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How Brexit will affect boob jobs, hip replacements and other medical devices

The European Parliament has finally passed laws policing the standards of medical devices. But will the UK reverse these gains? 

“The thought of going back to the way I was is tearing me up inside,” Terri-Ann, a single parent from Liverpool, told the BBC in 2011. She had received breast implants to endow her with the confidence to take her son swimming. But after learning that the implants were defective, she had two options: keep them in and risk painful disfigurement, or pay for a costly and risky operation that would leave her as insecure as she had been before the surgery.

“I am now getting over my second op. No driving again, feeling isolated as family and friends work, guilty because I'm off work and there are so many things I can't do” – A. Jones, the recipient of a badly designed artificial hip confided to an online support group. She expects to recover fully from her removal surgery, but many others will not be as lucky.

If you ask a member of the public how they feel about breast augmentation and hip replacement surgery, it is likely that their opinions on the two will be vary drastically. However, both come under the World Health Organisation’s definition of "medical device" (drugs fall under a different category). Also unlike most drugs, medical devices have historically been under-regulated both legally and clinically.

For five years, MEPs - including British ones - have been trying to change this with a bill proposing stricter regulation of medical and in-vitro diagnostic medical devices. Now, finally, the European Commission has adopted the suggestions into law.

But why are these new regulations needed? And with the UK heading for Brexit, will British patients soon lose access to these hard-fought gains?

The wild west of hip replacements

Several of the scandals involving medical devices have come about as a result of inadequate testing. In 2001, Poly Implant Prothèse (Pip) executives tried to boost profits by engineering their own industrial-grade silicon breast implants in-house, rather than continuing to buy the more expensive externally-produced medical-grade material. But the adjustment to the formula included chemicals that had not yet been tested on humans. Over 21 years, roughly two million sets of these poor quality breast implants were manufactured and marketed internationally. 

In the UK, an estimated 40,000 women - or ten per cent of all those using Pip - received implants including the dangerous chemical. As well as women, the product was used by an unknown number of men looking for chest, testicle and bum implants. 

After the Pip scandal broke in the late noughties, the UK government committed to tightening up regulation of cosmetic surgeries. It introduced a new registry of implants and banned the irresponsible advertising techniques of “cosmetic cowboys” (surgeons who marketed breast implants using financial inducements).

But breast implant manufacturers are not the only boobs. In late 2010, DePuys Orthopaedics, Inc, a unit of Johnson&Johnson, was forced to recall the Articular Surface Replacement (ASR). The company had exploited loopholes in existing US regulations that meant that new, untrialled medical components could be inserted into devices that were already on the market. Many of those using the device experienced damage to their bloodstream and the bones and soft tissue surrounding the implant, caused by poisonous particles cast off by the metal-on-metal joint as it wore down.

After the US recall of the hip replacement, the UK medical equipment regulator – the Medicines and Healthcare products Regulatory Agency (MHRA) – also issued a recall of the DePuys artificial hips. However, no review of the UK’s own regulatory frameworks was conducted.

The EU steps in...

The ASR and Pip scandals exposed systemic flaws in how medical equipment was authorised. In September 2012, the Socialists and Democrats group in the European Parliament proposed a bill to raise standards. The bill finally passed into law on 5 April 2017.

The new law encompasses everything from plasters to pacemakers. It means that manufacturers must now allow their devices to be scrutinised at every stage, from the initial design to when the device is in the market. There will also be random inspections of the factory floor. Those using the devices will receive unique identification codes and implant cards, which will allow them to be swiftly identified in the case of a faulty product. Patients will also be able to access a database showing clinical evidence of the safety of their device. 

Another major change, according to Dame Glenis Willmott, a Labour MEP and lead negotiator for medical devices – is that “particularly high risk devices, such as implants, joint replacements or insulin pumps, [will] be subject to additional expert assessments before they can be authorised”. In-vitro devices - equipment used by healthcare professionals to diagnose a patient - will also be subject to the rules. Four out of five of every in-vitro devices must now also be checked by a regulator. 

In addition, patients affected by equipment failure can now also expect financial compensation. 

And the UK steps out

The directives agreed by the EU are designed to be implemented through "indirectly effective law" - in other words, through secondary legislation, which in the UK would be the Medical Devices Regulations of 2002. However, by the time both laws come into force, the UK is likely to have left the EU. 

The UK government could choose to either retain this regulatory system, or to repeal it and create a new regime. For those Brexiteers who complain about "red tape, it may be tempting to do the latter. Yet the EU is not alone in supporting the content of its recent laws - international regulatory standards are moving in the same direction. Meanwhile, British companies trading in Europe will still have to abide by EU standards. 

Another option is to look at the non-EU countries – such as Australia and Switzerland – with mutual recognition agreements with the EU, ensuring that industry norms conform internationally. India, too, is currently reviewing a bill called the "National Medical Device Policy".

It took scandals and personal pain for the UK and other European countries to wake up to the problem of poor quality medical devices. Now recent gains could be reversed. Whether or not the UK post-Brexit decides to embrace the EU's new laws, it is undeniable that regulations need to be tighter. 

Anjuli R. K. Shere is a 2016/17 Wellcome Scholar and science intern at the New Statesman

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Meet Anne Marie Waters - the Ukip politician too extreme for Nigel Farage

In January 2016, Waters launched Pegida UK with former EDL frontman Steven Yaxley-Lennon (aka Tommy Robinson). 

There are few people in British political life who can be attacked from the left by Nigel Farage. Yet that is where Anne Marie Waters has found herself. And by the end of September she could well be the new leader of Ukip, a party almost synonymous with its beer-swilling, chain-smoking former leader.

Waters’s political journey is a curious one. She started out on the political left, but like Oswald Mosley before her, has since veered dramatically to the right. That, however, is where the similarities end. Waters is Irish, agnostic, a lesbian and a self-proclaimed feminist.

But it is her politics – rather than who she is – that have caused a stir among Ukip’s old guard. Former leader Paul Nuttall has said that her views make him “uncomfortable” while Farage has claimed Ukip is “finished” if, under her leadership, it becomes an anti-Islam party.

In her rhetoric, Waters echoes groups such as the English Defence League (EDL) and Britain First. She has called Islam “evil” and her leadership manifesto claims that the religion has turned Britain into a “fearful and censorious society”. Waters wants the banning of the burqa, the closure of all sharia councils and a temporary freeze on all immigration.

She started life in Dublin before moving to Germany in her teens to work as an au pair. Waters also lived in the Netherlands before returning to Britain to study journalism at Nottingham Trent University, graduating in 2003. She subsequently gained a second degree in law. It was then, she says, that she first learnt about Islam, which she claims treats women “like absolute dirt”. Now 39, Waters is a full-time campaigner who lives in Essex with her two dogs and her partner who is an accountant.

Waters’s first spell of serious activism was with the campaign group One Law for All, a secularist organisation fronted by the Iranian feminist and human rights activist Maryam Namazie. Waters resigned in November 2013 after four years with the organisation. According to Namazie, Waters left due to political disagreements over whether the group should collaborate with members of far-right groups.

In April 2014, Waters founded Sharia Watch UK and, in January 2016, she launched Pegida UK with former EDL frontman Steven Yaxley-Lennon (aka Tommy Robinson). The group was established as a British chapter of the German-based organisation and was set up to counter what it called the “Islamisation of our countries”. By the summer of 2016, it had petered out.

Waters twice stood unsuccessfully to become a Labour parliamentary candidate. Today, she says she could not back Labour due to its “betrayal of women” and “betrayal of the country” over Islam. After joining Ukip in 2014, she first ran for political office in the Lambeth council election, where she finished in ninth place. At the 2015 general election, Waters stood as the party’s candidate in Lewisham East, finishing third with 9.1 per cent of the vote. She was chosen to stand again in the 2016 London Assembly elections but was deselected after her role in Pegida UK became public. Waters was also prevented from standing in Lewisham East at the 2017 general election after Ukip’s then-leader Nuttall publicly intervened.

The current favourite of the 11 candidates standing to succeed Nuttall is deputy leader Peter Whittle, with Waters in second. Some had hoped the party’s top brass would ban her from standing but last week its national executive approved her campaign.

Due to an expected low turnout, the leadership contest is unpredictable. Last November, Nuttall was elected with just 9,622 votes. More than 1,000 new members reportedly joined Ukip in a two-week period earlier this year, prompting fears of far-right entryism.

Mike Hookem MEP has resigned as Ukip’s deputy whip over Waters’ candidacy, saying he would not “turn a blind eye” to extremism. By contrast, chief whip, MEP Stuart Agnew, is a supporter and has likened her to Joan of Arc. Waters is also working closely on her campaign with Jack Buckby, a former BNP activist and one of the few candidates to run against Labour in the by-election for Jo Cox’s former seat of Batley and Spen. Robinson is another backer.

Peculiarly for someone running to be the leader of a party, Waters does not appear to relish public attention. “I’m not a limelight person,” she recently told the Times. “I don’t like being phoned all the time.”

The journalist Jamie Bartlett, who was invited to the initial launch of Pegida UK in Luton in 2015, said of Waters: “She failed to remember the date of the demo. Her head lolled, her words were slurred, and she appeared to almost fall asleep while Tommy [Robinson] was speaking. After 10 minutes it all ground to an uneasy halt.”

In an age when authenticity is everything, it would be a mistake to underestimate yet another unconventional politician. But perhaps British Muslims shouldn’t panic about Anne Marie Waters just yet.

James Bloodworth is editor of Left Foot Forward

This article first appeared in the 17 August 2017 issue of the New Statesman, Trump goes nuclear