Introduction: In this study, we describe and depict unexpected sequelae of adult medical male circumcision (MMC) using the PrePex device. Materials and Methods: The PrePex system is an elastic compression device for adult MMC. The device is well studied, has been pre-qualified by the World Health Organization (WHO), and its use is being scaled-up in African countries targeted by WHO. We conducted a PrePex implementation study in routine service delivery among 427 men in the age range of 18-49 in western Kenya. We captured penile photographs to create a record of adverse events (AEs) and to monitor healing. Several unexpected AEs ensued, including some that have not been reported in other PrePex studies. We describe and depict those unexpected complications and resulting treatments to alert circumcision providers in the relevant areas. Results: We observed 5 device displacements (1.2%); 3 cases of early sloughing of foreskin tissue (0.7%) among men with long foreskins; 2 cases of a long foreskin obstructing urine flow, as it became dry and necrotic (0.5%); and 2 cases of insufficient foreskin removal caused by invagination for which surgical completion was necessary (0.5%). All of the participants healed completely by day 42 post-circumcision or shortly thereafter. Conclusion: The potential for these complications should be incorporated into PrePex training programs. Integration of devices into MMC programs in medically underserved areas requires the availability of prompt surgical intervention for some sequelae, particularly displacement events.

1.
Samuelson J, Baggaley R, Hirnschall G: Innovative device methods for adult medical male circumcision for HIV prevention: lessons from research. J Acquir Immune Defic Syndr 2013;64:127-129.
2.
Gray R, Kigozi G, Kong X, et al: The effectiveness of male circumcision for HIV prevention and effects on risk behaviors in a posttrial follow up study in Rakai, Uganda. AIDS 2012;26:609-615.
3.
Mehta SD, Moses S, Agot K, et al: The long-term efficacy of medical male circumcision against HIV acquisition. AIDS 2013;27:2899-2907.
4.
Auvert B, Taljaard D, Rech D, et al: Association of the ANRS-12126 male circumcision project with HIV levels among men in a South African township: evaluation of effectiveness using cross-sectional surveys. PLoS Med 2013;10:e1001509.
5.
Bitega JP, Ngeruka ML, Hategekimana T, et al: Safety and efficacy of the PrePex device for rapid scale-up of male circumcision for HIV prevention in resource-limited settings. J Acquir Immune Defic Syndr 2011;58:127-134.
6.
Mutabazi V, Kaplan SA, Rwamasirabo E, et al: HIV prevention: male circumcision comparison between a nonsurgical device to a surgical technique in resource-limited settings: a prospective, randomized, nonmasked trial. J Acquir Immune Defic Syndr 2012;61:49-55.
7.
Mutabazi V, Kaplan SA, Rwamasirabo E, et al: One-arm, open-label, prospective, cohort field study to assess the safety and efficacy of the PrePex device for scale-up of nonsurgical circumcision when performed by nurses in resource-limited settings for HIV prevention. J Acquir Immune Defic Syndr 2013;63:315-322.
8.
World Health Organization: WHO Prequalification of Male Circumcision Devices Public Report. Product: PrePex; Number: PQMC 0001-001-00. Geneva, WHO, 2013.
9.
Feldblum PJ, Odoyo-June E, Obiero W, et al: Safety, effectiveness and acceptability of the PrePex device for adult male circumcision in Kenya. PLoS One 2014;9:e95357.
10.
Rech D, Dickson K, Samkange C, et al: Adverse Event Action Guide for Male Circumcision. Washington, PSI and WHO, 2011.
11.
Feldblum P, Odoyo-June E, Bailey R, et al: Unusual complications following adult male circumcision using the PrePex device. Poster #TUPE133. Melbourne, Australia, International AIDS Conference, 2014.
12.
World Health Organization: Guideline on the Use of Devices for Adult Male Circumcision for HIV Prevention. Geneva, WHO, 2013.
13.
Mutabazi V, Bitega JP, Ngeruka LM, Karema C, Binagwaho A: Assessing odor level when using PrePex for HIV prevention: a prospective, randomized, open label, blinded assessor trial to improve uptake of male circumcision. PLoS One 2015;10:e0126664.
Copyright / Drug Dosage / Disclaimer
Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.
You do not currently have access to this content.