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What is Postmarket Surveillance?

Posted on in Defective Medical Devices

There is no shortage in advertisements seeking those who have been injured during the use of medications or medical devices. As a result, the FDA is pushing for stronger guidelines when it comes to the postmarket surveillance of these products in an effort to reduce the number of defective devices used by patients.

The reason for this action is to lower the number of recalls and reduce injury to patients. Postmarket surveillance is important because most drugs are approved based on clinical trials of the products. Clinical trials apply to a small control group that are selected by the manufacturer. This control usually does not have other medical ailments besides the one that the drug is designed to treat. Yet this will not be true of the general populous.

Postmarket surveillance then continues to monitor the performance and safety of the drug or product once it is released to the general populous who may have addition and varied medical conditions. Information is gathered through various databases, event monitoring for prescriptions, and patient registries. It is then gathered and compared through data mining and will be further be reviewed to uncover any potentially dangerous safety concerns.

Through this methodology, there is the potential for saving many lives and avoiding health scares when it comes to the patients who use these medications and medical products. Unfortunately, however, this cannot rewind the clock for those who have already sustained injury or have died from the use of products that were deemed dangerous far after the fact.

If you or a member of your family has been injured, or has died as a result of the use of a reported or recalled medication or medical device, you may have an opportunity to be recompensed. Call an Illinois defective medical device attorney to discuss your options and your case.

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