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.

http://www.tga.gov.au/alert/pip-breast-implants-tga-update-2-april-2012

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

Published in SCENIHR 

Can EU identify EDC's Staring Them in the Face?

EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY
Brussels, 22th of July 2015 

Report on public consultation on defining criteria for identifyingendocrine disruptors in the context of the implementation of the Plant Protection Product Regulation and Biocidal Products Regulation

This consultation was different from other public consultations in that respondents were asked to provide data (for example methodologies used to select endocrine disrupting substances or to identify the socio-economic impact of identified endocrine disruptors). No specific questions were included that asked respondents’ opinions. This report cannot, therefore, provide quantitative information on the views held by different stakeholders. 

"The socio-economic impact of identified endocrine disruptors" limiting jobs for poisoning women and harming children! 

A risk-based approach for regulating endocrine disruptors was proposed by many respondents who identified themselves as farmers, private companies, industrial or trade organisations, or authorities in non-EU countries. Many respondents supported the use of the WHO/IPC 2002 definition as a starting point for defining an endocrine disruptor.  

That's a very interesting figure DG Health & Food Safety ... "Many Respondents" 

PIP PUBLIC CONSULTATION

PUBLIC CONSULTATION on the preliminary opinion on the 'safety' of Poly Implant Prothèse (PIP) Silicone Breast Implants (2013 update)

The European Commission has launched a public consultation on the above-mentioned preliminary opinion following the Stakeholder Dialogue Procedures (Annex IV to the Rules of Procedures) of the Scientific Committees.

Background

In 2012, the Scientific Committee on Emerging and Newly Identified Health Risks, SCENIHR, was asked for an update of theOpinion on the safety of Poly Implant Prothèse (PIP) Silicone Breast Implants.

This was mainly due to the fact that the data available on PIP silicone breast implants was limited at the time of the opinion

In its 2012 Opinion, the SCENIHR concluded that the evidence to date, indicating a health risk for women with PIP silicone breast implants, was not strong. However there was some concern regarding an increased inflammation from ruptured PIP silicone breast implants. It was not possible to make a general risk benefit statement at that time. It was also concluded that the risk benefit assessment needs to be based on a patient by patient basis by the aesthetic surgeon, bearing in mind the time since the implantation and the psychological state of the patient.

The aim of this new Opinion is to update the rapid opinion from 2012 based on additional data produced by and collected from the Member States and other international fora, such as the International Laboratory Testing Panel for PIP breast implants.

Please note that this preliminary Opinion has been approved for public consultation in view of gathering specific comments and suggestions on the scientific basis of the opinion, as well as any other scientific information regarding the questions addressed to enable scientific Committees to focus on issues which need to be further investigated.

Submission of comments

All interested parties are invited to submit their comments and proposals on the preliminary opinion to the following website.

The deadline for submission of comments is 3 January 2014.

NOTA BENE:

1. In line with the transparency principle outlined in the Rules of Procedures of the Scientific Committees, all submissions and the names of the submitters in response to this public consultation may be made available to the general public via SANCO's website.

2. Only comments submitted in accordance with the Rules of Procedures (Annex IV) will be taken into account.

3. For more information

PIP Implant Analysis

British 'experts' advising the government do not consider further testing necessary on fraudulent PIP implants 

For some unexplained motive, the health authorities in Britain have taken the view that nothing can be gained by conducting further testing on fraudulent PIP implants. Yet physicians, surgeons, independent experts and victims, particularly those reporting immune system, neurological and toxicity illness still want answers!

"We hope that as more facts about PIP Implants emerge,  there will be a greater level of understanding of our symptoms and a better standard of care and treatment from the medical professionals treating us."

If you have explanted PIP implants and you wish to participate in and contribute to studies on PIP implants, you will find all the details you need here!

There are two forms to complete.  The first is the PIP Implant Analysis form which you see below and can be completed online, the second is the Symptom Survey which you can download here:
http://pipactioncampaign.org/Symptom%20Survey%20web.pdf 

PIP Implants can be sent for analysis regardless of where you are in the world.  Regrettably as many as half a million women and their families have been affected globally by the PIP implant fraud.

Participating in studies on PIP implants will not provide all the answers but it gives all of us hope that more will be learned about the effects of contaminated silicones on our bodies for the future.

Dr Beretta, the senior chemist undertaking the analyses at Milan University, talks about his preliminary findings in some detail on PIP Action Campaign's social networking and Facebook pages.  Please feel free to join in the discussions and to learn more about PIP Implant Analysis at our Facebook Group:

Request to join the PIP Action Campaign group on Facebook or find us on the web at PIP Action Campaign and at PIPSLEAK


Send the completed Symptom Survey with your implants to the laboratory at Milan University at the address that you can find at the end of the PIP Implant Analysis form below.  

Top British doctors call for removal of every PIP breast implant

Women paying unacceptably high costs of CE & MHRA Regulatory Failures 

Calls for Government to remove all PIP breast implants Damning new research shows their shells are faulty putting women at risk

By JO MCFARLANE

PUBLISHED: 00:50, 7 April 2013 | UPDATED: 00:51, 7 April 2013

Mail on Sunday

"The doctors who conducted the research, including nanotechnology professor Alexander Seifalian and top plastic surgeon Professor Peter Butler, now say all PIPs should be removed... 

...The researchers, from the Royal Free Hospital in North London and University College London, tested the strength of the material in the PIPs... 

Senior surgeons last night said the study should be taken seriously amid claims that the NHS has been failing to address the needs of women."

Read more: http://www.dailymail.co.uk/news/article-2305166/Top-doctors-removal-breast-implant-given-50-000-British-women.html#ixzz2Q6xsDE6r 

All PIP Implants must be REMOVED

Wear Something Yellow 7 December 2012

Please Join in and support this international social networking event to 

raise awareness of the health issues facing all those with toxic PIP Implants.

See the event on Facebook 

PIPSLEAK

T O X I C 

Octamethylcyclotetrasiloxane D4

Reprotoxic Category 2 Hazard statement H361f*** 

Suspected of damaging fertility.

P I P S L E A K

TOXIC PIP IMPLANTS

"Analyses of the silicone contained in PIP breast implants indicates that the material does not pose a long-term risk to human health," explained Susanne Ludgate, clinical director of MHRA. "None of the chemicals listed will cause harm at the levels found within PIP breast implants and many are used routinely in various consumer products." 21 August 2012

It is true that a few shampoos do contain octamethylcyclotetrasiloxane (D4) and decamethylcyclopentasiloxane (D5) but they are environmental toxins mostly found in industrial waste and slurry!

The Scientific Committee on Consumer Safety SCCS published an opinion 22 June 2010 on

octamethylcyclotetrasiloxane (Cyclotetrasiloxane D4) and decamethylcyclopentasiloxane (D5)

"The SCCS is of the opinion that cyclomethicone (D4, D5) does not pose a risk for human health when used in cosmetic products. Other uses were not considered in this risk assessment." and "noted that D4 is classified as a reprotoxic substance, category 3 [ECB 2006]."

Who knew?

The French Regulator Afssaps knew and informed international regulators. It's why French women are having TOXIC PIP implants removed. The TGA the Australian Medical Devices regulator also knew.

Who else?

The European Parliament : Adopted texts published 4 days before Keogh's Expert Group Final Report...

"Calls on the Commission to require adequate toxicological assessments of all medical devices, and to propose that the use of substances that are carcinogenic, mutagenic or toxic for reproduction (category 1A or 1B) be phased out, unless no substitutes are available;"

The British Government will continue to poison us ...

TIME TO STAND UP AND DEFEND YOUR HUMAN RIGHTS !

GAME ON

octamethylcyclotetrasiloxane (D4)

We have been extremely busy pushing the DoH to acknowledge the failings of Expert Group Report which has been impacting on our care and treatment since 18 June 2012.

Our submission is freely available to consult on our webpage. 

While we are waiting for NHS to return from their holidays to address our concerns, we made contact with the Director of Consumer Affairs and Public Health at the European Commission to urgently press for clarification on issues relating to one specific chemical found in PIP implants octamethylcyclotetrasiloxane (D4) which is classified as TOXIC.

As a result of our concerns the MHRA have found themselves under close scrutiny and we see the MHRA actively modifying documents, advice and information on their website.  While we regard aspects of this positively, because additional data is now being made available to women affected by PIP implants, we are not convinced that MHRA is working in best interests of those affected.  We suspect they are actively working to conceal their failures.