FDA Issues Recall on The Exactech Connexion GXL Hip Implant

On June 28, 2021, the FDA issued a recall of the Exactech Connexion GXL Hip Implant liners. This came following reports of high rates of failure around the 3-6 year mark- significantly sooner than the 15 to 20 years they had been marketed to last for. Although the liners are made of polyethylene, this model has seen rapid deterioration of the liner, exposing the metal and causing the metal components from the implant to rub together. This has resulted in many complications for patients with this implant.

Symptoms related to the Exactech Connexion GXL Hip Implant include:

  • Difficulty walking
  • Loosening of the implant
  • Joint Stiffness
  • Swelling and inflammation
  • Possible bone degeneration: osteolysis
  • Extreme Pain

If you have experienced any of these symptoms because of the Exactech Connexion GXL implant, speak with your doctor to discuss your treatment options. The doctor will likely recommend an X-Ray to check the alignment of the implant and to see if the hip has been fractured, dislocated, or is beginning to deteriorate. Usually, the only way to relieve the symptoms and correct the issue with the faulty device is for the patient undergo a hip revision surgery.

Nobody should be forced to undergo the financial and physical burden of a second surgery after being harmed by a defective product. That’s why The Yost Legal Group is investigating claims for those who have been harmed by the Exactech Connexion GXL hip implant. If you or a loved one has an Exactech Connexion GXL hip implant, you may be entitled to financial compensation. Call The Yost Legal Group at  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 you recover.

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.

Smith & Nephew Hip Litigation Approaches Settlement Agreement

After years of litigation, it appears that Smith & Nephew are getting close to reaching a settlement agreement for the Birmingham Hip Resurfacing (BHR) and R3 Acetabular hip implant cases. The Birmingham Hip Resurfacing system was recalled in September of 2015 due to complaints of pain, metallosis, fractures, dislocation, and premature system failure among patients. The R3 Acetabular metal liner was previously recalled in June of 2012 after high rates of failure and reports of injuries from the device.

The Smith & Nephew Birmingham Hip Resurfacing (BHR) is a type of metal-on-metal hip that uses a metal cup within the hip socket that connects to a metal ball capping the head of the femur. This was a popular choice for many because it required a less invasive surgery.

Metal-on-metal hips were marketed to younger, more active adults because of their claimed longevity. Unfortunately, these hips did the opposite of what was promised. Instead of the hips lasting 10 to 15 years, they failed in increasingly high rates.

Researchers discovered the 5-year failure rate for the metal-on-metal hip resurfacing to be 5%, quite a bit higher than the average of 2% for full hip replacements. This risk was even higher amongst women, with close to 9% failing at the five-year mark. The high failure rate of the implants has resulted in the need for revision surgery.

In addition to a high failure rate, the implants also caused a number of adverse effects in patients, including the development of pseudotumors near the implant. A pseudotumor is a buildup of fluid around the hip implant. It’s important to note that these are non-cancerous.  A pseudotumor can only be diagnosed through a MARS MRI. A MARS MRI allows your medical provider to view the soft tissue that surrounds the hip implant where pseudotumors are found.

Another issue associated with the defective implants is metallosis, a blood poisoning condition that occurs when toxic metal particles enter the bloodstream and nearby tissue. Metallosis is diagnosed through a blood test. The doctor will check the Cobalt and Chromium levels in the blood to determine if it is elevated.

Elevated Cobalt and Chromium levels can cause cognitive problems. Metallosis may also cause extreme hip and leg pain, or cause the implant to loosen, making grinding and clicking noises with movement. Unfortunately, the only way to treat metallosis is to have the metal hip implant removed.

The path to recovery following a hip revision surgery can be long. Common post-surgery difficulties for many include discomfort, pain, trouble with their gait, and a prolonged need for ambulatory assistance. The biggest issue following revision surgery is dislocation of the hip. Often the hip dislocates because the muscle, and tissue surrounding the bone have weakened. Another surgery may be necessary due to the extreme damage that the implant caused.

The Yost Legal Group is investigating claims for those who have been harmed by Smith & Nephew hip implants. If you or a loved one have suffered as a result of a Smith & Nephew Birmingham Hip Resurfacing or R3 acetabular hip implant, the time to act is now. Call 1-800-YOST-LAW or email us at info@yostlaw.com today for a FREE consultation. There is no fee unless we recover.

Exactech Offers Compensation for Faulty Hip—In Exchange for Your Legal Rights

In June of 2021, many orthopedic surgeons received a letter stating Exactech’s polyethylene hip implant had been recalled. The recall was due to the high failure rate of these devices. The implants were marketed to last between 15 to 20 years, but instead were failing around the 3-to-6-year mark. These failures led to discomfort and pain, and often, the only way to alleviate the symptoms was for the victims to undergo additional surgeries.

Exactech’s Connexion GXL hip implant is a medical device used in total hip replacements. This is a “metal on plastic” hip implant, featuring an acetabular liner made of a plastic known as polyethylene. These implants are failing due to the polyethylene liners deteriorating. The deterioration exposes the metal, causing the metal components within the implant to rub together, leading the device to breakdown prematurely.

The standard hip implant should have a failure rate of less than 1% per year, meaning at the 10-year mark, 90% should still be functioning. That has not been the case for those with the Exactech hip implant. A study revealed the average time to failure for individuals with Exactech’s Connexion GXL hip implant was just over 4 years. By comparison, the industry standard has most hip implants lasting between 10-15 years.

Exactech Looks to Avoid Legal Action After High Failure Rate Forces Recall of the Connexion GXL Hip Implant

After announcing the recall, Exactech hired the company Broadspire to reach out to those with their implants to see if they were having complications. For those suffering from complications, Broadspire has offered compensation to cover the revision surgery. However, the people who chose to accept the compensation had to first agree to waive their rights to future legal action against Exactech, ensuring that the injured cannot collect payment for the pain and suffering they had suffered.

Broadspire was hired by Exactech to save the company money. They are looking out for Exactech, not those who were harmed by the device. If you have the Exactech Connexion GXL hip implant and are suffering from complications DO NOT sign a contract with Broadspire. Doing so will waive your right to legal action and your ability to claim compensation for the pain and suffering you have experienced.

If you or a loved one has the Exactech Connexion GXL hip implant, call The Yost Legal Group at 1-800-YOST-LAW (1-800-967-8529) today for a free consultation or email us at info@yostlaw.com. We are investigating claims for those who have been harmed by the Exactech Connexion GXL hip implant. There is no fee or expense unless you recover.

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.

Baby Formulas Made from Cow Milk Linked to Necrotizing Enterocolitis (NEC) in Premature Babies

One in ten babies born in the United States in 2020 was premature. There were 3.6 million births that year. That means roughly 360,000 premature newborns. That number shows premature births are not an uncommon occurrence. All babies need special attention and care, even more so for premature babies. However, companies like Abbott Laboratories and Mead Johnson & Company, LLC have put these vulnerable newborns in mortal danger.

Over 30 years ago, researchers had already linked cows’ milk baby formula to necrotizing enterocolitis (NEC) after observing nearly 1,000 premature infants. Since then, but especially within the last 15 years, the data linking cows’ milk formula to NEC has only gotten stronger.

In fact, the data has gotten so strong that in 2011, the U.S. Surgeon General published The Surgeon General’s Call to Action to Support Breastfeeding, a comprehensive study that credibly linked babies who were not breastfed to a 137% increase in the likelihood of developing NEC.

Necrotizing enterocolitis (NEC) is a debilitating intestinal disease that can afflict premature and low birthweight newborns.

(Please be advised: Internet searches of the phrase “necrotizing enterocolitis” will return graphic imagery.)

Symptoms of NEC include:

  • Bloating
  • Blood in stool
  • Bowel death
  • Organ failure
  • Vomiting of bile

If left untreated, NEC can be fatal. That said, while it is possible for premature newborns who were breastfed to develop NEC (there is no single known cause), the science is rather clear. Cows’ milk baby formulas are an imminent hazard to premature newborns.

The U.S. Food and Drug Administration also agrees as evidenced by its recall of numerous cows’ milk baby formulas. On August 8, 2021, the FDA initiated the recall of nearly 80,000 units of formula.

However, many more Enfamil® and Similac® products remain on the market. Proceed with caution when feeding your newborn baby. It is also common for hospitals to treat premature babies with cows’ milk formulas.

If you or a loved one had a premature baby who developed necrotizing enterocolitis (NEC) after ingesting a cows’ milk baby formula, you may have a case. Please contact the experienced attorneys at The Yost Legal Group today. There is no time to waste. Call 1-800-YOST-LAW (1-800-967-8529) for a free consultation. There is no fee unless you recover.

What You Need to Know About Back-to-School Bus Safety

Schools are back—and in person. Across the nation, tens of millions of students are leaving their houses every morning and venturing out to school. Some are walking. Some parents are taking their children. And some students catch busses. On their ways to school, students are out early in the morning when drivers might not be as alert. There could be fog that reduces visibility. And with the end of daylight saving time looming, morning visibility will continue to decrease. With so many potentially dangerous factors, it is understandable parents might have concerns about school bus and bus stop safety.

For students’ safety and the safety of others, it is imperative students remain at least five feet away from the curb when waiting for the bus. Furthermore, they should maintain that safe distance until the bus comes to a complete stop.

Once students are on the bus, their safety is mostly in the hands of the drivers. However, students can decrease their potential risk should an accident occur by always remaining seated and facing forward when the bus is in motion and even when it is stopped at a red light.

Finally, upon arrival at the destination, whether that be school or the neighborhood bus stop, students should only get up from their seats after the bus has made a complete stop. Then, never cross too closely to the front or back of the bus after exiting the vehicle. And, as always, look both ways before crossing any streets.

Since 2009, an average of 121 fatalities have occurred each year in school-transportation-related crashes. 55% of the tragic losses were passengers, people who are most likely to be students. Furthermore, over the same period, 52% of school-aged-pedestrian fatalities in school-transportation-related crashes were between the ages of five and ten years old. The loss of life—especially at such a young age—is always tragic, which is why it is important for students to know about and practice the best ways they can keep themselves safe.

Of course, we at The Yost Legal Group are not here to be all “doom and gloom.” We are here to provide actionable information and contextualize the data so you have a clear understanding of the facts. That is why we need to provide this very important fact. According to a study conducted by the Department of Transportation and the American School Bus Council:

Students are about 70-times more likely to get to school safely if they take the school bus instead of traveling by car.

While the Motor Vehicle Administration and various police departments around the state are constantly reminding vehicle operators to drive safely, it is also important for us to inform students about the actions they can take to keep themselves safe. Being aware of their surroundings can make all the difference when the potential outcomes are an accident or no accident at all.

If you or a loved one has been seriously harmed as a result of a school bus-related accident, call the knowledgeable attorneys at The Yost Legal Group today: 1-800-YOST-LAW (967-8529). Injuries include, but are not limited to, hospitalization, traumatic brain injuries (TBI), and fatalities. Our attorneys are experienced and ready to handle your school bus accident claim with no cost to you unless you recover.

All Concussions Are Traumatic Brain Injuries—What You Need to Know

Traumatic brain injuries (TBI) cause disturbances in brain activity and function and can have long-lasting negative effects on a person’s quality of life. In severe instances, traumatic brain injuries can even lead to death. In fact, in 2019, there were 61,000 TBI-related deaths just in the United States.

Even mild concussions qualify as traumatic brain injuries despite the long-standing and pervasive misconception that concussions are not serious. Immediately seek help from a medical professional after suffering a concussion or experiencing a concussive incident.

The Three Types of TBIs:

  • Closed Brain Injury
  • Penetrating Brain Injury
  • Non-Traumatic Brain Injury

A closed brain injury occurs when there is non-piercing damage to the head that does not result in a break or fracture of the skull. Quick changes in momentum that result in jolts to the head can cause the brain to shake violently within the skull, resulting in bruising of and damage to brain cells and tissue.

These types of traumatic brain injuries occur most often in motor vehicle accidents, falls, and sports.

A penetrating brain injury occurs when the skull is pierced, causing direct damage to the brain.

Gunshot wounds (self-inflicted or otherwise) are the most common causes of penetrating brain injuries.

A non-traumatic brain injury occurs when there is no external assault, force, or trauma that causes direct damage to the brain.

Aneurysms and strokes can lead to non-traumatic brain injuries.

The Three Severity Levels of TBIs:

  • Mild TBI or Concussion
  • Moderate TBI
  • Severe TBI

There are three severity levels of traumatic brain injuries. For today, we will focus on the first, concussion, as it is the most common TBI.

Minor falls, collisions, blows to the head, and car accidents can lead to mTBIs. We also see concussions often in contact sports such as American football, boxing, and hockey. However, they are also common in “non-contact” sports such as soccer where players routinely hit the ball with their heads.

At The Yost Legal Group, we most often see concussions as a result of motor vehicle accidents. Even minor crashes can lead to concussions. What’s more, a victim’s head does not need to make contact with a part of the vehicle to suffer a concussion. The jolt and sudden change of momentum are often enough to cause a concussion—just as we mentioned above when detailing closed brain injuries.

Common Symptoms of Concussions

  • Blurred Vision
  • Dizziness
  • Headaches
  • Sensitivity to Light
  • Sensitivity to Sound

Please seek out a medical professional if you or a loved one has been involved in a slip-and-fall incident or motor vehicle accident and are experiencing any of the aforementioned symptoms. You may have a concussion, and medical intervention or monitoring might be necessary.

The experienced TBI attorneys at The Yost Legal Group are actively pursuing compensation for individuals who are the victims of traumatic brain injuries caused by the negligence of others. If you are a victim and have been diagnosed with a traumatic brain injury, please contact us as soon as possible: 1-800-YOST-LAW. Time is of the essence.