The effect of zafirlukast (Accolate) on early capsular contracture in the primary augmentation patient: a pilot study.

BACKGROUND The development of capsular contracture following breast augmentation presents a challenge to the plastic surgeon. Treatment of capsular contracture with the leukotriene antagonist zafirlukast (Accolate, AstraZeneca, Wayne, PA) has received much attention in the media; however, there is limited proof of its effectiveness. OBJECTIVE The purpose of this study was to prospectively examine a single surgeon's experience using zafirlukast in the treatment of capsular contracture in primary, submuscular breast augmentation with saline-filled, smooth-walled implants. METHODS Thirty-seven patients (74 breasts) who underwent primary submuscular breast augmentation with saline-filled, smooth-walled implants were evaluated at 1, 2, 4, 6, 12, 24, and 48 weeks postoperatively by 3 independent observers and rated for capsular contracture using a modification of the Baker classification. Patients who demonstrated any capsular contracture (higher than modified Baker 1.0) were offered off-label use of zafirlukast 20 mg PO BID for 3 or 6 months after full informed consent was reviewed and accepted. In addition, patients were offered liver function chemistries at the start of treatment and at 1, 3, and 6 months following zafirlukast treatment. The patients were assessed for implant mobility and capsular contracture at the initiation of leukotriene therapy and then again at 3- and 6-month time points. RESULTS Forty-one breasts in this series (55.0%) were found to have early, mild capsular contracture. Specifically, 25 breasts were graded 1.5 (33.8% of total), 14 breasts graded 2.0 (18.9%), 1 breast graded 2.5 (1.4%), and 1 breast graded 3.0 (1.4%). Mean follow-up was 6.3 months. A positive response (complete or partial) was seen in a statistically significant proportion of treated breasts (75.7%, P < 0.05). This response was maintained on a long-term basis, with a mean follow-up of 16.5 months. CONCLUSIONS 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.