This retrospective study reviews complications associated with the semi-permanent lip fillers bio-alcamid and bio in blue from 2004 to 2006, highlighting issues like swelling and product migration in nine female patients. Surgical corrections were performed with successful outcomes, demonstrating that complications can be addressed despite the risks of these materials. The study calls for stricter regulations and reclassification of dermal fillers as prescription medicines due to safety concerns.

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

2. 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.

3. 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.

4. 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

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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 patient
• The nodules were prominent
anteriorly and projected from
inside the oral cavity.

11. 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.

12. 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

13. 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.

14. 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.

15. 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 occur
2) 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.

16. 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.

17. 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