The Federal Drug Administration (FDA) is in charge of monitoring medical equipment recalls, and the process can be extremely difficult and frustrating. Many medical equipment manufacturers lack the proper records to contact patients directly in the event of a recall, which makes it difficult to ensure public safety if a device fails. In most cases, the manufacturer will voluntarily initiate a recall because of a product defect and reach out to the doctors and hospitals that install the devices. The hope is that the doctors and hospitals will reach individual patients, but that does not always happen.
Why Are Medical Devices Recalled?
If you have a medical device implanted that has been recalled, you should not panic. Most of the recalls are done for monitoring purposes to help patients avoid potential problems that have been discovered by the manufacturer. In rare cases, the recalls may require that the devices be removed.
There are three recall classes for medical devices and knowing these classes can give you a better understanding of how urgent the issue may be.
When the FDA uses a class I designation, there is a reasonable chance that the device in question could cause serious medical issues. If left unattended, the device in question could even create a fatal medical situation.
A class II warning involves a device that may cause temporary medical issues, or create physical harm that is reversible. A class II device also presents the possibility of a fatal event, but that possibility is much less likely than a class I device.
A class III device requires occasional monitoring and is not judged to be a serious medical threat.
The FDA monitors every recall plan issued by medical equipment manufacturers to make sure that every plan is being done in the best interests of the public. While a company can voluntarily recall its own product, only the FDA can terminate a recall. When the FDA determines that the product is no longer a threat to the public, it will usually terminate the existing recall.
What Should You Do?
Recalls are admissions of fault with product design or manufacturing, and successfully executing a personal injury lawsuit on a recalled product can be difficult. One of the biggest problems with medical device recalls is that the patients involved have to be vigilant to find information on their recall because of the lack of quality contact information kept by the manufacturers.
If you have a medical device implanted in your body, then it is up to you to keep track of potential recalls by monitoring recall websites or visiting the manufacturer’s website a few times a year. If you do see a recall, you should contact your doctor immediately to take the action recommended by the FDA and the manufacturer.
If you follow the instructions given for a recall and still experience medical problems, then you will want to contact an experienced personal injury attorney to determine your options. In some cases, recalls are issued after years of reported problems, and those situations could result in a successful lawsuit against the manufacturer. But before you start working with an attorney on a personal injury lawsuit for your defective medical device, it is in your best interest to follow up with your doctor to have the situation remedied first.