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Millions of injection needles leaking glue resin cover-up exposed!

ENGLISH PRESS RELEASE

Large-scale investigation into safety of syringes

Millions of injection needles are leaking glue resin

Syringes of the frequently used brand Terumo should be recalled immediately as they could unintentionally leak epoxy resin, claim experts in the Dutch current affairs program Dossier EenVandaag.

Millions of these needles are being used in hospitals, health care institutions and for vaccination programmes. The Dutch Health Inspection and the American Food and Drug Administration have announced an investigation into this matter.

These alarming production issues at Terumo Europe have been known for years, but so far nothing has been done with the information. The syringes are still being sold to hospitals, clinics, and to big pharmaceutical companies like GlaxoSmithKline, Sanofi Pasteur MSD and Merck. For the sake of patient safety, a whistleblower brought information on the scandal to Dossier EenVandaag after the company refused to tackle the problem internally.

Professor in Health Care Safety Jan Klein believes there should be immediate action: “I think this company should halt production. They should open up to anyone who is involved, and only resume production if these issues have been resolved satisfactorily. If necessary, all these needles should be recalled. They shouldn’t be used.”

Particles
This concerns ‘K-pack II’ syringes made by the Japanese manufacturer Terumo. Each month millions of these syringes are produced in Leuven in Belgium. There are also known resin issues with syringes of the type ‘Neolus’.

The syringes are sold in Europe and the United States. As read in leaked internal documents, photographs and video material, the epoxy glue that is used to attach the needle does not harden properly, which means it can enter the needle and the bloodstream of the patient. Doctors we have spoken to are not only concerned about the consistence of the glue, but also about the possibility that ‘particles’ might be injected into blood vessels. According to them, this could cause blood clots, with serious consequences like thrombosis or brain haemorrhage.

The whistleblower tells Dossier Eenvandaag that the issues have existed for more than 4 years, but that everything has been kept behind closed doors: ”You couldn’t find anything within our quality-evaluation system, it’s like a cover-up. Everyone has known about it for a long time, but nobody dares to open their mouth. For years they have been messing with the health of patients. They only think about money, about low production costs and are lying to customers.”

Reorganisation
In this edition of Dossier Eenvandaag our source tells us he can no longer keep silent about these abuses. He says 1 out of 5 syringes has a problem with glue resin. Extrapolated to the Dutch situation that would mean that at least one hundred thousand needles are flawed. This claim is supported by internal documents, minutes of management meetings, and internal research material. According to our source a solution to the problem would take a serious investment, something the company is not willing or able to do.

Currently, Terumo is preparing a reorganisation that will cost 200 employees their job. Our source says employees are worried too, and that a large part of the production is flawed. ’20 to 30 percent of those needles have flaws, and they are sold to the market and are used everywhere. A colleague told me that if she were to take her child to hospital, she would ask for different syringes’.

Vaccines
Terumo also supplies these syringes to pharmaceutical companies Sanofi Pasteur MSD and GlaxoSmithKline. They use the syringes for vaccines that are provided to the Dutch Health Administration. Dossier Eenvandaag has discovered that various vaccinations in the national vaccine programme are administered with Terumo syringes.

Especially young children are given these vaccines in consultation centres, which carries a risk, says pediatrician Gavin ten Tusscher from the Westfries Gasthuis in Hoorn:

”I think this is terrible. You have patients that have been subjected to something than can be potentially harmful. Not only the substance that can influence the hormonal balance in the body, but also the particles that can be injected. What does it do inside the body? Does it clot an artery, or damage it from inside?”

Ten Tusscher has for years researched substances than can cause hormonal imbalances. “Being subjected to these substances has much greater consequences for children than for adults. The gastro-enteritic channel of infants has a much bigger capacity for absorbing these harmful substances.”

Carl Heneghan, professor at Oxford University who specialised in medical supplies is not surprised that the problem hasn’t been noticed before. “The problem is that a manufacturer can keep on producing a medical resource, for up to 20 years, without anybody checking it. You just have to trust the manufacturer to make his products in the right way.”

BPA
The elementary components of the epoxy glue that is released are BADGE (Bisphenol A diglycidyl ether) and BPA (Bisphenol A), substances that are generally regarded as hormonally disruptive. They are commonly associated with fertility problems, breast cancer, obesity and prostate cancer. In 2014, the Dutch Health Council wrote an advice to the Ministry of Health, in which it warned about the possible dangers of BPA, and pressed for further research.

The use of BPA in baby drinking bottles and toys has been prohibited for several years now and in Denmark and France there is strict jurisdiction on the use of these substances in combination with food, toys and medical resources. Professor Leo Goeyens of Leuven University and the Free University in Amsterdam has warned about the consequences of BPA and BADGE for a long time. Dossier EenVandaag asked him to look at the documents. “There must be an investigation into how much of these substances have been released. If the maximum daily threshold has been exceeded, then the patients need to get medical advice. They must be informed.”

Professor Health Care Safety Jan Klein of the TU Delft demands immediate action. “The Inspection needs to analyse the problem, and when in doubt, it needs to demand that the company terminates production, and if necessary, recall all syringes.

Reaction
Terumo acknowledges to Dossier Eenvandaag that there is a problem with the glue. “We have investigated the issue, and there is the possibility that glue resin can enter the needle. However the amount of BADGE that can enter the body is far below the permitted level.”

Experts tell Dossier EenVandaag that those levels are established for oral ingestion through food and drink, and do not comply to injection directly into the body. Besides, the investigation put forward by Terumo has been paid for by the company itself, accounts for only several dozens of syringes and is therefore in no way representative for the total production.

Spokesperson Geert Lambrechts says: ”We think there is no risk for the patient, and that is why we haven’t informed them, nor our notified body”.

Inspection
Professor Carl Heneghan of Oxford University is very critical about the way these companies are supervised. “That this can continue, that these products can still enter the market is a cause for great concern about the inspection process and the role of supervising agencies.”

In the last couple of years, there have been several scandals involving medical supplies. Most recent examples are the leaking PIP-breast implants and the hip prostheses that released metal particles. Inspection of companies that make medical supplies like syringes is often done by so-called ‘appointed agencies’, privately-owned institutes which check whether medical supplies comply with European standards. These are the same companies that give a CE-certification to a manufacturer. The appointed agency which provided the Terumo syringes with a CE-certification is TUV-Rheinland. In 2013, that company had to pay compensation for damages to 1600 women with PIP-breast implants. The German company had provided the manufacturer with certifications even though the implants later proved to leak and tear, causing serious health problems. Carl Heneghan: “This is a classic example of control failure. I like to compare it to cars. We want Formula-1 cars, not old pieces of junk. In health care, we also want Formula-1 quality, but that obviously is too expensive”.

Terumo is a Japanese manufacturer of medical supplies. Worldwide, it employs twenty thousand people. The company has an annual revenue of 4 billion dollars. Since 1971, it has also been active in the United States and Europe.

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