ARTÍCULO CLÍNICO

 

Use of polyalkylimide in facial reconstructive and cosmetic surgery

Utilización de polialcamida en cirugía reconstructiva y estética facial

 

 

M. Cuesta Gil¹, A. Valverde Carrasco², B. Duarte Ruiz³, F. Riba García³, M. Castrillo Tambay³, V. del Pino⁴

¹ Jefe de Servicio de Cirugía Oral y Maxilofacial. Hospital General de Ciudad Real, España.
² Médico Residente. Servicio de Cirugía Plástica, Estética y Reparadora. Hospital de Alicante, España.
³ Médico Adjunto. Servicio de Cirugía Oral y Maxilofacial. Hospital General de Ciudad Real, España.
⁴ Cirujano Plástico. Práctica Privada. Madrid, España.

Correspondence

 

 

---

ABSTRACT

Objectives. To report our experience with the management and application of nonresorbible biomaterials (polyalkylimide) in patients with facial defects of diverse origin.
Material and methods. Polyalkylimide (Bio-Alcamid^®) was used in fourteen patients. Four patients had different grades of facial lipodystrophy secondary to antiretroviral treatment. Four patients sought to improve their labial profile. Three patients had previously undergone oncological excision and two had traumatic facial defects. Finally, one patient had a nasal defect due to rhinoplasty.
Results. All patients were very satisfied. No serious complications occurred. Implants were stable and durable.
Conclusions. The safety and simplicity of this technique, and the high degree of patient satisfaction, encourage the use of these substances to correct facial defects of diverse etiology.

Key words: Biomaterials; Polyalkylimide; Facial lipodystrophy; Facial esthetics.

---

RESUMEN

Objetivos. Presentar nuestra experiencia en el manejo y aplicación de biomateriales no reabsorbibles (poliaquilamida) en pacientes con defectos faciales de diversa etiología.
Material y métodos. Empleamos poliaquilamida (Bio-Alcamid^®) en un total de catorce pacientes. Cuatro pacientes presentaban distintos grados de lipodistrofia facial secundaria a tratamientos antiretrovirales. Otros cuatro, consultaron porque deseaban mejorar el aspecto de su perfil labial. Tres pacientes habían sido sometidos con anterioridad a exéresis oncológicas, y otros dos mostraban defectos faciales derivados de traumatismos. Finalmente, un paciente presentaba un defecto nasal, secuela de una rinoplastia previa.
Resultados. Todos los pacientes mostraron un índice muy elevado de satisfacción. No se registraron complicaciones graves. Queremos señalar la estabilidad y durabilidad del implante.
Conclusiones. La seguridad y sencillez de esta técnica asociada al alto grado de satisfacción manifestado por los pacientes, animan al empleo de estas sustancias en la corrección de defectos faciales de diversa etiología.

Palabras clave: Biomateriales; Poliaquilamida; Lipodistrofia facial; Estética facial.

---

 

Introduction

Since the mid-1990s, surgeons who perform reconstructive and cosmetic surgical procedures have injectable biocompatible materials⁹ available for filling and/or adding volume to regions as varied as the face and breasts. These materials are used in the face in both reconstructive surgery (to repair defects due to oncological excision or trauma) and cosmetic surgery (to fill lips to increase their prominence, repair clefts, etc).

The possibilities of this type of material undoubtedly are almost unlimited, therapeutic applications being conditioned by their components and physical and chemical characteristics. ¹³

The ideal filler for use in the human body is the patient’s own fatty tissue.^14,15 Liposuction techniques, centrifugation and decanting are used to obtain the material. This aspirated and treated fat can then be reinjected into certain areas of the body with defects as a filler. This apparently ideal and biocompatible technique, however, carries the risk of graft loss, with time, and the development of fatty necrosis.⁷

At present, a series of artificially synthesized materials exist that begin to degrade soon after injection in the receptor bed.¹¹ These materials are known as transitory or degradable materials, and their foremost representative is hyaluronic acid, which has effects that last for six to twelve months. Another type of materials, known as permanent biomaterials, last much longer in the body and their effects are more prolonged. These materials include polymethylmetacrylate (Artecoll ^®) and polyalkylimide (Bio-Alcamid ^®).¹³

In this article we report our small experience with polyalkylimide in filling facial defects of diverse origin. We would like to encourage readers to use such materials because of their good results, easy management, and low complication rate.

 

Material and method

We used polyalkylimide (Bio-Alcamid ^®) in a total of fourteen patients with a variety of indications for the use of this substance.¹⁰

Four patients had different degrees of facial lipodystrophy secondary to antiretroviral treatment (Cases 1 and 2). Four sought to improve their labial profile (Case 3). Three patients had previously undergone oncological excision (Case 5) and two had traumatic facial defects. Finally, one patient had a nasal defect due to rhinoplasty (Case 4). We want to emphasize that the way the lip projects in relation to the facial profile conditions the facial esthetics of individuals. We used polyalkylimide for this purpose (eg, to improve labial projection) in three women in their forties and in a much younger man. More than twelve months after application of the nonresorbible biomaterial, the injectable endoprosthesis remained stable and the cosmetic result was very satisfactory in every case.¹² (Fig 1, 2, 3, 4, 5, and 6)

A complete clinical history was obtained from all patients and they were informed verbally and in writing about the treatment (what it involved, complications and risks, etc). Broadspectrum antibiotic prophylaxis was begun and a sterile field was prepared. The needles supplied with the product were used to inject the filler in the hypodermis. The procedure was performed under local anesthesia (85%) in twelve patients. Only one session was needed to complete the procedure in every patient except one.³

When the patient is not sure about how much volume he or she wants to have implanted, preliminary treatment with resorbible material is performed, recording the milliliters of material injected in each area. After 8-10 months, patients were reevaluated and the volume of permanent biomaterial injected was adjusted in accordance with the previous result.

After applying the product, the receptor bed was massaged circularly and ice packs were recommended to reduce inflammation.

It should be noted that none of our patients had a history of collagenosis, active infection or radiotherapy in the treatment area, or untreated diabetes mellitus, which are contraindications for treatment.⁵

 

Results

The fourteen patients (100%) characterized the result obtained after injecting the biomaterial as «very satisfactory». All of them claimed that their social relations and selfesteem had increased and improved as a result of biopolymer treatment.

Patients evaluated the procedure as «not very traumatic or painful» in twelve cases. Only one patient said that «it was painful and produced intense swelling". More than twelve months after application of the nonresorbible biomaterial, the injectable endoprosthesis remained stable and the cosmetic result was very satisfactory in every case.¹²

No complication related with use of the biopolymer was observed.

 

Discussion

The injection of materials to correct defects of different sorts is not as recent as one might think. It dates back to the 1950s and 1960s, when paraffin was injected to increase breast volume in Hong Kong, Japan and Taiwan. Unfortunately, foreign body reactions developed (paraffinomas) in most cases. Some coursed as painless masses, but in other cases they led to the development of mammary ulcers that simulated neoplasms. So-called "liquid silicone" was later marketed and widely used in transsexual patients. Initially it was believed that use of the pure form of the product synthesized by Dow Corning would minimize adverse effects.¹⁵

We now know that "liquid silicone" causes severe chronic inflammation that sometimes requires extensive surgical debridement. Tissue migration of the biomaterial has been reported, ultimately resulting in death due to affectation of vital organs. For these reasons, «liquid silicone» is now prohibited by the DA.¹⁴

Bio-Alcamid ^® is a gelatinous polymeric gel consisting mainly of water (97%) with only 3% polyalkylimide.¹ For this reason, the main indication of this acrylic-derived material is the correction of soft tissue defects. When the implant is injected in the hypodermis, it is coated by a fine layer of collagen that isolates it from the surrounding tissues.4 This is why it is often referred to as an "injectable endoprosthesis". Unlike other fillers used years ago and now prohibited in Spain (eg, fluid or liquid silicone), Bio-Alcamid ^® is a permanently stable material, which prevents tissue migration.6 Another important advantage of this compound is its radiotransparency, so it does not interfere with the result of certain diagnostic tests.

Injectable materials are now used routinely in therapeutic procedures by surgeons who perform cosmetic and reconstructive surgery. This material makes it possible to quickly and effectively modify the nasogenial furrow, lip volume, malar prominences, and facial expression wrinkles. The use of Bio-Alcamid ^® is increasingly common in cosmetic therapeutic procedures for HIV-positive patients receiving antiretroviral treatment who exhibit marked signs of facial lipodystrophy. ^2,8

The use of this type of implants originates only mild discomfort, which can be relieved with first-line analgesics. Mild inflammation is frequent and disappears within 24-48 hours in most cases. Serious complications are exceptional and did not occur in any of our patients.

Interventions performed with proper technique are considered highly satisfactory by both patient and surgeon, the most important problems arising from the intrinsic nature of the implants. Polyalkylimide, as mentioned above, is a stable compound. This is why it is considered a permanent material. We have observed the stability and durability of this implant, together with the absence of migration of the material. However, we still do not know the long-term properties of this compound and until we have long-term results, no definitive conclusions can be drawn.

When we perform a procedure with injectable implants, patients must given their consent after being informed about the properties of polyalkylimide, as well as the existence of the so-called transitory injectable materials and their properties. Bio-Alcamid ^® is a permanent injectable substance that may have long-term results that are unacceptable to patients. For instance, years after undergoing a cosmetic intervention to enhance the malar region, the patient may eventually view the prominence that was once considered attractive and satisfactory as excessive. We must always remember that removal of these materials is difficult in most cases, and even almost impossible in some locations, like the lips.

The general guideline for direct use of nonresorbible material is to inject moderate volumes. After 4-5 weeks, we reevaluate the patient. If the result is insufficient, we can perform a new biopolymer injection. However, if the volume injected is excessive, it is complicated to remove the material and complications often develop.

 

Conclusions

1. Injectable materials used for cosmetic purposes are always administered under local anesthesia. This type of cosmetic corrections can be characterized as «a la carte» because the patient will choose the durability of the implant to be used, in addition to the region to be remodeled, with the surgeon who will perform the procedure.

2. The materials used are highly stable and their adaptability to thereceptor area and texture are excellent. Their biocompatibility and relation with the surrounding tissues eliminates the possibility of triggering allergic reactions to the implant.

3. Due to the nature of permanent injectable materials, we must avoid the sort of overcorrection that is sometimes demanded by patients to accentuate treatment results when using transitory injectables.

4. Generally speaking, the result obtained is considered highly satisfactory by patients. The texture and appearance achieved are considered natural as long as proper technique is used.

 

 

Correspondence:
Matías Cuesta Gil
Pasaje de Lanzarote 6, Portal 2, 3ºA.
13001 - Ciudad Real, España.
Email: matiasc@sescam.jccm.es

Received: 06.10.06
Accepted: 26.03.07

 

 

References

1. Terenzi V, Leonardi A, Covelli E, Buonaccorsi S, Indrizzi E, Fenicia V,Perdicchi A, Fini G. Parry-Romberg syndrome. Plast Reconstr Surg 2005;116:97e-102e.        [ Links ]

2. Burnouf M, Buffet M, Schwarzinger M, Roman P, Bui P, Prevot M, Deleuze J, Morini JP, Franck N, Gorin I, Dupin N. Evaluation of Coleman lipostructure for treatment of facial lipoatrophy in patients with human immunodeficiency virus and parameters associated with the efficiency of this technique. Arch Dermatol 2005; 141:1220-4.        [ Links ]

3. Orenstein A, Bar-Meir E. Bio-alkamid: avoiding the leak. Plast Reconstr Surg 2005;115:1789-90.        [ Links ]

4. Ramires PA, Miccoli MA, Panzarini E, Dini L, Protopapa C. In vitro and in vivo biocompatibility evaluation of a polyalkylimide hydrogel for soft tissue augmentation. J Biomed Mater Res B Appl Biomater 2005;72:230-8.        [ Links ]

5. Claoue BL, Rabineau P. The polyalkylimide gel: experience with Bio-Alcamid. Semin Cutan Med Surg 2004;23:236-40.        [ Links ]

6. Formigli L, Zecchi S, Protopapa C, Caporale D, Cammarota N, Lotti TM. Bio- Alcamid: an electron microscopic study after skin implantation. Plast Reconstr Surg 2004 ;113:1104-6.        [ Links ]

7. Mojallal A, Foyatier JL. The effect of different factors on the survival of transplanted adipocytes. Ann Chir Plast Esthet 2004;49:426-36.        [ Links ]

8. Protopapa C, Sito G, Caporale D, Cammarota N. Bio-Alcamid in drug-induced lipodystrophy. J Cosmet Laser Ther 2003;5:226-30.        [ Links ]

9. Pacini S, Ruggiero M, Cammarota N, Protopapa C, Gulisano M. Bio- Alcamid, a novel prosthetic polymer, does not interfere with morphological and functional characteristics of human skin fibroblasts. Plast Reconstr Surg 2003;111:489-91.        [ Links ]

10. Pacini S, Ruggiero M, Morucci G, Cammarota N, Protopapa C, Gulisano M. Bio-alcamid: a novelty for reconstructive and cosmetic surgery. Ital J Anat Embryol 2002;107:209-14.        [ Links ]

11. Bergeret-Galley C, Latouche X, Illouz YG. The value of a new filler material in corrective and cosmetic surgery: DermaLive and Derma- Deep. Aesthetic Plast Surg 2001;25:245-9.        [ Links ]

12. Alster TS, West TB. Human-derived and new synthetic injectable materials for soft-tissue augmentation: Current status and role in cosmetic surgery. Plast Reconstr Surg 2000;105:2515-20. 13. Klein AW, Elson ML. The history of substances for soft tissue augmentation. Dermatol Surg 2000;26:1096-9.        [ Links ]

14. Spira M. Failure to remove soft tissue injected with liquid silicone without the use of suction and honesty in scientific medical reports. Plast Reconstr Surg 2000;105:1909-14.        [ Links ]

15. Rudolph CM, Soyer HP, Shuller-Petrovic S, Kerl H. Foreign body granulomas due to injectable aesthetic microimplants. Am J Surg Pathol 1999;23:113-8.        [ Links ]