There are thousands of surgeries every year that involve using a medical device or implant to help patients with a variety of health conditions. Once a device is implanted, it becomes a part of your body and will stay with you until it is surgically removed.
Unfortunately, some medical devices have problems with them that aren’t discovered until months or years later. Some medical devices are defective and pose a risk of injury or death to the patients who received them.
The Food and Drug Administration recalls hundreds of thousands of devices, medications, foods, and supplements every year. If the drug company or medical device manufacturer issues a recall for a dangerous product, they should reach out to the person who is at risk of harm. Unfortunately, not all patients find out about the recall and they continue to live with the dangers of a defective device.
If a dangerous medical device caused you injury, or harm, or fatally took the life of a loved one, you may be able to file a claim against the medical device company. Talk to an experienced medical malpractice lawyer to understand your legal options for recovery.
What Are Medical Devices and Implants?
According to the Food and Drug Administration (FDA), a medical device can be “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory.”
Medical devices can be intended to:
- Use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- Affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
The FDA regulates several food and drug products and devices. The FDA regulates all sorts of food safety, drugs, medications, supplements, vaccines, blood transfusions, animal products, cosmetics, radiation-emitting devices, and medical devices.
FDA investigators (Consumer Safety Officers) inspect production facilities, investigate complaints, and review documentation for medical devices and other products.
The Center for Devices and Radiological Health (CDRH) approves medical devices, including manufacturing, safety, and performance of medical devices. Medical devices that are substantially equivalent to existing devices can be cleared but novel or new devices have to be inspected and approved for safety and efficacy.
What Are Examples of Implants and Medical Devices?
There are a variety of common medical devices in use today, from cosmetic implants to devices that keep the heart functioning. Medical devices can be classified as Class I to Class III.
- Class I devices have a low risk of harm, including bandages, surgical instruments, stethoscopes, bedpans, and non-electric wheelchairs.
- Class II are intermediate-risk devices, like infusion pumps for intravenous medication, electric wheelchairs, and pregnancy tests.
- Class III devices can carry a high risk to patients. Class III devices are often implanted, including pacemakers, breast implants, or deep-brain stimulators.
Some examples of Class III implants and medical devices include:
- Artificial hip
- Artificial knee
- Ankle replacement systems
- Breast implants
- Cochlear implants
- Implanted prosthetics
- Implantable cardioverter-defibrillators
- Mechanical heart valve
- Coronary artery stents
- Hernia mesh
- Balloon catheter
- Spinal spacers
- Intraocular lenses
- Intrauterine device (IUD)
- Spinal screws
- Artificial discs
- Ear tube
- Dental implant
How Are Medical Implants Monitored?
The FDA continues to monitor medical devices postmarketing. The devices are reviewed for safety, performance, side effects, and malfunction. The manufacturers also have postmarket surveillance requirements.
When patients or doctors experience problems with medical devices, they can report the problems to the FDA. The FDA has a Safety Information and Adverse Event Reporting Program. There are mandatory reporters and voluntary reporters. Mandatory reporters include manufacturers, importers, and user facilities. Voluntary reporters include doctors, healthcare professionals, patients, and caregivers.
If you report an adverse safety event to your doctor involving your medical implant or device, your doctor can report the event to MedWatch, the FDA’s reporting system. Information that can be reported includes:
- Unexpected side effects or adverse events
- Product quality problems
- Product Use/Medication Errors that can be prevented
- Therapeutic failures
The safety reports include information about the person involved, adverse event, the outcome of the event (hospitalization, death, disability, etc), date of the event, and other relevant information. After reporting the adverse event, the event is saved in a database. Safety evaluators may look for similar incidents and monitor the information for trends. The FDA investigator may look into the incident.
What Happens When There Is a Medical Implant Recall?
If the FDA determines there is enough information to warrant a safety concern, it can take action to protect public health. According to the FDA, “When a company learns that there is a problem with one of their medical devices,” it can propose a correction or removal. Correction addresses a medical device problem where it is used or sold. A removal takes it out of the market.
For some devices, if there is a removal, the device can be removed or changed out for a safer product. However, for some devices, it may not be practical or possible. For example, if there were problems with a knee implant, the patient may not want to undergo knee surgery to have the old artificial knee removed and a new one put in. Instead, removal may involve contacting doctors about the risks involved.
Depending on the type of medical device, implant, and recall dangers, medical implant recalls can involve:
- Inspecting the implants for signs of defects
- Implant repair
- Removing and destroying the implant
- Notify patients about the problem with the implant
- Monitoring the implant patient for health concerns
When an implant or device manufacturer initiates a recall, it notifies the FDA. The FDA may include the device on their recall notice website, complete with information about what patients can do if they were a recipient of the defective implant.
How Serious Are Implant Recalls?
The FDA classifies medical device recalls based on the risk to patient safety, from Class I to Class III.
- Class I is the most serious, where there is a reasonable chance that a product will cause serious health problems or death.
- Class II involves a device that may cause a temporary or reversible health problem or where there is a slight chance that it will cause serious health problems or death.
- Class III recalls are the least serious, where a product is not likely to cause any health problem or injury.
The FDA provides information about recalls in the Medical Device Recall Database. The FDA will classify the risk and notify the public in weekly Enforcement Reports. This and other consumer information about recalls are supposed to make sure patients are aware of the health hazards posed by their defective medical implants.
The Medical Device Recall Database can be used to search for specific implants. Users can search by product name, the reason for the recall, recalling manufacturer, or other information. Patients with a medical device can also search The Medical Device Recalls lists. These are medical device recall notices by date, with a new recall list every year.
For example, there were approximately 60 separate Class I recall notices in 2022. These recalls included everything from COVID-19 tests that were never authorized by the FDA to ventilators that could fail, resulting in at least one death.
Examples of Recent Medical Implant Recalls
There have been several types of implant recalls since 2018, from breast implants linked to cancer to ventricular assist implant kits with a weld defect. Here is some information about implantable device recalls by the FDA in recent years.
HVAD Pump Implant Kit for Pump Weld and Other Defects
On April 11, 2022, Medtronic recalled more than 1,600 HeartWare Ventricular Assist Device (HVAD) System implant kits. The HVAD helps the heart pump blood to the rest of the body. There was a malfunction with the weld on the pump, which caused the pump to rotate incorrectly. The defect could lead to severe injury or death, with at least one death reported.
On November 19, 2020, Medtronic had an earlier recall of HVAD pump implant kits because the devices could fail to start, restart, or have a delay in restarting after the pump stopped. Risks included heart attack, heart failure, hospitalization, and death. Two deaths were reported associated with the defects.
Implantable Cardioverter Defibrillators (ICDs)
On May 10, 2023, Medtronic recalled almost 350,000 ICDs and cardiac resynchronization therapy defibrillators (CRT-Ds) for energy output problems. These implantable cardiac devices are supposed to monitor and regulate heart rate and heart rhythm. There were problems with the activation of the short-circuit protection, leaving the patients vulnerable to cardiac arrest, serious injury, or death.
In February 2021, Medtronic had another recall of ICDs and CRT-Ds for shortened battery life risk. Almost 240,000 devices were recalled. This time, the problem was an unexpected and rapid decrease in battery life, to full depletion in as little as one day. There were 444 complaints made regarding these devices, with over a dozen suffering injuries because of slow heart rhythm or heart failure symptoms.
There was an even earlier recall by Medtronic for ICDs and CRT-Ds in 2018 for a manufacturing error that prevented electrical shock delivery. The delay or inability to deliver a shock to a patient in cardiac arrest or pace a slow heartbeat could result in injury or death.
S-ICD (Subcutaneous Implantable Cardioverter Defibrillator) System Due to Risk of Short-Circuit
On December 2, 2020, Boston Scientific recalled more than 2,800 implantable defibrillators because they could short circuit. Patients could experience less shock or no shock, and other electronic issues. During manufacturing, moisture could get into the device, causing the short circuit.
Massive Breast Implants Due to Risk Cancer
On July 24, 2019, Allergan recalled more than 240,000 breast implants due to the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a cancer of the immune system. Textured breast implants have a rougher surface that is less likely to move around in the implant pocket.
Based on FDA analysis, the risk of this cancer for Allergan textured implants is approximately 6 times higher than the risks of textured breast implants by other manufacturers. According to the American Cancer Society, “Of the 573 cases of BIA-ALCL, 481 have been attributed to Allergan implants.” This is a rare type of lymphoma that occurs more often in women with textured surface breast implants.
The guidance of the FDA was for healthcare providers to stop using these breast implants. However, for patients without symptoms, breast implant removal was not recommended for patients without symptoms. Patients were advised to learn the symptoms and contact their health provider if they see any signs or symptoms of the condition.
What If I Have a Problem But There Is No Recall?
If you don’t see your implant on the FDA recall list, it does not mean that the device isn’t defective. There may be hundreds or thousands of defective devices but injury victims don’t associate their injuries with the implant. If you think there is a problem with your implant, talk to your doctor. You may also be able to report your implant problems directly to the FDA’s MedWatch.
Some medical devices are not defective by themselves. However, the surgeon could have negligently performed the surgery, misplacing the implant, failing to follow proper surgical procedures, or even by leaving behind surgical materials inside the patient’s body after surgery.
If you suffered an injury, pain, or emotional distress after a surgical error, you may be able to recover compensation from the doctor with a medical malpractice claim. If the device was defective, you may be able to get damages from the medical device manufacturer. Damages can include medical bills, lost income, and pain and suffering.
If you think you may have been injured because of something wrong with your implant device, talk to experienced medical malpractice lawyers, like the trial attorneys at Gilman & Bedigian. Contact Gilman & Bedigian online or at 800-529-6162 for a free consultation.