About 90 percent of the more than 39,000 lawsuits filed against Bayer over Essure injuries have been resolved by a $1.6 billion settlement. Bayer said in a statement that the settlement resolves most filed and unfiled cases and that it continues to work with plaintiff’s lawyers to resolve the remaining cases.
FDA Actions and Essure Injury Complaints
The settlement comes after years of complains of adverse events involving the metal coils which are placed in the fallopian tubes. Some of these complaints say that the coils can perforate the tubes, tear the uterus, and that the coils can break causing little metal shards to migrate elsewhere in the body. Women have also complained of heavy bleeding, pain, and other side effects that the patients were forced to undergo hysterectomy.
In 2018, the U.S. Food and Drug Administration placed restrictions on the device and required patients to review the Patient- Doctor Discussion Checklist and sign prior to being implanted with the birth control device. Bayer made the decision to stop selling Essure in the United States not long after citing declining sales.
Post-Market Surveillance Reports
The required 522 study, a post-marketing surveillance plan, was also extended by the FDA from three to five years. The FDA published the first spreadsheet of Essure adverse events on August 11, 2020, which includes events that Bayer knew or learns of during the period of November 2016 to November 2020.
The first spreadsheet includes more than 1,400 events including pain, device fragments, pregnancy, and organ perforations, including 1376 reports of serious injury, 53 reports of death and 24 reports of malfunction.
Essure Lawsuit Settlement
Many of the plaintiffs alleged in court filings that Bayer knew or should have known about the risk of adverse events, including organ perforation, device breakage, and device migration. They also allege that Essure birth control was improperly design and can break and migrate after being implanted. They accused Bayer of misrepresenting the efficacy and safety of the contraceptive device and Women who suffered Essure injuries alleged in court filings that Bayer concealed the risks and dangers of the device from the FDA, the medical community and from the women who relied on the device.
Many of the terms of the settlement are confidential, and Bayer did not admit to any wrongdoing in the court filings.
Sunbeam Crockpots Recalled for Burn Injuries
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.
Ceiling Fans Being Recalled for Flying Blades Safety Risk
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.
Excedrin Issues Recall for Headache Medicine
Less than a week before what is known as the biggest hangover day of the year on New Year’s Eve, one of the biggest manufacturers of OTC headache medicines has issued a major recall. Excedrin is recalling five different brands, which was announced the day before Christmas Eve, December 23.
This recall includes Excedrin Migraine Geltabs and Caplets as well as Excedrin Extra Strength Caplets, Excedrin Tension Headache Caplets, and Excedrin PM Headache Caplets. The reason for the recall was for a failure to meet child resistant packaging requirements. Some of the medications may be able to develop holes in the bottom of the containers, which would give easier access to children. They could consume the pills, which could cause poisoning.
The Poison Prevention Packaging Act requires medications with the ingredients acetaminophen and aspirin to be in child resistant packaging. Almost 434,000 bottles were recalled. The bottles impacted by the recall have been on the market between March 2018 and September 2020. Bottles included in the recall include those with 50-, 80-, 100-, 125-, 250- and 300-count packages.
No reports of injury have been made so far, but it is recommended that consumers store the medication out of reach of children. They should also check the bottoms of the bottles. If you find a hole in the bottle, contact the company for a refund. You can call 800-468-7746 for further instructions.
Dangers of Overdose
An overdose of this kind of medication could have serious and potentially fatal effects. The first signs of an overdose of Excedrin from the acetaminophen include nausea and vomiting, loss of appetite, sweating, confusion, weakness and stomach pain. If not treated, it could cause pain in the upper stomach, yellowing of the skin or the whites of the eyes, and dark urine. You may also notice headache, hallucinations, a fast or slow heart rate, diarrhea, ringing in the ears and convulsions.
An overdose of this medication can lead to liver damage or death. If you find that a child has taken the medicine or suspect it may be the case, call Poison Control immediately. Immediate emergency medical attention is necessary.
The interactions between Excedrin and other medications with aspirin or acetaminophen can be serious and dangerous, which could lead to a fatal overdose. These two ingredients are found in other medications, which makes an overdose of Excedrin even more dangerous.
It is also possible that a child may have an allergic reaction to taking Excedrin. Symptoms include swelling of the face, tongue, lips or throat, difficulty breathing, and hives. Take any complaints seriously and get help right away.
Another rare reaction to medications which contain acetaminophen include a skin issue, which causes peeling and blistering. It can happen even if you’ve taken the medication before with no problems. It can cause you to feel light-headed, agitation, panic, confusion and bleeding.
More common side effects from this medication include upset stomach and feeling anxious or depressed as well as insomnia. If you are concerned that a child may have taken the medication, get medical attention as soon as possible.
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