Introduction: Significant capsular contracture (Baker Class III or IV), occurring at a rate of 4.6-25% in submuscular saline breast augmentation(1), presents a formidable challenge to the plastic surgeon. Certainly, the recent use of the leukotriene antagonist zafirlukast (Accolate; AstraZeneca, Wayne, PA) for contracture reversal has received much attention in the popular media. However, validation of its effectiveness rests only on limited case series and anecdotal reports(2,3). To this end, a single surgeon’s experience using Accolate in the treatment of capsular contracture in primary, submuscular augmentation with saline smooth –walled implants is presented.

Methods: From the period of January 2002 to January 2003, the senior author performed 49 bilateral submuscular augmentation mammaplasties with saline smooth-walled breast implants (98 breasts). All patients were placed on the same postoperative protocol, which included early implant mobility (massaging) and vitamin E 400 I.U. orally twice daily at 4 weeks. A prospective analysis of the effects of Accolate on early capsular contracture was carried out in the following manner. Patients were regularly evaluated in the office by the operating and clinical staff (2 independent observers) and rated for capsular contracture using a modification of the Baker classification(4). We define contracture as follows: Class 1=breast absolutely natural, augmentation undetectable; Class 1.5=breast soft, but implant is detectable by physical examination; Class 2=mild firmness, prosthesis not detectable by examiner or patient; Class 2.5= mild firmness and implant detectable by examiner but not patient; Class 3=breast moderately firm and detectable by patient; Class 4=severe firmness, obvious from observation, with pain. Patients who demonstrated any capsular contracture (>=1.5) were given Accolate 20mg orally twice daily and assessed at 3- and 6-month timepoints for any change in contracture. The endpoint of this study was 6 months or a return to a Class 1 capsular score. One patient failed to complete the study.

Results: Using our modification, 52 of the total 98 breasts had no capsular contracture and thus were rated Class 1 (53%). 45 breasts (46.0%) were found to have early, mild capsular contracture: of this group 28 breasts were Class 1.5 (28.6%), 16 breasts were Class 2.0 (16.3%), and 1 breast was Class 2.5 (1.02%). In this series only one breast demonstrated moderate capsular contracture (Class 3) (1.02%). Of these 46 breasts, 32 mildly contracted breasts Class 1.5 or greater have completed the protocol. Responses were scored as either complete (return to Class 1), partial (reduction in capsular contracture index by 0.5), or nil (modified Baker class the same or worse despite therapy). Mean follow-up was 6.3 months. After an average of 4.8 months of treatment, 14 out of 32 breasts (43.75%) demonstrated a complete response to Accolate therapy, whereas 9 of 32 (28.1%) demonstrated a partial response to the leukotriene antagonist. The remaining 9 of 32 (28.1%) had no response to therapy, either staying the same grade or worsening. Therefore, a positive response (complete or partial) was seen in a statistically significant proportion of treated breasts (71.875%; p<.001).

Conclusions: Our initial results support the effectiveness of Accolate in early capsular contracture after submuscular saline smooth augmentation mammaplasty. Further follow-up will demonstrate its long-term effects.