Our Texas City medical device injury lawyers have written several articles on the absence of real safety oversight for medical devices before they reach the U.S. market. The FDA does not subject medical devices to the more rigorous testing requirements that it imposes on some drugs.
Medical devices can reach the market with no safety testing at all if they are “substantially equivalent” to existing medical devices. This rule has, for example, allowed the use of surgical mesh (previously used in hernia repairs) for transvaginal prolapse repairs. This far more invasive repair has since been found to be unsafe and injurious to many patients.
The U.K. follows a similar scheme whereby medical devices face a far less rigorous testing process than drugs before they reach the market. Indeed, as a recent article in The Guardian pointed out, medical devices and Chinese toys entering the U.K. market are subject to the same level of safety checks. Both receive the “CE” mark to show that they meet European safety standards.
An evaluation to determine whether a product meets the standards to receive the CE mark must be done by a “notified body” accredited by the E.U. The evaluation can be done at the manufacturer’s site anywhere in the world. And the manufacturer gets to choose which “notified body” it would like to conduct the determination. In sum, it’s not difficult for a manufacturer that wants to sell a toy or a medical device in the U.K. to receive the coveted CE mark. The system lends itself to a certain amount of fraud and abuse.
Our Texas City medical device injury lawyers offer this information to our readers to show that we Americans are not the only ones to suffer from minimal oversight of medical device safety. It’s a worldwide problem.
If an unsafe medical device injures you, there might be little you can do to undo the physical damage to your health. But you can hold the manufacturer financially accountable for sending a defective medical device to market. You can make the manufacturer feel a financial pain equivalent to your physical pain. And we could help.
Our experienced Texas City medical device injury attorneys have been aiding injured victims to obtain the just compensation they deserve for their unwonted injuries for more than 12 years. We could help you too. Contact us today at 877-307-9500 for your free consultation.