Research

Documentation Report By Pierre J. J. B. Blais, B. Sc., Ph.D., C. Chem., F.C.I.C.

BREAST IMPLANTS – A GROWING AREA OF CONCERN

Diana Zuckerman, Ph.D., one of the scientists credited with initiating the report to the U.S. Congress on the FDA’s Regulation of Silicone Breast Implants in 1992, said that with the FDA’s approval of saline implants in spring 2000, and I quote, “the FDA has set a new low standard”. In connection with the events of 2005-2006 and the resubmission of silicone-gel-filled implants to the FDA and Health Canada, Dr. Zuckerman again went on record on several occasions advising caution and at one point labeling Health Canada’s advisory panel on breast implants as a “sham, with an Advisory Panel that includes several paid consultants to the companies that make breast implants”. The US and Canada have now returned to basically the same point as they were in the late eighties.

Manufacturers and surgeons will earn nearly a billion a year on breast implants. This is the reason why plastic surgeons and most doctors do not talk negatively about breast implants. The devices are part of a huge taxable cash-generating machine. They are also the cause of enormous health care costs that would otherwise not be incurred.

The safe salt water in saline is not simple or safe for long. Saline has a short shelf life and no hospital will wash a scratch with outdated saline, yet women are constantly being told how safe saline is and that in breast implants it remains good indefinitely. Yet, in reality it begins to turn septic in less than two years time.

On the occasion of FDA Panel Hearings in April 2000, Dr. Pierre Blais, a former Canadian Government researcher and Senior Scientific Advisor, prepared a report to the FDA. He made 14 recommendations on the process for approval and continuing sale of saline inflatable implants. Twelve recommendations were later implemented. However, the quality of fabrication is not significantly better. The new, improved silicone-gel-filled implants of today that Health Canada-approved in 2006, and the US in 2007 are no better than those sold in the eighties. In the meantime, promotion, both direct and indirect, through “reality” television shows is greater than ever while problems are as frequent and as severe as before. Dr. Blais current writings on the matter are summarized below:

Breast implants, some remarkably absurd and dangerous, have been used in increasing numbers since the fifties. Surrounded by dubious advertising, secretive surgical techniques, and widespread adverse effects, breast implants acquired a seedy image and their use was strongly condemned by the health care community until the seventies. Two product classes of breast implants remain, both relying on a thin outer shell filled with a solution of salt water or silicone gel. They are promoted as safe and government-approved. Neither assertion is correct.

In 1992, Canada and the United States imposed a Moratorium on the sale of silicone-gel-filled breast implants, largely in response to pressure from consumer and women’s groups concerned about rising morbidity . Saline-filled breast implants essentially became the sole option.

Saline-filled implants were presented as safe and natural, containing only salt (saline) and water. However, even if this was true at implantation, it did not remain that way for long. Saline has a limited shelf life and even if ’sealed’ within a breast implant, it turns septic. Saline implants are rarely hermetically ’sealed’. They do not have secure filling valves, allowing infiltration of the user’s body fluids and stray bacteria into the implant. Within a short time, the original saline solution incubates and decaying substances build up. When shell leakage occurs, the contaminated saline is discharged into the user. These problems are well known within the cosmetic surgery industry.

By about 1997, and because of problems with saline-filled implants, cosmetic surgeons and special interest groups lobbied for the return of silicone-gel-filled implants. After a bitter public debate, Health Canada relented and the sale of silicone-gel-filled prostheses resumed in Canada on October 20, 2006. The process was termed ‘licensing’. Conditions of sale include a disclosure of risks the products pose and the need for multiple replacements over the life of the user. Regrettably, the ‘license’ is being presented by breast implant interests as government approval and a proof of safety. The U.S. FDA ended its Moratorium on November 18, 2006, creating a similar situation in the US.

The lifting of the Moratoria in Canada and the U.S. led to a return to a pre-Moratorium situation when breast implants of all kinds could be sold for any application. In 2007, incidental to litigation involving breast implants and consumer products, the Court of Appeal of Ontario and the Supreme Court of Canada made it clear that Health Canada, the agency responsible for lifting the Canadian Moratorium, was under no duty to warn Canadians of dangerous medical devices, demonstrating that any claim of safety based on Health Canada’s ‘approval’ or ‘licensing’ is without substance. In the U.S., a legal peculiarity termed FDA ‘preemption’ placed similar limitations on legal recourse available to injured users of breast implants.

Post-Moratorium silicon- gel-filled implants are fundamentally the same as pre-Moratorium versions. They are still devoid of credible science, use the same constituents and technologies, and are no better made. They are manufactured by successors of firms who repeatedly went into receivership and continue to change hands at intervals of about two years. In 2006, when the Moratorium ended in Canada and the U.S., there were three significant breast implant makers (Mentor, MediCor, and Allergan). MediCor went into receivership in 2008. Its Chief Executive Officer was indicted for embezzlement of more than $94 million relating to the acquisition of breast implant manufacturing facilities. These manufacturers made both silicone-gel-filled and saline-filled implants.

Saline implants have a curious history. Commercialized in the mid-sixties, they were problem-plagued from the outset, laborious to insert, and easily contaminated during intraoperative filling. Shells failed early, valves leaked, and users complained of poor esthetics. Frequent deflations, infections, and deformity were problems which remained unresolved. By the early eighties, salines were rarely used and manufacturers nearly discontinued the products in favour of the less costly and more easily inserted silicone-gel-filled implants. The Moratorium of 1992 was a setback for the industry. Conversely, the saline implants became its salvation. More than 500,000 such implants were sold in North America during the Moratorium. Not surprisingly, all negative aspects of these devices received minimal public exposure. Now the situation is reversed with silicone gel implants receiving praise and promotion.

Breast-implant promoters are not reliable sources of information. The breast-implant industry earns close to 1 billion dollars a year from breast implants and relies on low-cost, easily inserted implants. The silicone-gel-filled implants fulfill this requirement admirably. To much of that community, quality and safety issues are secondary.

Most new breast-implant users are young women unfamiliar or unconcerned about events of the past. Like their predecessors, they will swell the ranks of chronically-injured breast-implant users whose health and appearance will continue to deteriorate. Many will be compelled to undergo repetitive breast surgery approximately every 5-7 years to replace or remove problem-riddled prostheses. Health-care costs engendered by the churning of implant users will rise and will greatly impact on Canada’s publicly-funded health-care system, already strained to the limit for essentials. The system was not designed to encompass cosmetic surgery complications and cannot cope with the treatment of its sequelae without diverting resources urgently needed elsewhere.

Less than 5% of new users are breast-cancer patients, nearly unchanged over the last two decades. About 10% of new implants go into existing users for ‘replacement’ of earlier implants that failed and left them disfigured. This number is rising, reflecting failures and ‘wearing out’ of devices inserted during the Moratorium.

Adverse effects from breast implants are as numerous and as severe as before and continue unabated. It appears that the lessons of the past have not been learned and augmentation procedures still converge to permanent, irrecoverable chest damage.

In many ways, the plight of breast-implant users appears to have worsened. The number of implant users is increasing too fast, the number of surgeons willing and capable of repairing damaged chests from breast implant misuse is decreasing, and few general practitioners are prepared to treat the long-term health problems of implant victims. Provincial health insurance programs and private third-party health insurers are reluctant to approve surgical costs for any form of breast surgery. It is morally wrong for any government to allow breast implants on the market and then to recoup lost revenue, as is being done in the U.S.A., and at the same time agreeing with the manufacturers and plastic surgeons that they are “safe and effective”.

Breast implants “are the least effective and most problematic devices” that have “ever been approved”, says Cindy Pearsons, executive director of the consumer advocacy group of the National Woman’s Health Network of Washington D.C. “The complications continue to rise with each successive year after surgery, and implants usually have a negative impact on a woman’s health”.

Enquiries are invited,

Adella Matthew
President

13 Responses to Research

  1. Louise Leifer says:

    Hi Dr Blais

    l had visted you back in the late 80 with my inplant which you have avise me that they were not to of be sold on the market . Since then l have implants put back which also broke but in 2003 ( they were replace with siltex saline mammary Mentor HS ref # 354-2645, lot#247103 (left breast)) 354-2645 lot#129454 which have just broken
    l was having a discharge from my nipple . what are your feeling on these implant

  2. Terri-Lynn Dunbar says:

    Dear Adella:
    Thank you for the above article on the “truth” about implants. It’s bittersweet, I must say. I had saline implants inserted in 2007 and then I began to feel a lot of pain and now I have more and more pain everywhere, especially in my neck and back and tingles and numbness in my arms and hand and hip. In 2012, I had the implants replanted with smaller implants, thinking this would reduce the problem. I am worse than ever! I want them out. I have good health coverage. However, I would like to know the best way to present it to the company so that they would cover the explanting surgery??? I am scared as I want the correct procedure. I heard there were some Silicone tests that will prove silicone is in my body; however, if there is no “diagnostic” evidence of silicone and I soley, rely on my symptoms..I’m afraid I will be denied explanting the implants. Any information you have would be greatly appreciated.
    God Bless you for your boldness,
    Terri-Lynn Dunbar

  3. Clara Elisha-McQueeb says:

    Dear Madam, I had breast implants in February 1992 in England. I was implanted with Mentor Silatex silicon gel implants. I took the decision to have them removed with no replacement in 1999 after they had made me very ill with a myriad of symptons. I wont list them-they are same as anyone elses but for one exception; since 2000 I have become Electromagnetically Hypersensitive. It is so acute that I cant be near electronics especially wifi equipment and this is scaring me to death as my life as I know it has changed. I especially react where there are people and computers in the same room ; my head starts rushing with voices and I get a giant clamp on my spine which cases a tight tingling sensation either side of my spine. I describe the sensation as being akin to the feeling of a giant centipede being clamped to my spine and chest so today I am unable to wear a Bra ( sounds weird? I know!) I was just wondering if you could clarify a couple of things for me-I understand that following the moratorium in the Us, this particular implant model was removed from sale .Do you know why ma’am? any information will be welcome as the british government also needs to be made to take responsibilty, given at no time did they follow suit and impose a moratorium on the sale of thes implants or cease from sale of the model, until the model was no longer available from Mentor.

    Many, Many thanks,

    Clara Elisha-McQueeb

  4. Vicki Cutter says:

    Are you able to give me Dr Blais email address. I live in Australia and would like to have my explanted silicone gel implants analysed. I was wondering cost and process of delivery to him. Thank you for any help!
    Sincerely Vicki

  5. una o neill.... says:

    I live in ireland nightmare I cant even get anyone to officialy diagnose me let alone believe me.help my health is getting worse by the day.in so much pain I have tissue swelling all over my body which is excruitiating.i have implants in ten years now…any advice would be most appreciated.

  6. Michelle says:

    I am a victim of Allergans gel silicone breast implants. Read all I could read in 2010 and seen that health Canada said they were safe.
    The surgeon Dr.Kaila from blue water surgery said they were completely safe. There was no mention of possible anythings other than capsulor contraction. This is why I picked the cohesive gel.
    By 2012 my hair was thinning didn,t realize it was the implants,,my feet hurt so bad somedays I could not walk. My hips started feeling stiff so much so that I would have to stand and stretch for a few minutes before I could begin walking. The pain in my jionts was diblilitating. Then in 2013 the brain fog hit, and worsened every day. Somedays I could not think very clear at all. I was scared to drive because my brain was in a fog.
    I could not keep foccused on any thing for more than a minute. I could not work as I was in such pain and couldn’t think. I had vertigo at least 4 times in a year., for no reason. My breast on the right hurt so bad that I was reduced to wearing a sports bra,, I became a person who was a nothing,,no emotion. I could not laugh I could not cry,,I was going through the motions of life and not living. finally had them removed 2015.
    They were ruptured I was never in an accident or was hit in the breasts.
    I now have deformed breasts and scars . Shame on you health Canada….you sold us women out for money? Where is my justice?

  7. Adella says:

    Yes. Shame on Health Canada and all the Surgeons and big companies that say this is safe. NOT!!

  8. Adella says:

    Louise, sorry for the late reply we had a glitch in our computer system and are responding as soon as we saw this email. This is Adella answering, not Dr. Blais. Dr. Blais advises that every implant is TOXIC. He never advises reimplantation of breast implants. |I have learned through 1000’s of women who have contacted me that it is true that ALL implants are extremely TOXIC. The belong in the garbage not your body. FDA stated in their book “Breast Implants” 1998 page 15, “that all implants leak from the 4th year on”.

  9. Adella says:

    Teri-Lynn, we are so sorry for the delay in response, we have had a terrible glitch with the computer and understood all of these questions were being forward to us. Please note that we are thinking of you and are here to help. Hopefully you have also had these removed! The only way you will have help is to constantly talk about the pain you experience, loud and clear. Don’t talk disease, because the medical system promotes that we do not have disease, however, focus on the extreme pain and indicate that it is getting worse. It will get extremely worse because the poison source is there affecting all your organs, glands, bones and brain, thus the headaches and brain fog. Let me know where you live and I will do my best to help you.

  10. Adella says:

    We would be happy to give you his email address as YES he still does testing on breast implants. Please contact me at adellaem@shaw.ca ASAP.

  11. Adella says:

    We are so sorry for the delay in our response, we didn’t know there were unanswered emails on our website. We would recommend getting explanted ASAP and not replanted. you could travel to the UK. Please contact us if you still require our help. Adella
    Dr. James McDiarmid, 1 Davy Road, Plymouth, UK Pl6 8BX
    Or Dr. David W Oliver – The Nuffield Hospital Exeter, Wonford Road, Exeter, UK EX2 4UG
    or Dr. Paul E Banwell – Marylebone, London, UK W1G 8SD

  12. Terri McGregor says:

    I sent an email Adella…

  13. Adella says:

    Dear Terri, I am so glad you contacted us via email. The answer to your email is rather complicated and we will do our best to explain it all to you. The FDA has known for many years that ALL breast implants develop lymphoma, they have only admitted it the last 10 years. Lymphoma grows on all breast implants in women. It does not grow on silicone implants in men, only woman – so it must have something to do with our female hormones. It grows and then it dies and sloughs off. In Canada, I am not aware of any depository for health issues. For your information, a number of years ago, we had a lengthly law suit regarding breast implants with Health Canada. You can find the court case on our website. It was lengthly and it was a class action. Joyce Attis was the leading lady. The judges ruling was this: He stated Health Canada does not have a duty to warn. He also stated that we could NOT appeal his decision so we had to go with the decision whether we liked it or not. Canada has long been a dumping ground for many companies. Surgeons are still implanting the TMJ or jaw implant that has been banned for many years in all countries we know of. We have failing hip implants along with many things. Canada allows most things on our market and the company is the only one who can withdraw the product. Our laws are such that we can not tell Health Canada to take medication, surgical instruments or implants off our market. We currently owe the company that makes the Lilly drugs, millions of dollars because Canada does not want to handle one of their medications and today the company is suing us for projected lost revenue. (These are the kinds of things that Health Canada does). Breast implants will never be taken of the market because they feel it generates wonderful income for the country they are sold in. For example, the plastic surgeons can then buy more than one house, summer cottages, more than one car, more than one boat. This is all money that is spent in our economy. I have heard that all breast implants sold in Canada are not top quality, they are the second in quality. USA keeps the top quality, Canada gets seconds and other countries like Mexico and Argentina get thirds (the garbage). The Implant Awareness Society is extremely sorry that you have breast cancer and that you are so ill. Thank you for sharing your story, we greatly appreciate it. With deep affection, Adella. Please connect with me if you have any further concerns or questions.

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