Tuesday 9 August 2016

Reporting Adverse Events Linked to Your Implants

Adverse event reporting is supposed to help the health & safety regulators identify potential problems. Not enough reports were being made all the time PIP were being used. In the UK the MHRA say they have been and will continue to monitor adverse event reports from PIP women. Most women have no idea they are able to report adverse events linked with their implants. But if we dont report our bleeds, ruptures, our lymph node surgeries and symptoms the MHRA and the government will continue to ignore us and our symptoms. 
If you have experienced an adverse effect you associate with your PIP implants, please report them and ask your GP and/or surgeon to do the same. 
Lets do it everyone! Report Yours!  ♡
♥ Together we can make a difference!
In the UK Report Yours to MHRA using this link
In France report adverse events to ANSM
In Australia report adverse events to TGA
https://apps.tga.gov.au/prod/mdir/udir03.aspx
In Germany report adverse events to Bfarm
In the USA report adverse events to FDA
In Sweden report adverse events to MPA
Please refer to your Medical Devices Regulatory authority if your country is not shown here.


Saturday 9 April 2016

Dear Emily❊

“More than 100,000 women and their families in the European Union have been affected by the PIP fraud,
I am one of these women, this is my story...”


PIP Action Campaign made a complaint to the EU Ombudsman regarding the treatment of the women affected by PIP implants. It is clear that the European Commission is not responding to the PIP crisis with honesty, credible science or compassion.

We are encouraging all women affected by PIP implants to write to Emily O’Reilly the EU Ombudsman with details of their own personal stories and experiences of PIP.

We want to let the authorities know the extent to which the current policy has added to the stress and horror of PIP for each and every one of us.

We would like everyone affected to take part and add their voice. Of course, the more women who write the better.

We know that behind every PIP implant there is a broken heart. This is why each “Dear Emily” letter will be a painful, emotional and a courageous act.

But we hope it will make a difference Dear Emily.

Lets try it and see!
Full details of PIP Action Campaign’s complaint to the Ombudsman, reference 174/2015/FOR, can be found on the Ombudsman website. In the final decision Emily O’Reilly stated “The Commission should continue to evaluate new scientific data relating to the safety of PIP implants." And that’s what we want!

http://www.ombudsman.europa.eu/en/cases/decision.faces/en/61195/html.bookmark

To contact Dear Emily, the EU Ombudsman, use the contact form on the Ombudsman website. 
You can type into the form or you can attach a file.
Find the Contact form here:
http://www.ombudsman.europa.eu/shortcuts/contacts.faces

You will also find web links to the Contact Form on all PIP Action Campaign & PIPSLEAK social networks.

If you have been affected by the PIP fraud you are invited to take part.

Monday 15 February 2016

What? Chemicals in Implants? Are they SAFE?

What chemicals & what manufacturing procedures were used by PIP in manufacturing fraudulent implants? ANYONE KNOW?


Doctor Brawer in the USA says:






The Australian Regulator (TGA) did some tests on PIP


From TGA Australia


TGA on Cyclic Siloxanes D4, D5, D6


Presence of D4, D5 and D6 siloxanes
AFSSAPS noted that some batches of unauthorised gels contained higher amounts of small silicone molecules (called low molecular weight siloxanes) than the authorised gel. Thus, the TGA is testing the gels to determine the presence of D4, D5 and D6 siloxanes. Test results from GC-MS analyses indicate D4 is present in the gels of PIP breast implants at between 0 and 261ppm, with a median of 136ppm. D5 is present between 0-710ppm, with a median of 434ppm. D5 is present between 0 and 1005, with a median of 470ppm. There does not seem to be any relationship between the year of manufacture of the gel and the presence of D4, D5 and D6 siloxanes. These values could change with the testing of further samples.
Information provided by the suppliers of the raw materials, which were used to produce the gel used in PIP breast implants, together with more recent detailed information provided to the TGA by AFSSAPS, does suggest that the TGA findings are a reasonable estimate of the content of these siloxanes.




The SCENIHR report reproduced this table showing the concentrations of D4, D5 and D6

Published in SCENIHR