Medical Devices

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. However, 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 Device Regulation

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.

The Medical Device Industry

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, to amount of Class 3 medical devices offered to consumers.

An increase in the amount 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 employ to avoid taking responsibility.

Medical devices are classified based on the amount of risk that they carry to the patient.

Class 1 Devices

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

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

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.

Commonly Known Dangerous Medical Devices

Hernia Mesh

Various hernia meshes, including those made by companies like Johnson & Johnson, Ethicon, and Atrium Medical, have been associated with recent lawsuits after being used in hernia surgeries. Meant to support damaged tissue, unfortunately defective hernia nets have instead led to secondary revision surgeries as well as serious side effects. These failing products have cost patients time, medical expenses, lost wages, unnecessary pain and suffering, and more.

Hernia meshes 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 a revision surgery after a faulty hernia mesh, or suffered any other side effects from the faulty product, you may be eligible for a compensation. Reach out to the legal network at MedFault today to learn how we can help.

Bair Hugger

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 a compensation. Reach out to MedFault’s team of expert attorneys today for a no-obligation consultation about how we can help.

Phillips CPAP

Certain respiratory devices manufactured by Phillips Respironics, such as ventilators, BiPAP, and CPAP machines were recalled after a potential dangerous health risk 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 Phillips respiratory devices may qualify for compensation after being exposed to dangerous chemicals and the increased risk of developing certain 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 who has jeopardized your health.

MOM Hip Replacement

After a hip replacement surgery, your focus should be on healing and recuperating. However, unfortunately recipients of certain “metal on metal” hip implants may be put at a higher risk of adverse affects after the surgery. The interaction of chromium, cobalt, and titanium in “metal on metal” implants can create a risk to the patient who is being exposed to greater amounts of metal ions or particles entering the bloodstream. Certain adverse affects may include kidney damage, allergic reactions, increased risk of secondary surgery, and more.

If you’re unsure if you received a MOM hip replacement, speak with your doctor. If you have experienced adverse affects after a hip replacement surgery, an experienced attorney may be another useful resource. MedFault can connect you with a network of experts who will review your case, help you understand your legal options, and help you get the compensation you may deserve.

The FDA decides whether an OTC drug can be sold by comparing it to OTC drug monographs, which specify acceptable ingredients, doses, formulations and labeling. OTC drugs that conform to an existing monograph can be sold without further FDA clearance. OTC drugs that do not fit an existing monograph must undergo the same review and approval as prescription drugs.

An OTC drug can have different approved uses and instructions than a prescription drug with the same name, so it’s important to follow the directions on the label and as given by your doctor.

If Dangerous Devices Have Been Discovered, Why Are They Still Available?

Certain dangerous medical devices remain available because for some patients, the rewards of receiving them outweigh the risks. Having your doctor take a complete history, as well as review the most up to date information, is key to ensuring you are prescribed the most accurate treatment. If you suspect your doctor has been negligent or careless with your health, MedFault can connect you to an experienced medical malpractice lawyer to help discuss the circumstances of your case.

Additionally, some FDA approved devices, such as those designated Class 1 or lower risk, may not had to provide clinical data. 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 installed 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 devices are actually reported. Certain lawsuits have helped those harmed by dangerous devices not only seek compensation, but also blow the whistle so that the same harm does not befall others.

Biological Products Include:

Vaccines
Vaccines
Vaccines
Vaccines
Vaccines
Vaccines
Vaccines

What to Do If You or a Loved One Has Been Harmed by a Dangerous Medical Device

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

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. The expert network at MedFault understands the gravity of the situation. Our professional medical malpractice and dangerous device lawyers can help you handle the situation 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.

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Next to the medicine itself, label comprehension is the most important part of self-care with OTC medicines

According to the FDA Website

Are All Drugs Dangerous?

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Regardless of whether a drug is prescription or OTC, brand-name or generic, it has the potential to cause side effects.

“Side effects, also known as adverse events, are unwanted or unexpected events or reactions to a drug,”- according to the FDA.

Side effects of a drug can be as minor as headaches or as severe as increased risk of kidney failure. Sometimes side effects are associated with all drugs in a particular drug class.

Type 2 Diabetes Drugs

Invokana, Invokamet and Farxiga are all SGLT2 inhibitors. Drugs in this class are associated with diabetic ketoacidosis (DKA), kidney injury, blood infection, urinary tract infections and lactic acidosis.

Antidepressants

Prozac, Zoloft, Paxil, Celexa and Lexapro are all selective serotonin reuptake inhibitors (SSRIs), which are linked to increased thoughts of suicidal behavior and birth defects.

Stomach-Acid Drugs

Prilosec and Nexium carry warnings for kidney injury and bone fractures, as do other members of the proton pump inhibitor (PPI) drug class.

Fluoroquinolone Antibiotics

Fluoroquinolones feature black box warnings — the FDA’s strongest warnings— for “disabling and potentially irreversible serious adverse reactions” such as tendinitis and tendon rupture; peripheral neuropathy and central nervous system effects.

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What to Do if You’ve Been Harmed

To many people, a drug is meant to bring relief and a biologic is the last hope for getting their lives back. So it’s even more devastating when the medicine intended to relieve their symptoms or prevent illness ends up leaving them with a debilitating condition.

Although it may not resolve medical issues, there are actions injured patients can take to help lessen the distress and help protect others from the same problems, including reporting side effects to the FDA and seeking compensation and justice through a lawsuit.

Lawsuits

A combined 97,805 personal injury/product liability cases were filed in U.S. district courts in 2014 and 2015. Drug-injury lawsuits may go after a company over marketing defects, design defects or manufacturing defects. Marketing defects, also known as failure-to-warn defects, are some of the most common types of product liability lawsuits.

Report to the FDA

The FDA encourages consumers to report adverse events to the agency. It evaluates each report to determine the level of seriousness and may ask for more information from the person who filed the report before taking action.

Featured Dangerous Drugs and Devices

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.

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