Post by zinnyI am a U.S. Vasclip patient who was extremely pleased with the outcome
of my procedure. I am not a Vasclip employee or a Vasclip
shareholder. I have been working in medical devices for over 15 years
and was contacted by a friend to whom I suggested the Vasclip
procedure, but who is now hesitating due to your half-assed vasectomy
research. Why are you trying to scare men?
Firstly, I'm not anti-Vasclip, and secondly I'm not trying to scare anybody.
The website does link to the Vasclip site in more than one place, including
general information on vasectomy they provide that is not particularly
related to Vasclip. I have wished them well with the device on several
occasions here, and in addition have posted Vasclip stories and press
releases to the website news ticker. That *has* generated a fair amount of
traffic to their site/s, and awareness of their product. As new press
releases are made I will continue to do this. I accept that any new device
will go through initial difficulties as there is an inevitable learning
curve for all those involved (manufacturer/Physicians/FDA etc.). Men do have
very limited B/C options, and I do sincerely hope the device goes on to be
an alternative. I also accept that this takes time and encouragement.
Should we believe statements made by corporations without question?
I don't believe we should. It is fair to say (as I already have done) that
Vasclip do not claim the device will enable earlier clearance, nor do they
claim it is reversable. It's also fair to say that Vasclip's use of
information, whilst naturally intended to show their product in a favourable
light, is not intended to mislead.
Due to the fact that claims for products and services made by manufacturers
are often less than honest, I exercise caution when it comes to looking at
these claims. Having said that, I'm all for new products and scientific
advancement. At the same time I like more information than is usually
initially available before I'd try something personally.
I don't believe it's wrong to market any device without the benefit of large
scale multinational trials going back years, in fact it's probably not
practical. The usual pattern is for new products to come on the market in
limited quantities based on small trials, and research continues from then
on. This is the current situation as I understand it in respect of Vasclip.
I do think as a very general point that once devices/products gain approval,
the interests are to provide shareholders with dividends, and research tends
to be less of a priority than it maybe should be.
I feel it's important to remember comments made by others in this thread. It
was started by Stephen saying:- "However, according to their secretaries,
two of them are no longer using the vasclip after vasectomy failures in
early patients." Giraud queried Vasclips use of studies to claim standard
vasectomy failure of 4%, and he also made the point that Vasclip "seemed" to
be using these studies to claim that their product was more reliable than
standard vasectomy.
We can argue forever about the studies referred to. None of them are studies
that compare standard vasectomy techniques against Vasclip, nor do such
studies exist at present. Yet I have to agree with Giraud that the research
is being used to make direct comparisons. I accept your point that that they
haven't misquoted the portions of the studies they have used, or been
especially selective in the one's they have chosen. If the studies are
entirely relevant for use as a comparison in this manner is up for debate,
but I'm not going to go down that route.
The point I would make is that there are other studies and review articles
that look at reliability. The most recent is probably the UK guidelines
currently in the final review stage. The document runs to126 pages, and
looks at 275+ studies (including most, if not all the ones Vasclip refer to)
, grading all of them for levels of evidence etc. This document is intended
as guidelines for all persons involved with the delivery of sterilisation
services, and the primary purpose is "Evidence based guidelines" to minimise
litigation against the NHS. Their analysis concludes in section 7.61. B that
"men should be informed that vasectomy has an associated failure rate and
that pregnancies can occur several years after vasectomy. The rate should be
quoted as approximately 1 in 2000 after clearance has been given". Whilst
looking at the results Vasclip have used in their comparison, I also have
this figure in mind, and 4%/1 in 2000 are vastly different.
It's not unfair to point out that the only data available on a product comes
from the manufacturer and has not been through peer review as yet. You
yourself point out that "As for the Vasclip clinical study data, I agree
having it published in a peer-reviewed journal would provide additional
credibility. This was one of my concerns when I first explored the Vasclip."
Whilst I accept your comments on the integrity of the Vasclip study, we both
know that to gain wide acceptance of the product, independant research will
have to be done, and the process of peer review of that research will have
to be gone through. This will inevitably take time, but will be necessary.
My comments on the two methods of how vasectomy reliability is calculated do
not refer to Vasclip. The UK guidelines mentioned above discusess this issue
briefly. Those comments, and the information on Jhaver's early research into
the vas occlusion clip are for general background interest. My comments that
men do take longer to become azospermatic than often assumed (as shown by
some of the studies mentioned) are not new. Much of the recent research into
how long it takes to clear does conclude that 3 months / 20 ejacs can't be
relied upon. This is a recurrent theme here in relation to vasectomy
procedures generally - not Vasclip. As I pointed out (and you acknowledge)
Vasclip do not claim their product speeds this up. I think it is responsible
to point out that research *does* indicate that many men are not cleared as
quickly as often assumed, but this should not be construed as a criticism of
Vasclip.
Post by zinnyNow please stop scaring my friends who refuse to get a vasectomy, but
are willing to go for a Vasclip procedure.
I seriously did not intend this to be the case, and aplogise if people think
my comments have cause any concerns.
I would say that I appreciate you are a satisfied customer, but there is
also the wider picture to consider. Those that suffer post-vasectomy
problems rightly insist that those that post "for" the procedure should
point out that there are risks as well as benefits, and men considering
vasectomy have the right to know this. In a similar vein, it's not unfair or
unreasonable to point out that Vasclip *is* a new device, and there is only
a very limited amount of data available on it's effectiveness and
complication rates, and none of it is independant research at this time. I'd
argue that men and their partners should make themselves aware of this fact,
and it should be considered along with all the other information they will
read in the course of research. Some people are happy to be in the forefront
of research, others prefer not to be amongst the pioneers.
Pointing out that there is no independant research etc. should not be
regarded as scaremongering or being critical of the device in any way - it's
just a fact.
David
www.vasectomy-information.com