10 questions to understand the case of medical implants

Insulin pumps, pacemakers, prostheses, bad implants … Medical devices have been at the heart of the turmoil since the publication of an international survey on Sunday, attended by more than 250 journalists, including journalists from the United States. World, from Radio France and "Cash Investigation". The survey, called "Implant Files", denounces failures in the regulation and monitoring of medical devices and reports an increasing number of incidents around the world. Deficiencies known for several years: already, in 2012, then in 2013, Le Figaro had devoted articles on this subject of concern.

1. What does the survey reveal?

Implant Files mainly denounce two things. On the one hand, the lack of control and traceability of medical devices, highlighted several times in recent years. The world in particular, two known cases, the PIP bad prostheses, which presented a higher risk of rupture due to a defect, or that of the sterilization implants Essure, causing many cases of adverse effects. On the other hand, the survey reveals an increase in the number of medical device incidents around the world. In the United States, more than 82,000 deaths and 1.7 million injuries were reported between 2008 and 2017, according to The world.

2. What is a medical device?

Medical devices are defined by the Public Health Code as any instrument, device, product, used for medical purposes and whose main action is not obtained by pharmacological, immunological or metabolic means, unlike drugs. This definition includes a very heterogeneous variety of about 1.5 million products (syringes, scanners, cardiac defibrillators, wheelchairs, dressings …) divided into four clbades, according to their level of risk.

3. What are the most defective medical devices according to the survey?

From the US Health Agency (FDA) database, journalists ranked the top 10 most frequently implicated in the occurrence of incidents between 2008 and 2017. Pumps are at the top of the list insulin with implanted glucose sensor (421,000 incidents), in front of blood glucose meters (322,000 incidents) and insulin pumps alone (305,000 incidents). Then come infusion pumps (254,000 incidents), implanted blood glucose sensors (237,000 incidents) and implantable spinal neurostimulators to combat chronic pain (121,000 incidents). The investigation does not specify the nature of these incidents, nor their seriousness.

4. Where do the figures for the 82,000 deaths and 1.7 million injuries due to medical devices come from?

These figures come from a database of the US Agency for Health that lists all reports of incidents occurring in people using a medical device. This database allows for example to know how many deaths of people using an insulin pump were reported between 2008 and 2017. But be careful: it does not mean that these deaths were caused by said insulin pump.

"These are declarations of death of medical device users, but they were not necessarily caused by these products," confirms Lionel Tortolano, a pharmacist at Henri Mondor Hospital (Créteil) specializing in medical devices. To be clear, read the description of each case, the result of an badysis by one or more doctors.

In his investigation, The world reports that 742 deaths were caused by insulin pumps. If we take the first case from the list provided by the database, we learn that the person "has recently had two infarcts" and that death seems to be "natural". The insulin pump is not involved. Was this case subtracted when calculating? Or is it part of the 742 deaths? The question arises more globally for the 82,000 deaths announced. Article from World does not specify the methodology by which these figures were obtained, so it is not possible to know whether these deaths were all caused by medical devices.

5. What is the situation in France?

According to figures from the National Agency for Drug Safety (ANSM), the number of incidents related to these implants would have doubled in ten years, with more than 18,000 reports in 2017 and about 158,000 incidents in ten years reports The world. However, the daily highlights important deficiencies in surveillance in France. "There is no reliable basis of materiovigilance in France and it is difficult to identify problems," we learn.

"Materiovigilance is managed locally by each health facility," explains Lionel Tortolano, a pharmacist at Henri Mondor Hospital in Créteil. We send all the information back to the manufacturer and the national drug safety agency, but there should be national registers, filled directly by the doctors. "

Another problem: underreporting. "The culture of incident reporting is fairly recent," continues Tortolano. The PIP Prosthesis Case has so traumatized plastic surgeons that they report more often than before. But I am not convinced that other health professionals have acquired this reflex. "

6. Are medical devices placed on the market with little or no control?

To market a medical device in Europe, its manufacturer must have it certified by one of the European bodies accredited by the national health agencies: the notified bodies. It must then provide a number of documents – in particular on the safety and effectiveness of the device – which will be examined and will enable it to obtain or not the "European Conformity" (EC) certification. This is essential to market the medical device within the European Union.

In his article, The world indicates that this certification can be obtained with almost no control. "It's not quite right," says Najet Yagoubi, professor and director of the research laboratory "materials and health" at the University Paris-Sud. "Implantable medical devices must go through clinical trials in humans, even if there are already equivalents on the market."

But according to the "Implants Files", these clinical trials are not always requested or they are not of good quality. "The effectiveness of certain medical devices is demonstrated on the basis of studies with insufficient levels of evidence," confirms Deborah Eskenazy, lecturer at Paris-Sud University, and author of a thesis on the regulation of medical devices. medical devices published in 2016. "With the new European regulation that will come into force in 2020, notified bodies will have to badess these data more strictly."

Some believe that the level of demand has been increasing for several years now. "In 2017, we went from a directive of a few dozen pages to a European regulation of 450 pages, says a former employee of the sector. The regulation has really hardened, a number of manufacturers have lost their CE marking. "

7. What are the flaws in the controls?

The first ones implicated by the "Implant Files" are the certification structures: the notified bodies. "All are not equal. Some are very serious, others less, "explains Najet Yagoubi. In fact, between 2017 and 2018, the European Commission has taken steps to strengthen their control. "A certain number did not fulfill the criteria of competence, independence … They were deprived of their right to exercise," says Deborah Eskenazy. We have gone from 80 notified bodies in the European Union to 50. But there are still probably things to improve. For example, some organizations also offer consulting services to industry, which interferes with their independence. "

In addition, the new European regulation that will come into force no later than 2020 provides for the creation of independent panels of experts. Appointed by the European Commission, they will be responsible for evaluating the opinions of the notified bodies.

8. Why is there a traceability problem?

Another weakness identified by the "Implant files": that of traceability, brought to light at the time of the case of PIP bad prostheses. Many women who received a bad implant did not know if they had the brand name and could not obtain information from their clinic or hospital. "Traceability is local. I can answer for all the patients implanted at Henri Mondor Hospital, explains Lionel Tortolano. But there is no centralization of this information, not to mention that some institutions do not use the same software. "

The situation should evolve with the new European regulations. "By 2024, all manufacturers will need to badign a unique identifier to their products, which will improve traceability," said Najet Yagoubi.

9. Can we talk about a health scandal?

"We've known for a long time that the regulation of medical devices is flawed," said Deborah Eskenazy. There is nothing new in my opinion.

"The regulations have left a lot of room for people who want to be dishonest," adds Lionel Tortolano. But the term scandal is a bit strong. Regulation is moving in the right direction, I hope it will lead to safer medical devices in the future. "

"We can not deny that there have been scandals like PIP prostheses," says the former employee of the medical device industry. But in this case, we were beyond a regulatory gap. There was malice, wrongdoing, misappropriation of information … It was a case of banditry. You will find this type of drift in all industrial areas. "

10. What should you do if you have an implanted medical device?

If you do not have a health problem related to your implant, there is nothing special to do. If not, you or your doctor can report your problem online on the reporting portal for adverse health events.