FDA recalls of medical devices are uncommon and always cause for concern.
When a product on the market starts receiving complaints or is discovered in postmarket surveillance to have issues, the company can either remove the product themselves or wait until the Food and Drug Administration steps in on their behalf.
The FDA is a branch of the federal government that oversees regulation and safety concerns for prescription medications, medical devices, over-the-counter drugs, cosmetics and particular food items. Many individuals have been implanted with devices that were later recalled; some had no problems at all, while others required revision surgery to rectify the problem. Let’s discuss the differences and whether you will need to take steps regarding your medical device.
The FDA uses the term “recall” to describe the removal or correction of a product on the market that violates federal regulations.
This doesn’t necessarily mean that a medical device must be removed or returned; it could just be a change to surgical instructions or a labeling alteration. Most recalls are actually conducted by the company that issued a defective product in the first place. This is called a “voluntary recall,” and is both cheaper and faster than one issued by the FDA.
A medical device manufacturer might hear patients complaining to their doctors, and they will act accordingly so they lose as little money as possible on the venture. (See our reporting on hip replacement recalls.)
However, if a manufacturer decides not to do that, then the FDA might take over. They will conduct a health hazard evaluation to determine the product’s safety and efficacy. This evaluation takes into account whether injuries or death has already been linked to the product’s use; whether any existing conditions could expose humans or animals to a health hazard; whether a particular sub-group is affected (children, surgical patients, etc.); and whether any scenarios are likely to occur. Their recalls are few and far between. But when they happen, they are comprehensive and expensive.
There are three types recalls as outlined by the FDA:
Class III Recall: This is the most common, least serious of all recalls. These products should not cause any health problems, but they are still in violation of FDA regulations.
Class II Recall: There is a serious risk of death or injury present, but it is not immediate. These recalls are preventative and meant to protect against future injuries. The FDA will work with the specific manufacturer to recall the violating products, making a plan to pull them from the market and to inform consumers.
Class I Recall: This means there is an immediate or significant danger of death or serious injury from the product in question. These are rare, and they should inspire absolute obedience. The FDA will create a plan for the manufacturer so that the recall is comprehensive and all recalled items are trackable. These products are meant to be taken from consumers and removed their homes.
There is also an action called “correction,” which keeps a product from being barred from the market. This is the “repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location.” Corrections can include supplementary surgical instructions, new labeling, additional parts and more.
Recalls have various depths to them, meaning how thoroughly they deal with the product’s problems. They might simply issue a public health warning to put the public on notice, or they might literally contact every person who received or bought a product to do an “effectiveness check.”
A company can also choose to withdraw the product entirely rather than comply with the FDA. A few companies did this after the FDA published their 2008 warning regarding transvaginal mesh devices. Instead of making sure their product complied with the new directives, they just pulled it from the market.
If you aren’t sure whether your device has any recall notifications, you can check with the FDA’s recall database by using simple search terms. You might also consider asking your doctor for the specific model number of your device if you can’t find it yourself.
Click here to search the FDA’s medical device recall database.
See more on FDA recalls for: