Our original article described the use of zafirlukast (Accolate) for the potential treatment of capsular contracture. Our findings represented the results of clinical observation rather than data from blinded prospective randomized studies. We felt that these beneficial findings were important enough to inform our colleagues of through a preliminary report. Discussions with several of them revealed that their patients had reaped similar benefits. Because this approach is new, we don't know whether these effects will be long-term. We have not been informed of any major complications with the use of these treatments. We have also been using montelukast (Singulair) to treat capsular contracture and have observed some improvement, but not to the same extent as that attained with zafirlukast. More definitive studies need to be performed before we know why these leukotriene blockers seem to benefit some patients with capsular contracture. We thank Dr. Gryskiewicz for presenting additional information regarding potential side effects of these phar-macologic agents. The risk of liver failure and death in patients taking zafirlukast, although small, is very worrisome. To date, this complication has only been reported in patients being treated for asthma. However, the risk level for this complication in patients taking zafirlukast for capsular contracture is unknown, and it may be only a matter of time before such an adverse liver complication occurs in this patient group. It is important for any prescribing physician to know all the potential side effects of any medication given to a patient. This is especially true of an off-label use. A patient must be informed of the risks and informed consent obtained. With regard to Dr. Gryskiewicz's specific recommendations, we believe that the use of objective, scientific methods to gather and report information on new clinical treatments is important. However, a double-blind prospective randomized study is often difficult to accomplish. One reason for presenting clinical observations of the sort reported in our article is to stimulate interest within the medical community in conducting such studies. We need to know more about the basic molecular mechanisms involved in the use of leukotriene blockers with regard to capsular contracture, in addition to the macro effect of these medications. Curiosity is the fuel that drives the scientific method. Many medications and treatments are used off-label with beneficial effects. If these treatments can spare patients further surgery and the inherent complications with minimal risk, one can argue for their use. However, we must be cautious as we proceed.
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Sabrina Schlesinger (2003) studied this question.
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