I first read of the off-labeled use of zafirlukast back in 2002. I had one patient with a unilateral Baker’s Grade IV capsular contracture who wanted to avoid surgery (open capsulectomy). I told her it wasn’t proven (only 30 patients) but that half experienced softening of their capsules. I went over the possible side-effects of the drug with her. She wanted to give it a try. So I prescribed zafirlukast 20 mg twice daily for 3 months. She responded with softening of her capsule. After 3 months she asked for a refill to try to achieve more softening. She now had a Grade II-III capsular contracture. I agreed. It softened to a Grade II and she was happy.
I now have another patient who is in the same state. I have decided to try to review the literature and see if the early study has been confirmed. The first six articles referenced below are the ones I found. All were small in number, ranging from 20-120 human patients or 40 rats.
The last article cautions us to remember the adverse side effects which can sometimes be worse than the problem being treated. In this case – liver injury with zafirlukast. Dr James L. Baker, Jr in a commentary (7th article referenced below) gives this caution:
The effectiveness of Accolate and Singulair in treating
capsular contracture remains anecdotal. It is quite possible that while acting as an antagonist against the
leukotriene receptor, Accolate and Singulair may in reality work as a histamine receptor site antagonist and cause the relaxation of the myofibroblast, with improvement in capsular contracture in some patients. However, the increasing evidence of an association between treatment with Accolate and liver dysfunction in patients with asthma, as reported by Dr. Gryskiewicz, is a powerful argument against widespread off-label use of asthma medications to treat capsular contracture without further investigation. In addition to liver toxicity, Churg-Strauss syndrome (systemic eosinophilic vasculitis) has been reported with both drugs, more frequently with Singulair. This syndrome can have permanent ramifications, including limitation of lifestyle.
Surgeons treating patients for benign conditions with
medications carrying potentially lethal side effects should thoroughly advise patients of the off-label status and the serious risks. I discourage the use of Accolate and Singulair in the treatment of capsular contracture until such time as we can prove through laboratory research exactly how these drugs work on the myofibroblast and capsular tissue and better determine the risk-reward ratio of the therapy.
The six articles which looked at the effectiveness of zafirlukast for treating capsular contracture while noting the positive response in many of their patients also note that further studies need to be done.
Zafirlukast appears effective in treating early capsular contracture after primary submuscular breast augmentation using saline-filled, smooth-walled implants. Further prospective studies with control groups and long-term follow-up will be needed to address many unanswered questions, including whether leukotriene inhibitors have long-term effects on capsular contracture following breast augmentation.
If this patient and I decide to proceed with zafirlukast treatment, I will be sure she is aware of the potential side effects (minor and major) of the drug.
For photos of a removed capsule and implant check here.
1. A new treatment for capsular contracture. (Letter to the editor); Aesthetic Surg. J. 2002; 21: 164-165; Schlesinger SL and Heck RT.
2. Zafirlukast (Accolate): A new treatment for capsular contracture; Aesthetic Surg. J. 2002; 22: 329-336; Sclesinger SL, Ellenbogen R, Desvigne MN, Svehlak S, and Heck R.
3. The effect of zafirlukast (Accolate) on early capsular contracture in the primary augmentation patient: A pilot study; Aesthetic Surgery Journal, Volume 25, Issue 1, Pages 26-30 (January 2005); R.Reid, S.Greve, L.Casas
4. The Effects of Zafirlukast on Capsular Contracture: Preliminary Report; Aesthetic Plastic Surgery, Volume 30, Number 5, October 2006 , pp. 513-520(8); Scuderi, Nicolò; Mazzocchi, Marco; Fioramonti, Paolo; Bistoni, Giovanni
5. Effects of zafirlukast on capsular contracture: controlled study measuring the mammary compliance; Int J Immunopathol Pharmacol 2007 Jul-Sep; 20(3):577-85; Scuderi N, Mazzocchi M, Rubino C
6. Reduction of Capsular Thickness around Silicone Breast Implants by Zafirlukast in Rats; Eur Surg Res 2008;41:8-14 (DOI: 10.1159/000121501); A. Spano, B. Palmieri, T. Palmizi Taidelli, M.B. Nava
7. Investigation of accolate and singulair for treatment of capsular contracture yields safety concerns; Aesthet Surg J. 2003 Mar;23(2):98-101; Gryskiewicz JM