Copyright © Barbara Stanistreet 2018

The author is an Australian resident who is unfamiliar with any regulatory body save for the Therapeutic Goods Administration, the body responsible for regulating therapeutic goods including medicines, medical devices, blood and blood products in Australia.

The Australian Broadcasting Corporation (ABC), Australia’s leading source of information and entertainment, recently televised headline news claiming that:

Australia is on track to become the first country in the world to eradicate cervical cancer within the next 20 years when, thanks to national vaccination and screening programs, it is anticipated the rate will drop from 1:1000 – 1: 100,000.

In fact, and in truth, the ABC could well televise headline news claiming that Australia had eradicated the disease entity known as Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL), a cancer of the immune system. Instead, the Therapeutic Goods Administration presides over a perilous situation, reporting its highest incidence. Our immune system fights to defend our bodies against invaders such as viruses, bacteria, and foreign bodies. Cancer can weaken the immune system by spreading into the bone marrow, and certain cancer treatments can temporarily weaken the immune system. It has been reported that BIA-ALCL is being diagnosed in between 1:1,000 to 1:10,000 Australian women opting for breast implantation for purposes of cosmetic augmentation or reconstruction.

The author attributes this dire situation to regulatory misconduct.

The cause of BIA-ALCL is as yet undetermined. It is not possible to predict who among all breast implanted women will develop cancer of the immune system. Whilst textured implants have been implicated, smooth silicone gel filled and saline implants have not been ruled out. In the absence of a definitive cause, each and every time an implanting practitioner places breast implants into the body of a woman in Australia, be it for cosmetic or reconstructive purposes, he/she exposes that woman to the risk of developing a potentially fatal cancer of her immune system. A steadily increasing number of Australian women have been diagnosed with BIA-ALCL. Some have died.

In the absence of reporting and record-keeping, the exact number of women who have been its victims, either in Australia or overseas, cannot be accurately calculated. Recent estimates disclose in excess of 600 women have been diagnosed world-wide, with 17 having died from the disease. It has been reported that countless affected women, for want of both patient and medical practitioner education, likely remain undiagnosed and untreated. Claims that this cancer of the immune system is rare are increasingly in dispute.

BIA-ALCL is found in the scar tissue and fluid near the implant and, in some cases, can spread throughout the body. In 100% of cases of implantation of either silicone gel filled or saline implants encased in a silicone shell, the body identifies the foreign material and reacts to defend itself by forming a capsule around the implant.

BIA-ALCL treatment requires implant removal and total excision of the capsule surrounding the implant. In its more aggressive presentation, treatment includes tumour excision, chemotherapy and/or radiation, antibody-drug conjugates, even stem cell transplant.

Because some cancers are known to lie dormant for years following seemingly curative treatment and then strike back, BIA-ALCL-affected women with whom the author is in regular contact share their concerns that a possible return of the cancer is not ever far from their minds.

A prominent overseas university researcher explained to the author that:

As a general rule, when someone has survived for five years without any signs of their cancer returning, we call them cured. I think for BIA-ALCL, the women that present with just fluid seroma that goes away on capsulectomy and explant are likely cured in that their cancer has not spread and there are no longer any signs of it. I think for the women who develop masses and/or metastases, we will have to monitor them very closely for at least five years. In fact, all of the women with BIA-ALCL should be monitored.

The TGA assessed the evidence provided by a group of professionals in the fields of Materials, Toxicology, Pathology, Immunology and Clinical Plastic Surgery relating to the quality, safety and efficacy of breast implants. From the available information, the TGA evaluators considered that “Reasonable steps had been taken to establish their safety, quality and efficacy.”

Dr Ingrid Hopper, Head of the Drug and Device Registries at the Monash University School of Public Health and Preventive Medicine, oversees the running of the Australian Breast Device Registry. When interviewed on ABC radio, Dr Hopper stated “We think they are relatively safe”.

Claims from advisers asserting that “Reasonable steps have been taken to establish their safety”, or “We think they are relatively safe” should not ever be construed as confirmation of breast implant safety.

TGA approval affords no guarantee whatsoever that in Australia, breast implants are either free from harm or injury, or safe for human implantation. Once breast implants come into contact with the body’s tissues and fluids, their biological behaviour is unknown.

The TGA considers all breast implants ‘high-risk implantable devices’ but it does not regulate their use once they have been approved for supply to the Australian market. This decision is between the treating doctor and the patient. It is up to the doctors to warn their patients of the risks and possible side effects.

Each and every implanting practitioner is responsible for his/her own actions, and the provision of assurances to prospective recipients that TGA ‘approval’ equates to breast implants being ‘safe’ could well imperil the lives of breast implanted women in Australia.

There were no silicone gel filled breast implants on the Australian Register of Therapeutic Goods until 29 June 2001, at which time a manufacturer [McGhan], satisfactorily demonstrated their quality, safety and efficacy.

Here the author makes note of the corporate evolution of McGhan. In 1986, McGhan merged with Inamed. On 20 December 2005, Inamed was acquired by Allergan.

McGhan (Inamed/Allergan) submitted a Product Registration File Document to the TGA for evaluation, approval, and subsequent addition to the Australian Register of Therapeutic Goods (ARTG) to allow for their legal supply in Australia.

The Product Registration File Document relating to the McGhan (Inamed/Allergan) implants placed into the author’s body included details regarding:

  • – Materials used in the construction of the device, including type of gel, shell, patches, overlays, adhesives and textured surface components for the McGhan Style 410 FM BioDIMENSIONAL BIOCELL Textured Cohesive Gel-Filled Mammary Implant
  • – Information regarding specific implant material content including chemical descriptions
  • – Material specification for silicone sheeting

Both manufacturer (McGhan) and regulator (TGA) were keenly aware that the Freedom of Information Act 1982 (FOI Act) in Australia protected (and continues to protect) trade secrets and proprietary information, yet the TGA and McGhan (Inamed/ Allergan) entered into a commercial-in-confidence agreement whereby the commercially confidential information would not be disclosed to anyone including:

  • – implanting surgeons
  • – prospective implant recipients and
  • – women suffering because of them who are unable to obtain an accurate diagnosis and appropriate treatment

How is it possible for implanting surgeons in Australia to discharge their legal duty to take reasonable care if, in the absence of knowledge of the materials and chemicals contained in breast implants, they proceed with implanting unknown materials and an unidentifiable cocktail of chemicals into the bodies of women in Australia? No implanting practitioner in Australia can attest to the safety of breast implants.

And how are prospective breast implant recipients in Australia able to give informed consent to the procedure? The ethical and legal requirements of consent have two aspects – the provision of information and the capacity to make a voluntary choice. Without knowledge of the materials and chemicals in breast implants, implanting practitioners are unable to meet the legal requirements of consent. Surely no woman of adult years and sound mind would voluntarily consent to surgery to have breast implants placed in her body which exposed her to the risk of developing cancer of her immune system.

A TGA representative suggested the author approach the surgeon who placed the McGhan (Inamed/Allergan) devices into her body for information about the materials and chemicals used in their manufacture. The author acceded to this suggestion. Some months later, a reply was forthcoming, but it did not come from her implanting surgeon. Rather, it was delivered on Allergan letterhead, via the office of her breast implanting surgeon and interestingly, Allergan had specifically addressed it to the author at her home address:

Thank you for your enquiry concerning your silicone gel filled breast implants.

 Silicone gel-filled breast implants are constructed of a silicone elastomer shell and are pre-filled with cohesive silicone gel.

 Silicones are synthetic polymers made of silicone, carbon, hydrogen and oxygen as well as other chemical elements.

Allergan breast implants are manufactured to the very highest standards. Amounts and concentrations of materials used in the manufacture process are considered proprietary information and cannot be supplied to you.

 We trust that the enclosed information is of value and please do not hesitate to contact us should you require any further assistance.

Every patient has a right to determine what is going to be done to his/her body. Doctors in Australia are required to inform patients of all the risks connected with an operation or procedure. Patients must not only be informed of such risks, they must also fully understand them.

A Decision of the Supreme Court of New South Wales (Court of Appeal) : Rogers v Whittaker (1991), 23 N.S.W.L.R. 600 affirmed:

Except in the case of an emergency or where disclosure would prove damaging to the patient, a medical practitioner has a duty to warn the patient of a material risk inherent in proposed treatment. A risk is material if, in the circumstances of the particular case, a reasonable person in the patient’s position, if warned of the risk, would be likely to attach significance to it …

Currently, every woman in Australia who undergoes breast implantation relinquishes her basic human rights:

  • – to determine what shall be done with her body and
  • – to obtain an accurate diagnosis and appropriate treatment should she join the ever-increasing numbers of women who become ill following breast implantation.

Unable to source appropriate medical help in Australia, the author travelled to the USA and consulted with an internationally recognised expert in the field of environmental medicine who diagnosed her suffering at least in part from the biological effects of exposure to platinum salts suspended in silicone gel.

As an attachment to one of the author’s numerous applications to Australia’s Information Commissioner for access to the specific pages of any documents that identified the chemical catalyst hexachloroplatinate as that used in the manufacture of her silicone breast implants, one of her treating specialists submitted a request for information:

I write in support of the application by my patient, [name supplied], to seek access to the specific pages of any document that identifies the chemical catalyst hexachloroplatinate as being used in the manufacture of her silicone breast implants which have now been removed, which myself and a number of her treating practitioners believe to be the cause of a diverse range of medical health effects from which she has suffered.

 [Name] has previously been diagnosed by a world expert as suffering from the toxic effects of exposure to platinum salts. There is some considerable academic literature referring to the toxicity of hexachloroplatinate.

 In addition, she suffers from a range of symptoms which have been difficult to diagnose and I believe that if this information were to be supplied to her treating doctors, it would facilitate her management and subsequent treatments.

The Information Commissioner refused access to documents requested under the Freedom of Information Act 1982 leaving the author’s specialists unable to diagnose and treat her.

Stanistreet and Therapeutic Goods Administration [2014] AICmr 21 (26 February 2014).

The law [in Australia] imposes on a medical practitioner a duty to exercise reasonable care and skill in the provision of professional advice and treatment. That duty is a “single comprehensive duty covering all the ways in which a doctor is called upon to exercise his skill and judgment”; it extends to the examination, diagnosis and treatment of the patient and the provision of information in an appropriate case. …

The double blind skin patch testing subsequently undertaken using hexachloroplatinate, tetrachloroplatinate, and samples of both the gel and the shell from the McGhan (Inamed/Allergan) implants removed from the author’s body triggered a systemic anaphylaxis. It was determined that it would not be prudent, under any circumstances, to apply any further platinum-containing skin patches onto or under her skin.

The TGA banned silicone breast implants for only two of the 14 years they were banned by the FDA in the USA because the manufacturers were unable to guarantee their safety. A TGA representative advised the author that the TGA allowed their supply in Australia if the benefits outweighed the risks. Just how does the TGA calculate how many breast implanted women will develop cancer of the immune system, and how many will need to die, so that other breast implanted women might feel good about themselves?

Information obtained from court documents have identified a number of dangerous chemicals contained in breast implants which could well cause serious health problems.

After a decade-long effort, the TGA confirmed that the platinum catalyst used in the author’s McGhan (Inamed/Allergan) silicone gel-filled breast implants was manufactured from [the platinum salt known as] hexachloroplatinic acid (also known as hexachloroplatinate). This information was released to the author only, and the TGA advised they would not be publishing the information.

It is not claimed that platinum, or platinum salts alone, are responsible for all clinical manifestations appearing in patients with silicone gels and elastomers.

The occupational literature is emphatic that no one should come into contact with platinum salts, that there is no safe exposure to platinum salts, and that any amount of platinum salt exposure is too much. Platinum salts were described as a cause of allergic sensitisation in the late 19th and early 20th centuries with hexachloroplatinic acid clearly the most allergenic. Between 10%- 20% of exposed individuals suffer its acute allergies.

Hexachloroplatinate is known to initiate an allergic inflammatory response. The consequence of long-term exposure to hexachloroplatinate is the development of severe and chronic inflammation. There is accumulating evidence that long-term inflammation may cause BIA-ALCL.

Allergan (formerly known as McGhan, then Inamed) textured implants account for the highest percentage of cases of BIA-ALCL in Australia and New Zealand.

Information provided to the author under FOI disclose that McGhan (Inamed/Allergan) made changes to its cohesive gel from that detailed in its original pre-market application. There was a change in the ratio of starting materials and more cross links [hexachloroplatinate] resulting in a firmer gel able to hold the shape required in the anatomically styled implants.

Though the Regulatory Consultant to the Australian sponsor claimed it would be very important for these gel changes to be approved, the author has been unable to obtain access to any documents confirming this approval.

Serious concerns have been raised by Australian women who have developed BIA-ALCL that cosmetic surgeon Dr Daniel Fleming is a leading member of the Government’s TGA Expert Advisory Panel on BIA-ALCL. The author’s careful search of the internet does not uncover any evidence that he is either qualified or experienced in specialised fields such as Plastic Surgery, Immunology, Toxicology, Environmental Medicine, Chemistry, Science, Pathology or Public Health – fields which might establish his legitimacy for this role. The acceptance of experts’ testimony must surely be dependent on their credibility. The internet does reveal that Dr Fleming is known to perform more breast implantations than anyone else in all of Australia. How is it that in this advisory role, Dr Fleming is not seen to have anything other than a major conflict of interest?

The manufacturers of these medical devices, and the practitioners who place them into the bodies of millions of women who unwittingly give their consent, are clearly influenced by incomes rather than outcomes.

BIA-ALCL is an iatrogenic disease. It is 100% preventable yet the TGA refuses to ban breast implants. In response to the author’s concerns, correspondence was received from the Acting First Assistant Secretary, Medical Devices and Product Quality, Therapeutic Goods Administration in January 2017:

I can advise you that at this point in time, the TGA is not considering banning the supply of breast implants in Australia. However, the TGA is considering amending the legal framework to enable to TGA to provide more information about the materials/chemicals in breast implants.

The Principal Lawyer Regulatory Legal Services Branch Australian Government Department of Health subsequently advised the author that any such amendments would not be likely to take effect until at least 2020.

Implanting practitioners who place breast implants into the bodies of women in Australia should be penalised with convictions for fraud and/or assault when they fail to obtain consent, thereby violating their patients’ interest in self-determination and autonomy, and when they fail to disclose to prospective breast implant recipients the known and obvious risks of the procedure.