infect Dis (2012); 55(11): pp.1568-74.
  3. Salati SA & Al Aithan B, ‘Complications of Dermal Fillers – An Experience from Middle East’, Journal of Pakistan Association of Dermatologists, (2012); pp.22:12-18
  4. Sclafani AP & Fagien S, ‘Treatment of Injectable Soft Tissue Filler Complications’, Dermatol Surg (2009); 35: pp.1672-1680.
  5. Lloyd’s Register Quality Assurance, (2016), <www.lrqa.co.uk/ medical-devices/regulation>
  6. Medicines and Healthcare products Regulatory Agency and Department of Health, ‘Medical devices regulation and safety’, 2015, <https://www.gov.uk/.../medicines-medical-devices.../ medical-devices-regulation-safety>
  7. Sung MS, Kim HG, Woo KI, Kim YD. Ocular ischemia and ischemic oculomotor nerve palsy after vascular embolization of injectable calcium hydroxylapatite filler. Ophthal Plast Reconstr Surg 2010;26:289e91.
  8. Kim YJ, Choi KS, ‘Bilateral blindness after filler injection’, Plast Reconstr Surg, 131(2013).
  9. Lazzeri D, Agostini T, Figus M, Nardi M, Pantaloni M, Lazzeri S, ‘Blindness following cosmetic injections of the face’, Plast Reconstr Surg, 129(2012).
  10. Bray D, Hopkins C, & Roberts DN, ‘A review of dermal fillers in facial plastic surgery Current Opinion in Otolaryngology & Head and Neck Surgery’, 18(2010),pp.295–302.
  11. Wu H, Moser C, Wang H, Høiby N & Song Z, ‘Strategies for combating bacterial biofilm infections International Journal of Oral Science’, 7(2014) pp.1–7.
  12. Medicines & Healthcare products Regulatory Agency (2016), <https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency>
  13. FDA, ‘Soft Tissue Fillers Approved by the Center for Devices and Radiological Health,’ FDA, 2015, <http://www. fda.gov/MedicalDevices/ProductsandMedicalProcedures/ CosmeticDevices/WrinkleFillers/ucm227749.htm>
  14. GMC, ‘Guidance for all doctors who offer cosmetic interventions’, General Medical Council, (2016), <http://www. gmc-uk.org/guidance/news_consultation/27171.asp>
  15. RCS, ‘Professional Standards for Cosmetic Practice’, Royal College of Surgeons, <https://www.rcseng.ac.uk/publications/ docs/professional-standards-for-cosmetic-surgery> 

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