An implantable ligation device that achieves male sterilization without cutting the vas deferens

Abstract

Objectives To determine whether the Vasclip implant procedure would (a) be equivalent to vasectomy in producing azoospermia, (b) produce greater patient satisfaction postoperatively, and (c) result in lower complication rates, postoperative pain, hematoma formation, spermatic granuloma, and surgical site infection when compared with historical controls. Methods Sterilization and complications were studied in 124 consecutive patients. Results Successful sterilization, defined by azoospermia at 10 to 14 months, was observed in 116 of 119 subjects. The effectiveness seemed to be equivalent to that of vasectomy. The incidence of postoperative pain and hematoma formation was similar to that with standard methods. The Vasclip procedure had similar infection rates and seemed to have lower rates of sperm granuloma when compared with vasectomy. In 3 subjects with persistent presence of sperm, histologic examination after traditional vasectomy indicated that misalignment of the device led to partial vas incision with recanalization. Patient acceptability was high: of the clinical study patients, 99% of survey respondents would recommend that other men considering a vasectomy have the Vasclip procedure. Conclusions The Vasclip implant procedure represents a new, effective, office-based alternative to vasectomy. Physicians’ benefits can include reduced procedural time and reduction of postprocedural complications. Potential patients’ benefits include reduced risk of postoperative infection and sperm granuloma formation.