Ockham's Razor and the PrePex Male Circumcision Device
Year: 2016
Type: letter
Abstract: To the Editor—We thank Brook for his comments. We noted the limitations of our study [1] in the discussion, which addressed many of the points raised by Dr Brook. Space limitations preclude a detailed response to each of these concerns, here. We acknowledged that the study was hypothesis generating, rather than hypothesis testing, and that further research is required to definitively address the question of whether the ischemia induced by the PrePex device increases the growth of Clostridium tetani and potentially the risk of clinical tetanus. Nevertheless, our article provides evidence for the plausibility of this hypothesis. We found evidence of anaerobic overgrowth 7 days after placement of the PrePex device, compared with the microbiome of the uncircumcised penis and the microbiome following conventional surgical circumcision. This suggests that the necrotic foreskin and low oxygen tension of the subpreputial space provide an anoxic environment conducive to anaerobic replication, and it potentially explains the unpleasant odor associated with the PrePex device that has been noted by both patients and providers [2, 3]. As noted in our article, there have been 2 deaths due to tetanus among 3800 PrePex recipients in Uganda, with a tetanus mortality rate of 52.6 cases/100 000 (95% confidence interval, 6.4–190), which far exceeds the estimated tetanus mortality rate following conventional circumcision of 0.6 cases/100 000 (based on approximately 13 tetanus deaths [4] out of 2 147 105 procedures up to 2014) [5]. Despite the limitations of tetanus surveillance and reporting in Uganda, this differential in tetanus mortality supports a higher risk of tetanus following PrePex use. This increased risk of tetanus associated with the PrePex device has been seen in other countries throughout sub-Saharan Africa [6]. In summary, our article does not and cannot prove that the PrePex device causes an enhanced risk of tetanus, but it adds to the growing body of evidence that this may truly be the case. Brook's letter raises many arguments, both germane and speculative, to which we respond with Ockham's razor, pluralitas non est ponenda sine necessitate (“plurality should not be posited without necessity”). There is a need to definitively determine whether the PrePex device increases the risk of tetanus, both to prevent such complications and to avoid undermining conventional surgical circumcision programs in sub-Saharan Africa. Financial support. This work was supported by the National Institute of Allergy and Infectious Diseases (grants 1K23AI093152-01A1 [to A. A. R. T.] and R01AI087409-01A1 [to R. H. G. and A. A. R. T.]). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Potential conflicts of interest. All authors: No reported conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.
Language: English
Topic: Genital Health and Disease
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W2472010673