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Chirurgia delle Labbra

Danni dei filler, permanenti e semipermanenti

La chirurgia e la terapia correttiva dei "danni" provocati dai filler permanenti e semipermanenti sempre più sta diventando una parte importante dell'attività professionale di chi si occupa con frequenza della patologia legata al labbro.

Negli anni passati infatti era frequente fare ricorso a sostanze quali silicone, metacrilato, idrogel, etc. che si sono poi rivelati, nel tempo, dei veri e proprio ordigni bellici in potenza. La loro "esplosione" infatti, oltre apparire nei momenti più imprevisti ed imprevedibili è causa di disagio, di stress e di incertezza circa le tecniche ed i trattamenti utili per la soluzione al meglio del problema da loro causato.

Il silicone, utilizzato in elevate quantità negli anni passati, per la sua capacità di essere inserito facilmente e per la sua reale efficacia nell'aumentare il volume delle labbra e degli zigomi, si è mostrato a distanza di tempo un prodotto in grado di migrare e di essere causa di infiammazione oltre che causa di una disarmonia delle aree trattate. L'utilizzo del cortisone, inserito nel nucleo dell'area infiammata, è in grado, nella maggior parte delle volte, di migliorare la componente infiammatoria senza però risolvere il problema della presenza del silicone che unicamente attraverso un intervento chirurgico potrà essere affrontato e trattato. La chirurgia infatti nella maggior parte dei casi è in grado di rimuovere il maggior volume possibile di silicone e di rimodellare le aree trattate recuperando l'armonia perduta. Il volume residuo che non viene rimosso, perché troppo abbondante o perché in aree non trattabili ed a rischio per la presenza per esempio di strutture nervose, in genere non è causa di ulteriori problemi se non sporadici episodi di infiammazione locale trattabili con terapia medica.

Differente invece è il caso di pregresse infiltrazioni con metacrilato ed altri prodotti con caratteristiche simili che, una volta infiltrate e diventate causa di infiammazione, solo con ripetuti trattamenti medico/chirurgici sarà possibile in qualche modo tenere sotto controllo! Andrebbe infatti informato chiaramente il possibile Interessato all'utilizzo del prodotto che il risultato è realmente molto barilante e costante nel tempo ma che i rischi di un possibile grave problema esistono davvero! Nonostante infatti il tentativo delle Case Produttrici dei vari prodotti di minimizzare gli effetti collaterali e le complicanze e la rassicurazione che semplici soluzioni quali, la possibilità di rimuovere con un ago il prodotto causa di problema dall'area infiltrata, in realtà non esiste una unica e certa soluzione ma vari procedimenti chirurgici e terapie antiinfiammatorie finalizzate a rimuovere quanto più possibile l'indesiderato ospite e ridurre la quota reattiva locale.

Personalmente dopo anni di "guerra" ai filler "pericolosi" e di numerosi Pazienti trattati per cercare di risolvere ed eliminare i danni e problemi causati da questi prodotti, ritengo che dovrebbe essere presentato un consenso che contenga delle foto di alcuni dei numerosi casi clinici costantemente afflitti da tali problemi affinché il consenso ad accettare l'inserimento di questa tipologia di filler sia davvero informato! Questo però non fa parte di politiche aziendali attuali perché, solo per citare un esempio, ad un mio articolo pubblicato su una rivista scientifica che metteva in guardia sui possibili effetti collaterali di uno di questi filler, la risposta, proprio del referente della Casa Produttrice non è stata quella di cercare di comprendere il disagio della Paziente e di affrontare il problema ma di controbattere con numeri di pazienti trattati con "successo" (senza tenere conto che chi ha problemi difficilmente apparirà nelle statistiche) e di considerazioni tecniche scientifiche sul volume del materiale presente e su altri aspetti che nulla hanno a che vedere con l'evidenza dei fatti sugli effetti collaterali presenti e possibili!

Aquamid: Where Is the Reality?

Aquamid: Where Is the Reality? [QUESTION]

Sir:
When we read the numerous accounts of the astonishing results obtained by so many colleagues through the use of Aquamid (Ferrosan, Soeborg, Denmark) infiltrations, to treat depressed areas, for example, or to raise deep wrinkles of the face for aesthetic purposes, it occurs to us to think that the cases that sometimes come to our attention are absolutely rare. Aquamid is a soft-tissue filler, a transparent polyacrylamide gel consisting of approximately 2.5% crosslinked polyacrylamide and 97.5% apyrogenic water. It is used for soft-tissue augmentation and contour correction, with minimal reports of significant complications after injection into the face.1,5 After discussing personal experience with other colleagues who report an increasing number of such cases, multiplied by the; large number of practicing surgeons just in Rome, we think that many cases, really, have not been reported, certainly not intentionally, possibly because the patients did not return for follow-up. Just to give an example, we present the case of a 30-year-old woman who presented with a swollen area that included the entire right cheek as far as the inferior palpebral region. The patient had sustained an injury to the face years earlier and had already undergone numerous reparative operations, with results, according to the patient, that were not completely acceptable. Consequently, to correct a depression of the operated area, the patient had undegone treatment by infiltration of an indeterminate quantity of injectable polyacrylamide. Approximately 3 years after the operation, however, the patient noticed swelling that was fluctuant and, as time passed, tended to increasingly move into a dependent position. Amagnetic resonance imaging study confirmed the presence of the material previously infiltrated and revealed no other noteworthy findings. The patient underwent surgery, during which the same preauricular incision was used that had been used during one of the previous operations. After a brief, blunt subcutaneous dissection, an area was reached that appeared fluctuant; it was lined by an easily lacerable membrane of reactive tissue and contained some pasty liquid material, exactly corresponding to the methacrylate placed previously. We removed the methacrylate together with the lining capsule, which appeared, however, to be tenaciously adherent to the underlying tissue planes. Taking into consideration the patient's need to maintain adequate filling of the area (which intraoperatively was deprived of the polyacrylamide support and again appeared depressed), we proceeded to prepare a dermoadipose graft, by drawing from the inguinal region and fixing it in the subcutaneous site. The patient had an optimal postoperative period and at 3 months after the operation showed an optimal result even in terms of aesthetic appearance. A certain degree of reabsorption of the inserted graft is probably to be expected, but this can be remedied by lipofilling over the next few years. We wish, therefore, to emphasize the possible problems related to the use of so many foreign materials that perhaps are too easily used ever more frequently because of statistics and results that may overstate their success.

DOI: 10.1097/PRS.0b013e3181774619
Fabio M. Abenavoli, M.D
Andrea Servili, M.D.
Roberto Corelli, M.S.

San Pietro Hospital
Fatebenefratelli
Rome, Italy

References

  1. von Buelow, S., von Heimburg, D., and Pallua, N. Efficacy and safety of polyacrylamide hydrogel for facial soft-tissue augmentation. Plast. Reconstr. Surg. 116: 1137, 2005.
  2. Christensen, L., Breiting, V., Janssen, M., Vuust, J., and Hogdall, E. Adverse reactions to injectable soft tissue permanent fillers. Br. J. Dermatol. 154: 755, 2006.
  3. Amin, S. P., Marmur, E. S., and Goldberg, D. J. Complications from injectable polyacrylamide gel, a new nonbiodegradable soft tissue filler. Dermatol. Surg. 30: 1507, 2004.
  4. De Cassia Novaes, W., and Berg, A. Experiences with a new nonbiodegradable hydrogel (Aquamid): A pilot study. Aesthetic Plast. Surg. 27: 425, 2003
  5. Breiting, V., Aasted, A., Jorgensen, A., Opitz, P., and Rosetzsky, A. A study on patients treated with polyacrylamide hydrogel injection for facial corrections. Aesthetic Plast. Surg. 28: 45, 2004.

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Aquamid: Where Is the Reality? [ANSWER]

Sir:
Contura International was informed about an article published in this Journal by Fabio M. Abenavoli, M.D., Andrea Servili, M.D., and Roberto Corelli, M.S. (Aquamid: Where Is the Reality? Plast Reconstr Surg. 2008;122:32e-33e). The article referred to a patient who apparently was injected with the Contura injectable filler Aquamid. This patient developed a swelling at the injection site 3 years after treatment. When a preauricular incision was made, and the area drained of some pasty liquid material, the authors then describe the drained material as containing methacrylate together with the capsule lining. I would like to highlight the inconsistency in the article. Aquamid consists of approximately 97.5 percent nonpyrogenic water and 2.5 percent cross-linked polyacrylamide. Aquamid is a homogenous hydrogel and is free of microparticles. Therefore, the material drained from the patient could not have been Aquamid, since there was methacrylate present according to the authors.1 Another key point to note is that Contura recommends that Aquamid be injected in a linear, fan-shaped manner to enable tissue integration and thereby reduce the risk of adverse events. This injection technique minimizes the risk of encapsulation.2,3 In the article, the authors' shows some pasty liquid material being removed; this is inconsistent with the above-mentioned Aquamid injection technique. The safety and efficacy of Aquamid have been documented in several clinical trials involving more than 1000 patients. These clinical studies have been published in leading peer-reviewed journals.4 To date, more than 300,000 injections have been performed, and the adverse events risk is at 1:1000, and is infection. These infections have resolved after treatment with antibiotics.

Ieva Ankorina-Stark,
Ph.D. Contura International A/S
Sydmarken 23
Soeborg 2860, Denmark
ivas@contura.com

References

  1. Christensen L, Breiting V, Janssen M, Vuust J, Hogdall E. Adverse reactions to injectable soft tissue permanent fillers. Aesthet Plast Surg. 2005;29:34-48.
  2. von Buelow S, Pallua N. Efficacy and safety of polyacrylamide hydrogel for facial soft-tissue augmentation in a 2-year follow-up: A prospective multicenter study for evaluation of safety and aesthetic results in 101 patients. Plast Reconstr Surg. 2006;118 (Suppl.):85S.
  3. Christensen L, Breiting V, Vuust J, Hogdall E. Adverse reactions following injection with a permanent facial filler polyacrylamide hydrogel (Aquamid): Causes and treatment. Eur J Plast Surg. 2006;28:464-471.
  4. De Santis G, Jacob V, Baccarani A, et al. Polyacrylamide hydrogel injections in the management of human immunodeficiency virus-related facial lipoatrophy: A 2-year clinical experience. Plast Reconstr Surg. 2008;121:644.

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Aquamid: Where Is the Reality? [REPLY]

Sir:
I read with great interest the letter by Dr. Ieva Ancorina Stark, who proposes the analysis of the given topic from a perspective different from the one that I suggested in my article published in Plastic and Reconstructive Surgery.1 Actually, I was contacted by the Danish
maker of the product and I also recently spoke to their representatives, explaining to them that my article in and of itself is not to be considered an attack to their product but only as a warning to the several profiles of criticism to which their product can give rise. Concerning the specific case of my patient, let me say that I only reported what happened: a lady came to me in the hospital asking to be helped out of the difficult situation she was living in and specifying that her problem was caused by an infiltration with Aquamid. Anyway, in recent weeks, another, similar case has come to my attention. In this case, a 62-year-old patient
had undergone an infiltration with polyacrylamide in the zygomatic area 1½ years earlier. She was sure about the product with which she had been infiltrated, as the doctor had given her the name of the product. The product moved into a lower position on the right side, so that the area presented itself as fluctuant and swollen. There was no infection. I started a treatment with corticoid, and I am following the evolution of the local situation.
There are a number of factors that can contribute to the insurgence of the described collateral effects. Among the several factors it is possible to enumerate, for example, is the incorrect use of the product or an exaggeration in the dose of it. What is certain, however,
is that products such as Aquamid and Formacril (or similar products) must be used with great caution and patients must be advised of the chance of the occurrence of the above-mentioned collateral effects, even beyond the general warnings indicated and described
by the pharmaceutical makers.

DOI: 10.1097/PRS.0b013e3181a2060e
Fabio M. Abenavoli, M.D
San Pietro Hospital
Fatebenefratelli
Rome, Italy

References

  1. Abenavoli FM, Servili A, Corelli R. Aquamid: Where is the reality? Plast Reconstr Surg. 2008;122:32e-33e.

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Chirurgia Estetica delle Labbra · Dottor Fabio Massimo Abenavoli · Partita Iva 07598870587