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Defective Medical Device Recalls Up 97% Since 2003

on 03/18/2014

From 2003 to 2012, the number of recalled faulty medical devices nearly doubled but damage control minded FDA regulators believe the figure reflects an increased awareness among device makers of the types of issues that merit recall action. There were a total of 604 recalls in 2003, compared with 1,190 in 2012.

The data on recalled devices was compiled from manufacturer submitted reports. At least one source attributed the increase in recalls to medical device companies taking a more cautious and patient-centric approach to reporting the events to the FDA. Regardless of the reason for the increase, the FDA views the increase as a win for consumer safety and an expectation of long-term device performance improvement. Consumers may not buy that as the devices get recalled only after they are FDA-approved, sent to market, and tested on humans as guinea pigs.

Examples of faulty medical devices in recent years include metal hip implants, transvaginal mesh, NuvaRing, cardiac stents, and more. Recalled medical devices affect patients differently and not every patient experiences symptoms warranting a revision surgery or other invasive procedure. However, the vast majority of patients in need of a corrective surgery often experience long-term medical problems stemming from the initial injury. Transvaginal mesh complications led to a significant decrease in quality of life due to discomfort and pain, including dyspareunia for many patients.  NuvaRing users were placed at a higher risk for deep vein thrombosis, blood clots, and fatal pulmonary thromboemboli. 

Many of these recalls center not just on the device itself but the lack of warnings and/or overzealous marketing. In the example of NuvaRing, the device was marketed to women as a safe alternative to birth control pills. Rather than disclosing the more dangerous side effects, the company focused on the minor side effects of headache and cramps coupled with the tagline “month-long protection against pregnancy, so women who use NuvaRing don’t have to think about contraception every day.”

The number of Americans affected by these defective medical devices and many more is staggering. Patients suffer from an unknown and unacceptable increase in the risk of certain lifelong health problems without knowing the full set of facts, as they cannot rely on the information the manufacturer has disclosed. 

If a recalled medical device has injured you, contact the attorneys at Watts Guerra

Tags: Medical Device Mass Torts, Defective Consumer Products, Mesh

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