Breast feeding with PIP Implants?

Breast feeding with PIP Implants?

As many as 100,000 European and 500,000 women worldwide received criminal, non-compliant PIP implants: the majority of these women are of reproductive age, a minority are recovering cancer patients. 

The UK government have commissioned a number of reports in response to the scandal: but one report is guiding women’s care and treatment in the UK:

Poly Implant Prothèse (PIP): breast implants: the final report of the Expert Group

The Final Report of group of experts was published in June 2012 it reported:

…current advice from the MHRA is that women with PIP breast implants should continue to breast feed their infants. In theory it is possible that the lower molecular weight siloxanes could migrate into breast milk; the MHRA have therefore arranged for chemical analysis of a sample of breast milk from a patient with ruptured PIP implants and we will publish the results as soon as they are available.

The ‘results’ of the chemical analysis on breast milk were published in an Annex to the Keogh Final report seven months later.  It has emerged that this analysis has not been peer reviewed and was conducted on a single subject!

PIP Action Campaign write to the Department of Health and MHRA to offer breast milk samples for testing

Appeal image

 

Why is it important for women with PIP implants to know about D4 in breast milk?

D4  CAS 556-67-2 octamethylcyclotetrasiloxane is a known, category 1, Endocrine Disruptor Chemical (EDC)

Why is it crucial to protect pregnant women and children from EDCs?

Until a couple of decades ago, scientists still believed that the placenta shielded cord blood would protect the unborn child from most chemicals and pollutants. However, studies which analyse the blood of newborn babies show that their blood already con- tains hundreds of hazardous chemicals such as heavy metals, flame retardants, dioxins, phthalates and pesticides. Many of the sub- stances that have been found in newborn babies are known to cause cancer, to be toxic to the brain and nervous system and are suspected to disturb the hormonal system.

Contact with EDCs during critical stages of development in the womb seems to cause serious health effects which may become evident only decades later, e.g. when a child reaches puberty or anytime later. Studies with animals showed that hormones during pregnancy “programme” cells, organs, the brain and behavior before birth and thereby set the individual’s track for the entire life- time. It seems that the actual timing of the exposure seems to be more important than the actual dose. Read More on ECD,s from BUEC consumer organisation in EU

MHRA response to request to test samples of breast milk of mothers with PIP implants

Re: breast milk samples for testing

Thank you for offering to send in two breast milk samples for analysis, however,  the MHRA is not planning to undertake further testing of samples of breast milk from women with PIP.  Clinical experts we have consulted agree that PIP silicone gel breast implants would not pose any significant risk. There is also no evidence of any harm to breast feeding infants in women who may have experienced ruptures in their PIP implants.

The final SCENIHR report on PIP  (http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_043.pdf) published on 15 May 2014 has the following inclusion: 

9.2.2. Nursing infants

Low levels of siloxanes in breast milk have been found in a single subject with a ruptured PIP implant. However, siloxanes have been found at detectable levels in over 20% of breast milk samples taken from women without breast implants. Moreover, commercially available semi-skimmed cow’s milk was found to contain considerably higher levels of total silicone than the sample of breast milk taken from women with a ruptured PIP implant. Thus, no identifiable increased risk for the nursing infant is anticipated from breast milk from a mother with ruptured breast implants.

 

SCIENCE? “YOU CANNOT BE SERIOUS!”

A single paragraph for nursing mothers, confirming low-levels of siloxanes have been found in a single subject. No identifiable increased risk for the nursing infant and no need for further study!  Who are these people? 

In the UK:

The PIP implants working group

The working group on PIP breast implants was appointed by the Department of Health to review the potential health risks of PIP breast implants and to advise the Department on policy in relation to women who received these implants. It was chaired by Sir Bruce Keogh, a cardiologist and NHS medical director, and consisted chiefly of plastic surgeons from the British Association of Aesthetic Plastic Surgeons (BAAPS) and one toxicologist, Professor Ian Kimber.

Read more: Journal of the Royal Society for Medicine 

 

What has BAAPS to say?

Absolut removal: new evidence prompts breast implant action in Sweden

UK surgeons demand similar testing of removed devices

London – 5 June, 2013 – In the wake of Sweden’s announcement that, based on new evidence, all PIP implants in their country should be removed as a preventative measure, the British Association of Aesthetic Plastic Surgeons (www.baaps.org.uk) today reiterates its own call for similar analysis to take place in the UK as a matter of urgency. The BAAPS, the only organisation based at the Royal College of Surgeons exclusively dedicated to aesthetic (‘cosmetic’) surgery, and which represents the vast majority of NHS plastic surgeons in private practice, welcomes the findings as ‘finally’ addressing some of the previously unexplained symptoms witnessed in patients.

“The combination of higher concentrations of D4 and the changes in the silicone which happen when the implant is within the body, finally explain the issues that surgeons and patients have been seeing and experiencing around the country. We urge the Government, who we know have collected in vivo specimens, to perform similar analyses – as a matter of urgency.”

The BAAPS has repeatedly warned (http://www.baaps.org.uk/about-us/press-releases/1460-analyse-this and http://www.baaps.org.uk/about-us/press-releases/1462-pip-implants-there-are-still-unanswered-questions) that there remain unanswered questions about the devices.

 

Department of Health responds to our concerns over D4

I am afraid to say that our reaction is similar to the response you received from Sir Bruce Keogh in August (2012) to the extensive dossier you submitted following our meeting.  There is nothing in the new material you have sent us which is unfamiliar to us and would justify reviewing the conclusions of Sir Bruce’s expert group.  The fact that a substance such as the siloxane D4 requires a “hazard” label in its pure state, or in concentrated solution, does not mean that it is a significant hazard to health in the very small concentrations typically found in PIP implants, or for that matter in a range of consumer products.  

… the expert group took enormous care to set out a fair and balanced assessment of these risks.

EC Scientific Opinion D4 and D5 in consumer products

ABSTRACT: SCCP concluded in its opinion (SCCP/0893/05) adopted during the 6th plenary meeting of 13 December 2005 that “On the basis of provided data, the SCCP is unable to assess the risk to consumers when Octamethylcyclotetrasiloxane (D4) is used in cosmetic products. Despite the size of the dossier submitted by industry for evaluation, it is unfortunate that the dossier lacked meaningful information/data on actual consumer exposure to D4. 

SCCS is the EC Scientific Committee on Consumer Safety (SCCS/1241/10) they concluded:

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.

This conclusion is based on the currently available in-use concentrations as cited in this opinion.

It should be noted that D4 is classified as a reprotoxic substance, category 3 [ECB 2006]. The NOAEL for systemic toxicity (150 ppm) used for this risk assessment also covers reprotoxic effects (NOAEL = 300 ppm).

The Commission Services should consider whether an environmental risk assessment associated with the use of cyclomethicone (D4/D5) in cosmetic products is required.

The SCCS adopted this opinion at its 7th plenary meeting of 22 June 2010

 

Has anyone considered an environmental assessment?

Yes! REACH

In 2012, the European Commission responded to PIP Action Campaign’s request for details of the classification of D4. This confirmed D4 as ReproToxic in humans with labeling exemptions in personal care products and High Risk Category III implantable Medical Devices. We were informed of the substance review and environmental evaluation of D4 underway by UK Competent Authority for REACH, HSE.

According to the HSE: “Based on the available information, D4 meets the Annex XIII criteria for both a ‘persistent, bioaccumulative and toxic’ (PBT) and a ‘very persistent and very bioaccumulative’ (vPvB) substance in the environment. This conclusion was endorsed by the ECHA PBT Expert Group in November 2012.”

HSE has confirmed that following the completion of this evaluation and the conclusion reached, EA is now working on  a formal proposal for restriction on the basis of the environmental concerns.

D4 meets the Annex XIII criteria in the environment what does it mean for my health?

The criteria in REACH, European regulator of hazardous substances say in Article 57 Substances of Very High Concern SVHC’s include:

• Substances which are persistent, bio-accumulative and toxic (PBT) in accordance with the criteria set out in Annex XIII of the REACH Regulation;

• Substances which are very persistent and very bio-accumulative (vPvB) in accordance with the criteria set out in Annex XIII of the REACH Regulation;

What did the Nina Cromnier, Chair of the Management Board ECHA, say about D4 and human health risk when we raised concerns?

You are highlighting an important concern for the health and safety of citizens resulting from cyclic siloxanes D4, D5 and D6. The European Chemicals Agency (ECHA) is aware of the debate around these chemical substances.

What is known about EDC’s and their effect on health?

Endocrine disrupting chemicals are linked to a wide range of health problems

Because correct hormone signalling is integral to the healthy functioning of the body, EDCs can have a wide range of potential health effects. Timing of exposure is as important as dose, as hormones play vital roles not only in maintaining the state of the body, but also the development of vital organs during foetal and childhood growth. The foetus, infant and adolescent are those considered to be at greatest risk of harm from EDCs.

Reproductive health: Male fertility and physical abnormalities of the male reproductive tract such as malformations of the penis and undescended testicles have been linked with exposure to chemicals, such as some phthalates, which inhibit the action of testosterone during foetal development.

Cancer: Endocrine disruptors can interfere with biological pathways involved in the initiation and progression of cancer and also re-programme organs so they are more likely to become cancerous later in life. For example, man-made oestrogens are thought to be involved in breast cancer development.

Obesity: Exposure to EDCs could also make worse the effects of energy imbalances between diet and exercise, resulting in greater risk of obesity and obesity-related disorders such as diabetes and cardiovascular disease.

Immune system function, cognitive function and behavioural disorders, as well as increase in cardiovascular diseases, have also been linked with endocrine disruption.

Read more: CHEMSEC International Chemical Secretariat

Who is most at risk from D4?

The foetus, infant and adolescent are those considered to be at greatest risk of harm from EDCs Chemsec

 

So what about tests on breast milk SCENIHR?

Low levels of siloxanes in breast milk have been found in a single subject with a ruptured PIP implant

What about testing more than one subject & recommending urgent preventative removals of all non-compliant PIP implants?

Thank you for offering to send in two breast milk samples for analysis, however,  the MHRA is not planning to undertake further testing of samples of breast milk from women with PIP.  Clinical experts we have consulted agree that PIP silicone gel breast implants would not pose any significant risk. There is also no evidence of any harm to breast feeding infants in women who may have experienced ruptures in their PIP implants.

Who are these clinical experts?

A PIP Action Campaign member and mother responds to the MHRA UK

It cannot possibly be a big inconvenience to your day to have to test a few more samples of breast milk. The only reason I can see for your refusal is that you may have serious concerns as to the consequences of test results. If you found levels of silicone that were too high then this could lead to a higher volume of women demanding removal and this would cost more money. You have to ask yourselves exactly why you are here. If it’s to protect people then you should be wanting to gather as much information as possible so that you can be more reliable in your recommendations and protect women, their unborn babies and nursing babies. If you truly believe nursing with ruptured breast implants is safe then why not prove it by testing these samples? I do not know a single scientific study that can claim to be reliable from testing a single subject. It’s absolutely crazy, and potentially very dangerous.

Independent experts have already raised concerns about EDC exposure in women with PIP implants

The PIP implants were found to contain a higher proportion of small-sized molecules D4, D5, D6 than the norm. D4 (octamethylcyclotetrasiloxane) was identified as an endocrine disrupting chemical (EDC) of ‘high concern’ in 2007 by a report commissioned by the European Commission entitled ‘Study on enhancing the Endocrine Disrupter priority list with a focus on low-production chemicals’. The effects of low doses of such chemicals, particularly on the developing fetus, have been well documented. While most regulatory levels of impurities in breast implants are considered acceptable in the range of a few parts per million, Le et al. showed that EDCs are capable of affecting developing neurons in vitro at concentrations of less than one part per trillion. Considering these known risks and the fact that most women receiving breast implants were of reproductive age, we would expect the MHRA and the Department of Health to fulfil its duty of care and thoroughly investigate these risks as well as provide full information to patients. Read More

Is this the only evidence the SCENIHR Final Opinion is not being driven by scientific rigour?

Unfortunately not.

4.3.2. Reports produced by individual Member States and other governments

Because of the political and other concerns regarding PIP implants, there have been major efforts in several countries to assess the health implications of implant leakage and implant rupture. Much of this important work is not yet published in scientific literature. As a consequence the SCENIHR has deviated from its normal practice of relying almost exclusively on the published literature.

 

D4 is TOXIC 

It is currently classified as follows

Human health Repro. Cat 3 R62: Possible risk of impaired fertility.

Human health Hazard class and category: Repr. 2. 

Hazard statement: H361f: Suspected of damaging fertility.

D4 is categorized as an endocrine disruptor (cat 1).

Hazard

 

– D4 is found in silicone breast implants and in higher concentrations in criminally manufactured PIP breast implants.

– D4 has been found in the prosthetic fluid associated with PIP implants

– The Majority of women with PIP breast implants are of reproductive age, the majority of breast cancer patients affected have oestrogen-sensitive tumours

– Thousands of women with fraudulent PIP implants report immunological, neurological and endrocrinal symptoms.

– Thousands of women with fraudulent PIP implants are known to be undergoing surgeries to remove massively silicone saturated lymph nodes

 

What conclusion has the SCENIHR reached?

 

“There is currently no convincing medical, toxicological or other data to justify routine removal of intact PIP implants.” 

 

PIP ACTION CAMPAIGN calls on the European Commission to immediately withdraw the SCENIHR Final Opinion and initiate criminal negligence proceedings.

 

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