Bio-Alcamid, My Experience

In fact, it is a complex material, with a difficult injection process and considerable potential for immediate and long-term hazard if not treated properly. It is a very unforgiving product if mishandled.

Bio-Alcamid™ is described by the manufacturer as a hydrogel, a mix of polyalkylimide (96%) and water (4%). Amongst its stated characteristics are primarily ease of removal; being chemically inert; and not migrating. Unfortunately, in practice, in a small number of patients this has proven not to be the case.

Jones et al, writing in Dermatologic Surgery (Volume 33, Issue s2, Pages S193-S198) describe five cases of a late-appearing abscess (in patients with HIV where Bio-Alcamid™ had been placed for large facial volume replacement) some considerable time after placement which then required incision and drainage and antibiotics.

A review by Pacini S, et al. (Bio-Alcamid™: a novelty for reconstructive and cosmetic surgery. Ital J Anat Embryol 2002;107:209–14.) of 2000 cases showed a late abscess complication rate of 12/2000 cases, a rate of less than 1%. All five cases showed contamination with streptococcus. My personal experience with a range of HIV-positive patients some of who are severely immunosuppressed with marker CD4 counts of less than 100 and some who are co-infected with hepatitis C has shown a similar infection rate although my laboratory sample have failed to yield any organisms except a coliform in one instance.

Migration of the product can be a potential problem although data is relatively scarce. Certainly the contention that Bio-Alcamid™ will not migrate is in my opinion and experience false and this leads to a deeply disturbing result in a group of patients for whom cosmetic appearance and improvement are exquisitely important. Raman Malhotra and Adam Ross at the Queen Victoria Hospital, East Grinstead have recently published a retrospective series of 4 patients referred to them where they conclude “Bio-Alcamid™ use can potentially result in long-term orbitofacial complications including infection, abscess formation, recurrent swelling, migration and inflammatory nodules, particularly if manipulation, massage or removal using bimanual expression is attempted”. As a result, they caution specifically against over vigorous manipulation and/or repeated attempts to remove by expressing the product.

The manufacturer describes and demonstrate on their information DVD the successful expression of the product after puncture with a large bore needle. My experience has been that this rarely delivers the required result. In cases where removal is required, I now place patients on prophylactic ciprofloxacin 500mg bd prior to aspiration.

The site is cleaned with betadine and a 16 or 14-gauge needle is introduced directly into the implant (preferably either under ultrasound guidance or after ultrasound images have located the implant and more precisely the depth from the external skin. The implant is then aspirated into a syringe. As a routine I then irrigate the area with 20 mls bacteriostatic saline and 250mg ceftriaxone, aspirating each time and measuring the volume in and out. This has proved successful and resolves the issue.

Finally, although there are problems associated with the product it has provided good large volume replacement for my patients. I believe the key fault is to regard this product as just another dermal filler. It isn’t. It needs to be thought of as a surgical implant with all the hazards that may entail. Scrupulous attention to detail is required. The patient group itself is vulnerable to bacterial infection and the large volumes required may make migration more likely.

I am moving away from using Bio-Alcamid™ because I believe there are now better products available with vastly superior and demonstrable safety records, especially the large volume hyaluronic acids such as Restylane® Sub Q; and also importantly and bizarrely, the manufacturer has, after six years of relatively stable pricing, doubled the price of the product. This puts it outside the reach of most of my patients and I think will effectively end use of this product in the UK.