Allergan Implants More Likely Than Others to Cause Cancer

In 2011, the Food and Drug Administration (FDA) identified a link between some textured breast implants and a form of Lymphoma known as Breast Implant-Associated Anaplastic Large Cell Lymphoma, or more commonly called BIA-ALCL.

Despite evidence to suggest there was a link between textured implants and BIA-ALCL, it wasn’t until July of 2019 that the FDA called for Allergan, a top producer of these implants, to place a voluntary recall on their textured implants. This came amid growing reports of women developing this rare form of cancer after receiving textured implants. Allergan complied and issued worldwide recall of their BIOCELL and NATRELLE textured implants and tissue expanders. Allergan’s implants and expanders has been confirmed to pose a greater risk for BIA-ALCL than other manufacturers similar textured implant models. The smooth surfaced implants and expanders manufactured by Allergan are not included in this recall and are still considered generally safe for use at this time.

If an individual is confirmed to have received these implants, they should know the signs and symptoms of BIA-ALCL. Cleveland Clinic reports that on average, symptoms begin to appear 8 years after implant but can present as early as one year after surgery. The most common symptoms to look for are sudden enlargement of one or both breasts, painful lumps in your breasts or armpits, hardening of one or both breasts, and skin rashes that could appear around the breast region.

Individuals with textured implants are encouraged to reach out to their medical provider and schedule an appointment to discuss the recall and their increased risk for cancer. Should symptoms be present, a physical exam by the provider and further testing such as a Magnetic Resonance Imaging (MRI) or Ultrasound may be ordered to search for a mass or fluid. If either are present, a biopsy may be necessary to test the surrounding fluid and tissue of the implants for signs of cancer

Many individuals with textured implants have opted to remove their implants out of the fear of developing cancer.

If you are your loved one have been diagnosed with BIA-ALCL or have had your recalled implants removed or replaced due to fear of developing BIA-ALCL, please contact one of our experienced attorneys here at The Yost Legal Group for a free consultation. We can be reached at 1-800-YOST-LAW (967-8529) or by emailing us at info@yostlaw.com. There is no fee unless we recover.

Exactech Faulty Liners Leaving 200,000+ Patients At Risk Of Implant Failure

In 2021 Exactech’s Connexion GXL Hip liner and Optetrak/Optetrak Logic Knee implants were recalled leaving more than 200,000 people with faulty devices in their bodies. As of 2019, the FDA reported that there were about 90,000 people in the United States with an Exactech hip implant, and around 147,700 with an Exactech knee implant.

The Exactech hip liners and knee implants were recalled in 2021 due to an extremely high failure rate. The recall was expanded to include all Exactech knee and ankle units in February of 2022, and in August of 2022 an additional 40,000 hip devices were added to the recall as well. The high rate of failure of these products has been attributed to poor packaging as well as manufacturing defects, namely replacing the industry standard polyethylene with a cheaper option to cut costs.

For those with the Exactech implants they may experience the following complications:

  • difficulty walking
  • loosening of the implant
  • joint stiffness
  • swelling and inflammation
  • bone degeneration (osteolysis)
  • pain

If you have an Exactech product and have developed symptoms, you should make an appointment with your orthopedic doctor. They will be able to check your implant via X-Ray to ensure there is no problem with the alignment of your device, or signs of device failure. The main indicator of a faulty Exactech liners is bone degeneration (osteolysis). If the x-rays show evidence of bone degeneration at the site of the implant, the doctor will typically recommend revision surgery to replace the faulty device.

If you or a loved one has an Exactech implant, call to speak with one of our experienced Exactech lawyers. Our firm is working diligently to file Exactech lawsuits for those who have suffered from a faulty Exactech product. Call 1-800-YOST-LAW 1-800-967-8529 or email us at info@yostlaw.com today for a free consultation. There is no fee or expense unless we recover.

Understanding Necrotizing Enterocolitis (NEC) – How To Spot The Signs

What is Necrotizing Enterocolitis?

Around 1 in every 1,000 premature infants develop Necrotizing Enterocolitis (commonly known as NEC). Necrotizing Enterocolitis (NEC) affects both the stomach and intestine. The intestinal tissue becomes enlarged and dies off.  NEC mainly occurs in babies that are born before 38 weeks, those that are given a feeding tube, or babies with a birth weight that is less than 5 pounds 5 ounces.

There are four variations of NEC.

Classic: This develops in babies born prior to 28 weeks, usually a baby is diagnosed with NEC three to six weeks after being born.

Transfusion-associated: Is when a baby requires a blood transfusion to increase the red blood cells. Usually, a baby is diagnosed with NEC 3 days following the transfusion.

Atypical: This is when a baby is diagnosed with NEC within seven days of being born.

Term Infant: Most babies born after 39 weeks are at a much lower risk of being diagnosed with NEC. Generally, this is a result of a birth defect.

Symptoms of NEC include:

  • Belly pain or swelling
  • Food Aversion/ Refusing to eat
  • Lack of Normal Weight Gain
  • Extreme exhaustion or lethargy
  • Bloody stool or diarrhea
  • Vomiting
  • Fever

NEC is often diagnosed in one of three ways: through a blood test, fecal test, or an x-ray. The blood test can determine if bacteria or infections are present in the blood. The fecal test will look for blood in the stool. An x-ray of the stomach can show gas that surrounds the intestine.

Necrotizing Enterocolitis (NEC) is typically a result of a premature infant being fed cow milk-based formula before their digestive system was capable of breaking down the enzymes contained in cow’s milk. The underdeveloped digestive system becomes inflamed, and the tissue begins to die off as a result of this. Baby formula manufacturers have been aware of this risk yet failed to warn consumers that their products could be harmful to premature infants.

If you believe that your child may have NEC, The Yost Legal Group is here to help you through this difficult time. Give our office a call at 1-800-YOST-LAW (967-8529). There is no fee unless we recover. All consultations are free.

Risky Business: Tractor-Trailer Accidents on the Rise

Tractor-trailers are responsible for transporting 70% of all products and goods across the United States. Unfortunately, these tractor-trailers can pose a serious threat to those they share a road with. There has been a significant increase in trucking accidents over the last decade despite new regulations intended to promote safer transport.

According to the National Highway Traffic Safety Administration (NHTSA), there is an estimated 500,000 tractor-trailer-related accidents every year. Accident statistics cite inexperience, mechanical failure, and fatigue as some of the leading causes of trucking-related crashes.

Under the Federal Motor Carrier Safety Administration (FMCSA) regulation 395 a driver can only work 70 hours over 8 days, thus the 70-hour 8-day rule. This has been established in an attempt to decrease the number of tractor-trailer accidents each year due to driver fatigue. Over the course of 8 days, a truck driver cannot exceed more than 11 working hours per day.

While these regulations were intended to minimize the amount of driver fatigue, a survey by the American Transportation Research Institute found that 66% of drivers indicated increased fatigue while driving as a result of the new rules. This may be due to sleep disruption, circadian rhythm, stress about meeting deadlines with enforced resting periods, and other factors that cannot be mitigated by a mandatory rest period.

The Trucking Industry Poses a Serious Threat to Everyday Drivers

Below are some staggering facts about tractor-trailer accidents in the United States:

  • Tractor-trailer accidents are often more severe and dangerous than passenger vehicle accidents due to the weight and size of the trucks.
  • Every 15 minutes there is a trucking accident that results in an injury or fatality.
  • Thursdays are the most dangerous day of the week, with 18% of all trucking-related accidents landing on a Thursday. Monday and Wednesday are noted to have the next highest number of crashes.
  • Tractor-trailer accidents occur most often between 12pm and 3 PM, and 12am-6am, coinciding with the body’s natural decrease in alertness at these times due to dips in the circadian rhythm.
  • 16% of tractor-trailer accidents occur on the weekends.
  • The rate of occupants’ death in big trucks has significantly decreased since 1975. Today, 97% of all fatalities in tractor-trailer crashes are occupants of a passenger vehicle.

If you or a loved one has been involved in a tractor-trailer accident, the experienced lawyers at The Yost Legal Group are here to help. Call 1-800-YOST-LAW (1-800-967-8529) today for a free consultation. We will investigate your case and help you get the justice you deserve. There is no fee unless we recover.

Reports of BIA-ALCL linked to Textured Implants

Millions of women have opted for textured implants when undergoing breast augmentation or breast reconstruction. Textured implants were designed over 50 years ago to prevent or minimize the development of scar tissue and decrease the likelihood of capsular contracture. For this reason, many women and surgeons alike favored this style of implant, especially in breast reconstruction cases where there is a heightened risk of capsular contracture.

FDA Warns Textured Implants Could Increase Risk of Cancer

Unfortunately, recent studies have linked textured implants to breast implant associated anaplastic large cell lymphoma (BIA-ALCL). In October of 2021, the FDA released an article regarding strengthened safety requirements pertaining to breast implants. The article included studies and updated information about the increased risk of BIA-ALCL in patients with textured implants.

 

Diagnosed BIA-ALCL-Cases-by-Year-Graph

Diagnosed BIA-ALCL Cases by Year

 

The graph above depicts an alarming increase in BIA-ALCL diagnoses in recent years. Of those receiving a positive diagnosis, 90.4% had an Allergan implant, 7.3% had a mentor implant, 1.5% had a Sientra implant, and the remaining .09%were from various other breast implant manufacturers.

Currently, the Food and Drug Administration has not recommended removal of textured implants if you are not experiencing any symptoms. However, many women are opting to have them removed or replaced with smooth implants out of fear of developing cancer for a first, second or even third time.

You should discuss any concerns you have of developing BIA-ALCL with your doctor and/or get tested for CD30 before surgical intrusion.

It is important to note that BIA-ALCL is not breast cancer. BIA-ALCL is a type of blood cancer that is commonly spread through breast tissue and lymph nodes. It typically takes around 7-10 years to develop. Common symptoms of BIA-ALCL include:

  • A change in the shape of the implant or the breast
  • The development of breast asymmetry
  • Increased firmness in the breast
  • Pain in or around the breast
  • The development of lumps around the breast or armpit
  • Itching or redness around the breast
  • Swollen lymph nodes
  • Development of fluid around the implant
  • Lesions
  • Fever
  • Fatigue
  • Night sweats

If these symptoms are present patients will typically receive an ultrasound or MRI to check for fluid or lumps around the implant. If either are present the patient must then undergo a biopsy where the fluid or tissue is tested for CD30. A CD30-positive test result indicates the presence of hematopoietic malignancies (blood cancer).

If you or a loved one have been diagnosed with BIA-ALCL after a breast implant surgery, you do not have to go through this process alone. The attorneys at The Yost Legal Group are currently investigating and pursuing claims for women who have been diagnosed with BIA-ALCL after receiving Allergan Biocell textured breast implants. Call us today at 1 (800) YOST – LAW or email us at info@yostlaw.com for a free consultation. We will investigate the circumstances of your individual case, answer any questions you have, and fight to get you the compensation you deserve.

Unskilled Truckers Creating Deadly Roadways for Passenger Vehicles

In April of 2019, a 23-year-old lost control of the truck he was driving and plowed into stopped traffic in Colorado. This tragic accident cost four people their lives, and catastrophically injured six others. While the driver was later found guilty of vehicular manslaughter, a bigger problem still remains. Trucking companies across the U.S. are facing a labor shortage and as a result, untrained and unskilled drivers are getting behind the wheel of 10,000+ lbs. trucks. The result of which can be deadly.

Trucking Related Casualties to Become the 5th Leading Cause of Death in the United States

In the United States, the trucking industry accounts for nearly three quarters of all product transport. It also accounts for nearly three quarters of all fatal passenger vehicle accidents. Nearly 97% of all casualties in trucking related accidents were those in passenger vehicles. It is predicted that by 2030 trucking related casualties will become the 5th leading cause of death in the United States.

According to the Federal Motor Carrier Safety Administration (FMCSA) the top cause of truck accidents is mechanical defects, such as the brake failure in the tragic 2019 crash. In these instances, proper training can be the difference between life and death when these failures occur. Knowing how to maintain control of the truck or how to use safety features designed specifically for the possibility of losing control of the truck, such as a runaway truck ramp, can save lives.

A runaway truck ramp is a safety feature present on many major roadways for trucks that are out of control. These ramps are filled with gravel or sand and use kinetic energy to rapidly slow large vehicles safely away from passenger vehicles. In the case of the Colorado crash, runaway ramps were available for the driver to use for instances of brake failure or otherwise. Unfortunately, due to lack of sufficient training, the driver failed to use them, resulting in deadly consequences.

The average truck is about 16 times the size and weight of most passenger vehicles. Trucking companies have a responsibility to ensure that their employees have the proper training, supervision, and experience to be able to handle a vehicle of that size. When companies neglect this responsibility, they are sending potentially deadly weapons onto the road, and when tragedy strikes, the company must be held accountable.

Neither you nor your loved ones should be at risk of serious injury or death due to negligent trucking companies and untrained drivers. The Yost Legal Group works diligently to provide justice for those who have faced wrongful injury or death due to the carelessness of others. If you or a loved one has been affected by a truck accident, we may be able to help. Contact us today at 1 800 YOST LAW for a free consultation.

Baby Formula Linked to Increased Risk for NEC in Premature Infants

More and more parents across the country are filing suit against manufacturers of cow-milk formula designed for preterm infants. Studies have provided evidence that cow-milk formula has been linked to a condition called necrotizing enterocolitis (NEC) in premature babies, the result of which can be deadly. Despite evidence of the risk posed by these products, they were still marketed as a safe, and even superior alternative to breast milk. As a result, many premature newborns developed NEC and have suffered serious injury and even death.

What is NEC?

Necrotizing Enterocolitis (NEC) is a deadly bacterial infection that affects primarily premature newborn infants. This condition, caused by the inability of the infant to digest food properly, leads to inflamed intestinal tissue, which causes the tissue to die. This can lead to holes in the intestinal walls, which allows harmful bacteria from the intestines to leak into the abdominal cavity, which can rapidly cause a very dangerous infection of the blood stream called sepsis.

While NEC cases can range in severity, with some only causing mild discomfort, others can quickly turn deadly for a newborn. For newborns weighing less than 3 pounds 5 ounces the mortality rate for NEC can be 50% or more. Nearly 9 out of 10 infants diagnosed with NEC are premature.

What Causes NEC?

In 1990, a multi-center study was performed in which 926 pre-term newborns were observed. Of the 926 newborns, 51, or roughly 5.5% developed necrotizing enterocolitis. The mortality rate for those diagnosed with NEC was 26%. This study found that infants that were fed cow milk formula only were 6-10 times more likely to develop NEC. Infants fed a mixture of human milk and formula were 3 times more likely to develop NEC. Among infants born 30 weeks or later, NEC was exceedingly rare among infants whose diet included breast milk. It was 20 times more likely in those fed formula only.

Formula Manufacturers Failed to Warn Consumers

For over 30 years, it has been known that formula poses a threat of increasing a preterm newborn’s risk of developing NEC, yet brands such as Similac and Enfamil, which are known for their cow-milk based formulas, continue to be produced and marketed as intended specifically for pre-term infants. Furthermore, they have failed to provide any warning of the harm that cow-milk formula can cause to pre-term babies.

By failing to warn consumers of the risks posed by their product, Similac and other cow-milk based formula companies deprive parents and caregivers the ability to make informed health decisions on behalf of their premature child. By advertising their products as being specifically designed for premature infants, these companies falsely lead parents to believe that they are safe for their baby to consume, even going so far as to market their products as being safer for a preterm infant than breast milk! As a result, many families have been devastated by the onset of NEC in their newborns, leading to severe and even fatal consequences.

Call Now.

If your baby has been diagnosed with NEC, The Yost Legal Group is here to help you through this difficult time. No parent should be left uninformed of the risks these cow-milk based products pose to their preterm newborns by manufacturers they trust to provide safe formula for their child. Act today by calling us at 1 (800) YOST LAW (967-8529) to hold these manufacturers accountable.

Allergan Breast Implant Recall: What You Need to Know

In 2019 Allergan issued a voluntary worldwide recall of their Biocell textured breast implants and tissue expanders. This came amid reports of women with Biocell implants and expanders developing breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma that brutally attacks the immune system.

Allergan Breast Implant Warranty Will Not Cover Operative Costs

Allergan announced that they will work with harmed parties by replacing defective textured implants with smooth implants under the BIOCELL replacement warranty, although they will not be providing or assisting with operative costs or fees. This means the only cost covered is for the product alone, not the operation or any other associated costs.

What is BIA-ALC?

Specifically linked with Allergan Biocell textured breast implants and tissue expanders, breast implant associated anaplastic large cell lymphoma (BIA- ALCL) is not a type of breast cancer. BIA-ALCL is a very rare and slow-moving blood cancer that attacks the immune system.

Typically, ruptured blood cells secrete seromas – pockets of fluid – which build up within the fibrous scar capsule encompassing the implant where the BIA-ALCL cultivates. An extraction of that fluid should be tested for a protein called CD30 which is found in “higher than normal” amounts on lymphoma cells. It is reported to take seven to 10 years to progress and present itself, so it is highly recommended that women who have undergone reconstructive surgery are screened regularly for cancer growth.

How Common is it?

Reports in the US alone total an alarming 355 confirmed cases between July 2019 and January 2021 of the 733 confirmed cases worldwide. Since then, the FDA announced over 35 women had died as a result of contracting BIA-ALCL.

What Can I Do?

No studies show how to prevent this disease, but if you acquire any symptoms such as breast pain, lumps or swelling you should contact your doctor immediately to discuss all concerns. The good news is that BIA-ALCL is completely treatable when found early, by performing an “en bloc capsulectomy” in which the implant and any surrounding scar tissue are completely removed.

What about the BIOCELL replacement Warranty?

Currently the BIOCELL replacement warranty only covers the cost of the implants that are ruptured, defective, or deflated. In November of 2021, they updated their warranty to pay up to $7500 for revision surgery required after developing cancer from their product. It is important to note- this offer is only available to those who have received a BIA-ALCL diagnosis. In exchange, you must waive your right to legal action in the future. Additionally, the warranty does not cover the costs associated with pain management, treatment, and additional appointments required because of the cancer or other complications.

Prior to signing any agreements with Allergan, call for a free consultation- you may be entitled to compensation beyond just the cost of revision surgery.

Do I Have A Case?

While there are manufacturers producing implants other than Allergan or McGhan, there are no current litigations currently linking BIA-ALCL with other styles. Because the evidence of scientific studies currently show BIA-ALCL is not as common in other implants, for now we are only pursuing Allergan and McGhan textured implants. As time goes on, things may change regarding the correlation between other implants and BIA-ALCL. If you have any questions about your eligibility, please contact us for a free consultation.

The Time to Act is Now.

If you or a loved one have been diagnosed with BIA-ALCL after a breast implant surgery, you do not have to go through this process alone. Please contact our experienced attorneys at The Yost Legal Group for a free case evaluation. We can be reached by email or phone at info@yostlaw.com or 1-800-YOST-LAW, or you can fill out our web inquiry form and we will respond to you as soon as possible.  We will investigate the circumstances of your individual case, answer any questions you have, and fight to get you the compensation you deserve.

Allergan Breast Implants Linked to Rare Cancer

In an informative new video brought to you by The Yost Legal Group, Founding Attorney Tom Yost explains the alarming, established link between Allergan’s popular texturized breast implants and tissue expanders and a rare form of non-Hodgkin’s Lymphoma. This type of cancer is called Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Allergan failed to warn women of their products’ link to cancer, and due to their negligence, hundreds of thousands of women are at risk of developing cancer.

Allergan Did Not Complete FDA-Required Studies, Did Not Warn Women About Link to Cancer

Allergan had been required by the FDA to complete safety studies after their product went on the market as a condition of FDA approval. However, they did not complete these tests. When their products’ link to BIA-ALCL was made apparent, Allergan withheld this information and did not inform women of this serious risk.

Instead, patients were offered the Confidence Plus Warranty Program, which would offer free Allergan replacement breast implants. However, in exchange for this warranty program, patients were asked to sign a release of all claims against Allergan. Many patients were unaware of the relinquishment of their rights.

Allergan Breast Implants Responsible for Majority of Reported Breast-Implant Related Cancers

 Due to Allergan withholding information about the link to cancer, hundreds of thousands of women are at risk of developing BIA-ALCL. In fact, Allergan products are responsible for more than 80% of reported breast implant-related cancers.

What Are The Symptoms of BIA-ALCL?

  • Breast pain and swelling
  • Fluid accumulation at the implant site
  • Skin rashes
  • Lumps or masses

How Long After Surgery Does it Take for BIA-ALCL to Manifest?

It can take years after implant surgery for cancer to develop. It is reported that it can take on average 9 years after the implant surgery for BIA-ALCL to manifest.

What Should You Do if You Have Allergan Implants or Tissue Expanders?

Those with Allergan implants are advised to have continued and frequent cancer screenings. The FDA has advised recipients of these implants against removal surgery unless they have been diagnosed with this cancer or are experiencing symptoms.

The Skilled Defective Products Attorneys at The Yost Legal Group Are Here to Help

If you have received Allergan textured breast implants or tissue expanders and developed BIA-ALCL or have since had them surgically removed, you may be entitled to compensation. At The Yost Legal Group, our team of attorneys will provide you with answers and help recover the best possible compensation for your experience. Contact us today by submitting a contact form online or calling our office toll-free at 800-YOST-LAW today for a free legal consultation.

Link Between Necrotizing Enterocolitis and Cows’ Milk-Based Baby Formula and Fortifiers Exposed

The Yost Legal Group has produced an important educational video about the alarming link between certain types of baby formula and fortifiers (those that are specifically manufactured for premature infants) made with cows’ milk and Necrotizing Enterocolitis (NEC) in premature babies (babies born prior to 37 weeks gestation).

NEC is a serious gastrointestinal condition with a high morbidity rate that may require emergency intestinal surgery. It could lead to what is known as Leaky Gut Syndrome, where holes form in the intestinal wall and harmful toxins and fecal matter leak out, potentially leading to sepsis or even death.

Shortly after birth, when a premature infant is unable to breast and/or bottle feed, they are often fed cows’ milk-based formula and/or fortifiers through a feeding tube. However, researchers have concluded that the underdeveloped gastrointestinal tracts of premature babies have a difficult time digesting the proteins in cows’ milk. As a result, preterm infants that receive formula and/or fortifiers made using cows’ milk through their feeding tubes are much more likely to develop NEC. Unfortunately, this condition can be fatal, or require a lifetime of care.

“The manufacturers of Similac or Enfamil failed to warn parents and healthcare providers of the risks of premature infants ingesting their cows’ milk-based formulas and fortifiers – even though suitable alternatives were available.”

  • Tom Yost, Founder, The Yost Legal Group

Symptoms of NEC in Premature Infants Include:

  • Pain and swelling of the abdomen
  • Changes in a baby’s heart rate and blood pressure
  • Diarrhea and blood in the stool (sometimes not visible)
  • Vomiting that is yellow or green in color
  • Feeding intolerance or residuals
  • Inability to gain weight
  • Unusual lethargy

Manufacturers of Cows’ Milk-Based Formula and Fortifiers Withheld Information About Harm to Premature Infants

The manufacturers of cows’ milk-based formula and fortifiers, Similac and Enfamil, failed to warn parents and healthcare providers of the risks of premature infants ingesting their products. Despite suitable alternatives being available such as preterm infant formula and fortifiers made using human milk, mothers’ own breast milk, and human donor breast milk, the manufacturers of Enfamil and Similac continue to market their cows’ milk-based formulas and fortifiers for premature babies with feeding tubes, putting them at significant risk.

If you or a loved one’s premature infant has been diagnosed with NEC due to being fed cows’ milk-based formula and/or fortifiers, they may be entitled to compensation. Contact the defective product lawyers at The Yost Legal Group by filling out and submitting a contact form online or calling our office at 1-800-YOST-LAW (1-800-967-8529) for a free legal consultation today.