Patients who have received hazardous medical implants – Report

Health News Monday, November 26, 2018

Source: Graphic.com.gh

2018-11-26

An investigation revealed that unsafe and untested medical devices were found in patients' bodies.

Features include pacemakers, rods to correct thorns, as well as artificial knees and hips.

The investigation revealed that implants that had failed in baboons, or that had only been tested on pigs and corpses, were entering the market.

The industry says that it has transformed millions of lives for the better.

BBC Panorama collaborated with the International Consortium of Investigative Journalists and 58 media organizations around the world, including The Guardian and the British Medical Journal.

The therapy tested on pigs and corpses

The survey uncovered a lax regulatory system in Europe that allows companies to "shop" dozens of security organizations until one of them approves of their product.

He also revealed that doctors can be left in the shadow of the real risk of the treatments that they recommend to their patients.

Maureen's the good pig of India?

Maureen McCleave, 82, originally from Esbad, was the first person in the UK to be equipped with the "Nanostim" pacemaker because of an irregular heartbeat.

Pacemakers are vital implants that transmit electrical impulses to the heart to make them beat regularly.
Traditional cables have wires from the battery to the heart that transmit the electrical impulse, but the cables can break.

The Nanostim was the first lead-free pacemaker to sit in the heart.

Maureen stated that she was "on the moon" to be first and that she felt like a "good pig of India" when she was implanted with the device at the Bart Hospital in London.

"I was so grateful to have been chosen because it sounded too good to be true."

But three years after its installation, Maureen's Nanostim battery failed and the surgeons could not get it out.

She now has a traditional pacemaker that keeps her alive. The Nanostim is still sitting in her heart.

She says, "I do not like the thought that I have a piece of metal or anything in my heart that does nothing and that it just sits there."

Maureen was not alone – several piles failed and parts fell inside the patients.

The pacemaker has been removed for safety reasons. At least two people died and 90 events were recorded in which patients were seriously injured by the device.

In Germany, security agencies refused the Nanostim pacemaker because of the lack of evidence. Still, it has been approved by the British Standards Institute in the UK.

How big is the problem?

All medical devices are not dangerous. Many save lives or greatly improve the quality of life.

However, the survey revealed that some devices were failing in patients, including:

Implants that cracked in people's backs and failed in baboon tests.

Birth control implants that caused internal damage and bleeding.

Failure of implantable defibrillators.

Mesh implants for incontinence causing abdominal pain.

The BBC also discovered a treatment for children with a highly curved spine, or scoliosis, on the market after testing only pigs and cadavers.

However, due to a lack of transparency and data collection, the magnitude of any problem in the medical device industry remains a mystery to patients and physicians alike.

I have an implant, what should I do?

If you are worried, a group of experts set up by the International Consortium of Investigative Journalists has put some advice in place.

He recommends: "Your first point of contact should be the medical team that performed the operation.

"If you can not come back for any reason, you should consult your primary care physician.

"The doctor should be able to refer you to a specialist who is familiar with the device and the operation you have undergone."

How is all this allowed?

Europe does not have a government body that verifies medical devices before they are put on the market.

Instead, a series of companies called notified bodies issue CE marks – the same mark of approval as for appliances such as toasters and kettles.

There are 58 in Europe and approval by means means that a product can be used anywhere in the European Economic Area (the EU plus Iceland, Liechtenstein and Norway).

But if one organization refuses, one company can shop and ask another.

But surely you need proof?

Less than the patients might think.

And there are so many secrets that even surgeons implanting these devices do not always see the evidence on which a device has been approved for its safety and effectiveness.

The British standardization institution said that she could not discuss Nanostim's evidence because of "confidentiality requirements".

Even the UK's regulatory body, the Medicines and Health Products Regulatory Agency, claims to be "bound by professional secrecy with respect to some of the measures we have taken regarding individual devices ".

The investigation however revealed that there was only one clinical study before Nanostim was approved for public use.

He followed only 33 patients for 90 days.

Professor Rita Redberg, one of the world's leading cardiologists and the University of California at San Francisco, said: "We are talking about a permanently implanted pacemaker, so I think that It is a very small study.

"They're supposed to last 10 or 20. A 90-day follow-up is not enough to learn a lot about the pacemaker."

What does the industry say?

MedTech Europe, the body representing the medical device industry, said: "Millions of people have benefited safely from medical devices and can now lead healthier, more productive and more independent lives.

"Life is unimaginable today without the hundreds of thousands of medical devices in our hospitals and homes."

And she defended the system of notified bodies that were "chosen for the expertise, impartiality, transparency and independence of their staff".

Abbott, who made Nanostim, says that many patients have been helped by unleaded stimulators and that many more will benefit from this technology in the future.

He said: "In accordance with the European CE marking approval process, the Nanostim lead-free stimulation system has been approved based on solid performance and safety data.

"In addition, when approving the CE Marking, Nanostim was evaluated as part of a post-marketing European clinical follow-up study."

What is the solution?

The Royal College of Surgeons of the United Kingdom has called for "radical regulatory changes".

Professor Derek Alderson, President of the Royal College of Surgeons, said: "All implantable devices need to be registered and monitored in order to monitor the long-term effectiveness and safety of patients."

But when the European Union suggested tightening the rules, the industry launched a campaign called "Do not lose the 3".

He mentioned that manufacturers can provide new products to patients three years faster in Europe than they are in the United States.

The new regulation on medical devices will come into force in Europe in 2020, but activists believe that the new rules do not go far enough.

German MEP Dagmar Roth Behrendt told Panorama that an intensive lobbying campaign led by the industry undermined the proposed reforms.

"This is a success for them and a failure for the European Parliament and for European patients, I have no doubt.

"For me, it's like an open wound, that we could do nothing more for European patients and that for the safety of European patients, we have pain."