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.
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.
ConclusionsIf 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.
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.