The term “medical device” covers nearly every item used in medical care. Medical devices are specifically designed for particular medical uses ad can be extremely complex and spotting a defect in them may be impossible until after they are already causing serious harm to a patient’s health.
Common Types of Defective Medical Devices
Just a few of the devices that have been recalled or identified as potentially defective in recent years include:
- DePuy hip replacement implants: These implants were used in thousands of hip replacement surgeries, but their high failure rate and risk of patient injuries have resulted in several recalls.
- Knee replacement implants: Nearly 700,000 people in the U.S. undergo knee replacement surgery every year, but loosening or misalignment in the implant can cause bone fractures, nerve damage, and severe pain.
- Transvaginal mesh: Intended to treat pelvic organ prolapse (POP) and related conditions, many forms of transvaginal mesh have been recalled for causing severe soft tissue damage in the very region of the body they were intended to support.
- DaVinci and other surgical robot errors: Surgical robots are intended to help surgeons perform more delicate operations with less harm to surrounding tissue. When the system malfunctions, however, serious harm can result.
- Mirena: The Mirena IUD is a popular form of birth control, but some patients have reported serious injuries like uterine rupture, ectopic pregnancies, and life-threatening infections.
- Guidant cardiac defibrillator: Also known as a pacemaker, these items are intended to help treat heart disease and help the heart maintain a normal rhythm. Guidant’s defibrillators were part of a massive 2005 recall after defects were discovered, however.
- Cypher stent: Stents are used to help coronary arteries and veins stay open, so the blood can flow through them. Cypher’s stents were designed to release medication to help prevent plaque buildup in arteries. They were later linked to blood clots, heart attacks, strokes, and death.
- Bair hugger blanket: Designed to help keep patients warm during surgeries, these blankets have been implicated in cases of severe burns, hyperthermia, and deep joint infections when used during hip or knee replacement surgeries.
- Calaxo bone screw: These bone screws are used to repair the anterior cruciate ligament (ACL) in the knee, which can be ruptured during sports or other activities. The Calaxo screw was recalled in 2007 after being linked to severe pain in post-operative patients.
What Is a Defective Medical Device?
A “defective medical device” is any medical device that does not work as intended, due to a flaw in its manufacture, its design, or the warranties and warnings that came with the device to explain how, where, and why it should be used. The list of potentially defective medical devices ranges from items like surgical instruments to implants, pacemakers, and prosthetics.
Typically, a defective medical device will suffer from at least one of three potential defects these can be manufacturing defects, design defects or warning defects.
Ways Medical Devices Can Be Defective
- Manufacturing defects. These defects are most often found in the materials used to make the device. For instance, patients with certain hip replacement implants have suffered from heavy metal poisoning when cobalt metal used in the device moved into the surrounding tissues. The use of cobalt to make the device, and the failure to use a coating or shell to prevent it from contacting the patient’s body directly, are examples of manufacturing defects.
- Design defects. When a medical device is made out of materials that are appropriate for its function, but it is designed in a way that causes harm, the device is said to have a “design defect.” A hip replacement that is made from non-toxic materials but that has a hinge that is too weak to support the weight of an adult human’s body might be said to have a design defect. If it were designed with a stronger hinge, the defect may be remedied.
- Warning defects. Not all items can be made completely safe. If some risks still exist – as they often do for medical devices – the device must come with adequate warnings for the healthcare team and for patients, so that the risks can be understood and monitored. A lack of adequate warnings can cause a device to be used on the wrong patient or for the wrong condition.
Questionable Approval Process for Medical Devices
Most people in the United States trust that before a medical device is used on patients, the U.S. Food and Drug Administration (FDA) has subjected the device to rigorous testing and review. But this is not always the case.
Many medical devices approved by the FDA are not fully tested or examined by the agency. In fact, the FDA generally relies on manufacturers to perform their own studies, and even that does not happen in some instances. Instead, some medical devices come to market through a process known as “premarket notification.” It is also called the 501(k) clearance process, after the section of the law that allows the process to operate.
The 501(k) process requires the manufacturer to demonstrate that the product being reviewed is “substantially equivalent” to a device that has already been approved for market. The FDA typically assumes that the new device, being “substantially similar” to a previously approved device, is at least as safe and effective as the previously approved device. However, the actual outcome is often quite different.
A recent study performed by the Institute of Medicine (IOM) on the 501(k) process, however, ended with the recommendation that the FDA make major changes to the 501(k) process. The IOM stated that the 501(k) process “lacks the legal basis to be a reliable premarket screen of the safety and effectiveness” of medical devices.
The IOM went further. It recommended that devices that have already been reviewed by the process should be reexamined thoroughly by the FDA to ensure that they are, in fact, safe and effective. In other words, instead of assuming these items are safe and effective, the FDA should require testing of them – which has not yet occurred for many devices.
If You Have Been Injured, The Time to Take Action Is Now
Attorney Scott C. Gottlieb has years of experience focusing solely on personal injury law. Our law firm fights for every client we represent, putting in the hard work and client-centered focus it takes to ensure that you receive full and fair compensation for the harm you’ve suffered. To learn more, contact our Binghamton law office today for a free consultation.