46 Chapter 3 almost all lumpectomies without resulting in inferior oncological outcomes, except for when the tumor is located too close to the PF.21 Based on the current literature, it can be stated that with proper patient selection -in terms of minimal (more than 5 mm) tumor distance to the PF- the effect of PF preservation on locoregional recurrence is not clinically relevant and routine removal of the PF does not seem evident.20, 22 It is recommended to remove the PF at the tumor site when the tumor is located within 5 mm of the PF, in order to obtain clear margins. Direct macroscopic invasion of the PF warrants not just removal of the PF but also removal of a portion of the underlying muscle. Furthermore, postmastectomy radiation therapy should be considered in these cases. The ten year incidence of regional metastasis after mastectomy has previously been reported to be 3.8%.23 The observed 5.7% in the PF preservation group and 6.6% in the PF removal group in the study by Dalberg et al are somewhat higher. However, multiple factors influence these recurrence rates, including tumor stage at the time of the operation, tumor biology and adjuvant therapy. More importantly, no significant difference was observed between the two treatment arms. Sandelin et al reported a low incidence of 2.0% regional recurrences. Based on these data, there are no indications that preservation of the PF leads to higher rates of regional recurrence, distant metastasis, or mortality.15 These oncological outcomes seem reasonable, because multiple studies showed that breast cancer is a systemic disease from the start without any influence of the status localis on the systemic outcomes of distant metastasis and mortality.21, 24, 25 The amount of bleeding complications requiring reoperation were 1.1% and 1.8%.13, 16 These data are in concordance or lower when compared with the previously described 1.0%-3.9% in simple mastectomy with direct reconstruction.9, 26, 27 It seems reasonable that preservation of the PF decreases the incidence of postoperative bleeding complications requiring reoperation, because 50% of postoperative bleeding complications requiring reoperation have been found to originate from the PM (caused by dissection on the surface of the well vascularized muscular tissue).9 Seroma is a burdensome problem for patients and caregivers, often leading to multiple additional hospital visits. The incidence of seroma differs widely in the literature, and studies report ranges from 3 to 85%.28 These wide ranges are probably caused by the various definitions that are given to the complication ‘seroma’, for example in terms of drainage days or seroma requiring a reoperation. Salgarello et al reported an incidence of 1.2% in their study, but these rates could be an underestimation being a retrospective analysis without a primary focus on seroma rates.13 The results from the RCT’s are more suitable to answer the question if PF preservation lowers the incidence of seroma. In Dalberg’s RCT the
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