.

  • Written by Bruce Baer Arnold, Assistant Professor, School of Law, University of Canberra
It's not just women who are the losers following the latest TGA announcement. People with all types of medical devices need better regulatory protection. from www.shutterstock.com

The proposed ban on some textured breast implants announced by the Australian pharmaceuticals and medical devices regulator earlier this week tells us something very disquieting about the effectiveness of consumer protection.

It will not reassure women living with breast implants concerned about their risk of cancer, or anyone else with an implantable medical device regulated by the Therapeutic Goods Administration (TGA).

It also exposes inadequacies in the regulatory system that have been apparent for years.

What’s new?

The proposed ban relates to the import and distribution of certain types of breast implants with a textured surface because of their well documented link with a rare type of cancer known as anaplastic large cell lymphoma. The proposal is unsurprising given bans in Europe.

But Australia’s proposal comes after months of criticism by consumers, medical specialists and legal academics who wanted to see an earlier and and better-communicated ban.

The TGA also says it is seeking advice from Allergan, the manufacturer whose implants were the focus of restrictions in Europe.

Yet concerns about the safety of a succession of implants and the inadequacy of Australia’s regulatory responses are not new. Advice from Allergan should have been sought a year ago.

Here’s what we asked the TGA last year

In responding last year to our queries about implants, the TGA indicated that although importation of the textured implants had been stopped after the ban in France there were no restrictions on implanting those devices in Australia.

The TGA was unaware of how many implants were available for implantation. (Unawareness about what is on the shelf was also evident regarding pelvic mesh, a similar regulatory failure).

The TGA was not going to inform potential recipients of the implants, something that is at odds with its new-found recognition that patients are concerned about potential harms.

What we have now is a proposed rather than actual ban. It is driven by criticism rather than TGA initiative and does not provide much reassurance about the TGA’s capacity to prevent harms rather than slowly respond to harms.

What if you are living with these implants?

The proposal announced this week is restricted to import and distribution. It does not require removing all breast implants or all textured breast implants. It does however mean that people with the implants listed on the TGA website should be watchful.

The TGA lists the affected breast implants on its website, and says the risk of anaplastic large cell lymphoma associated with these is between 1-in-1,000 and 1-in-10,000.

Yet it’s likely many women will experience fear, alongside anger or bewilderment that the TGA has taken so long to act.

Some people will deal with that fear through preemptive surgery: removal of the implants after getting specialist advice. Costs will come out of their own pockets. Some will talk to lawyers.

What’s the legal issue?

Uniquely, consumers cannot sue the TGA if it gets things wrong. The TGA has a special exemption in its Act regarding civil litigation.

However, people who are injured by implanted medical devices can take manufacturers and medical specialists to court. Their challenge is to prove that the devices caused cancer or other injury.

Litigation in Australia with defective joint implants demonstrates that manufacturers have deep pockets and will be adversarial when it comes to class actions (litigation by groups of injured people) or individual victims. Litigation will often take years. Injury compensation will sometimes be inadequate.

That is one reason why better regulation is fundamental. We need to prevent the injury through timely action by government agencies rather than trying to fix a foreseeable serious harm via legal action once it has occurred (and hope victims have the strength to fight for their rights).

How engaged is the regulator?

The TGA is funded by the businesses it regulates. Like its counterpart the FDA in the United States, it is underfunded and demoralised. It views its mission through the eyes of those businesses, an example of regulatory capture. It has been the subject of numerous inquiries about its performance.

Regrettably, the TGA has been described as unresponsive. It is comfortable dealing with the businesses it is supposed to regulate. It is uncomfortable dealing with the public. It faces ongoing criticism about its apparent indifference. In response to such criticism it belatedly announced an action plan regarding oversight of devices. There hasn’t been much action.

In practice, meaningful regulation of devices is being left to investigative journalists, academics with a specialisation in law and medicine, and consumer advocates. Neither the Coalition nor the ALP have wanted to grasp the TGA hot potato, but reform is necessary.

What is needed?

Our forthcoming research demonstrates the cost of running the TGA is dwarfed by the cost to patients, national productivity and the taxpayer of the TGA’s failures.

TGA legislation needs to be amended, in particular to ensure that the protection of consumers comes ahead of relations between the regulator and business. Independence of manufacturers is imperative. Adequate resourcing is essential. So is a cultural change within the TGA, including meaningful engagement with consumers rather than closed-door consultations with business.

Underpinning those changes we need a comprehensive database of implants and incidents, one readily accessible by epidemiologists.

We need trust in the health system and in gatekeepers such as the TGA. Anyone with an implant or considering an implant needs to know that the TGA will actively minimise harms rather than relying on assurances from businesses that have a vested interest in minimising disclosure. Good regulation involves more than a quiet life for regulators.

The authors do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.

Authors: Bruce Baer Arnold, Assistant Professor, School of Law, University of Canberra

Read more http://theconversation.com/the-tgas-proposed-breast-implant-ban-exposes-a-litany-of-failures-and-fails-to-protect-women-120281

Your Airbnb guest could be a tenant. Until the law is cleared up, hosts are in limbo

A Victorian court decision that an Airbnb agreement had the status of a lease has profound implications for guests and hosts. Daniel Krason/ShutterstockWith summer holidays around the corner, many Vic...

Bill John Swannie, Lecturer in College of Law and Justice, Victoria University - avatar Bill John Swannie, Lecturer in College of Law and Justice, Victoria University

5 reasons I always get children picture books for Christmas

Children who love being read to are more likely to find learning to read easier. from shutterstock.comChristmas is just around the corner. If you’re wondering what to get your child, your friend...

Kym Simoncini, Associate professor Early Childhood and Primary Education, University of Canberra - avatar Kym Simoncini, Associate professor Early Childhood and Primary Education, University of Canberra

Tough nuts: why peanuts trigger such powerful allergic reactions

The humble peanut. Tasty for most, treacherous for some. Dr Dwan Price, Author providedFood allergens are the scourge of the modern school lunchbox. Many foods contain proteins that can set off an ove...

Dwan Price, Molecular Biologist and Postdoc @ Deakin AIRwatch pollen monitoring system., Deakin University - avatar Dwan Price, Molecular Biologist and Postdoc @ Deakin AIRwatch pollen monitoring system., Deakin University

Must end soon! But not too soon! The catch in time-limited sales tactics

Time-limited offers leverage risk-aversion. That is, the more you dislike risk, the more likely it is you will take the bait and buy now. www.shutterstock.comAs Christmas shopping ramps up, you may be...

Daniel Zizzo, Professor and Academic Dean of the School of Economics, The University of Queensland - avatar Daniel Zizzo, Professor and Academic Dean of the School of Economics, The University of Queensland

Refugees without secure visas have poorer mental health – but the news isn't all bad

Refugees without permanent visas can experience a prolonged sense of insecurity and displacement. From shutterstock.comThere are more than 29.4 million forcibly displaced asylum seekers and refugees a...

Yulisha Byrow, Postdoctoral Research Fellow, UNSW - avatar Yulisha Byrow, Postdoctoral Research Fellow, UNSW

God made the rainbow: why the Bible welcomes every colour in the gender spectrum

The Bible affirms, in various ways, the inclusion of those who diverge from male-female gender norms. ShutterstockThis article is part of a series exploring gender and Christianity “God made ...

Robyn J. Whitaker, Senior Lecturer in New Testament, Pilgrim Theological College, University of Divinity - avatar Robyn J. Whitaker, Senior Lecturer in New Testament, Pilgrim Theological College, University of Divinity

Jojo Rabbit: Hitler humour and a child's eye view of war make for dark satire

Jojo's allegiances in the film are split between an imagined friends and a real hideaway. Fox SearchlightJojo Rabbit is not Disney Studios’ first foray into Hitler parody. In 1943, it produced ...

Benjamin Nickl, Lecturer in International Comparative Literature and Translation Studies, University of Sydney - avatar Benjamin Nickl, Lecturer in International Comparative Literature and Translation Studies, University of Sydney

Boosting Your Child’s Learning through Play

Being a parent is probably the highest responsibility one has in a lifetime. Once it happens, it becomes ongoing and keeps posing new challenges to us. Of course, it may seem easy from some perspe...

Diana Smith - avatar Diana Smith

Different ideas of Christmas Gifts to give to your beloved ones

"CHRISTMAS GIFTS – one of the best festival gifts to give to your closed ones. Find Christmas presents for everybody on your checklist. Christmas is now here, and if that you haven't got a hop on ...

News Company - avatar News Company

The Ultimate Guide to Sneakers and Sneaker Brands

When it comes to finding the perfect pair of sneakers, it can be hard to know where to start. Finding the right pair for any kind of occasion can be difficult, so brushing up on your knowledge of sn...

News Company - avatar News Company

Conservative landslide at UK's Brexit election; Trump's ratings rise on strong US economy

Led by Boris Johnson, the Conservatives won 56% of the vote and will have an 80-seat majority. AAP/EPA/ VIckie FloresAt the December 12 UK election, the Conservatives won 365 of the 650 House of Commo...

Adrian Beaumont, Honorary Associate, School of Mathematics and Statistics, University of Melbourne - avatar Adrian Beaumont, Honorary Associate, School of Mathematics and Statistics, University of Melbourne

Johnson's thumping win an electoral lesson in not just having policies, but knowing how to sell them

With Johnson's crushing win, Brexit will now happen. But this may also be the start of the break-up of the UK. AAP/EPA/Vickie FloresSo for all the talk of narrowing polls, tactical voting, and possib...

Simon Tormey, Professor of Politics, University of Bristol - avatar Simon Tormey, Professor of Politics, University of Bristol

View from The Hill: Morrison won't have a bar of public service intrusions on government's power

Scott Morrison has rejected or sidelined a number of recommendations from the long-awaited Thodey review. AAP/Paul BravenScott Morrison has rejected or sidelined a number of recommendations from the l...

Michelle Grattan, Professorial Fellow, University of Canberra - avatar Michelle Grattan, Professorial Fellow, University of Canberra

VIDEO: Michelle Grattan reflects on the year in politics

For their last video for the year, University of Canberra Vice-Chancellor Deep Saini and Michelle Grattan look backwards to the big issues which have shaped political discourse. They discuss the surpr...

Michelle Grattan, Professorial Fellow, University of Canberra - avatar Michelle Grattan, Professorial Fellow, University of Canberra

Choosing a Heavy Weighted Bathmats

Decorating your bathroom doesn’t finish with the paint choice or tile colours. You can change the whole room with the change of your towel set. There are no rules that say that you need to have a ...

News Company - avatar News Company

God as man, man as God: no wonder many Christian men today are having a masculinity crisis

How men saw God shaped how they saw themselves, and in turn, how they saw women. WikimediaThis article is part of our Gender and Christianity series. To understand contemporary Christian ideas about...

William Loader, Emeritus Professor of New Testament at Murdoch University, Murdoch University - avatar William Loader, Emeritus Professor of New Testament at Murdoch University, Murdoch University

Australia needs a national crisis plan, and not just for bushfires

Bushfires aren't the only catastrophic emergency Australia is likely to see. AAP Image/Mick TsikasCalls are growing for a national bushfire plan, including from former prime minister Malcolm Turnbull...

Andrew Gissing, General Manager, Risk Frontiers, Adjunct Fellow, Macquarie University - avatar Andrew Gissing, General Manager, Risk Frontiers, Adjunct Fellow, Macquarie University

Your Christmas shopping could harm or help the planet. Which will it be?

Many Australian consumers are concerned at the environmental impact of their shopping habits, especially at Christmas. AAPAustralian shoppers are set to spend $52.7 billion this Christmas. In the word...

Louise Grimmer, Senior Lecturer in Marketing, Tasmanian School of Business and Economics, University of Tasmania - avatar Louise Grimmer, Senior Lecturer in Marketing, Tasmanian School of Business and Economics, University of Tasmania

Right-swipes and red flags – how young people negotiate sex and safety on dating apps

For many young people, app dating is just part of regular dating life. freestocks.org/UnsplashPopular commentary on dating apps often associates their use with “risky” sex, harassment and ...

Kath Albury, Professor of Media and Communication, Faculty of Health, Arts and Design, Swinburne University of Technology - avatar Kath Albury, Professor of Media and Communication, Faculty of Health, Arts and Design, Swinburne University of Technology

Sick and Tired of Your Dead End Job? Try Teaching!

Tired of the same old grind at the office? Want an opportunity to impact lives both in your community and around the world? Do you love to travel and have new experiences? Teaching English is the perfect job for you! All you need is a willingness to ...

News Company - avatar News Company

The Impact of an Aging Population in Australia

There’s an issue on the horizon that Australia needs to prepare for. The portion of elderly citizens that make up the country’s overall population is increasing, and we might not have the infrastructure in place to support this. Australians h...

News Company - avatar News Company

LifeStyle

Boosting Your Child’s Learning through Play

Being a parent is probably the highest responsibility one has in a lifetime. Once it happens, it...

Different ideas of Christmas Gifts to give to your beloved ones

"CHRISTMAS GIFTS – one of the best festival gifts to give to your closed ones. Find Christmas pr...

How to Have a Peaceful Retirement

Retirement is the time to treat yourself after a lifetime of working, to complete your bucket list...

Latest Wednesday Lotto Results

Wednesday Lotto draw 3917 Lucky numbers for this draw were 43 followed by 25. The rest of the...