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.

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.

cookie wrote:

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

Damn right the MHRA should apologise!

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.

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 ...