According to the Food and Drug Administration, FDA, a medical device is an “instrument, apparatus, implement, machine, contrivance, implant intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.” These instruments have good intentions; however, the question that must be asked is: are all medical devices really safe? Unfortunately, we do not live in a perfect world, resulting in the possibility of defects with medical advancements. When it comes to medical devices, defects are exposed in the form of recalls. In order to ensure your safety, you must become aware of the medical devices you are exposed to.
The Answer is No:
Are all medical devices safe? The answer is no. The reason for this is due to their inherent classification. As noted by the FDA, the Medical Device Regulation Act enacted in 1976 outlined three classes for medical devices:
- “Class I devices are subject only to general controls. They typically present the lowest potential for harm and are simpler in design than Class II or Class III devices. Examples of Class I devices include elastic bandages, examination gloves, and hand-held surgical instruments.”
- “Class II devices are those for which general controls alone are insufficient to provide a reasonable assurance of safety and effectiveness. In addition to complying with general controls, Class II devices are also subject to special controls identified by the agency, which may include special labeling requirements, performance standards and post market surveillance. Examples of Class II devices include powered wheelchairs, infusion pumps, and surgical drapes.”
- “Class III devices generally are those for which insufficient information exists to determine that general or special controls are sufficient to provide a reasonable assurance of safety and effectiveness. Examples of Class III devices include replacement heart valves, silicone gel-filled breast implants, and implanted cerebellar stimulators.”
Because different classes pose different risks, there is no guarantee for the safety of all medical devices. Class I devices are typically safer than Class II devices, and Class II devices are typically safer than Class III devices.
History of Harmful Devices:
Throughout history, there have been certain medical devices that have been notoriously harmful. First, intrauterine devices (IUDs) are T-shaped instruments that are meant to prevent pregnancy. IUDs have been known to cause menstrual bleeding, cramps, and other side effects. According to the Recall Center, the Mirena IUD has been recalled before due to infection, pain, bleeding, fatigue, confusion, and effects of anesthesia when the device is implanted.
Furthermore, many hip implant devices have been recalled. For example, DePuy- a sect of Johnson & Johnson- recalled its ASR implants after a study revealed the high failure rate of the device. The implants failure was due to a plethora of reasons, including: loosening, misalignment, infection, fractures, dislocation, sensitivity, pain, necrosis, swelling, and many other symptoms.
These specific devices are just two of the many harmful medical devices that are recalled every year. It is vital to make sure you are are not risking your health due to a faulty medical device.
Tracking:
The FDA consistently monitors medical devices to ensure safety for people across the United States. The FDA keeps track of a list of medical devices that may pose a risk to people using them. If you are using a medical instrument, it is important to check this website to see if the device you are using has been recalled.
Your Rights:
As a consumer and user of medical devices, you are entitled to many rights and protections. Initially, the burden of safety falls squarely on the shoulders of producers of medical instruments and the Food and Drug Administration. It is the duty of the manufacturer to comply with all FDA rules and regulations. Additionally, it is the job of the FDA to ensure these rules and regulations are followed. When a device is deemed faulty, the FDA recalls the device and notifies the public. Under the Federal Food, Drug, and Cosmetic Act, the FDA has the authority to regulate food, drugs, and cosmetics; this includes medical devices. As such, you have the right to be protected by the FDA.
The Importance of Counsel:
When it comes to medical devices, the legality of it all can become very tricky. At the Brooks Law Group, we are firm believers of justice. If you believe you are a loved one has been injured due to a medical device, please do not hesitate to contact our attorneys who will not rest until you get the compensation you deserve. At the Brooks Law Group, our educated and experienced lawyers are trained to fight for your rights. Please visit our website to file a free case evaluation and call us at 863-299-1962.
