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RISKS

As with any new medical procedure, there is alway less documentation to support the safety and efficacy of the procedure in the early days, than there is later. Pro-Vas Occlusion offers a less invasive alternative to vasectomy and the vasectomy procedure has been around for decades. Although the Pro-Vas Occlusion procedure is new, the technology upon which it is based has been in clinical use for some time and has proven to be highly reliable. Titanium spring ligation clips have been used in applications such as in isolating neuroaneurysms. Failure in this application can result in massive brain hemorrhage and death. This same highly reliable technology has been modified and optimized for use in occluding the vas deferens. The FDA has cleared this device for marketing and so far results have been very positive.

The risks associated with new procedures often relate to the uncertain efficacy of the procedure. At this time the effectiveness of using the Pro-Vas applier for permanent male sterilization has not been evaluated in comparison to standard vasectomy procedures.

Whether you choose to have a traditional vasectomy or a Pro-Vas Occlusion procedure, your doctor will instruct you to use an alternative form of birth control until after a semen analysis (typically conducted at 8-weeks) validates the success of the procedure. Patients who follow these instructions are therefore at no more risk of an unwanted pregnancy than they were before their vasectomy or Pro-Vas procedure. Once a semen analysis shows that no viable sperm remains in the semen, then patients will typically be cleared for unprotected intercourse. At that point, the risk of pregnancy is then dependent on the possbility of recanalization; a complication that can occur in up to 1-3% of cases. This risk can be minimized through the use of such devices as the SpermCheck^® home-based semen analysis test kit during the first 18-months post-operatively.

Other risks associated with traditional vasectomy include; complications, perhaps most notably; chronic post-vasectomy testicular pain syndrome. The origins of this complication remain debatable, however, it is thought by some practitioners that minimizing dissetion and disruption of the testicular artery, not severing the vas deferens and not using cautery are likely to minimize the incidence of this complication. It has also been noted that the development of sperm granuloma has been associated with some cases of chronic pain and since sperm granuloma might be expected to occur less frequently in patients without severed vas deferens, this could be a positive factor when assessing the risk of chronic post-vasectomy pain. Studies still need to be done to verify these hypotheses.

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