Comparing the MHRA and the FDA - from our archive

by Annie66 12th January 2012, 7:27 pm

Context - we used to have a surgeon on here who was posting under the pseudonym
'Snake'. S/he had some interesting things to say about PIPs a few years ago. Snake was anonymous but much of what s/he said could be verified through other sources.

First point: Snake made a comparison between the procedures used by the FDA
(the US regulator) with
those adopted by the MHRA (the UK
regulator). Snake noted:

"...The problem with a specific brand of implants [PIPS] is that most of
the ruptures are not being reported, and MHRA doesn't have sufficient data to
take action. With the very same company [PIPS], the FDA inspected the
production line, and just said that their standards were not good enough..."

https://boobjobsupportforum.forumotion.co.uk/t2485-are-any-fda-approved-implants-used-in-the-uk-today

Second point: MHRA relied on self-report data from the manufacturer rather
than bother to check the production line directly (the way the FDA did). In other
words, they had no system in place to guard against fradulent behaviour - they
just assumed that a manufacturer would act 'honestly' in reporting problems. And as we have now seen, in a 'light-touch' regulatory environment *some* companies will distort information and do as they please (parallels with the banks anyone??)

I actually wrote to the MHRA myself about this, and this was their reply:

" For each report [of an adverse incident] the MHRA carries out an
investigation in conjunction with the
manufacturer. The
manufacturer is requested to carry out an analysis of the failed device (if
this is available) and report back with their conclusions. Any
further action taken by the agency is based on the assessment of the
information provided in the final report taking into consideration the number
of reports of similar problems that we may have already received.

https://boobjobsupportforum.forumotion.co.uk/t8735p40-pip-implants

Third point: Snake argued that the MHRA is playing this down because the UK doesn't have the surgical capacity to
replace the implants of 40,000 patients

"... Have you got any idea of how long it would take to replace the
implants for 40.000 patients? It would take 80 plastic surgeons a full year of
work, if they treated 500 patients a year and didn't have any complications
after that. I don't think we have 80 plastic surgeons in the UK that are
willing and able to work full time at this, but, if the gel was said to be
dangerous, every single patient would want the implants out in a week, not in a
year. As I said, I am afraid the UK is not in a position where it is
easy to say that the gel is dangerous"

https://boobjobsupportforum.forumotion.co.uk/t8735p40-pip-implants
At the very least some heads should roll at the MHRA. That organization, its management and its values needs to be restructured from head to toe ...

I would recommend that any ladies taking legal action ensure their solicitors are aware of all this background information ...

by momojack 12th January 2012, 7:43 pm

Interesting reading.. goes to show that NO company can be/should be trusted to self regulate!

And, just because we dont have the resources to take all of these implants out right now, doesnt mean we shouldnt make a start!

xx

by roxanne 12th January 2012, 9:13 pm

Absolutely, I couldn't agree more. This is exactly why they are playing down the matter

And momojack, that's the point, you cannot trust the private companies to self regulate.

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Comparing the MHRA and the FDA - from our archive

Comparing the MHRA and the FDA - from our archive

Re: Comparing the MHRA and the FDA - from our archive

Re: Comparing the MHRA and the FDA - from our archive

Re: Comparing the MHRA and the FDA - from our archive