Posted 1 year ago

Articles

Has my medical implant been recalled?

Picture of <span class="auth">Author</span></br>Halfloop Team
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Halfloop Team
What is a medical implant recall?

What is a medical implant?

Medical implants are devices, such as pacemakers, hip replacements, stents and dental implants, placed inside the body by a healthcare professional to address health issues.

What is a recall?

A recall happens when a product needs to be modified or removed from the market due to safety concerns. This can affect both new patients and those who have already received the implant, necessitating its potential removal, modification, or change of monitoring. Recall notices may be issued many years after implantation, as previously unknown safety issues become apparent.

X-ray showing implants in both legs
hip and knee rep xray
Chest xray showing a pacemaker
Pacemaker chest Xray
Chest xray showing a pacemaker
How do you find out about a recall?

Most patients believe that there is an efficient system in place to alert them about any recalled implants, much like recalling defective parts of a car. However, this is not the case.

Current system flaws:

There is no consistent method for patients to be individually notified of recalls. This often demands vigilance on the patient's part. You may be contacted by the hospital where you were treated but this is not always the case.

While manufacturers will attempt to notify patients of the recall, they do not always know who has their products implanted. Similarly, many patients are not aware of their specific implant details.

Steps that patients can take proactively:

Identify your implant: Check your medical paperwork or consult your primary care physician or the hospital where the implant procedure took place.

Check for recalls:
- Directly contact the manufacturer of your implant.
- Search medical device recall databases: For the US, this is called MAUDE; EUDAMED for Europe; and MHRA for the UK.
- Consult your family doctor or surgeon. They can verify if there is a recall on your implant.

Note that recalling an implant does not always mean it needs to be removed. The recommended action depends on the device's potential issues, the level of risk, and your health condition. If you discover that your implant has been recalled, you should contact your doctor to determine the best course of action for you.

The future

The current system is still often reliant on the patient knowing the details of their implant and proactively looking out for implant recall notices. The clinical teams and hospitals involved will also do their best to contact all known patients. One of the problems unfortunately is that comprehensive databases, with records of every single known implant that are in patients, do not exist. 

At Halfloop, we are building a new system to make this information more accessible and convenient for patients, while maintaining their privacy and security.

The future of implants
child cochlear implant
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