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Defective Medical Devices:IntroductionBackgroundLet Us Work for YouConnect with Us Back to Top

Although medical devices have revolutionized health care, when they are defective these devices can have disastrous consequences. If a medical device manufacturer designs and sells a defective medical device, they end up injuring patients they are supposed to help.

Furthermore, instead of recalling a faulty device, some manufacturers will try to cover up the problem and deny anything is wrong with their device. When the product remains on the shelves of medical supply stores and in hospitals, more people will inevitably suffer.

Background

There are hundreds of devices that have been deemed “defective” throughout the years. These devices range from breast implants and birth control patches to artificial hips and heart stents.

The makers of medical devices are expected to conduct rigorous testing on the products they sell. The testing performed by medical device manufacturers as well as independent doctors and scientists in clinical trials is used to determine if a device is safe enough to be used in medical procedures.

Unfortunately, there are loopholes in the system that make it possible for some medical devices to come to the market with limited testing and with no evidence that the products are safe. The problem typically stems from the 510(k) approval process that the Food and Drug Administration (FDA) allows.

The 510(k) approval process permits a medical device to be approved with minimal testing through a fast-tracked process, as long as there is a substantially similar product with approval. The approval process can occur even if the similar product has caused problems, provided that the product has not been the subject of an official recall.

The 510(k) medical device approval process may allow dangerous medical devices, such as transvaginal mesh implants as well as hernia mesh implants, into our marketplaces.

Let Us Work for You

We help people harmed by dangerous medical devices. With decades of collective experience, our attorneys have successfully represented many patients in lawsuits against medical device manufacturers. We are ready to evaluate your case, provide you with information and help you take proper action against the medical device manufacturer that harmed you.

Please call (800) 720-5913 or contact us to speak with the product liability attorneys at Lee Murphy Law Firm today.

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