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When a medical device malfunctions or causes unforeseen side effects, it can do more harm than good. Patients and medical professionals need to have the most up-to-date information about the devices that they trust in order to make informed decisions.
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Medical devices can be life-saving resources for many patients. From pacemakers to insulin pumps, medical devices can empower users to live longer, healthier, more autonomous lives. They can also help diagnose or detect problems, helping doctors make educated decisions about treatment.
Medical devices can be diagnostic tools, such as x-ray machines and ultrasound devices. They can be simple and relatively common, such as bedpans, tongue depressors, or blood pressure cuffs. Medical devices may also be more complex, such as artificial organs. They do not have to be used solely by medical staff to qualify as a medical device, as many consumers use medical devices themselves at home.
All medical devices are regulated by the FDA, as per Section 201(h) of the Food, Drug, and Cosmetic Act. The intended use of the device is what classifies certain items as medical, as opposed to recreational, and thus subject to federal regulation. Anything classified as a medical device has to be tested and approved by the FDA before it can be marketed to consumers and medical professionals. The FDA also has the power to recall medical devices deemed unsafe off of the market.
However, even with the maximum amount of oversight possible, some dangerous medical devices still slip through the cracks. Unfortunately, these hazards can be passed onto the consumer, who is turning to these devices in a time of trouble and medical necessity. When companies conceal information from the public or fail to conduct adequate research, it can bring pain, hardship, and complications to those who have used their products. All consumers deserve to know the facts about what they use, but this is especially meaningful for someone using a medical device as a patient.
Medical devices are classified based on the amount of risk that they carry to the patient.
Examples of Class 1 medical devices include dental floss, bandages, and examination gloves. While some of these may be used by professionals, many Class 1 devices are common household staples. They carry the least amount of risk to the patient.
Class 2 devices are riskier than Class 1 and are more commonly associated with more serious conditions. Examples of Class 2 medical devices include some common-use objects like powered wheelchairs and some hospital tools like surgical drapes.
Class 3 devices are often life-saving innovations, but also bring the most risk to the patient. Because of this, they are the most stringently tested and regulated by the FDA. Some examples of Class 3 devices include pacemakers and artificial heart valves.
Over the past 10 years, the medical device industry has essentially doubled in size. However, while more and more companies have begun to manufacture medical devices, or expanded their own offerings, the number of adverse events associated with medical device usage has also been on the rise. According to recent data, there has been an 88% increase in reported adverse events associated with the use of medical devices in America. At the same time, there has been an 11% expansion, a significant amount of growth, of the amount of Class 3 medical devices offered to consumers.
An increase in the number of medical devices being manufactured and offered can point to more innovation in the industry. For instance, while cardiovascular devices offer the most amount of risk in recent years, they also offer some of the greatest rewards to the patients who receive them. Because of their great potential for good as well as harm, medical devices need to be stringently monitored. Ideally, dangerous medical devices would never be put on the market at all.
For those who have already been affected by faulty or dangerous products, financial compensation may be available to help ease the burden of financial stress, pain, suffering, and more that you may have suffered. Reach out to MedFault today to be connected to expert legal teams with experience obtaining justice against Big Pharma. Our attorneys have the financial resources, tools, and experience necessary to face off against the large teams of defense attorneys companies often employ to avoid taking responsibility.
Certain respiratory devices manufactured by Philips Respironics—such as ventilators, BiPAP, and CPAP machines—were recalled after potentially dangerous health risks came to light associated with their use.
The interior linings of certain devices were made with polyester-based polyurethane, meant to reduce the amount of noise they made when operating. However, the foam was shown to break down when in use, meaning that certain small particles were absorbed by patients’ airways. Black debris from the foam, as well as potentially carcinogenic chemicals, were released to be inhaled or swallowed by users of these machines. Additionally, certain cleaners and cleaning techniques make the breakdown of the dangerous foam more likely.
Users of affected Philips respiratory devices may qualify for compensation after being exposed to dangerous chemicals and the increased risk of developing certain health conditions. If you or someone you know used one of these devices, MedFault can connect you to a legal network of experts with the tools and resources available to take on a large company that may have jeopardized your health.
If you suspect that you were injured after using a Philips CPAP machine, you may qualify for compensation.
Various brands of hernia mesh used in hernia repair surgeries, including those made by companies like Johnson & Johnson, Ethicon, and Atrium Medical, have been the subject of recent lawsuits. Meant to support damaged tissue, some defective hernia mesh has instead led to secondary revision surgeries as well as serious side complications such as adhesion, hernia reoccurrence, and bowel perforation. These failing products have cost patients time, medical expenses, lost wages, unnecessary pain and suffering, and more.
Studies of people who underwent hernia repair surgery found that one-third of patients are later hospitalized due to complications and between 7.5% and 10% of patients experience hernia recurrence.
Hernia mesh can be made from either animal byproducts or manufactured synthetically. Unfortunately, neither method escaped the manufacturing mistakes made by these companies. If you or someone you know had to have revision surgery after being implanted with a faulty hernia mesh, or suffered any other side effects from the faulty product, you may be eligible for compensation. Reach out to the legal network at MedFault today to learn how we can help.
During certain surgeries, contracting surgical hypothermia—or a dangerous lowering of the body’s temperature—is a very real risk to the patient. The Bair Hugger system was designed to circumvent that risk by collecting air, warming it, and dispensing heat to the patient via a disposable blanket. Different-sized blankets, as well as air blowers, made the Bair Hugger adaptable to patients of all different ages and sizes.
Unfortunately, the Bair Hugger system has been associated with an increased risk of serious infections acquired during surgeries. Because of the way the system circulates contaminated air, studies have shown that it promotes bacterial growth in an already vulnerable area.
Infections and complications from Bair Hugger devices are particularly common during knee or hip replacement surgeries. If you or a loved one developed an infection after any surgery that used a Bair Hugger device, you may be eligible for compensation. Reach out to MedFault’s team of expert attorneys today for a no-obligation consultation about how we can help.
If you suspect that you were injured after using a Bair Hugger machine, you may qualify for compensation.
Oftentimes adverse events are only discovered after medical devices have been approved for patient use. Some FDA-approved devices, such as those designated Class 1 or lower risk, may not have to provide clinical data at all. After the 2002 Medical Devices User Fee Act green-lighted the “least burdensome route” to approval, it is possible that receiving FDA approval on some devices still does not guarantee they’ve undergone the most rigorous testing available.
Finally, unless a problem is reported to the FDA, it’s possible that dangerous medical devices can continue to be prescribed and used until action is eventually taken. The FDA’s voluntary reporting system means that doctors, patients, and manufacturers can report problems with medical devices, but experts estimate that only a fraction of dangerous complications is actually reported. Legal action can not only help those harmed by dangerous devices seek compensation but also blow the whistle so that the same harm does not befall others.
If you’ve been injured by a medication, medical device, or medical error, you may be eligible to file a lawsuit. Find out if you qualify.
Between 2008 and 2018, defective medical devices caused more than 80,000 deaths
Being harmed by a defective medical device may be a concerning or alarming experience. The tools we use to help us through difficult medical situations should be as trustworthy as possible. When they cause severe complications and adverse events, it is important that it is reported to help protect other patients from similarly being injured.
Medical device injuries can be severe and life-altering. No patient should have to navigate treatment and recovery on their own. Below are some resources to help hold manufacturers accountable for the harm you may suffered.
If you’ve been harmed by a medical device or know someone who has been, there are three main professional parties you should consider reaching out to:
-Your doctor
-The FDA to report the problem
-An experienced dangerous medical device attorney
The expert network at MedFault understands the gravity of the situation. Our professional defective medical device lawyers can help you by researching the complex medical issues involved, pinpointing any and all negligent parties, assembling expert teams able to take on the many challenges put up by the defense, and finally, helping you get the compensation you may be entitled to.
Schedule your free legal consultation to learn more about your rights to possible compensation.
We rely on drugs and medical devices to improve our quality of life, but sometimes companies market unsafe products that may cause terrible — sometimes irreversible — side effects.
