Unsafe medical devices that have not been adequately tested have been routinely used in patients in the UK, throughout the EU and around the world, a new investigation has uncovered.
Devices including pacemakers, hip and knee replacements, and spinal rods were found to have been used in spite of some having only been tested on pigs and dead bodies, while others were revealed to have failed when tested in baboons.
The investigation has been led by the International Consortium of Investigative Journalists, working in partnership with 59 media organisations worldwide, including BBC Panorama, The Guardian and the British Medical Journal.
Understanding the scale of the problem
The investigation looked at more than eight million health records, including recall notices, safety warnings, legal documents, and corporate financial filings. Various widespread issues were uncovered, with medical implant malfunctions including those that broke, misfired, corroded and ruptured.
Among the various issues implant patients experienced were back implants that cracked, internal injury and bleeding from birth control implants, abdominal pain due to mesh implants and misfiring implanted defibrillators.
These issues were found to be connected to 1.7 million injuries and nearly 83 000 deaths over the past decade. In almost 500,000 cases the device in question was ultimately removed via surgery following an adverse event.
In response to the investigation Professor Derek Alderson, President of the Royal College of Surgeons, called for a drastic change, saying, “There needs to be compulsory registration of every new device and implant that goes into a patient in the United Kingdom."
Separately to this investigation concerns have been expressed about a commonly used breast implant. Women in France have been advised not to use “textured” silicone breast implants although no warning has been issued to women in the UK. The Medicines and Healthcare Products Regulatory Authority do, however, continue to “keep a very close eye” on developments. One women interviewed by the BBC advised that she had been diagnosed with breast implant associated lymphoma (BIA-ALCL).
How did unsafe medical implants make it onto the market?
In Europe, a significant issue was that there is no single body responsible for certifying medical devices as safe for use. Instead, there are 58 different companies, known as “notified bodies” who are able to issue CE marks that approve a product for use in the European Economic Area (EEA). Once a device has been given a CE mark by one of these notified bodies, it can then be used in any of the countries in the EEA.
This system created a problem as, under the current rules, if one notified body rejects a device for use in the EEA, the manufacturers, importers or retailers can simply go to another one of the CE mark issuing companies and try again.
This creates a situation where companies can effectively “shop around” until they get the right result and also potentially incentivises notified bodies to approve a device to avoid potential customers taking their business elsewhere.
What to do if you are concerned about a medical implant
The International Consortium of Investigative Journalists offers the following advice to anyone worried about a medical implant they or a loved one have received.
"Your first point of call should be the medical team that performed the operation.
"If you cannot go back to them for whatever reason, you should consult your primary care doctor.
"The doctor should be able to refer you to a specialist who is familiar with the device and the surgery you had."
Where a faulty medical device has resulted in harm to you or a loved one, you may also wish to investigate the possibility of claiming compensation.
Claim compensation for a faulty medical implant
If your health or that of a loved one has been harmed as a result of an unsafe medical implant, you may be entitled to claim compensation. Depending on the circumstances, you may be able to make a claim against the manufacturer, the retailer, the importer (if the implant came from outside the EU) or other parties involved in the production, distribution or sale of the implant.
IBB Claims medical negligence lawyers can make claims for compensation for medical equipment failures, with particular expertise relating to hip implants, breast implants, dental negligence, cosmetic surgery and vaginal mesh implants. We also regularly support clients with a wide range of other medical negligence claims, including sodium valproate claims.
Our team has been recognised by the Legal 500, a leading client guides to the legal profession, for our skill in handling clinical negligence claims.
Legal 500 judges IBB as having a “good” clinical negligence department and “puts the client’s interests at the forefront of every decision.” Simon Pimlott has “a real eye for detail and works incredibly hard to get the best result for each client.”
To find out more about our specific expertise relevant to your situation, please get in touch.
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