RxISK is powered by people working behind the scenes – picking at threads and sometimes finding something rather different to what they expected. One of those who can’t resist a loose thread is Suzanne Stevens, who has been interested in our Sudoscan problem.
Many of you suffering with PSSD or related PRS, PRSD and PGAD conditions have been emailing Impeto Medical in Paris to see what can be done about access to a genital adapter for their Sudoscan device. See Sudoscan Saga.
Impeto’s medical person , a Dr Jean-Henri Calvet, replied to some people with what seems like a genuine letter saying he is awfully sorry but they are a small company and they are trying to get a marketing seal of approval and can do nothing until they get this – even though there is an investigator in Paris using the adapter who has published results 2 years ago.
(There is no readily available photo of Dr Calvet. The image above shows Impeto’s CEO Philippe Brunswick making a pitch for their devices on US television. The featured blog image shows a bunch of investigators working with Impeto devices and image at the bottom is Impeto’s twitter image).
Despite a seemingly friendly, but very much pro-forma, letter, the situation looks fishy. Impeto have been told that people are committing suicide despairing that anything will ever be found to help them. They have been told that in the absence of evidence from a test that would confirm the existence of the condition, part of that despair stems from people with PSSD and related conditions being ridiculed by doctors and other “healthcare” staff – suggesting they need to go on an antidepressant or stop accessing google or they will remain ill for the rest of their lives.
It would have been very easy to bring 4-6 volunteers affected with PSSD over to Paris for testing there. Why not do it?
Well it seems Impeto Medical who make Sudoscan are embroiled in a patent dispute with another company and there have been published articles questioning whether their device works at all.
The device isn’t complex – its a modified version of a lie detector and likely could be build by someone reading this blog. For the record comparable devices (albeit ones with intravaginal probes) can sell for Euro 40K or USD 50K. There is a lot of money in these simple devices.
For the last century, Americans have been the device makers par excellence and Americans now have as many devices in their bodies as the rest of the world put together – as a compelling documentary on Netflix – The Bleeding Edge brought out – see Trailer.
A recent BBC Panorama program – The Great Implant Scandal – also brought out how lax the regulation surrounding devices is in Britain and Europe
Jeanne Lenzer has been writing extensively on this, and her recent book The Danger within us, has laid a basis for much of this coverage.
Against this background, Suzanne who had been writing to Impeto, getting nowhere, and increasingly getting a fishy smell figured on writing to MHRA who regulate both drugs and devices in the UK, or did before the European Medicines Agency took over, and of course will now do so again.
From: Susanne Stevens
Sent: 22 August 2019 17:41
To: Devices Regulatory <Devices.Regulatory@mhra.gov.uk>
Subject: Sudoscan device
Can you please tell me if MHRA has any information re Sudoscan and in particular the Sudoscan device with genital adapters.
On Mon, Sep 2, 2019 at 10:53 AM
Narramore, Michael <Michael.Narramore@mhra.gov.uk> wrote:
Thank you for your query.
Please be aware that MHRA do not directly approve or certify medical devices; conformity is self-certified by the manufacturer or assessed by a notified body depending on the risk classification of the device. In addition the medical device regulations are based on mutual recognition throughout the EU and medical devices may be certified in any EU Member State. Because of this, MHRA do not hold information on individual medical devices and are not able therefore to respond to your questions regarding Sudoscan.
You have not explained what information you require regarding the device, however you may contact the manufacturer directly for information relating to the Sudoscan device and its certification as a medical device. If you have specific concerns regarding the device or the technology behind the device you may report these to MHRA for investigation.
Please note that we are happy to give general advice on the Medical Device Directives and new EU Medical Devices Regulations. Any views expressed by us on the interpretation of the legislation represent our best judgement at the time based on the information available; they are not intended to be a definitive statement of law, which can only be given by the courts. Accordingly, we would always advise you to seek the views of your own professional advisers.
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London, E14 4PU
From: Susanne Stevens
Sent: 02 September 2019 11:18
To: Narramore, Michael <Michael.Narramore@mhra.gov.uk>
Subject: Re: Sudoscan device [REF: E/2019/1574]
Thank you I must not have made it clear enough but what I am asking is have there been any adverse events about sudoscan referred to the MHRA
From: Narramore, Michael <Michael.Narramore@mhra.gov.uk>
Date: Tue, Sep 3, 2019 at 11:57 AM
Subject: RE: Sudoscan device [REF: E/2019/1574]
Thank you for the clarification. Unfortunately, due to confidentiality requirements of the medical device regulations (Article 20 of the Medical Device Directive 93/42/EEC) and the Enterprise Act 2002 (section 237), we are not able to disclose information on adverse incidents relating to specific products or manufacturers.
We need some more of you out there to start pulling threads or commenting on this email sequence and helping us understand it.
First, it seems to suggest that Impeto could ship their device across the Channel and start using it tomorrow if they wanted to.
Second, what is the basis if any of MHRA withholding information on Device Wrecks where they make it available for Drug Wrecks?
(A note on terminology: adverse events and side effects is much too mild a term for what goes wrong on Drugs. When things get to the point where a doctor or patient reports a problem, they are usually reporting a Drug Wreck not a trivial event. This is even more likely to be the case for Devices which as the Netflix, Panorama and Lenzer work brings out destroy lives. Device Wreck seems a much more fitting term).
Is there no way to find out what might have happened with Impeto’s Sudoscan, and perhaps its genital adapter in particular, or maybe Impeto devices more generally?
A picture for Jean-Henri has turned up – he’s standing on the Left.
Follow Impeto on Twitter?