This retrospective study summarises the complications that have developed in 26 patients treated with Bio-Alcamid® for Pectus excavatum, tries to determine risk factors and describes the management strategy employed to treat these adverse effects.
Methods/Technique:
We describe a retrospective evaluation of 26 patients that underwent correction of Pectus excavatum with Bio-Alcamid® injections performed between 2004 and 2010 by the senior author.
Results/Complications:
26 patients were treated with Bio-Alcamid® for Pectus excavatum deformity between 2004 and 2010. 25 patients were male and one female. The age range was 17 to 64 years with an average age of 34 years. Patients received between one and eight injections, the average being 2.9 treatments. Patients were injected 10ml to 340ml of Bio-Alcamid® and the average amount was 101ml per person.
Out of the 26 patients 9 had complications, therefore the complication rate was 34.7%. Complications included migration of the filler, spontaneous discharge of the material, coalesced filler, hollowing due to migration of the material, swelling and localized inflammation, superficial soft tissue infection, severe infection with signs of sepsis. Not included in the statistic was mild inflammation, swelling or redness immediately after the injection of the material.
Four patients had one, three patients had two, one patient had three and one had four complications. In total 9 patients with a total of 17 complications received treatment after having been injected with Bio-Alcamid® for Pectus excavatum. Six out of the nine patients that received total volumes of filler exceeding 100ml had at least one complication (67%). Although we have seen early complications the more severe ones typically occurred 2 to 4 years after the initial treatment.
Treatment options for complications included aspiration of filler and/or pus with a large bore needle, drainage of filler through a 3mm punch hole, open excision in two selected cases plus antibiotic coverage. Two patients had custom made chest implants inserted at a later stage, the female patient had an exchange of her breast implants demonstrating severe capsular contracture and one patient opted for thoracic surgery.
Conclusion:
Procedures and fillers used for cosmetic and reconstructive indications should be as safe as possible. Initial studies showed very low complication rates of under 0.2%, whereas over the years other groups published series with increasing complication rates of up to 4.8%. We consider an overall complication rate of 34.7%, as seen in our series, as too high. It could be that our complication rate was higher because we used much more volume of filler material than groups that mainly treated facial lipodystrophy and other soft tissue defects with much smaller amounts of filler. Also the relatively high number of treatments per patient might have had an impact on the risk of inflammation and infection since the filler is repeatedly injected into the same anatomic region and therefore contamination cannot be ruled out completely despite strict antiseptic measurements and prophylactic antibiotics. Any foreign material injected into the body may provide a favourable environment to harbour bacteria and therefore one must assume that large volumes and multiple installments of Bio-Alcamid® will increase the risk of inflammation and infection. Material sent for microbiology in our as well as in other series showed strains of Streptococcus oralis and Staphylococcus aureus that were sensitive to Amoxycillin and Flucloxacillin respectively.
Initial reports claimed that Bio-Alcamid® does not migrate. More recent studies showed migration. In our series migration of the filler occurred always distally to the injection site following gravity especially when large volumes were used.
Depending the type of complication antibiotic therapy and aspiration of the material with a large bore needle might be sufficient although we agree with other authors that this is sometimes difficult. Even a long time after implantation, the gel can be removed by puncturing the membrane with a 3mm punch biopsy and squeezing the gel out. This maneuver proved to be successful in most instances. We never had to use irrigation systems that other groups advocate but two of our patients underwent open excisions in order to treat a severe infection and in the other instance to exchange breast implants in the same session. There were no mortalities in our series but one patient already required treatment of his complications on four different occasions.
Interestingly we saw an increase of complications in our patient group 2 to 4 years after initial treatment and share this experience with other authors. Because most complications are reported years after the injection of the material, total complication numbers might be underestimated. Instead we favor the use of custom made silicone implants for treatment of contour defects of the chest in patients presenting with Pectus excavatum.