A Royal Commission into Australia’s regulation of “Medical Devices”

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Mesh Awareness Australia, Breast Implant Illness Australia and New Zealand and Essure Problems Australia and New Zealand are calling for a Royal Commission into Australia’s archaic regulation of medical devices. 

The current pre market process for approving medical devices believe it or not, is less onerous and rigorous than the approval process for pharmaceutical drugs

Medical devices, such as Surgical Mesh (Hernia, Urogynecological, Rectal, Breast), Breast Implants, Birth Control Devices (Essure, IUD’s), Stents, Hip Implants are all approved and monitored in Australia on evidence supplied by the Manufacturer.

In 2012, a systematic review of medical device regulation, revealed that medical devices were being approved on limited data. Currently in Australia regulations allow for manufacturers to determine who conducts their product research and which subsequent studies they elect to publish. This means that manufactures have the ability to cherry pick and manipulate their research in order to get their medical device quickly onto the market.(1)

In 2018, an ABC investigation reported that 90 per cent of the highest risk medical devices were all approved without clinical trials because they were assessed as ‘sufficiently similar’ to existing products. (2)

Dr Rita Redberg, editor of JAMA Internal Medicine, argues that one of the issues with Medical Device studies is that they don’t use control groups, therefore it is impossible to determine how the device compares to alternative or existing treatments.(3)

Despite this somewhat gaping hole in the medical system, Australians have been led to believe that medical devices have been thoroughly and rigorously tested by independent regulators.

However, as the men and women who have began to suffer from complications from their medical devices now realise, this is not the case.

Believe it or not, devices, such as Surgical Mesh, Breast Implants, Essure Birth Control were all approved throughout the world without any clinical evidence of their safety and efficacy.

For Example one Urogynecological Mesh device the Intravagnal Sling (IVS) was heavily marketed to women by the Australian Medical Assoiation, yet was only tested on 13 large dogs before being approved and implanted into women(4).

Furthermore, the Therapeutic Goods Administration will not disclose to patients like women with Breast Implants, or men and women with Surgical Mesh the exact materials or chemicals that are contained in their device, due to confidentiality agreements with the suppliers.  

In addition, Australia’s post market surveillance of medical devices, in terms of their performance and complications, can only be described as negligent. As a result, Australian lives continue to be at risk of injury and death. 

Despite being in the best position to identify complications, surgeons, doctors, or nurses are not mandatory required to report adverse events to the Australian regulator, The Therapeutic Goods Administration (TGA).

Instead, the reporting of complications is left to the Medical Device manufacturer, who generally displays a financial bias towards reporting these complications. It therefore comes as no surprise that complications are underreported to a staggering degree.(1,3)

Dr Rita Redberg estimates that between only three and seven percent of all adverse events ever get reported and that medical devices, which are falsely considered safe by regulators, are more often than not, tragically implanted into patients.(3)

The absence of mandatory reporting also means that there are no accurate figures on how many patients have been injured or have died from such medical devices.

Although each implantable medical device comes with an implant log, individual barcode and lot number that is placed on a patients operative notes, Australian regulators have no national database to record or track the number of devices being used on patients.

As a consequence, regulators have no way of notifying patients that the medical device implanted in their body has been recalled or withdrawn from the market.

Unfortunately this is the case for all the women who have been implanted with Essure birth control devices. Although the device was recalled in August 2017 by the Therapeutic Goods Administration, the hundreds of women that were implanted with this device have never been directly informed or contacted. 

This means that those Australian’s like the Essure women who are implanted with defective medical devices have been left to suffer in silence, more often than not, dealing with debilitating complications because they unaware that their medical device has been recalled or withdrawn.

However what is most heartbreaking for these men and women is that our regulation system exempts both the regulator and manufacturer from financial responsibility.

As a result, patients whose lives have been destroyed by a faulty medical device are forced to pay exorbitant fees for medical treatment, medications, consultations, investigations and costly surgeries, which include having their device removed. These costly expenses have forced many to apply for early access their or their partners superannuation.

Furthermore, the majority have been forced to live in debilitating pain, barely surviving financially with exorbitant medical costs. Unfortunately many are unable to work due to their complications and those that are unable to work are denied disability pensions.

Essentially manufacturers have been given permission by our regulatory authorities and governments to walk away from their moral, ethical and financial responsibility.

What is more disturbing is that there are currently reforms being proposed to streamline approval processes to enable new products to appear in  the Australian market much faster  by relying on ‘Comparable Overseas Regulators” such as America’s Food & Drug Administration (FDA).

Mesh Awareness Australia, Breast Implant Illness Australia and New Zealand and Essure Problems Australia and New Zealand all believe that a Royal Commission is urgently needed to expose and change this archaic regulatory system.

We all would like to see urgent reforms to Australia’s regulation of Medical Devices.

Reforms that include

1. Classify all implantable medical devices as class lll High Risk

2. Mandatory reporting of all complications by medical practitioners, nurses and hospitals.

3. Manufacturers required to track and report how many medical devices are in use.

4. National independent database for all implantable devices that is independent of the manufacturers and The Therapeutic Goods Administration. A database that requires mandatory reporting by medical practitioners, nurses and hospitals. A database that is open to the public. a database that tracks the full range of health problems affecting patients.

5. Monitoring and transparency around medical practitioners and hospitals disclosures of conflict of interests to patients. 

6. Overhaul of informed consent procedures by medical practitioners. Introduction of penalties for medical practitioners who do not obtain informed consent. Furthermore an understanding that informed consent is more than a patient’s signature on their operation paperwork. 

If you want to see changes in how medical devices are approved and regulated in  Australia please sign our petition.

Australians must be protected.

Amendment: 18.02.19
*We are pleased that Breast Implant Illness Australia and New Zealand has joined us in our petition.

You can access their closed facebook group in the link below

https://www.facebook.com/groups/BreastImplantIllnessAustraliaNZ/

And

Essure Problems Australia and New Zealand has joined us in our petition
You can access their closed facebook group in the link below
https://m.facebook.com/groups/995375637192617/

You can also access Mesh Awareness Australia’s public facebook page in the link below
https://m.facebook.com/meshawarenessaustralia/

References

 1. Kramer, D. B., Xu, S., & Kesselheim, A. S. (2012). How Does Medical Device Regulation Perform in the United States and the European Union? A Systematic Review. PLoS Medicine, 9(7), e1001276. 

https://doi.org/10.1371/journal.pmed.1001276

2.Mario Christodoulou, Alison Branley, Sophie Scott. (2018) The Implant Files, ABC News
https://www.abc.net.au/news/2018-11-26/implant-files-shine-light-on-medical-device-industry/10521480

 

 3. Rita Redberg: (2017) ‘FDA proposal to delay reporting of device malfunctions “should be tossed”’, The Cancer Letter. 

https://cancerletter.com/articles/20170728_3/

 4. Joanne McCarthy (2017) ‘Australian Medical Association president confirms AMA role in pelvic mesh scandal.’, Newcastle Herald.

https://www.theherald.com.au/story/4872857/ama-says-pelvic-mesh-support-not-our-proudest-hour/

 3. Rita Redberg: (2017) ‘FDA proposal to delay reporting of device malfunctions “should be tossed”’, The Cancer Letter. 

https://cancerletter.com/articles/20170728_3/

 4. Joanne McCarthy (2017) ‘Australian Medical Association president confirms AMA role in pelvic mesh scandal.’, Newcastle Herald.

https://www.theherald.com.au/story/4872857/ama-says-pelvic-mesh-support-not-our-proudest-hour/