Tuesday 14 May 2013

In the News




Murielle Ajello, president of the Movement for the defense of women with prostheses and implants (MDFPIP), asked the presiding judge to show these pictures to the plaintiffs. The court has not yet responded to this request

Photos of the PIP manufacture are available to refresh the memories of officials >>>See more 










Saturday 11 May 2013

¿Who are these people?

MHRA Announcement 10 May 2013


In response to the recent publication of an article criticising the findings of the British 'expert' group.  The MHRA, with responsibility for protecting public health, does what it does best and refutes the growing evidence!  And, instead of investigating legitimate concerns raised by doctors, surgeons, medical associations and Societies, medical scientists and toxicologists, the Department of Health and MHRA continue to put British women at risk with a cavalier attitude to their health and well-being. 



"MHRA News
10 May 2013

The Department of Health has issued the following statement in response to an opinion piece about PIP breast implants by Dr Victoria Martindale and Andre Menache that was published in the Journal of the Royal Society of Medicine on Thursday 9 May.
 
A Department of Health spokesperson said: 
We stand by the conclusions of the original report and want to reassure women that PIP implants do not pose a significantly increased risk to health.
“The expert group report thoroughly analysed the toxicology of chemicals in the implants, including the potential effect on women of reproductive age. The main panel was advised by a sub group that contained four independent toxicology experts.
“The wellbeing of women who have had PIP breast implants has always been our main priority.”
 
More information on the Professor Sir Bruce Keogh’s expert group report into PIP breast implants and the MHRA’s testing of them can be found on the MHRA website:
Final testing results for PIP breast implants are published
end quote



TOXINS in PIP Breast Implants - How have the British got it so wrong, for so long?

TOXINS in PIP Breast Implants - How have the British got it so wrong, for so long?



PIP breast implant campaigners question findings of independent report
The Guardian
The PIP breast implants that were fraudulently filled with industrial-grade silicone may have caused their recipients harm, claim two environmental scientists and campaigners who dispute the findings of the independent inquiry into the scandal, which ...
See all stories on this topic »

The Guardian
Ruptured PIP safety claims disputed
Belfast Telegraph
Claims that ruptured PIP breast implants should not cause any long-term health problems have been disputed by experts. 09 May 2013. Claims that ruptured PIP breast implants should not cause any long-term health problems have been disputed by experts.
See all stories on this topic »

Belfast Telegraph
Breast implants risk to unborn babies
The Australian
"We feel that the PIP breast implant scare is an example of regulatory and quality control failure that urgently requires addressing as an integral part of the ongoing review of plastic surgery," the authors say. Last night the British Association of...
See all stories on this topic »
Emergency care 'out of control', PIP scandal continues and the man with 'nine ...
Pulse
Meanwhile, The Guardian warns that the faulty PIP breast implants could be more harmful than the initial review had concluded. Two environmental scientists and campaigners dispute the findings of the independent inquiry into the scandal, which ...
See all stories on this topic »

Could PIP breast implants damage unborn babies?
Parentdish
A spokesperson for the NHS told Sky news: "We stand by the conclusions of the original report and want to reassure women that PIP implants do not pose a significantly increased risk to health. The well-being of women who have had PIP breast implants ...
See all stories on this topic »


Chemicals in Breast Implants found Hazardous for Unborn Babies
TopNews New Zealand
Chemicals in Breast Implants found Hazardous for Unborn Babies The Royal Society of Medicine's report has revealed that chemicals in faulty breast implants can cause damage to unborn babies. Thousands of women are now said to be exposed to ...
See all stories on this topic »

TopNews New Zealand
Blogs
Ruptured PIP safety claims disputed « This Is Guernsey
By PA
Ruptured PIP safety claims disputed. Thursday 9th May 2013, 12:11AM BST. Claims that ruptured PIP breast implants should not cause any long-term health problems have been disputed by experts. Tweet. Claims that ruptured PIP breast ...
This Is Guernsey » This Is Guernsey

Web
PIP Breast Implants May Harm Developing Fetus
According to a new study published in the Journal of the Royal Society of Medicine, PIP breast implants may cause significant damage to a developing fetus.
www.medicalnewstoday.com/articles/260295.php
PIP breast implant campaigners question findings of independent ...
Two scientists say they are worried about chemical in the silicone filling that could effect on the development of a foetusThePIP breast implants that were ...
news168.co.uk/.../pip-breast-implant-campaigners-question-fi...
PIP breast implant campaigners question findings of independent ...
http://hits.guardian.co.uk/b/ss/guardiangu-feeds/1/H.25.4/76611?ns=
www.thebellforum.com/showthread.php?t=95404
PIP Breast Implants May Harm Developing Fetus | Alternative Fuse
A recent report published in the Journal of the Royal Society of Medicine reveals that PIP breast implants do in fact pose health threats, and can cause damage ...
news.alternativefuse.com/.../pip-breast-implants-may-harm-de...

 PIP breast implant link to foetal risk 'alarming' | Irish Examiner
Solicitors representing some of the Irish women who received faulty PIP breast implants have said new claims about potential risk to unborn children are.
www.irishexaminer.com/.../pip-breast-implant-link-to-foetal-ri...


U.K. pair challenges earlier finding that substanded PIP breast ...
A top U.K. health regulator's report last year concluding Poly Implant Prosthese's (PIP) substandard breast implants didn't pose long-term health risks to women ...
www.fiercemedicaldevices.com/story/uk.../2013-05-09


Ruptured PIP safety claims disputed - MSN News UK
Claims that ruptured PIP breast implants should not cause any long-term health problems have been disputed by experts.
news.uk.msn.com/uk/ruptured-pip-safety-claims-disputed


Department of Health responds to paper on PIP breast implants ...
The Department of Health has issued the following statement in response to an opinion piece about PIP breast implants by Dr Victoria Martindale and Andre ...
www.mhra.gov.uk/NewsCentre/CON272251


Claims that ruptured PIP breast implants should not cause any long ...
View the photo Claims that ruptured PIP breast implants should not cause any long-term health problems have been disputed by experts on Yahoo! News UK.
uk.news.yahoo.com/.../claims-ruptured-pip-breast-implants-no...


TOXIC PIP Implants

 Breast Implants 'Could Harm Unborn Babies' - Sky NewsSky News
A French team disagrees with NHS medical director Sir Bruce Keogh after he said PIP implants were not toxic or carcinogenic. 1:24pm UK, Thursday 09 May 2013. PIP breast implants. The implants were fraudulently filled with industrial-grade silicone ...
See all stories on this topic »
PIP Implants Dangerous for Unborn Babies, says Study
TopNews United States
Under the published study in the Journal of the Royal Society of Medicine, a group of researchers have saidPIP breast implants can affect the unborn babies. Earlier, NHS had cleared doubts that the PIP does not carry toxic or carcinogenic substances.
See all stories on this topic »

TopNews United States
Chemical in faulty breast implants used by 47000 women in UK ' causes ...
Daily Mail
Women with faulty PIP breast implants are at risk of chemical exposure that causes damage to unborn babies, experts have warned. Their report disputes previous warnings by the NHS that material inside the implants was 'not toxic or carcinogenic'.
See all stories on this topic »

Daily Mail

PIP Implant News Updates

News Update
 
Call for improved safety data on medical implants
NHS Choices
Collecting and publishing high quality data could help prevent widespread problems with medical implants, such as those seen with Poly Implant Prothèse (PIPbreast implants. The PIP scandal caused global concern after it was discovered that French...
See all stories on this topic »
Medical device assessment 'inconsistent' claim
Health Service Journal
Notified bodies give products the CE mark seal of approval within the European Union, but the PIP breast implant scandal shows that the process cannot guarantee “safe and effective” patient care, according to a research group led by Edmund Neugebauer ...
See all stories on this topic »

News Update

Latest NEWS
PIP implants scandal puts consumer protection on agenda
PublicServiceEurope.com
The defective implants, alleged to have been made from cheap industrial silicone unintended for medical use, were prone to ruptures and leaks. To make matters worse, the financial impact of expensive surgical removal was significant for the thousands ...
See all stories on this topic »

PublicServiceEurope.com
Real Risk in Injections and Implants
New York Times
Although there is widespread awareness that this sector has the potential to trigger a crisis as serious as the 2012 PIP breast implant scandal, when it emerged that as many as 47,000 British women might have been given faulty implants, very little has...
See all stories on this topic »
Experts call for regulator to stop needless cosmetic surgeries
Times of India
This lack of regulation of both the products and specialties has been responsible for the recent disaster of PIP breast implants and the next disaster waiting to happen would be of dermal fillers." " The need of the hour is to set up a review body by ...
See all stories on this topic »

Saturday 4 May 2013

PIP Factory of Fear

PIP implants: as victims from abroad seek redress

"The company PIP realized 85% of its turnover abroad. Venezuela, Colombia, Australia, Spain, Holland, Great Britain ... There are more than 300,000 women around the world have been implanted with the PIP implants."






Friday 3 May 2013

TOXIC PIP IMPLANTS

WHY?


British and Australian Government data ignores ALL published medical and clinical studies. Why?

British, Australian and Spanish governments are NOT treating, testing or monitoring women affected by implants who present with of symptoms of toxicity. Why? 

European Commission with responsibilities for high-risk, category III medical devices ignored senior doctors concerns for years before the French Police forced the closure of P.I.P.  Why?

TÜV certified implant safety, even when concerns were raised by European surgeons and the British Regulator MHRA but never made any checks.  Why?

Why aren't affected women and children being tested, monitored and treated?
Why are British women told its ok to breast-feed their new-born infants with ruptured toxic PIP implants?

Why wont those responsible for public health and safety take responsibility, when our lives are at stake? 

Why?


Why are women so sick? 1.Perchloroethylene


Tetrachloroethylene (Perchloroethylene)

127-18-4

Hazard Summary-Created in April 1992; Revised in December 2012Tetrachloroethylene is widely used for dry-cleaning fabrics and metal degreasing operations. Effects resulting from acute (short term) high-level inhalation exposure of humans to tetrachloroethylene include irritation of the upper respiratory tract and eyes, kidney dysfunction, and neurological effects such as reversible mood and behavioral changes, impairment of coordination, dizziness, headache, sleepiness, and unconsciousness.  The primary effects from chronic (long term) inhalation exposure are neurological, including impaired cognitive and motor neurobehavioral performance.  Tetrachloroethylene exposure may also cause adverse effects in the kidney, liver, immune system and hematologic system, and on development and reproduction. Studies of people exposed in the workplace have found associations with several types of cancer including bladder cancer, non-Hodgkin lymphoma, multiple myeloma.  EPA has classified tetrachloroethylene as likely to be carcinogenic to humans.






  • Please Note: The main sources of information for this fact sheet are EPA's Integrated Risk Information System (IRIS) (2), which contains information on inhalation chronic toxicity and the RfC, oral chronic toxicity and the RfD, and the carcinogenic effects of tetrachloroethylene; and the Agency for Toxic Substances and Disease Registry's (ATSDR's) Toxicological Profile for Tetrachloroethylene. (1)
  • Uses
  • Tetrachloroethylene is used for dry cleaning and textile processing, as a chemical intermediate, and for vapor degreasing in metal-cleaning operations. (1)
  • Sources and Potential Exposure
  • Over the past few decades, concentrations of tetrachloroethylene detected in ambient air have declined with reductions in the use of tetrachloroethylene. (2)
  • Tetrachloroethylene has also been detected in drinking water supplies from contaminated groundwater sources. (2)
  • Occupational exposure to tetrachloroethylene primarily occurs in industries using the chemical (e.g., many dry cleaning facilities) and at industries manufacturing the chemical. New dry cleaning technologies and practices introduced over the past couple of decades result in substantially reduced occupational exposure (1, 2)
  • Assessing Personal Exposure
  • Tetrachloroethylene can be measured in the breath, and breakdown products of tetrachloroethylene can be measured in the blood and urine. (1)
  • Health Hazard Information
  • Acute Effects:
  • Effects resulting from acute, inhalation exposure of humans to tetrachloroethylene vapors include irritation of the upper respiratory tract and eyes, kidney dysfunction, and at lower concentrations, neurological effects, such as reversible mood and behavioral changes, impairment of coordination, dizziness, headache, sleepiness, and unconciousness. (1, 2)
  • Animal studies have reported effects on the liver, kidney, and central nervous system (CNS) from acute inhalation exposure to high levels of tetrachloroethylene. (1, 2)
  • Acute animal tests in mice have shown tetrachloroethylene to have low toxicity from inhalation and oral exposure. (1)
  • Chronic Effects (Noncancer):
  • The major effects from chronic inhalation exposure to tetrachloroethylene in humans are neurological effects, including sensory symptoms such as headaches, impairments in cognititve and motor neurobehavioral functioning and color vision decrements.  Other effects noted in humans, generally at higher exposures, include liver damage,  kidney effects, immune and hematologic effects, and on development and reproduction. (1, 2)
  • Animal studies have reported effects on the liver, kidney, and CNS from chronic inhalation exposure to tetrachloroethylene. (1, 2)
  • EPA has calculated a  Reference Concentration (RfC) of 0.04 milligrams per cubic meter (0.04 mg/m3) based on neurotoxicity in occupationally-exposed adults. The RfC is an estimate (with uncertainty spanning perhaps an order of magnitude) of a continuous inhalation to the human population (including sensitive subgroups) that is likely to be without appreciable risk of deleterious noncancer effects during a lifetime.  It is not an estimator of risk but rather a reference point to gauge the potential for effects.  At exposures increasingly greater than the RfC, the potential for adverse health effects increases.  Lifetime exposure above the RfC does not imply that an adverse effect would necessarily occur. (2)
  • The Reference Dose (RfD) for tetrachloroethylene is 0.006 milligrams per kilogram body weight per day (mg/kg/d) based on neurotoxicity in occupationally-exposed adults. The RfD is an estimate (with uncertainty spanning perhaps an order of magnitude) of a daily oral exposure to the human population (including sensitive subgroups) that is likely to be without appreciable risk of deleterious noncancer effects during a lifetime. It is not a direct estimator of risk, but rather a reference point to gauge the potential for effects. At exposures increasingly greater than the RfD, the potential for adverse health effects increases. Lifetime exposure above the RfD does not imply that an adverse health effect would necessarily occur. (2)
  • EPA has medium confidence in both the RfC and RfD values overall.  Although EPA’s confidence in the evidence of neurotoxicological hazard is high, EPA has medium rather than high confidence in the study estimates they were based on because they were derived from a LOAEL rather than a NOAEL and data were insufficient for dose-response modeling; additionally, the studies focus on occupational subjects and lack data to characterize potential susceptibility and variability across humans.  EPA has medium confidence in the database due to limitations in both the available human and animal database (4)
  • Reproductive/Developmental Effects:
  • Some adverse reproductive effects, such as menstrual disorders, altered sperm structure, and reduced fertility, have been reported in studies of workers occupationally exposed to tetrachloroethylene.  However, the evidence is inconclusive. (2)
  • Some studies of residents exposed to drinking water contaminated with tetrachloroethylene and other solvents during pregnancy suggest an association of tetrachloroethylene exposure with birth defects, however firm conclusions cannot be drawn due to several limitations of these studies. (2)
  • Increased fetal resorptions and effects to the fetus have been reported in animals exposed to high levels of tetrachloroethylene by inhalation. (2)
  • Cancer Risk:
  • Studies of dry cleaning workers exposed to tetrachloroethylene have shown associations between exposure to tetrachloroethylene and several types of cancer, specifically bladder cancer, non-Hodgkin lymphoma and multiple myeloma. There is also limited evidence suggestive of associations with esophageal, kidney, cervical and breast cancer. (2)
  • Animal studies have reported an increased incidence of liver tumors in mice, from inhalation and gavage (experimentally placing the chemical in the stomach) exposure, and kidney and mononuclear cell leukemias in rats, via inhalation exposure. (1,2)
  • EPA has classified tetrachloroethylene as likely to be carcinogenic to humans by all routes of exposure based on suggestive evidence in epidemiological studies and conclusive  evidence in rats (mononuclear cell leukemia) and mice (increased incidence of liver tumors). The International Agency for Research on Cancer (IARC) has classified tetrachloroethylene as probably carcinogenic to humans (Group 2A).
  • EPA uses mathematical models, based on animal or human studies, to estimate the probability of a person developing cancer from breathing air containing a specified concentration of a chemical.  EPA calculated an inhalation unit risk estimate of 2.6 × 10-7 (µg/m3)-1.  EPA estimates that, if an individual were to continuously breathe air containing tetrachloroethylene at an average of 4 ug/m3 (4 x 10-3mg/m3) over his or her entire lifetime, that person would theoretically have no more than a one-in-a-million increased chance of developing cancer as a direct result of breathing air containing this chemical. Similarly, EPA estimates that continuously breathing air containing 40 µg/m3 (4 x 10-2 mg/m3) would result in not greater than a one-in-a-hundred thousand increased chance of developing cancer, and air containing 400 µg/m3 (4 x 10-1 mg/m3) would result in not greater than a one-in-ten thousand increased chance of developing cancer. For a detailed discussion of confidence in the potency estimates, please see IRIS.
  • EPA calculated an oral cancer slope factor of 0.0021 (mg/kg/d)-1 based on extrapolation from inhalation dose-response data. (2)
  • Physical Properties
  • Tetrachloroethylene is a nonflammable colorless liquid with a sharp sweet odor; the odor threshold is 1 ppm. (1)
  • The chemical formula for tetrachloroethylene is C2Cl4, and the molecular weight is 165.83 g/mol. (1)
  • The vapor pressure for tetrachloroethylene is 18.47 mm Hg at 25 °C, and it has a log octanol/water partition coefficient (log Kow) of 3.40. (1)

  • Conversion Factors: 
  • To convert concentrations in air (at 25 °C) from ppm to mg/m3: mg/m3 = (ppm) × (molecular weight of the compound)/(24.45). For tetrachloroethylene: 1 ppm = 6.78 mg/m3. To convert concentrations in air from µg/m3 to mg/m3: mg/m3 = (µg/m3) × (1 mg/1,000 µg).
  • Health Data from Inhalation Exposure
  • AIHA ERPG - American Industrial Hygiene Association's emergency response planning guidelines.  ERPG 1 is the maximum airborne concentration below which it is believed nearly all individuals could be exposed up to one hour without experiencing other than mild transient adverse health effects or perceiving a clearly defined objectionable odor; ERPG 2 is the maximum airborne concentration below which it is believed nearly all individuals could be exposed up to one hour without experiencing or developing irreversible or other serious health effects that could impair their abilities to take protective action.
  • ACGIH TLV - American Conference of Governmental and Industrial Hygienists' threshold limit value expressed as a time-weighted average; the concentration of a substance to which most workers can be exposed without adverse effects.
  • LC50 (Lethal Concentration50) - A calculated concentration of a chemical in air to which exposure for a specific length of time is expected to cause death in 50% of a defined experimental animal population.
  • LOAEL - Lowest-observed-adverse-effect level.
  • NIOSH IDLH - National Institute of Occupational Safety and Health's immediately dangerous to life or health concentration; NIOSH recommended exposure limit to ensure that a worker can escape from an exposure condition that is likely to cause death or immediate or delayed permanent adverse health effects or prevent escape from the environment.
  • ACGIH STEL - American Conference of Governmental and Industrial Hygienists' recommended short-term exposure limit; a 15-minute TWA exposure which should not be exceeded at any time during a workday.
  • OSHA PEL - Occupational Safety and Health Administration’s permissible exposure limit expressed as a time-weighted average; the concentration of a substance to which most workers can be exposed without adverse effect averaged over a normal 8-h workday or a 40-h workweek.
  • The health and regulatory values cited in this factsheet were obtained in 2012.
  • a Health numbers are toxicological numbers from human studies, animal testing or risk assessment values developed by EPA.
  • b Regulatory numbers are values that have been incorporated in Government regulations, while advisory numbers are nonregulatory values provided by the Government or other groups as advice.  OSHA numbers are regulatory, whereas NIOSH, ACGIH, and AIHA numbers are advisory.
  • c The LOAELs for neurological effects are from the two principal studies on which the RfC is based.
  • References
  • Agency for Toxic Substances and Disease Registry (ATSDR). Toxicological Profile for Tetrachloroethylene (Update). U.S. Public Health Service, U.S. Department of Health and Human Services, Atlanta, GA. 1997. 
  • U.S. Environmental Protection Agency. Integrated Risk Information System (IRIS) on Tetrachloroethylene. National Center for Environmental Assessment, Office of Research and Development, Washington, DC.  2012. 
  • National Institute for Occupational Safety and Health (NIOSH). Control of Exposure to Perchloroethylene in Commercial Drycleaning.Publication Number 97-154. 1997. 
  • American Conference of Governmental and Industrial Hygienists (ACGIH). 2009 Guide to Occupational Exposure Values. ACGIH, Cincinnati, OH.  2009.
  • National Institute for Occupational Safety and Health (NIOSH).  Pocket Guide to Chemical Hazards.  U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention.  Cincinnati, OH.  2007.
  • American Industrial Hygiene Association (AIHA).  The AIHA 2011 Emergency Response Planning Guidelines and Workplace Environmental Exposure Level Guides Handbook. 2011.


P.I.P. Factory of our NIGHTMARES

Who Says PIP Implants are not Toxic?

Just the Australian, British, Spanish Governments.... ?













Images From PIP Factory 02 May 2013