Medical device regulation 'not fit for purpose', MP states

A historical lack of transparency in the UK’s medical devices industry has led to debilitating consequences for patients, the government admitted this week.

Speaking at a parliamentary debate this week, under-secretary for health and social care, Jackie Doyle-Price, said that regulation has been concerned more with the commercial interests of businesses rather than patient safety.

The debate was secured by Labour MP Owen Smith, who called for UK/EU-wide regulatory change from class III implantable devices.

Smith drew on examples of vaginal mesh devices, which have gained notoriety recently over the harmful effects they’ve had on patients.

“Many of the variants of vaginal mesh, like most of the other devices now on the market, are developed without any real clinical trials, and certainly without the randomised controlled clinical trials we are familiar with in respect of medicines; that is an extraordinary fact. We understand why that is the case, but there are other ways in which the device manufacturers could ensure their devices were safer and definitely not going to harm patients,” Smith said during the debate.

Smith also highlighted the failings of regulatory institutions across the UK and Europe, including the Medicines and Healthcare products Regulatory Agency (MHRA) and the numerous notified bodies. Notified bodies, which are licensed by the MHRA, are responsible for providing CE marks to medical device companies once it has reviewed any clinical data and the efficacy and safety of a product. However, Smith raised the issue that since there are numerous notified bodies spread across Europe, if a company fails to get a CE mark from one, it can easily try the next notified body.

The MHRA’s process for reviewing surgical mesh implants was compared to being more “akin to the system that applies to toasters or plugs, and the way in which they get kitemarks, than to the way in which medicines are approved,” Smith stated.

For instance, the verification process for reviewing mesh implants by the MHRA amounts to a “two-week desktop exercise carried out by three people at a cost of £20,000,” one MP said during the debate.

In 2017, Doyle-Price refused to suspend the use of mesh and related the issue with the implants to clinical practice rather than the devices themselves.

Now Doyle-Price admits that mesh has ‘transformed the lives of some women’ and is now recommending that women who have suffered due to mesh treatment pursue legal action against their practitioners.

Doyle-Price said the government was working on a number of actions to ensure that existing legislation is effective.

This includes a joint assessment of notified bodies by multiple authorities to ensure that assessments of new medical products and new standards for clinical data are required for any high-risk device coming to market.

Responding to a request for comment by Medical Plastics News, Smith said: “I’m glad the Minister acknowledged that commercial interests have been historically prioritised over patient safety in the regulation of medical devices, but the Government needs to go further by toughening up the licensing process and committing to a national registry of all devices to protect patients.

“Medical devices can save and transform lives, however, when faulty or poorly designed, they have also damaged and ended the lives of many thousands of patients around the world. The regulatory system for medical devices in our country, and across the wider world, is simply not fit for purpose and must be properly reformed.”

Founder of campaign group Sling the Mesh, Kath Sansom, told MPN that many women are still being told that “mesh is not to blame”.

The youngest member of the support and awareness group was just 15 when she joined and now suffered from daily pain five years later, Sansom explained.

“The Government were backing surgeons until last year saying mesh was the best treatment option for women suffering [stress urinary incontinence] SUI or prolapse and only stopped this line when Baroness Cumberlege announced a suspension. Now they are telling women to sue their surgeons for giving them mesh! To me it is a sign that surgeon societies have had way too much power to influence decision makers. Meanwhile patients who have been desperately trying to tell the establishment since 2007 that mesh is causing life changing complications have not been listened to,” Sansom added.

MPN also reached to MHRA for comment on the safety of medical devices and whether current regulation is effective enough to ensure patient safety.

“Patient safety is our highest priority. As a regulator our work is underpinned by robust and fact-based judgements to make sure that the benefits justify any risks. The regulatory system for medical devices has been in place for 25 years. Over that time medical technology has improved and transformed countless lives,” an MHRA spokesperson said.

“We have actively championed the new Medical Devices Regulations(MDR), which significantly strengthen the regulatory framework for medical devices. In particular, they raise the threshold for clinical evidence required, increase the requirements and scrutiny placed on notified bodies, support greater traceability of products through the supply chain and significantly increase the availability of information to patients and clinicians.

“Even if every conceivable safety measure is performed there will always remain an element of ‘risk’ associated with the use of medical devices and surgery, however small. The final decision of what is an acceptable risk for any condition and for any individual patient ultimately rests with the clinician and patient, and this is at the heart of the informed consent process, supported by information within the manufacturer’s instructions made available to clinicians. If someone thinks that they might have had a side effect or complication from a medical device, they can report it to us through our Yellow Card Scheme.”