Dermal & Soft Tissue Filler: Polyalkylimide gel (Bio-Alcamid)

Generic name: injectable water-based polyalkylimide gel (4% polyalkylimide, the rest is water)

Brand(s): Bio-Alcamid

Maker / Website: Bio-Alcamid (www.bioalcamid.com) is produced by Polymecon (www.polymekon.it)

Cost: about $150 - $300 per cc depending on treatment volume

Allergy test required: No

Durability: Permanent; can be removed via aspiration although it is unclear how complete such removal may be.

Function / Purpose:
Cosmetic augmentation and reconstruction of the face and body, including treatment of facial lines and folds (e.g. nasolabial folds), lip augmentation, depressed scars, enhancement of cheekbones and jawline, replacement of facial volume lost due to age, lipoatrophy and so forth. Polyalkylimide gel is not indicated for the treatment of fine wrinkles.

Summary:
Injectable water-based polyalkylimide gel contains a small percentage of polyalkylimide (4% in Bio-Alcamid) while the rest is water. In many ways, polyalkylimide gel is chemically and mechanically similar to polyacrylamide gel (Aquamid). However, the manufacturers claim polyalkylimide to have advantages, such as greater stability, better integration with living tissues and simpler removal if required. It is non-biodegradable and the results are considered permanent. The removal requires aspiration and it is unclear how complete such removal may be.

Details:
Injectable water-based polyalkylimide gel contains a small percentage of polyalkylimide (4% in Bio-Alcamid) while the rest is water. Bio-Alcamid is manufactured by Polymekon, Brindisi, Italy. It is used to treat soft tissue deficits like facial lipoatrophy and lipodystrophy, Poland syndrome, Pectus excavatum (sunken chest), gluteal atrophy, etc. In plastic and reconstructive surgery it is used for building up facial volume in areas like the cheeks, chin, jaw and for lip augmentation. It can be used to correct pitted scars, facial folds and furrows (such as nasolabial folds and frown lines) but not fine lines.

In many ways, polyalkylimide gel is chemically and mechanically similar to polyacrylamide gel (Aquamid). However, the manufacturers claim polyalkylimide to have advantages, such as greater stability, better integration with living tissues and simpler removal if required. It is non-biodegradable and the results are considered permanent. The removal requires aspiration and it is unclear how complete such removal may be.

It is injected subcutaneously through a syringe, often under local anesthesia. After the treatment, a thin layer (0.02 mm) of collagen gradually forms around it over a period of 4-8 weeks, completely surrounding the gel, isolating it from the host tissues and making it an endogenous prosthesis. It is radio-transparent (for x-rays), although it can be located by using ultrasound.

Also large quantities can be injected in one session without an immune response. Amounts of 5ml to 20ml are normally injected into the face. Its manufacturer claims that Bio-Alcamid should not degrade or move and that it can also be removed through aspiration or puncture and manual pressure.

While infection is always a possibility with the use of any implanted material, no other major complications have been reported so far. However, long-term safety data are not yet available.

Bio-Alcamid comes in pre-filled syringes (1cc, 3cc and 5cc). Bio-Alcamid has been commercially available since 2000 in Europe and Mexico. The FDA has not yet approved its use in the United States. In Canada it is available under the Special Access Program, which involves application on a patient-by-patient basis.