The toxic chemicals in the fraudulent shells and fillers of PIP breast Implants seep out into surrounding body tissue, migrate into body organs, can cross the placenta and can be found in breast milk.
These toxic chemicals make women very sick and many report debilitating symptoms directly linked to silicone toxicity. Jan Spivey and Marie Robinson Co – Founders of PIP Action Campaign
Established in 1991, French company Poly Implant Prothese (known as PIP) was found guilty of fraud in 2013, along with its founder, Jean- Claude Mas, who was sentenced to four years in jail.
To the thousands of women who were mislead into thinking these implants were produced in a ‘safe’ manner, and have since suffered immeasurably, both physically and emotionally, this four year sentence seemed like an incredible insult. When Jean-Claude was found guilty for fraud he was fined a mere 75,000 euros, and has since spent approximately 18 months in jail.
At one point in time, PIP was the third largest breast implant manufacturer in the world, producing up to 100,000 implants each year.
Not willing to spend four years in prison, Jean-Claude has asked for an appeal, and his case began last week in France, sparking outrage in the victims who are terrified they may now never see him face his crimes.
What Was Found In PIP Implants?
When the truth was revealed about what was in these faulty breast implants, women were horrified. Instead of using medical grade silicone, PIP elected instead to use the much cheaper industrial silicone. This type of silicone is untested and not licensed for use in the human body.
Not coincidentally, PIP implants had a 500% higher risk of leaking and or rupturing than other models on the market.
Other chemicals found in PIP implants included: Toluene * Acetone Xylene Cyclohexane Ethylbenzene *D6 * Chloroform * Dichloromethane * Ethanol * Ethyl Acetate * D4* D5* Platinum * Caesium* Methanol * Isopropanol * 1-Butanol * Butyl * Benzophenone * di-2-ethylexyl phthalate. (source)
TÜV Rheinland, the German notified body, was responsible for ensuring that PIP implants complied with the regulations, issuing a CE certificate which tells buyers and surgeons that the implants are safe. PIP implants were then sent out into the market, where they were used in approximately 500,000 women in many countries worldwide.
Upon further investigation into the ingredients of PIP implants, it was discovered that the manufacturer had also added Baysilone (a fuel additive), as well as Silopren and Rhodorsil – both of which are used as electrical cable coatings.
PIP also made male chest, buttock, and testicle implants with their industrial silicone.
It’s important to note that these chemicals have never been tested for their effects on humans. (source).
“It’s not a debate about cosmetic surgery …
It’s a serious health problem
Women affected by PIP implants want justice.
In silence we must live with our pain…
The anguish of the scandal
Robbed of rights, uncertainty
Fear, helplessness and loneliness.
Humiliated for defending our dignity
Here is the reality no-ones sees
that others caused.”
Jean-Claude On What He Did
Statements by Jean-Claude Mas, Founder of PIP
Throughout the entire duration of the 2013 investigations, Jean-Claude Mas kept a provocative and scornful stance that particularly shocked the different protagonists of the case.
- He confessed in particular during his hearing at the police that he had given the order to “hide the truth in 1993” from the German certification body TÜV.
- He then detailed all fraud without the slightest embarrassment, and without showing any remorse, saying “I knew this gel was not approved, but I did this knowingly because the PIP gel had better value for money.”
- Subsequently, and despite the exponential number of complainants and severity of the effects highlighted by physicians, Jean-Claude Mas continued to declare that his gel “did not pose a risk to human health.”
- Speaking about the complainants, Jean-Claude Mas declared that, “These people are frail or are doing it for the money. I lived well at the time.” That is to say, he lived with a fixed salary of 30,000 euros a month.
- Right from the start of the trial he explained that he did not “make anyone take any risks” and that “the PIP gel was not approved but was approvable,” adding that “toxicity wise, it’s the same” (as authorized Nusil gel). (source)
There is 100% evidence that all cohesive silicone gel Implants, including the “new and improved” implants, “gel bleed” inside the body while still intact, exposing the body to platinum as well as 40+ toxic ingredients and heavy metals. (source) (source)
Victims Terrified This Man Will Not Pay For His Crimes
When three of the UK’s largest cosmetic surgery providers of PIP implants refused to help women, some turned to the NHS (National Health Service) instead and were able to have their PIP implants removed. But some women are still waiting and have received no help or compensation. Many are still incredibly ill and in desperate need of medical intervention.
As you can see below from these truly grotesque photos, PIP implants were often removed looking just like this. For this particular victim, both sides had severely ruptured, so the silicone had to be scraped out of her breast cavity. This woman will now also have silicone in her body that cannot ever be fully removed, since it travels throughout the body. The red bits are scar tissue which also had to be removed. .
It is estimated that over 40,000 women in the UK received these PIP implants. You can read here how PIP implants have affected other women worldwide.
Breast Implant Manufacturers: Should Any Be Trusted?
Over the years we have heard from countless women who are saline and silicone breast implant patients and who have suffered from complications, involving both short- and long-term health conditions believed to be related to their implants. Implants rupture and leak. Implants sometimes migrate. Implants often harden and cause capsular contracture.
Nearly all will need to be replaced at some point.
Reported conditions involve local infections, necrosis, hematoma, connective tissue disorders and immune disorders like fibromyalgia, rheumatoid arthritis, chronic fatigue syndrome, multiple sclerosis, lupus, Sjogren’s syndrome and others. National Cancer Institute studies indicate that women who have breast implants are at increased risk of brain cancer, lung cancer, emphysema, pneumonia and suicide.
Although research paid for by implant companies disagrees, those findings need to be evaluated by independent researchers. And now we learn that a rare type of immune system cancer, anaplastic large-cell lymphoma (ALCL), is found growing near the capsule of scar tissue around the breast implant. The risk of developing ALCL for women with implants was significantly higher than that found in women without breast implants.
From Terry O’Neill, President, National Organization for Women (NOW) Foundation – Presented to the U.S. Food and Drug Administration, General and Plastic Surgery Devices Panel Review of Post-Approval Studies for Silicone Gel-Filled Breast Implants on August 30, 2011 (source)
The breast augmentation industry is worth billions. With an estimated 5-10 million women worldwide undergoing this procedure each year, it’s obvious that this industry is worth a lot of money. It is equally clear that it is not in the best interests of many of these companies for women to know how many risks and complications are involved.
By the late 90’s, approximately 400,000 USA women had filed and won a massive lawsuit with Dow Corning, who also made dangerous implants which ruptured at an alarming rate, with silicone leaking into women’s bodies, causing an untold amount of damage to their health. Some women have since died after having these implants put in.
Women Take Note: Silicone Is Found in ALL Implants On The Market Today
While much of the public may think that Dow’s case is old news and that the newer implants aren’t as dangerous, many women today who have these so-called ‘newer and safer’ implants are telling a much different story, reporting ruptures and ill health.
Women are often misguided into thinking that saline implants ‘only contain saline.’ This is false. The outer shell on all implants is made with silicone and a mix of other chemicals and heavy metals.
It’s vital to know that silicone, once it has leaked from the implants, cannot be removed from the body.
The distributor Sientra (who until recently handled the market for the ‘Silimed‘ implants, had this brand removed from the market because of “contamination fears,” where manufacturing particles such as cotton and silica were found in the implants) was also previously quite open about their findings and wrote in their own data sheet that their breast implants can cause adverse effects and complications such as:
- Reoperation (additional surgeries)
- Implant removal with or without replacement
- Implant rupture
- Capsular contracture
- Implant displacement
- Implant palpability/visibility
- Infection (including Toxic Shock Syndrome)
- Breast feeding difficulties
- Calcium deposits
- Delayed wound healing
- Breast tissue atrophy/chest wall deformity
- Connective tissue disease (CTD)
- CTD signs and symptoms
- Neurological disease
- Neurological signs and symptoms
- Changes in nipple and breast sensation
- Potential effects on offspring. (source FDA’s website)
Read The Manufacturer’s Data Sheets
Often women do not receive true informed consent before signing up to have breast implants. I know I didn’t. At the time, back in 2007, I did not even think to question if implants could be dangerous.
In my case, my own vanity overrode my sensibility.
These warnings are quite clearly listed in many brands, however. Mentor’s data sheets, for example, are well known for their “newer, safer cohesive gel implants” that many women tout as safe.
Mentor warns about many of the possible risks and complications. If all women read this in detail before they decided yes to this operation, would they end up going ahead with the procedure? I think many would not.
While I think it’s important that Mentor makes these risks clear, it is likely that if something were to go wrong you would then be unable to sue because you had been warned ahead of time.
Again, I urge you to be very sure you know what you could be in for before saying yes.
Safety Studies Not All Completed
Other studies that were meant to be completed to prove the safety of ‘newer and improved implants’ were not at all carried out adequately. According to the article “FDA Questions Studies Of Implant Safety,” Mentor, who make the Memory Gel implants, had lost a whopping 79% of the women involved in the study. Allergan, who make Natrelle implants, also lost 40% of their women only two years after the study began.
- Both of these companies now have their implants used in countless breast augmentations worldwide.
- We only have to look at the case of PIP to see that manufacturers can get away with using toxic and dangerous ingredients, at least for a while. Jean-Claude had his toxic implants on the market for approximately ten years before they were recalled.
- If you are to ask for full ingredient listings of a certain brand, the companies do not respond to emails (give it a try yourself and see!) and they certainly do not list these important details on their websites.
- I’ve managed to find only a short list from the FDA of what is in the shells or inside of both saline and silicone implants.
Detected Heavy Metals in Implant Shell and/or Gel:
- Aluminum (source)
A Warning To Women
If you are going to have something put into your body, you need to know, and have the right to know, exactly what the device is made of.
The appeal case of Jean-Claude and other members of PIP continues and I hope to update you in the near future.
I am personally praying for justice for the women affected by these toxic implants.
Until then, please think very carefully about what you may already have in your body (even if they are not PIP implants), and if you are considering having breast implants, please do a lot more research before you make this life-changing decision that could possibly detrimentally affect your health and well-being.
Forty-seven thousand women in the UK are thought to have been exposed to non-compliant PIP implants. The PIP health fraud has affected more than 500,000 women worldwide.
In addition to suffering a shocking array of symptoms, women have genuine concerns for their children exposed during pregnancy or while breast feeding. Women have rights as patients and consumers and as victims of crime.
Many women have sustained terrible injuries, many have been traumatised, virtually all express anxiety at facing an uncertain future.
Yet they have been denied their rights to a duty of care, denied access to healthcare and treatment, their consumer rights have been undermined and their right to justice obstructed by regulatory failings and powerful industry lobbies operating in the European Union and beyond.
PIP is not just about a devious, delusional manufacturer, but a corrupted regulatory system for medical devices which is failing all women.
Jan Spivey Co-Founder of PIP Action Campaign and Survivor Of PIP
RADIO INTERVIEW WITH JAN SPIVEY, JESS LEWIS AND TRACEY AHMET
If you are alarmed by this issue, please sign this petition here:
Report Your PIP Implants
Experienced an adverse event you associate with your PIP?
United Kingdom gov.uk/report-problem-medicine-medical-device
Thank you to Sophia Lamere for assisting with the French translation.
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