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FDA Warns of Increased Death Risk with Common Surgical Balloons and Stents

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Team of Surgeons Operating.

The U.S. Food and Drug Administration is updating its warning about surgical balloons and stents that are coated in the drug paclitaxel. The agency’s letter warns that there is an increased risk of
death when these medical devices are used to treat peripheral arterial disease in a patient’s femoropopliteal artery.

Back in January, a few weeks prior to this recent update, the FDA notified doctors and health care providers about this potential increased risk of death in patients receiving paclitaxel-coated balloons
and paclitaxel-eluting stents as part of their medical procedure. This initial warning was based on data in a study published by the Journal of the American Heart Association.

The FDA Conducts Its Own Study.

Since then, the FDA has been conducting its own study, analyzing long-term data from patients being treated with paclitaxel-coated products in procedures treating peripheral arterial disease. The FDA’s preliminary review of this new study identifies what it calls a “potentially concerning” sign of increased mortality. The study focused on patients who were treated with paclitaxel-coated surgical balloons and stents as part of their medical procedure, and it compared their health to patients
who underwent similar procedures, but with uncoated devices.

Researchers looked at almost 1,000 patients and date going as far as five years following their initial medical procedure. The data showed that about 50% of those patients using paclitaxel-coated products had an increased risk of mortality.

Doctors use paclitaxel-coated stents and balloons to help improve the blood flow to a patient’s legs. The devices also help to decrease the likelihood of a patient requiring additional medical procedures to re-open blocked blood vessels.

What Does This Study Mean?

Although the findings are dire, the FDA is warning health care professionals and researchers to interpret these findings with caution. The agency highlighted that the study is based on very limited
long-term data, which could lead to a high variability in the estimated death risk. The data in this new study was also pooled, which, according to the FDA, can increase the level of uncertainty in the test results. Finally, the connection between the use of the product and the actual cause or mechanism of the patients’ deaths have not been analyzed.

Despite this uncertainty, the FDA says that its findings do indicate an alarming increased risk of death from using paclitaxel-coated medical devices, the FDA is recommending that doctors and health care professionals look for alternative treatment options and to avoid these products. The agency is also urging medical professionals to inform their patients about an increased risk of death from using paclitaxel-coated balloons and stents, and to discuss alternative treatment options with them.

The agency says that it will continue to conduct further studies to analyze whether the benefits of these paclitaxel-coated devices outweigh the evident risk of long-term mortality. The agency also plans to consider the use of these devices in other types of medical procedures, such as treatment for limb ischemia and arteriovenous access stenosis. The FDA’s report states that it will continue a transparent
discussion about the risk of these medical devices and guide future regulations of them, if needed.

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Defective Products

Firefighting Foam Lawsuits Surge as Health Risks Linked to “Forever Chemicals”

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Toxic Firefighting Foam at the Center of Growing Legal Battle

Thousands of individuals across the U.S. are pursuing legal action after being diagnosed with cancer and other serious illnesses allegedly caused by exposure to Aqueous Film-Forming Foam (AFFF)—a fire suppressant widely used by the military, firefighters, and airport personnel.

PFAS: The “Forever Chemicals” Linked to Cancer

AFFF contains per- and polyfluoroalkyl substances (PFAS), toxic compounds that persist in the human body and environment. These “forever chemicals” have been linked in scientific studies to a range of health problems, including kidney, testicular, liver, and thyroid cancers, as well as thyroid disease and ulcerative colitis.

Nearly 9,000 Lawsuits Consolidated in Federal Court

The AFFF multidistrict litigation (MDL), currently underway in federal court, has consolidated close to 9,000 individual claims. Plaintiffs allege that manufacturers failed to disclose the health risks associated with PFAS despite internal evidence of harm.

Corporate Misconduct Under Scrutiny

Recently unsealed documents suggest that companies like 3M were aware of PFAS toxicity but marketed their products as safe and environmentally friendly. The revelations have intensified public scrutiny and fueled demands for accountability.

Major Settlements Signal Legal Momentum

Several large settlements have already been reached. Carrier Global Corp agreed to a $615 million payout to resolve water contamination claims tied to PFAS exposure. The volume of new cases continues to rise, with nearly 500 added to the MDL in March 2025 alone.

Key Trials and Scientific Review Ahead

The court has scheduled a series of bellwether trials to help determine the strength of the scientific and legal arguments on both sides. A “Science Day” on June 20, 2025, will focus specifically on the link between PFAS and cancers such as thyroid and liver cancer.

Who May Be Affected

Individuals at highest risk include firefighters, military service members, airport personnel, and residents living near military installations where AFFF was routinely used. Those exposed through contaminated drinking water or occupational settings who later developed qualifying illnesses may be eligible for compensation.

Next Steps for Potential Claimants

Legal experts note that many firms are offering free case evaluations and require no upfront costs to file a claim. As litigation intensifies, advocates urge anyone affected by PFAS exposure to seek legal guidance and explore their options for recovery.

Those looking to inquire about a potential compensation claim can visit https://www.afffexposure.com/.

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Sunbeam Crockpots Recalled for Burn Injuries

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Sunbeam Products has issued a recall of one of its crock pot products due to a burn hazard. The recall came just two days before the Thanksgiving holiday, during a time when crock pots are often in use.

Details of the Crock Pot Recall

The product involved in the recall is the Crock-Pot 6-Quart Express Multi-Cooker. Almost one million of these defective products have been sold. According to the recall, the multi-cooker may pressurize if the lid hasn’t been locked in place completely. The pressure can make the lid to detach when the crock pot is in use. If the hot food or liquid ejects from the pot, it can lead to serious burns.

The recall impacts mostly purchases in the US with almost 29,000 in Canada. The cookers were bought at Walmart, Target and online at Amazon as well as other national retailers. The timeline was from July 2017 and up to the time of the recall. The crock put costs between $70 and $100. To find out if your crock pot is part of the recall, you can look at the bottom of the base or on the electrical plug on one of the prongs for the codes K196JN through K365JN and L001JN through L273JN.

It’s advised that anyone with this product not use it as a pressure cooker, but it can be used for sauted and slow cooking recipes. The company will send lids to consumers for free to replace the defective ones if they contact the manufacturer.

The recall notice advised that if consumers use the product as a pressure cooker, they should make sure the lid is in the fully locked position. They can tell if it is secured by making sure the arrow on the lid is aligned with the lock on the base.

Burn Injuries and the Serious Consequences

Sunbeam has gotten more than 100 reports where the lid detached in use. This resulted in almost 100 burn injuries. These burns range from first-degree to third-degree.

A first-degree burn is considered superficial because it only impacts the first layer of skin. This type of injury may not require medical care, but it can be quite painful. However, some cases may require a visit to the doctor or hospital if it covers a large area or hurts too much. Third-degree burns are much more serious and require immediate medical care because the burn impacts the other layers of skin. Infection is often a major concern with third-degree burns as well as other complications.

A person with a third-degree burn may feel a great deal of pain, but it can also be numb. There is often scarring from this type of burn. However, any burn can be considered serious if not taken care of properly.

While many products are recalled and often ignored, this recall from Sunbeam is considered serious and should not be taken lightly. Anyone with one of these products is at risk for serious and permanent injury.

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Ceiling Fans Being Recalled for Flying Blades Safety Risk

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Nearly 200,000 ceiling fans have been recalled after reports were made that the blades of the fans came off while in use. Injuries and property damage were reported from some of the incidents.

Faulty Ceiling Fans and the Dangers They Present

Hampton Bay Mara ceiling fans were for both indoor and outdoor use. They were sold at Home Depot in store and online. These products were sold during April and October of 2020. The fans come in black, matte black, matte white, and polished nickel. They feature a remote control and a color-changing LED light.

Of the almost 200,000 products, almost all were sold in the US. Nearly 9000 were sold in Canada. Anyone who has purchased one of these fans should stop using them and check that the blades are secure. Consumers should look for movement in the blades when the fan is shut off. They should also inspect for gaps between the blades that are uneven and movement of the body or clip.

If anyone notices a problem with their ceiling fan, they are to contact King of Fans for a free replacement. The company that makes the fans has promised to replace any problem products for free. There have already been 47 reports where the blades detached from the body while in motion. Two of those reports showed the blades hitting someone with four reports showing property damage. The defect comes from the fan flywheel and the locking clip for the blade, which allows the blade to become detached.

Ceiling Fan Installation Dangers and Risks

Ceiling fans can be dangerous even without a defective product. If you DIY an installation and it isn’t done properly, you could end up with disastrous results. Because the fan is heavy, if it’s not attached correctly, it can come crashing down. Added to the weight of the fan is the rotational pull when it’s turned on. It’s critical to know how to install a fan properly to prevent injury.

Electrical issues can also cause damage and injury if the circuits are overloaded. This is more likely to be an issue in an older home, which may not be equipped to handle the increased electrical load. A fire can start in a bedroom where a ceiling fan is located. By the time you are aware of it, the fire may have spread out of control.

If the ceiling fan blades detach, they can hit someone in the head or elsewhere on the body. Since the fan is in use, the extra power from the blades turning can give them a stronger impact when they hit an obstacle. You could end up with a concussion or even a fracture or broken bone from one of these blades. If you have a faulty ceiling fan and need it replaced, don’t continue using the fan until a new one is installed. Consider hiring a professional and get a new fan to prevent injury to you or your family.

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