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Medical Device Recalls – Why Such a Dramatic Increase in Recent Years?

Tennessee attorneys at Gilreath & Associates explore facts and figures behind medical device recalls and why the FDA is calling this rise a win

From 2003 to 2012, the instance of medical device recalls nearly doubled. There were roughly 604 total recalls in 2003, but by 2012, this number rose to 1,190. Included in this calculation are devices that the FDA notes as Class I recalls (i.e. product defects that pose a risk of serious health consequences and/or death), which increased from seven to 57.

This information comes to the FDA from manufacturer submitted reports.

What is the cause of this increase? Are medical devices made poorly now or have standards of production fallen?

Experts suggest that the cause for the increase in medical device recalls is that the companies who specialize in medical devices are becoming more stringent about their production. Furthermore, these companies are taking more cautions steps like using a more patient-centric approach and reporting any incidents to the FDA.

For this reason, the FDA views this increase as a win for consumer safety and with it, an expectation of long-term improvement in medical devices. The downfall to this attitude is that consumers may be reluctant to take this at face value. Consumers may fear the medical companies are using humans as guinea pigs since the products are typically only recalled after FDA's approval of the product(s).

Recent Product Recalls

Given there have been roughly 600 product recalls in the past 10 years, the list is quite long. Some examples of significant recent recalls include:

  • Metal hip implants – patients with defective metal-on-metal hip replacements experienced a variety of devastating symptoms ranging from poisoning in the most extreme cases to bone loss/fracture, fatique, swelling, difficulty walking and general discomfort.

  • Transvaginal mesh – patients who needed to have transvaginal mesh implanted experienced a significant decrease in the quality of life. This was due to discomfort and pain—including dyspareunia (i.e. painful sexual intercourse) in many cases.

  • NuvaRing – those who were prescribed the NuvaRing for birth control experienced a higher risk of deep vein thrombosis, blood clots and pulmonary thromboemboli—i.e. the sudden obstruction of an artery in the lung caused by a blood clot that has dislodged from somewhere else in the body—(which tended to be fatal).

  • Cardiac stents – a delivery system malfunction caused separation at the inner catheter's tip, which often times required surgery to remove, or worse, thrombosis, amputation or cardiac arrest. At least one death has been blamed on defective cardiac stents.

  • Tracheostomy tubes – one voluntary recall involved leaky tubes, which could potentially lead to a sudden spike of CO2 in the blood. For patients using assisted mechanical ventilation, this spike could prove deadly.

The Hidden Danger of Recalled Medical Devices

Any device that does not work properly and/or leads to human injuries or death is never a good thing –however, the real trouble is that patients react differently to medical devices. Moreover, not every patient will experience the same symptoms, although, most will experience problems stemming from the initial injury that caused the need for the medical device.

This may keep the FDA from issuing a recall, warranting a revision or any other invasive procedure.

In reality, the numbers we outlined in the beginning could be much higher. One reason for this could be due to patients suffering from unknown illnesses (leading to the doctor and patient not having all of the facts) that could increase the risk of any number of lifelong health problems.

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Why Consumers Should Expect a Further Increase in Medical Device Recalls

The researchers from the FDA concluded that the bulk—around 80%—of medical devices recalled between 2010 and 2012 were made in the United States.

One reason for the high number is that the U.S. has much more advanced systems for spotting issues and alerting patients. Furthermore, foreign companies have a tendency to under-report devices for recall. In addition to better recall reporting, domestic medical device manufacturers have a higher likelihood of undergoing stringent FDA system inspections.

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

For more information on safety recalls including recalls for drugs and medical devices (as well as food and other regulated products), the FDA website provides a detailed list. And in keeping up with our increasingly "connected" society, the FDA also updates information on recalls on the social media site Twitter.

If you believe you or your family member has been a victim of a defective metal-on-metal hip implant or another type of defective medical product, we urge you to schedule a consultation with specialized attorneys at Tennessee's Gilreath & Associates today.

And to learn more about defective medical products, medical malpractice and related issues, continue browsing our blog and Tennessee Personal Injury Guide.

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