“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.