2012 sees the MHRA bowing to public pressure [once again], this time over breast implants.
For years they have fence sat [unsurprisingly] with regard to the safety of breast implants made in France and filled with gel meant for mattresses.
Figures suggest that the MHRA have downplayed the chance of rupture with the implants, in fact, down played by as much as eight times!
Today's Mail Online reports that silicone leaks from the implants are causing agonising pain as well as swelling and lumps under the armpits. Fears have also been relayed that the implants may increase the risk of cancer.
The Mail online writes:
Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) has been accused of playing down the dangers. Over the last fortnight it has repeatedly urged women not to panic, simply saying that anyone who was worried should contact her surgeon. While it banned further use of the implants, it said that there was only a 1 per cent chance of rupture, compared with a 5 per cent rate reported in France.
But on Friday night the MHRA received new data from one of Britain’s biggest chains of plastic surgery clinics. This placed the rupture rate at around 8 per cent, although it was not clear if the figure applied to patients or to individual implants.
The MHRA have recently slammed the door closed on a line of questioning I put to them regarding apparent SSRi withdrawal "specialists" that they claim exist in the UK. Upon asking them for the names of these "specialists" they, more or less, stonewalled me and told me that they would not answer any more of my questions on the subject.
No problem, I can still speculate, can't I?
I'm left wondering if the MHRA only act when reports of dodgy medical devices, drugs and/or vaccines hit the mainstream press. Their house was supposedly put in order when BBC's Shelley Jofre exposed them in a Panorama documentary and it was only with mounting public pressure that they investigated GlaxoSmithKline for suppressing clinical trial evidence relating to Seroxat - the findings of that investigation were what we already knew, the action taken by the MHRA was to send GlaxoSmithKline's, then CEO, JP Garnier, a "You've been a naughty boy, don't do it again" type of letter.
So, now it appears that the MHRA have received "new data" regarding the breast implant debacle.
One has to ask why the British drug regulator are, seemingly, always last to hear about the dangers of drugs or devices. An agency put in place to monitor the safety of drugs/devices should not only be alert, they should also alert the people they were put in place to protect. The post-marketing surveillance team at the MHRA are clearly unable to do their job...it's left to the British press and/or bloggers to give the MHRA the proverbial kick up the backside.
They are supposed to be a watchdog, I think pharmaceutical lapdog would be a more appropriate term.
MHRA Wishing To Call The Shots
ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE
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