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.

How Can I Pay For My Hernia Mesh Lawsuit?

Approximately 1.3 million people undergo hernia repair every year. Over half of these patients require surgery for herniation in the groin area, but abdominal hernia repair makes up for a large part of this number as well.

A hernia happens when weakness in muscle or tissue allow organs to spill into the body. This can result in symptoms including:

· Pain in and around the hernia

· Bulging skin

· Swelling

· Nausea

· Blood in the stool

These symptoms, particularly if they are lasting, should not be ignored.

It is not always necessary to treat a hernia surgically. In many cases, small hernias can be addressed through lifestyle changes and will simply need monitoring from a medical professional. However, sudden pain or a tender bump in the region of the hernia may indicate a medical emergency and should be brought to the attention of a healthcare provider immediately.

Hernia Mesh

One of the simplest ways to repair a hernia is with a support structure like mesh. Hernia mesh provides scaffolding for damaged and weakened tissue. Once placed, new tissue will grow around the mesh and the mesh itself will be absorbed into the body. However, for many people, hernia mesh can fail and produce symptoms even more painful than the hernia itself.

Failed hernia mesh may result in:

· Infection

· Organ perforation

· Seroma

· Hernia reoccurrence

· Bowel obstruction

Some types of hernia mesh may even produce neurological disorders and abnormal liver function.

In most cases, these mesh products will need to be removed, requiring additional surgeries that further endanger the health and safety of the patient. In fact, hernia mesh revision and repair is often a painful and involved procedure that requires an extensive and very uncomfortable recovery period. This injustice demands the attention of an experienced and aggressive defective medical device attorney.

Know Your Rights

When you are injured by hernia mesh or any other dangerous medical product, you have every right to hold the manufacturer accountable and seek compensation for any damages that occur. This may include:

· Additional surgeries and medical care

· Wages lost due to an inability to work

· Physical pain

· Emotional suffering

There are already a number of hernia mesh cases headed to trial. Our Minneapolis personal injury lawyers are here to help you understand if your case can move forward and to provide you with exceptional legal representation every step of the way.

Going it alone will likely result in inadequate compensation. Your best bet is to work with an experienced lawyer who will stand by your side, protect you from insurance companies and others more interested in settling quickly than settling fairly, and help you secure the total compensation your failed hernia mesh demands.

It is important to note that hernia mesh needn’t be recalled for you to have legal recourse in the case of injury. Our attorneys are well versed in the nuances of medical device liability law and will work to build and prove your case regardless of a product’s current availability. In many cases, the FDA is aware of dangers long before a recall is issued, but even when a product does not have several complaints, individual injuries may be eligible for legal action. We will discuss this with you while reviewing your case at our Minneapolis office.

Hernia Mesh Legal Fees

You have a right to seek compensation with the assistance of an attorney when hernia mesh fails. You also have a right to seek this compensation without having to worry about paying legal fees and court costs as they arise.

The hernia mesh lawyers at GoldenberLaw work on a contingency basis. This means that, unless your case is won and a settlement or verdict is awarded, you don’t pay a dime. We only collect payment if you collect payment. There is no risk or obligation in contacting us for a case evaluation. Call us at 612-436-5026 to schedule your free consultation and learn more.

About GoldenbergLaw

GoldenbergLaw has been assisting victims of serious injury in and around Minneapolis and St. Paul for over 30 years. Many of our attorneys also provide representation for class action lawsuits, assisting people throughout the nation in getting fair compensation following injury from a defective medical device.

While the primary goal of our firm is securing full compensation for victims of serious injury, we believe we have an additional responsibility to promote safety and protect consumers against the dangers of poorly designed and manufactured medical devices, including hernia mesh. By holding negligent corporations accountable, we are able to set precedent and change policy, helping protect people from future damage while getting maximum compensation for those for whom prevention is too late. We would be honored to discuss this with you in greater detail during your initial case review to help you better understand the goals of our law firm.

Our Success

The attorneys at GoldenbergLaw have been successful in securing large settlements for victims of injury caused by defective drugs, dangerous medical devices, physician malpractice, and other types of negligence – including more than $100 million for victims of the 35W Bridge collapse. Our approach, experience, and dedication to helping victims of serious injury get justice has resulted in numerous awards and recognitions – though it is justice, not recognition, that drives our practice. We welcome an opportunity to meet with you free of charge to discuss your case, your rights, and the most effective way to secure the compensation you are due.

Contact Us

If you have been injured by defective hernia mesh or if you have been forced to undergo additional surgeries after having mesh placed, GoldenbergLaw can help. Call us at 612-436-5026 to schedule your free consultation and learn more. Located in Minneapolis, our hernia mesh lawyers serve St. Paul, surrounding areas of Minnesota, and the nation.

What is Hernia Mesh Made of?

There are two different kinds of hernia mesh: absorbable and non-absorbable. Absorbable mesh is typically made of animal tissue that has been processed for medical use. This type of mesh is designed to disintegrate as new tissue grows to strengthen the hernia repair. Non-absorbable mesh is made of synthetics and is designed to provide long-term reinforcement to the hernia repair site. Some types of hernia mesh combine absorbable with non-absorbable material, though these are not as common.

While the absorbable hernia mesh is less likely to result in injury, all patients who have had hernia mesh placed are at risk for serious complications, making it important that symptoms of failed mesh be monitored. These include:

  • Pain and swelling
  • Heat or soreness around the surgical site
  • Difficulties passing stool
  • Fever and nausea

According to the FDA, bowel perforation and obstruction are the most common consequences of defective hernia mesh. The agency also lists hernia migration and contraction, internal bleeding, infection, and blockage of the small and large intestines as potential consequences of mesh hernia repair. If you have had hernia mesh placed and are experiencing symptoms of mesh failure, swift action is necessary to prevent potentially fatal consequences. If your hernia mesh has resulted in additional medical expenses, financial burdens, and personal pain and suffering, the St. Paul defective medical device attorneys at GoldenberLaw are here to help you get the full compensation you deserve.

With over 30 years of proven results, the product liability lawyers at our firm have the experience and dedication your case demands. We encourage you to call us at 612-436-5026 to schedule a free consultation and learn how we can help you get fair compensation for all of your damages.

GoldenberLaw is located in Minneapolis. We serve hernia mesh patients living in the Twin Cities, surrounding areas of Minnesota, and throughout the nation.