As medical technology has advanced in recent years, more patients are finding themselves having various types of medical devices implanted in their bodies in an attempt to have better health, and in some cases, save their lives. While many of these devices work fine, there have been increasing concerns that some devices are creating hidden problems for many patients. Whether it’s artificial joints, pacemakers, stents, or surgical mesh, some healthcare professionals and journalists are expressing serious concerns for patients.
Approval of Medical Devices
Based on various studies, many of today’s most used medical devices are approved by the Food and Drug Administration with far less scrutiny than patients and healthcare professionals realize. In fact, data shows that most devices are evaluated less than most drugs that go to market, and in some cases are used on patients without first being evaluated through clinical trials. However, this does not mean these devices have not worked fine for thousands of patients. But based on these findings, it’s clear the approval process does need improvement.
Why are Medical Device Implants Used?
In most patients, medical device implants are used as an option when the person’s condition or illness does not respond well to drugs, or when surgery is not a viable option for their circumstances. However, some investigative medical journalists believe these devices should not be used until additional research is conducted to determine the effectiveness of the devices, as well as any side effects that may result.
Tracking Potential Problems
For many people in healthcare and journalism who have concerns about the possible dangers associated with medical device implants, one of the biggest problems is that there is very little data available tracking potential problems associated with the devices. While the Food and Drug Administration (FDA) does have a database allowing doctors and hospitals to report adverse events and deaths related to medical device implants, the database does not have any figures showing how many patients across the United States have been implanted with the devices. This is due to the FDA not requiring manufacturers to report how many patients have been implanted with various devices. Because of this, there is no way to accurately judge how dangerous a device may be. For example, if there are 100 deaths reported for a device, healthcare professionals don’t know if that rate is high or low, since they don’t know how many devices have been implanted in patients.
Safety After Introduction
For many devices, it has been found that the FDA allowed manufacturers to prove the safety of the devices after they were already on the market and implanted in numerous patients. Known as conditional approval, it has become a common practice within the industry, allowing companies to get their medical devices on the market much faster than if they had to conduct safety studies beforehand. While in some cases the aftermarket studies have shown numerous devices to be safe and effective for patients, there have been other studies that have shown the opposite. However, despite the potential problems associated with this practice, there are currently no plans for the FDA to change this practice.
Lack of Reporting
While having a database for reporting adverse events and deaths sounds perfectly reasonable, the biggest problem involves a lack of reporting by healthcare professionals. According to data, only about one percent of adverse events are ever reported to the FDA database. However, as additional details regarding this matter are revealed, it’s expected that this issue will become more important to the FDA, manufacturers, and healthcare professionals who work with patients needing these devices.
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