VasClip & Pro-Vas

VasClip and Pro-Vas no longer have active websites and do not appear to be supported by the vast majority of urologists. This page remains only for reference and may not reflect current medical views.  For more about the problems associated with VasClip and Pro-Vas, see this article by Dr. Douglas Stein.  

Vasclip is a new arrival on the birth control scene. It’s not currently available outside the US, and of limited availability within the US. The main difference between Vasclip and conventional techniques is that the vas deferens is not cut – a clip is placed over the vas deferens instead. The technique is otherwise very similar to standard NSV vasectomy.

Using a clip does not mean that Vasclip is more likely to be reversible. Vasclip themselves say that there is no data available to suggest that it is more reversible than conventional techniques, and like conventional techniques men considering it should view it as permanent sterilisation. There is an interesting article on vasweb.com. It’s written by a physician who regularly practices conventional vasectomy, and has performed the Vasclip procedure.

Whilst conventional vasectomy techniques are mostly covered by healthcare insurance schemes, Vasclip isn’t. The position of the healthcare insurance companies is summarised well by a page on the Aetna website. Basically, insurance companies won’t pay for the Vasclip procedure on the grounds that they consider that at the moment the device is experimental, investigational and unproven. They point to the lack of evidence based studies documenting recanalization due to device failure, how successful it is at stopping the flow of sperm, follow up protocols and evidence that it offers advantages over conventional vasectomy in terms of infection, pain and epididymitis.

We have a Vasclip page in the personal experiences section with four stories to date. If you are considering the Vasclip procedure you would be well adsvised to read them.

More information is available on the Vasclip website, and at Yahoo groups there is a discussion forum for Vasclip. You will need to register for Yahoo groups to access this group.

Vasclip was given FDA approval in August 2002, and was launched in the US in April 2003. To the best of my knowledge the device has yet to receive regulatory approval anywhere outside the USA.

A word about the FDA approval process, and how it applies to Vasclip. There are several types of FDA approval – Vasclip has been granted a licence known as a 510(K) licence. In effect, this is a notification to the FDA of an intent to market a medical device. This is known as Pre market Notification – also called PMN or 510(k). It allows the FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories.

The original application and FDA reply is on the FDA website. Vasclip’s application for a licence was on the basis that a similar device has already been approved by the FDA – the Hem-O-Lock clip, used to ligate blood vessels. The data they submitted on the effectiveness of Vasclip was the original trial of 124 men. The FDA reply allows Vasclip to market the device subject to normal licence conditions, with the note that the effectiveness of the device has not been evaluated in comparison to standard vasectomy techniques.

The first independent study into the effectiveness and complications of Vasclip was published in April 2006. The main conclusion was that the device failed due to misplacement in roughly 2.5% of cases. A second independent study found that the failure rate of the device was 25%. However, there were only a total of 8 men in the study. What the researchers found was that though the clip could be correctly positioned, new channels for the sperm form through the process of scar tissue and spermatic granuloma’s. This is the primary cause of vasectomy failure in the other methods in regular use, and the reason the fascial interposition technique is combined with conventional surgery. Fascial interposition is where the end of the severed vas deferens are folded over and buried in different levels of muscular tissue – well away from each other, to stop this happening.

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