Class I Medical Devices Can Be Dangerous
Monday, March 14th, 2011Before a medical product can be available for the public to consume, they should need an approval from the Food and Drug Administartion. A levlel of control is then given by the FDA that will guarantee the device’s safety and effectiveness. This classification comes in three categories: Class I, Class II, and Class III.
Medical devices that are under the Class I category are controlled very least by the FDA. These devices are said not to cause any risks of acquiring illness or injury that is why there is less supervision for products included in this category. On the other hand, Class II devices comply with all the regulations that Class I categories go through; they only differ in terms of Class II devices having to go through special controls like requirements for a special label, and postmarket inspection. Moreover, the one that needs an approval from the FDA are Class III medical devices. Take for example devices must be assured that it will not cause any danger which is why they need to go though scientific reveiws.
Whenever we use products that are categorized as Class I devices, we never think about experiencing any injury or illness in the future because these are products that have lower risks of giving complications to its users. But for a Class I medical device, Poligrip does not agrre to this.
Poligrip is a kind of denture cream adhesive that will help one’s denture stick to its place. According to numerous studies, this product can cause zinc toxicity. A lot of complications can result from this zinc toxicity like nerve damage. As a Class I medical device, Poligrip can still have a lot of dangers.
Currently, GSK is facing a lot of Poligrip lawsuits. It is best to contact your lawyer after you notice symptoms surfacing from Poligrip use.