Houston Texas Plaintiff Litigation Law Firm

When it comes to medical devices, patients in Houston may feel secure if they learn that the device is cleared by the U.S. Food and Drug Administration. However, this security can be misleading. This is because there is a significant difference between a product being FDA cleared and FDA approved.

The FDA regulates prescription drugs, over-the-counter drugs, biologics, medical devices and surgical implants, among other products. If a product is FDA approved, this means that the FDA has determined that the benefits of the product are greater than any known risks that may accompany the use of the product in the way it was intended. For FDA approval, the manufacturer of the product must provide the agency with a premarket approval application as well as the results of the clinical tests of the product. FDA approval is generally required to sell products in the nation that have a significant benefit but also present the potential for significant risks. Class III medical devices, such as pacemakers, breast implants and replacement heart valves must be FDA approved.

While dangerous medical devices are receiving more attention in the news these days, it can still be difficult for patients in Texas and across the United States to determine whether a medical device they are considering putting in their body is dangerous or has a history of being defective. Americans should be able to depend on the agencies governing medical devices to inform them when a device causes harm. Unfortunately, until recently this has not been the case.

The U.S. Food and Drug Administration (FDA) has stated that it will end a program that had allowed manufacturers of medical devices to keep reports of harm concealed from U.S. citizens. The program, known as "alternative summary reporting" is two decades old but has collected and kept secret thousands of reports of harm caused by medical devices. The FDA plans to open these records to the public within a matter of weeks.

Modern medicine is truly remarkable. It seems as if advancements in the medical world are being made every day. However, it is essential that drug manufacturers thoroughly test their products before putting them on store shelves, to ensure consumers in Texas and across the nation are safe.

Unfortunately, sometimes in a quest to get their product on the marketplace before competitors do, drug manufacturers let dangerous drugs slip through the cracks -- or worse, knowingly leave a dangerous drug on the market. It is essential that drug manufacturers are held accountable in such situations. This is because a dangerous drug can cause a patient to suffer a worsened condition or even death.

It may seem like using surgical robotic devices may be less risky than traditional surgical methods. After all, advances in technology may mean that large incisions and other surgical risks are minimized. However, Texans may be concerned to learn that the U.S. Food and Drug Administration has issued a warning stating that the use of robotic devices in cancer operations may be unsafe.

The FDA stated that surgical robotic devices may increase safety risks and could even lead to poor surgical outcomes for those who undergo operations using these devices. The FDA reviewed recent studies that claimed that there is limited data on the risks of using robotics during cancer operations. Thus, the FDA determined that it cannot properly verify whether robotic devices are an effective way to perform operations on those with cancer.