Pip info.

by **COOKIE** 27th July 2010, 2:07 pm

I don't think we've had this info here and I found this whilst trawling looking for PIP info -

Sally Taber reports on a meeting with Dr Susanne Ludgate Medical
Director and Jonathan Plumb Clinical Lead at MHRA with regards to the
Medical Device Alert - All metal-on-metal (MoM hip replacements and PIP
breast Implants in which MHRA apologised for lack of communication with IHAS and the independent sector.

Damn right the MHRA should apologise! Pip info. 852192

PIP implants - Dr Ludgate has had concerns re the
French Manufacturer for some time - having had a higher number of
ruptures reported. MHRA's opposite number in France stopped their
production in March. It has been Identified as not using the same
Silicone Gel as they received the CE mark for in 2001.The Notified Body
did not pick up this fact - MHRA are of the view that this changed in
2005.
It is expected that the report will arrive very shortly - the outcome
of which will need to be shared with the Minister Earl Howe as to
whether it is a Patient Safety issue and the NHS may have to finance any
diagnostics recommended or removal of the implants. It could be as many
as 50,000 implants involved. A roundtable of Plastic Surgeons in France
(SOF.CPRE) has taken place. BAAPS have put advice on their website
advising women who have had PIP implants in the last 6 months to have an
Ultrasound. This has pre-empted any advice that the MHRA will come out
with.

I hope the NHS does come through and help everyone needing to have these implants removed, I think it's disgraceful that women are having to fund these surgeries themselves.

Scource from HERE

by Annie66 27th July 2010, 8:00 pm

cookie wrote:
MHRA apologised for lack of communication with IHAS and the independent sector.

Damn right the MHRA should apologise!

They've handled this very badly - not surprising really given that their
‘regulation’ procedures involved leaving it to the manufacturer to carry out the analysis on their own dodgy failed device! Please someone explain to me how that system was ever going to catch an unprincipled manufacturer who was knowingly engaged in fraudulent activity !?

They're culpable and they know it. Unfortunately it would take a high-flying QC, a big budget and a lot of time to drag a government agency through the courts ...

by **RoxyChick** 27th July 2010, 9:48 pm

Thanks for that Cookie.

Annie, you're so right. It was flawed from the very beginning and it was only a matter of time before it was exposed. PIP implants have been a worry of ours for so long, and the MHRA have willingly allowed them to be used without knowing for sure if they were safe.

They have a lot of blood on their hands.

by Annie66 27th July 2010, 10:10 pm

RoxyChick wrote:. PIP implants have been a worry of ours for so long, and the MHRA have willingly allowed them to be used without knowing for sure if they were safe.

If the French authorities hadn't acted then PIPs would still be used here right to this day because, let's face it, the MHRA 'system' would sure as hell not have picked anything up ...

by **nads** 27th July 2010, 10:14 pm

I hate that they knowingly made cheap implants that they knew would be going into women's bodies Pip info. 852192

I bet they wouldnt make/use substandard penile implants and if they did they would act much quicker (sorry, the feminist in me is coming out)

by **RoxyChick** 27th July 2010, 10:24 pm

Annie66 wrote:
RoxyChick wrote:. PIP implants have been a worry of ours for so long, and the MHRA have willingly allowed them to be used without knowing for sure if they were safe.

If the French authorities hadn't acted then PIPs would still be used here right to this day because, let's face it, the MHRA 'system' would sure as hell not have picked anything up ...

So true. So true.

Nads, it's sick isn't it. They've taken a chance with the health of hundreds of thousands of women, all for the sake of money.

I just wished we were around ten years ago to really warn women about these shoddy implants.

by Annie66 27th July 2010, 10:36 pm

I agree Nads, the whole thing is grotesque. It shows such a complete disregard for women :mad: This PIPs issue was in the scientific journals in 2007 plus the company had a previous history for producing unreliable products! (e.g. hydrogel implants and the related £1.5 millon court case). But oh no MHRA just carried on having a nice little sleep through the whole thing :rant:
Definitely no need to apologise for releasing the feminist within in this context!
xx

Roxy - yep, the fact of the matter is that you would have been better off following the advice on the internet (BJSF, Snake etc) in relation to PIPs than relying on anything the MHRA had to say.

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