How lobbying blocked European safety checks for dangerous medical implants

Suspect injuries, malfunctions, and deaths

Although the global implant industry is dominated by US manufacturers, and the US is by far the largest sales market, many firms chose Europe to try out their new—and sometimes harmful—products. This is done long before the devices have been tested to the satisfaction of the US Food and Drug Administration.

Examples of products certified as safe in Europe and later found to be flawed include PleuraSeal, a lung sealant that leaked6; RoboDoc, a robotic surgical device that caused tendon rupture and nerve damage6; and Brio, a deep brain stimulation implant to treat Parkinson’s disease, which had to be removed from some patients after body fluids seeped into the device and it stopped working.7

In addition, European patients were the first to try Nanostim, a breakthrough pacemaker, some of which developed battery problem (box 1); Trilucent, a breast implant filled with soybean oil, some of which went rancid, prompting regulators to recommend that thousands of women have them removed; and ASR resurfacing hip replacement.

Each of these devices was eventually recalled, put on hold, or discontinued.

Official regulatory statistics often fail to capture the stories of European patients exposed to danger. Not all manufacturers learn of injuries associated with their products. When they do, companies are required to file an “incident report,” indicating that a device may have caused serious harm or put a patient in danger. However, it is up to manufacturers to assess whether an incident meets these criteria and whether the product is suspected to have been a contributory cause.

Despite their limitations, incident reports offer the best available view of potentially dangerous medical products in use in Europe. Yet national health authorities refuse to make them public.

ICIJ reporting partners in 16 European countries have spent months seeking access to detailed injury and malfunction data held by national regulators. But in each case, freedom of information requests were denied or led to incomplete responses, full of redactions.

In Belgium, regulators said it would take one person 5489 days to black out patient data or commercially sensitive information before requested documents could be released. In the UK, reporters tried asking only for injury reports relating to Essure, a sterilisation implant known to have harmed many women, but were told this would violate the manufacturer’s commercial secrecy.

Regulators in 19 countries—responsible for the safety of more than 85% of EU citizens—did respond, however, to an ICIJ request for the raw numbers of reported malfunctions, injuries, and deaths. The data they provided shows a steep rise in incident reports over recent years.

In Germany, confidential reports have almost tripled in the past nine years. Regulation last year received 14 034 suspected device associated injury and malfunction reports.

In France and the UK, incident reports have more than doubled in nine years, reaching 18 208 and 19 559, respectively. In Spain, they have quadrupled in seven years, while in Italy reports quadrupled in just four years.

Without more detailed data—such as the number of different devices on the market and how frequently they are used—it is impossible to know whether the rising number of injury and malfunction reports means products are getting more dangerous.

However, several countries, including the UK, Italy, and the Netherlands, said sharp increases in part reflected improved reporting practices.

Christian Gluud, head of the Copenhagen Trial Unit in Denmark, says keeping incident reports confidential is effectively an “expropriation” of information belonging to patients, and that it should be shared openly in the interests of public health.

“To me, this looks totally medieval,” he says. “It should be urgently changed. We need much more transparency. Only if patients and doctors have full access to all the benefit and harm data can they make informed decisions on whether to use a particular medical device.”

Although the EU is currently reviewing how much information should be shared with the public on a newly expanded system called Eudamed, the European Commission told ICIJ that injury and malfunction reports were likely to remain confidential as they were commercially sensitive for manufacturers.

Until Eudamed is fully upgraded, no single authority even keeps a register showing the number of medical devices certified as safe for use in Europe.

Light touch Europe

For nine years, lobbyists pressured politicians as they wrote and rewrote plans to reform Europe’s safety rules before the Regulation on Medical Devices was finally signed into law last year, ready to come into effect from 2020.

Throughout, lobbyists fought to keep as much as possible of the EU’s existing, light touch safety regime. This allowed private, for-profit certification firms, known as “notified bodies,” to approve high risk products, as safe—often without any supporting evidence from human trials.9

The battle over how medical devices should be regulated shows how well-connected lobbyists can overwhelm a process designed to protect the public. Lobbyists won over European politicians and bureaucrats with an array of tactics, including unsubstantiated claims about safety and dark warnings of lost jobs, increased taxes, and fewer healthcare choices.

At the moment, the only assurance of safety given to doctors and patients is the small “CE” logo on the implants packaging or instructions, which the patient may never see.

Disliked proposal

In 2008, European Commission officials had become aware that notified bodies, vying with one another for business, were routinely awarding CE certificates for new, high risk implants without being shown sufficient supporting evidence. In response it produced several reform options, among them a proposal to transfer responsibility for assessing high risk devices, including implants, to a new department within the European Medicines Agency “on an equal footing” with the EMA’s work regulating drugs.10 In both Europe and the US, all new drugs must show an acceptable level of safety and effectiveness in clinical randomised trials.

These proposals for rigorous testing overseen by the EMA brought a barrage of 200 responses, including 117 submissions from manufacturers, industry trade associations, notified bodies, consultants, and experts, 27 from government regulators and just 33 from healthcare workers and academics. The majority of respondents were against involving the EMA, but there was a clear split, with industry and the notified bodies firmly rejecting the idea and doctors, academics, patients, and consumers largely in favour.11

If the commission’s proposals were taken forward, warned MedTech Europe in it’s response, “patient care and access to new medical technology is, in our view, likely to suffer.”

Scandals and loopholes

This emphatic response might have been the end of the matter, but two high profile scandals surfaced, beginning in 2010.

French regulators discovered that tens of thousands of women had received breast implants that were susceptible to rupture. In France alone, more than 18 600 women had Poly Implant Prothèse (PIP) implants surgically removed.

Meanwhile, several makers of all-metal hip implants stopped production. In 2012, journalists from The BMJ and The Telegraph went undercover, posing as representatives of a rival hip manufacturer and asking Slovakian notified body EVPU to provide a CE mark, certifying their new all-metal hip as safe.12 The body provisionally approved the journalists’ hip design, which had been deliberately drafted to mirror that of a dangerous hip product that had been subject to a safety recall.

Changing course

Spurred by public outrage, the European parliament called on the commission to renew efforts to overhaul safety regulations.13 But when new proposals finally emerged from the commission in 2012, they looked very different from what it had proposed in 2008.

According to an official “impact assessment,” deeper research had led the commission to conclude any weaknesses in the system “do not suggest that [the regulation of medical devices] is fundamentally unsound.”11 There was no need to stop notified bodies from approving the safety of implants and other high risk devices, or to transfer that task to the EMA.

The commission explained that it had held “targeted meetings at [a] senior level with representatives from industry associations and with notified bodies.” Several fact finding events had taken place, but records show they were dominated by industry lobby groups, with few independent medical specialist present and even fewer patient groups. Meanwhile, countries where lots of jobs depended on medical device firms, including Germany, the UK, and Ireland, began to line up in support of industry.

In its response to the commission, the UK regulator, the Medicines and Healthcare Products Regulatory Authority (MHRA), argued that it would be wrong to end the notified body system or to place additional requirements for clinical trials on devices before they are approved.

In documents obtained by ICIJ news partner Le Monde, MHRA said the PIP breast implants and all-metal hip scandals could not be blamed on failure in the regulatory system. The PIP case was the results of fraud, it said, and issues around most metal-on-metal hips would not have been spotted even under a more transparent regime.

“Pre-market authorisation would result in delays in the availability of new and innovative medical technology for European patients.

“Additional requirements for clinical trials will also place substantial costs on manufacturers and delays could mean that it is uneconomic to bring some devices to market,” said the MHRA.

The commission’s 80 page impact assessment explained how a new, centralised regulator was “inappropriate.”11

Parroting the lobbyists, it explained how current regulations allowed device makers to get cutting edge technologies into European hospitals for less than €10m (£9m; $11m). The cost for heavily regulated drug companies to develop a new product was about €1bn.11

The case for rejecting tougher safety regulations was overwhelming, the commission document concluded. Most importantly, it said, such a move would bring no safety benefits for European citizens: “US studies … point to the faster pre-market assessment in Europe compared to FDA clearance of medical devices, whilst safety levels were considered equal.” The referenced studies were by Boston Consulting Group, whose work had been paid for by industry lobby groups.14

Boston Consulting had compared the number of products recalled because of serious risk to patients, and had said: “[T]he number of recalls in Europe is identical to that in the United States,” but it used absolute numbers rather than relating it to the total number of procedures. The research served as an evidential bedrock for the commission’s rejection of fundamental reforms to device regulation. And it would be deployed by lobbyists, later on, to win round MEPs.

Emotional appeal

By time the commission’s industry friendly proposal was in its first reading in the European parliament in 2013, German social democrat MEP Dagmar Roth-Behrendt was trying to build support for the reintroduction of many of the substantive reforms that the commission had initially supported but later dropped. Roth-Behrendt wanted an agency to look after the high risk devices instead of the notified bodies. She also wanted manufacturers to have to show that devices were not just safe but benefitted patients.15

An experienced parliamentarian, Roth-Behrendt says she always saw device regulation as the “missing cornerstone” in European health law.

“I never tried to be radical; I always tried to compromise,” she says. But her plans came under fierce attack from lobbyists. “The medical device industrial organisations were radical. They tried to destroy whatever is possible. Their line was not to change any existing legislation,” she says.

In advance of a crucial 2013 vote on the Roth-Behrendt plan, MedTech Europe16 launched an online lobbying campaign, once again relying heavily on Boston Consulting’s claim that the latest cutting edge implants were approved three years faster in Europe without additional risk to patients. The campaign’s catchphrase was: “Don’t lose the 3.”16

The lobbyists claimed Roth-Behrendt’s reforms would cost industry €17.5bn and would make European citizens no safer than they were before.

Although the parliament had been divided shortly before the October 2013 vote, Roth-Behrendt’s push for fundamental reforms was ultimately defeated.17

“I saw a huge amount of lobbying in the 25 years I was in the European Parliament,” Roth-Behrendt tells ICIJ partners. “But the way this was done was the blackest I’ve ever seen.”

Victory for lobbyists

Although the EU’s new safety regulations were not signed into law for another four years, any hope of fundamental reform died with Roth-Behrendt’s failed efforts.

When the text was finally agreed last year, Vytenis Andriukaitis, the EU commissioner for health and a retired cardiac surgeon, said he “happily welcome[d] the final compromise, which contains a series of crucial improvements to the current system.”18

Glenis Willmott, who succeeded Roth-Behrendt as the European parliament’s point person for tracking and reporting on medical devices law,19 blames the failure to secure more fundamental reforms on her centrist and right wing peers.

Willmott, now retired from politics,20 says the legislation ultimately represented a compromise, including some valuable measures. There are new powers to appoint a panel of experts that will, in some instances, double check the work of notified bodies and a new requirement for all implants to be given an identification number to help keep track of them. These measures were “a big step forward,” she says.

Not everyone agrees. Carl Heneghan, professor of evidence based medicine at Oxford University, says: “The new device regulations give the impression of creating safer devices, but more regulation does not necessarily mean better regulation.” He says they amount to “a hundred pages of smoke screen.”

Alain Braillon, a senior consultant at Amiens University Hospital and health products expert, says: “Europe’s rules are all about helping companies to sell more implants—they are nothing to do with public safety. The European Union is a political union firstly aimed to ensure the free movement of goods, services, and capital.”

Most angry of all is Roth-Behrendt. “Medical devices must be safe and reliable. That hasn’t been achieved in the past, and it won’t be in the future,” she says. “With medical device scandals happening, those lawmakers and decision makers who have prevented better regulation or watered it down should explain themselves. Why did they not [do more] for more patient safety?”

Victory for trade bodies

At a conference in Berlin in October 2017, Dario Pirovano, a senior figure at MedTech Europe who had worked as a consultant for the commission earlier in his career, gave a presentation that listed industry successes, including some big ones.

He noted that proposals for an EU public authority to assess safety, similar to the FDA, had been scrapped and a proposal to require testing for efficacy—as is required in the US—had been rejected.

Other “major blockers to innovation” had been “deleted or balanced,” Pirovano said.

For the MedTech Europe industry group and for its members, he declared, EU’s new regime was a “positive result.”

In 2016, The BMJ published an independent, peer reviewed study examining the safety record of medical devices approved for use in both the US and Europe. The study compared the safety profiles of 206 new devices approved in the two countries over six years. In contrast to the Boston Consulting study,¹⁴ it found that devices “approved first in the EU were ... associated with a nearly threefold greater rate of safety alerts and recalls.”21

ICIJ asked Boston Consulting if it accepted the findings of The BMJ study, and for a response to criticisms of the company’s methods. The consultancy firm declined to comment.

ICIJ asked the European Commission about the different conclusions reached by Boston Consulting and The BMJ study. In a statement, it said: “A comparison between the US and new EU legislative framework would require a more detailed discussion. Different analyses come to different conclusions and generally recognise that each of the two systems has specific benefits.”

It added: “The Commission always acts in the European interest, not in the interest of any one group or stakeholder. In reforming the system of medical devices, commercial interests were never prioritised over patient health.”