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Surgical Audit Retrospective study on complications of BioAlcamid Filler in the period 2004-2006 Dr. Patrick Treacy

Introduction

Synthetic biodegradable hyaluronic acid fillers are widely used as relatively safe injectable methods of lip augmentation but their duration is limited to only four months. Because of this many physicians use alternative non-biodegradable materials like polyacrylamide gels and polyvinyl acid, to create a longer lasting semi-permanent product.

Introduction The search for the ideal filling material has been ongoing for centuries. Various materials, including collagens, autologous fat, hyaluronic acids, poly-L-lactic acid, polyacrylamide, liquid injectable silicone and calcium hydroxylapatite, are among the products currently used for this indication. Bio in Blue (Polymekon, Brindisi, Italy) is high purity polyvinyl alcohol (8%) and water (92%). Polyvinyl alcohol is a non-toxic substance used in medicine as a drug-carrier and a substitute for human plasma expander.

Retrospective Study Retrospective Study of nine cases requiring surgical correction of product migration of semi-permanent lip fillers Bio-Alcamid and Bio in Blue over 2 year period

Bio-Alcamid is a non reabsorbable polymeric material composed of 96% of apyrogenic water and 4% of an alkylimide-amide group.

It is considered novel in aesthetics because it is considered intermediate between injectable filler and a common prosthesis

Introduction

However, these increased duration fillers, have an increased risk of swelling, granuloma, product migration and other long-term adverse events.

Treatment options include intralesional steroids, 5-FU, immunomodulatory drugs minocycline, rifampicin, anti-inflammatories or surgical correction.

Treatment Options

This report documents surgical correction of nine cases of problems related to the adverse side-effects related to the semi-permanent fillers Bio-Alcamid or Bio in Blue (Polymekon, Brindisi, Italy) over a three year period.

Case Reports Nine female patients in otherwise good health were referred to the author by aesthetic doctors in the UK and Ireland with moderate nodular swellings in their labial area over a period of two years. They all reported a history of their lips having being injected with the cosmetic filler Bio in Blue or Bio-Alcamid at the site of the swelling to correct and project the labial profile.

Case Reports In every case a 23G needle was used and entrance was made 0.5cm medial to the oral commissure with infiltration done along the vermilion border. Each hemilip was injected with amount of 0.5-0.9ml of BioAlcamid or Bio in Blue .

Five of the patients were injected with Bio In Blue and four with Bio-Alcamid.

Case Reports Four of the patients had previously been injected with another type of HLA filler prior to the use of these semi-permanent type fillers. The labial swellings were each worsening in appearance as time passed and the patients were emotionally distressed. Numerous doctors had treated the patients with injections of Dexamethasone (40mgs/ml) or Triamcinolone (40 mg/ml) at intervals, with no resolution of the swelling.

Case Reports There was no relevant medical history and the patient did not have any clinical evidence of autoimmune or allergic diseases. On palpation, each patient presented with firm longitudinal swellings measuring 3 cm 2 cm along the lines of filler implant in each patientThe nodules were prominent anteriorly and projected from inside the oral cavity.

Case Reports The patients were all were willing to accept surgical correction and histological evaluation of their problem. Surgical excisions were carried out by direct use of a size 11 scalpel blade, usually without the use of local anaesthesia, allowing the nodules to point under digital manipulation.

Case Reports The wound was cleaned and the vermillion tissues approximated in some cases with 5-0 Vicryl Rapide sutures (Ethicon, Inc) to achieve closure or haemostatis. The operation sites healed well and most had healed within a few days with no infection. Excision biopsies showed no evidence of foreign body giant cells or irregular crystalline structures and stopped

Discussion BioAlcamid is a non reabsorbable polymeric material composed of 96% of apyrogenic water and 4% of an alkylimide-amide group. These chemical aspects of BioAlcamid are responsible for a greater chemical stability of the polymer, a better resistance to basic and acid hydrolytic phenomena, and high resistance to water. Unlike other materials, BioAlcamid sometimes be removed even after long time after implantation.

Discussion Injectable dermal fillers are registered as devices rather than prescribable medicines in the United Kingdom, requiring only CE marking (which relates to production standards, not efficacy) for release on to the market.In the United States they have to be approved by the Food and Drugs Administration (FDA) as medicines. Therefore over 140 injectable fillers are available in the UK compared with six in the US.

Conclusion The purpose of this retrospective case report is to 1) Demonstrate that surgical correction of product migration or granuloma is possible when these complications occur2) Highlight poor European medical regulation concerning safety of dermal fillers. 3) Increase awareness of the cosmetic doctor to stop providing extended duration dermal lip fillers as treatments.

Conclusion Official consent for dermal fillers should mandatory document all adverse effects including those of infection, product migration and granuloma formation

EU legislation should reclassify dermal fillers as prescribable medicines rather than medical devices. Same CE mark as a children's teddy bear.

Conclusion The ability to reclassify fillers as prescription medicine in Europe would effectively control marketing and sale of these fillers as well as regulate who can perform these dermal injections It would also provide an automatic ban on commercial advertising.Because of this, Bio-Alcamid has been taken off the market and the original manufacture has since stopped production. In Canada, class action lawsuits were enacted against the company