Medical devices are supposed to improve the quality of a patient’s health. When they are surgically implanted, patients expect an extensive recovery and regular medical check-ups. But no patient should expect the medical device to cause new injuries or to be recalled.
Medical devices are supposed to undergo a rigorous approval process with the Food and Drug Administration (FDA) before going on the market, but some screening fails to identify defective devices. Here are some things every patient using a medical device should be aware of regarding product recalls.
Who is Responsible for a Medical Device Recall? The FDA can legally require a company to recall a medical device. In many cases, however, companies recall their own medical devices.
What Does a Recall Mean? A medical device is recalled when it no longer meets FDA requirements. A recall means a medical device is defective, poses a risk to a person’s health, or both.
A recall may mean the device needs to be removed and replaced. It may also mean the device needs repairs or monitoring.
There are three classes of medical device recalls. A Class I Recall is the most serious and indicates there is a reasonable chance the recalled medical device could cause serious illness or even death.
A Class II Recall means a product may cause temporary health problems. A Class III Recall is the least serious type and occurs when the FDA instructs a manufacturer to make a correction that violates FDA regulations.
What is the 510(k) Approval Process? The FDA approves 90 percent of medical devices under the 510(k) process, including many devices which have been recalled in recent years. These include hip implants, external heart defibrillators and transvaginal mesh.
The process – also called Premarket Notification – was designed to bring new treatments to patients faster. Manufacturers must notify the FDA of their intent to market a medical device at least 90 days in advance. Medical device manufacturers are required to submit premarket notification if they plan to introduce a device for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety could be affected.
How to Learn About a Medical Device Recall. Your doctor or the medical device manufacturer should notify you. You can visit the manufacturer’s website to check for recall notices. The FDA also maintains an online medical recall database. Finally, large medical device recalls may receive media coverage, which may answer some of your questions.
What to Do When a Medical Device Recall Occurs. You can expect to work with the manufacturer as well as your doctor or surgeon.
You should follow your doctor’s advice, except if he or she asks you to sign a form authorizing the release of your medical records before treatment is undertaken. This would allow your physician to release your medical records directly to the manufacturer. It is not in your best interest to sign the release before speaking to an attorney.
Contact a Boston Medical Device Recall Lawyer. If you have a medical device which has caused you injury – or which you suspect has caused you pain and injury – you should contact an experienced Boston product liability lawyer. You may be entitled to file a lawsuit to recover damages for pain and suffering, medical costs and other expenses. You may also be entitled to damages if a loved one has suffered illness or been killed as a result of a defective medical device.
Medical device recalls are debilitating for patients who have often already suffered physical pain. Recall lawsuits are complex. If you have been injured by a defective medical device, Breakstone, White & Gluck has the experience, expertise and resources to obtain you results in your claim.
For a free legal consultation, contact us today toll-free at 800-379-1244 or 617-723-7676 or use our contact form.