FDA States Medical Device Recalls Up 97%

By Staff Writer

In the past decade, medical device recalls have nearly doubled. By 2012, the instances of medical device recalls have risen from 604 to 1,190.

This drastic increase, experts suggest, is because:

• Companies are becoming more stringent about the production of medical devices

• Companies are taking steps that are more cautious during production

• Companies are using a more patient-centric approach to reporting incidents to the FDA

Due to these factors, the FDA views the increase in recalls as a win. More recalls means there are less dangerous products on the market; thus, making it safer to have a medical device. Although the FDA considers this a good thing, there is a possibility of a downfall in consumer attitude. Some consumers can see this as the FDA using the public market as guinea pigs since recalls are only issued after an initial approval.

Examples of Recent Product Recalls

There have been approximately 600 new product recalls in the last decade. Some examples of the kinds of products that have been recalled recently include:

• Metal hip implants
• Transvaginal mesh
• NuvaRing
• Cardiac stents
• Tracheostomy tubes

The Hidden Dangers of Recalled Medical Devices

Devices not working properly leading to human injury and/or death are dangerous. However, the most dangerous aspect is that every patient can react differently to medical devices. Moreover, the same symptoms may not be present in every patient. Most patients, however, will experience some problem(s) stemming from the original need for the medical device.

A lack of widespread reaction to a medical device may keep the FDA from issuing a recall, warranting a revision or any other invasive procedure.

Another danger that can stem from recalled medical devices is that the reported numbers could be incorrect. For this reason, the exact number of Americans affected by defective devices could be higher due to patients suffering from unknown illnesses. This can lead to doctors and patients not having all the facts; thus, leading to an increased chance of lifelong health problems.

Can We Expect Further Increases in Recalls?

Currently the United States accounts for roughly 80% of the medical device recalls between 2010 and 2012 worldwide. This is due to the US having better recall reporting. By comparison, foreign companies have a tendency to under-report devices for recall. In addition, domestic medical device manufacturers have a higher likelihood of undergoing stringent FDA system inspections.

Foreign-made devices may increase in the near future because of a new multinational Medical Device Single Audit Program (MDSAP) that is set to launch in the near future. The MDSAP will provide FDA reviewers with more access to inspection data from medical device makers in Australia, Canada and Brazil. This better access may result in the FDA finding more devices that may be potentially harmful to patients.

More information on safety recalls including recalls for drugs and medical devices can be found on the FDA’s website. Furthermore, the FDA also updates information on recalls on the social media site Twitter. And to learn more about the increase in medical device recalls, read our latest knowledge center article.

If you believe you or a family member has been affected by a defective medical device like the Medtronic Infuse or a metal-on-metal hip, please schedule a free consultation with Tennessee’s Gilreath & Associates today to discuss your case. Or, continue browsing our blog and knowledge center for updates on cases, and general information about these issues.

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