How Safe is Hernia Mesh?

Concerns over the lack of clinical evidence and medical device testing of hernia mesh products has led to an outcry in the United Kingdom.

New data shows that there are more than 100 different types of surgical hernia mesh that were purchased by the National Health Service (NHS) Trusts from 2012-2018 in England and Scotland to perform the approximately 100,000 hernia operations every year; however, there are concerns about the safety of these products. In the United Kingdom, hernia mesh devices can be approved if they are ‘similar’ to older products—older products which may not have been required to undergo any rigorous testing or clinical trials to determine their safety.

International guidelines estimate that one in 10 patients will experience “significant chronic pain” following mesh repair. Professor Carl Heneghan, a medical device expert at the University of Oxford, explained that the complications may be due to a lack of testing before the hernia mesh products enter the market.

He explained that some devices have only been required to be tested on animals such as rabbits for a short period of time, with the implanted mesh only left inside the animal for a few days. He reported that “if there’s no remaining immune reaction, you pass the test” and the product goes to the market. Professor Heneghan stresses the inadequacy of these tests due to their limited nature and the fact that they cannot test for pain, which is the most common complication of surgeries involving hernia mesh.

Professor Heneghan asserted that there was “no chance” that the more than 100 types of hernia mesh devices used by the NHS were all individually tested because there have not been 100 trials in this area of medical device testing. He calls for the NHS to “immediately” stop using those devices that have “no clinical evidence attached to them whatsoever.”

Exposed Hernia Mesh Manufacturer Video

The UK’s news agency, the BBC, recently viewed a leaked promotional video intended for the medical community that was funded by Ethicon—one of the world’s largest mesh manufacturers.

The video, which is over a decade old, shows a surgeon discussing how some older types of mesh can become “hard as stone” after only one year inside of a patient and can cause damage to the body, including chronic pain. However, the product mentioned in the video is still being sold by Ethicon and used by the NHS in England and Scotland.

How has the UK Government Responded to these Findings and Concerns?

Director of Devices at the Medicines and Healthcare Products Regulatory Agency (MHRA) Graeme Tunbridge said that “the benefits and risks of using mesh for hernia repair have been considered in detail by clinicians and the professional bodies who represent them. We continue to monitor and review evidence as it becomes available and will take any appropriate action on that basis.”

Mr. Tunbridge acknowledged that the medical device testing system “does need strengthening” and said that new legislation on medical device testing, which would include strengthening requirements on manufacturers to ensure that sufficient clinical evidence is in place for their products, would take effect in May 2020.

A spokeswoman for the Department of Health and Social Care said that “on the rare occasion where a patient has suffered as a result of a mesh procedure, we are taking steps to improve patient safety- including improving how we listen to patients and how the system learns when concerns are raised.”

How has the U.S. Responded to Hernia Mesh Complications?

The U.S. Food and Drug Administration (FDA) considers the mesh used for hernia mesh repair surgeries to be safe, but acknowledges that ‘in rare cases’ complications may occur and that the most severe of these complications may be deadly. The FDA also recognizes that complications with the mesh may result in, at the very least, severe pain and require revision surgery.

However, the FDA claims that many of the more severe complications associated with hernia mesh repair pertain to recalled mesh products that are no longer on the U.S. medical device market.

A 2016 study analyzing the long-term recurrence and complications associated with elective incisional hernia repair reported that the number of complications after hernia surgeries increased over a five year span. Out of the 3242 participants in the study, 1050 participants required another abdominal surgery.

What is a Hernia?

A hernia occurs when an organ, intestine, or fatty tissue squeezes through a hole or weak spot in the surrounding muscle or connective tissue. Most commonly, hernias occur at the abdominal wall and sometimes may be visible as an external bulge particularly when straining or bearing down.

Types of Hernias

  • Inguinal hernias occur in the inner groin
  • Femoral hernias occur in the upper thigh or outer groin
  • Incisional hernias occur through an incision or scar in the abdomen
  • Ventral hernias occur in the general abdominal or ventral wall
  • Umbilical hernias occur near the belly button
  • Hiatal hernias occur inside the abdomen, along the upper stomach

How Common are Hernia Repairs?

Hernia repairs are extremely common; more than one million hernia repairs are performed each year in the U.S. Since the 1980s, there has been an increase in mesh-based hernia repairs. Surgical mesh is supposed to strengthen the hernia repair and reduce the rate of recurrence. Currently, more than 90% of the one million plus hernia surgeries performed each year in the U.S. use hernia mesh to perform the repairs.

Surgeons cutting hernia meshWhat is Surgical Hernia Mesh?

Surgical hernia mesh is a medical device used to provide additional support to tissue that has been weakened or damaged by a hernia. Hernia mesh is a surgical implant which often made of a synthetic plastic called polypropylene or animal tissue that reinforces torn or damaged tissue around hernias and strengthens it as it heals.

Synthetic materials can be absorbable, non-absorbable or a combination of both types of materials. Animal-derived mesh is made of animal tissue that has been processed and disinfected to be suitable for use in an implanted device; animal-tissue based mesh is absorbable. Non-absorbable mesh will stay in the body forever and is considered a permanent implant intended to provide permanent reinforcement to the repaired hernia. However, absorbable mesh will degrade over time and is not intended to provide permanent reinforcement. As the material disintegrates, new tissue grows and ideally provides strength to the repair.

What are Hernia Mesh Complications?

The most serious complications of hernia mesh are also some of the most common:

  • Adhesion- Scar-like tissue that sticks together and leads to bowel obstructions.
  • Bowel obstruction – Occurs if the mesh adheres to the intestines and cuts off blood flow.
  • Bowel perforation – Occurs when the hernia mesh punctures or erodes into the bowel.
  • Infection – Chronic infection symptoms may not occur until years after hernia mesh surgery.
  • Rejection – Materials within the hernia mesh may trigger the body’s immune system and cause the body to reject the mesh.
  • Migration – If the hernia mesh detaches after surgery, it can migrate through the abdomen and lead to adhesions, fistulas, abscesses, and bowel obstruction or perforation.
  • Recurrence – A common complication of hernia surgery is that hernias may return.
  • Chronic pain

Nearly one-third of people who have hernia surgeries experience some type of complication—excessive pain is the most frequent complication. These complications may appear shortly after surgery or years later.

How GoldenbergLaw Can Help You

GoldenbergLaw is currently investigating hernia mesh failure cases where an individual required a revision surgery. If you need a hernia mesh lawyer, we have the expertise and experience to help bring you justice. Contact us today for a free consultation, and let us deliver the Gold Standard you deserve.

Juul Is Officially Not Cool

All PR is good PR, unless you’re Juul right now. With appearances across international news broadcasts, popular YouTubers’ channels and even on TikTok (the newest social media platform loved by teens), the perils of Juul have become widespread knowledge, exposing the company’s unethical development practices and marketing tactics. 

A recent Reuters investigation concluded that the company has been entrenched in controversial developments from its early stages. A former employee has disclosed that discussions around the product’s potency and addictiveness were debated initially, however any employee concerns about product safety took a backseat to the company’s exponential growth. What’s become clear is the true effects of Juul are surfacing through numerous studies investigating the potency and addictiveness of the product, particularly amongst teenage users. 

Juul Delivers More Nicotine than Most Cigarettes

In a new study out of Penn State University College of Medicine, researchers analyzed blood samples from six Juul users who were asked to puff on their device every 20 seconds for 10 minutes (a total of 30 puffs). “The Juul users we studied obtained blood nicotine concentrations almost three times as high as most of the e-cigarette users we previously studied,” said Jessica Yingst, a research project manager. 

When the research participants were also asked to rate their withdrawal symptoms and other effects like ni

cotine craving and anxiety before and after vaping, they reported higher levels of nicotine dependence than more than 3,000 long-term users of other e-cigarettes. “In previous studies, we found that e-cigarette users were less addicted than smokers. However, the high nicotine delivery of the product and the scores on this study suggest that Juul is probably as addictive as 

cigarettes,” said study co-author Jonathan Foulds, a professor of public health sciences.

Following this, according to interviews with over a dozen tobacco researchers, pediatricians and Reuters review of Juul patents and nicotine chemistry, “the breakthrough “nicotine salts” formula that made the Juul e-cigarette so addictive – and ignited the company’s explosive market-share growth – made Juul especially attractive to teenagers and other new users who otherwise would never have smoked cigarettes. 

Teens Seduced by Smooth Flavors and ‘Smoke Rings’

CDC research reveals two thirds of teens weren’t even aware Juul contained nicotine 

With the latest figures showing that two thirds of Juul users aged 15-24 didn’t always know that Juul contained nicotine, it’s no wonder why there’s concern around youth addiction and vaping-related illnesses, especially as young users continue to post photos or videos of themselves performing smoke stunts or smoking multiple Juul’s on social media, often tagged under the hashtags such as #juullife or #doit4juul. 

In the latest available data from the CDC in September 2019, it shows that more than one in four high schoolers – 27.5% – reported using e-cigarettes in the previous month, a figure that’s consistently kept climbing month after month, despite the growing public concern about the product. 

In an effort to try and curb youth addiction and usage, Juul recently stopped selling its best-selling Mint flavored pods at the beginning of November. The company’s surprise announcement came just weeks after it pulled the popular Mango, Creme, Fruit and Cucumber flavors from the shelves in October. 

Juul now only sells its Menthol, Classic Tobacco and Virginia Tobacco varieties, but there’s still cause for concern that teens will shift from Mint to Menthol. Studies published in the medical journal JAMA found that nearly 60% of high school students who vape use Juul, and mint was the most popular flavor among US 10th and 12th graders.

The Repercussions of a Youth Epidemic 

Vaping death toll hits 42, with 2,100+ cases reported nationwide 

Sadly, with the latest figures from the CDC revealing that 42 deaths and 2,172 vaping-related injury cases have been reported in addition to figures of American youths  addicted to nicotine reportedly reaching more than 5 million, it is clear this is an epidemic that is not going away any time soon.

If you or a loved one has been affected by Juul addiction or injury, we’re here for you. 

We are currently investigating cases where an individual has used JUUL for at least three months and developed:

Lung Injuries 

Heart Injuries 

Addiction

Alternative Injuries

Or has had a stroke or seizure

Do I Have a Case?  

If you or a loved one has been diagnosed with a severe lung disease such as Bronchioloitis Obliterans or pneumonia, suffered a heart attack, seizure, or stroke, or developed a nicotine addiction after the use of a JUUL e-cigarette product, please reach out to the Minnesota e-cigarette lawyers at GoldenbergLaw.  We will guide you through the legal process and fight to get you fair compensation. GoldenbergLaw delivers the gold standard advocacy you deserve.

 

Litigation Update: Time to Round Up Roundup?

The link between the popular weed killer Roundup and cancer became public in 2015 when the International Agency for Research on Cancer (IARC)—the agency devoted to cancer research within the World Health Organization—released a report exposing the connection between Roundup’s active ingredient glyphosate and cancer.

Since the IARC released this report, thousands of Roundup users have tied their diagnoses of Non-Hodgkin’s Lymphoma to Roundup exposure and taken legal action.

What Is Happening With The Roundup Litigation?

As of November 2019, analysts project that there are more than 45,000 Roundup plaintiffs in the United States. That number stands in sharp contrast to Bayer AG’S July 2019 estimate of 18,400.

Bayer AG has lost all three Roundup lawsuits it has taken to trial, with each jury finding that the plaintiffs’ exposure to glyphosate caused their diagnoses of Non-Hodgkin’s Lymphoma. Several additional trials that were scheduled for fall 2019 have been postponed to early 2020.

What Have The Roundup Trials Revealed?

In addition to juries finding that glyphosate can cause cancer, the Roundup trials have revealed questionable business practices by Monsanto—the original manufacturer of Roundup. Monsanto glyphosate-structure-chalkboardwas purchased by Bayer AG in 2018.

Documents produced at the trials have exposed that Monsanto engaged in “ghostwriting” research about glyphosate.  In other words, the company paid prominent scientists, researchers, and journalists to put their names on favorable research about glyphosate that was actually produced by Monsanto employees. Additionally, Monsanto allegedly lobbied for help from the Environmental Protection Agency (EPA) to hide a negative study of glyphosate that was released by the Department of Health and Human Services.

Bayer AG’s Legal Response

Bayer AG inherited massive litigation expenses with their acquisition of Monsanto for $63 billion in 2018. Since then, the Roundup crisis has already cost Bayer AG more than $30 billion in market value. Analysts have estimated that settling all of the U.S. Roundup lawsuits could cost anywhere between $2.5 billion to $20 billion. The company announced in July 2019 that it had begun mediation talks with Ken Feinburg to attempt to reach a settlement.

What Is Bayer Saying About Roundup Now?

Bayer AG continues to assert that Roundup is safe and that glyphosate is not carcinogenic. Therefore, the company has never considered pulling Roundup off the market despite the mounting allegations, research, and trial verdicts questioning its safety for consumers.

Bayer AG has been steadfast in refusing to add a warning label to Roundup products, issue a recall, or any outright discontinuance of the products containing glyphosate. However, that strategy comes with legal consequences. As long as the product continues to be sold without a warning label, the company is exposed to lawsuits linking ongoing Roundup use to future cancer diagnoses.

Despite refusing to remove Roundup from the market or add a warning label, Bayer AG announced in June 2019 that it was researching a glyphosate alternative at a cost of $5.6 billion.

What Are The Symptoms of Non-Hodgkin’s Lymphoma?  

Symptoms of Non-Hodgkin’s Lymphoma – the illness allegedly caused by use of Roundup exposure – include:

  • Painless, swollen lymph nodes in your neck, armpits, or groin;
  • Abdominal pain or swelling;
  • Chest pain, coughing or trouble breathing;
  • Persistent fatigue;
  • Fever;
  • Night sweats;
  • Unexplained weight loss 

What Should I Do Now?

If you or a loved one has been diagnosed with a form of Non-Hodgkin’s Lymphoma after Roundup use and/or exposure, please reach out to GoldenbergLaw’s Minnesota Roundup Cancer Attorneys. We will guide you through the legal process and fight to get you the compensation needed to help get your life back on track. Let us deliver the Gold standard advocacy you deserve.