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.

Frequently Asked Questions About Zimmer M/L Taper Hip Replacement Failure

Scientific studies have linked the Zimmer M/L taper and Zimmer M/L taper with Kinectiv technology hip devices to causing dangerous metal poisoning when implanted in the human body. A judge recently awarded $2 million to a man injured by a Zimmer M/L taper hip device with Kinectiv technology at a trial in New Mexico. There are currently several dozen lawsuits filed throughout the country against Zimmer for injuries caused by the hip device.

Why Is My Hip Replacement Failing?

Artificial hip replacements are meant to correct conditions of the hip and to provide support and pain relief to a patient. Some metal-on-metal hip devices have the potential to cause more damage than benefit due to metal-on-metal wear and metallosis. Studies have recently concluded that the Zimmer M/L taper hip replacement product can cause such metal wear.

Zimmer M/L Taper Failure Due to Metallosis

The Zimmer M/L taper and Zimmer M/L taper with Kinectiv technology hip prostheses are made up of several component parts. There is a neck piece and femoral stem that are to be inserted inside the human femur bone. The neck piece is connected to an artificial head, which is often the Zimmer VerSys head. The junctions of these pieces, where they connect together, can be problematic because the parts are made of metal.artificial hip joint diagram

While there are varying reasons why a hip implant may cause problems, one such reason has to do with metal-on-metal wear. Hip replacement failure can result from corrosion sustained at certain junctions of artificial hip implants made of metal. Interfaces susceptible to metal-on-metal wear include the area where the metal stem meets the metal neck or where the metal neck meets the head. The body joints move, resulting in these artificial hip parts moving and rubbing together. This can lead to the release of metallic particles into the bloodstream, negative reactions with the tissue, and additional complications that can require revision surgery.

The potential for metal-on-metal wear and resulting metallosis has been known since at least the early nineties. Yet manufacturers such as Zimmer still produced such a product, claiming it was safe.

In 2012, Zimmer recalled certain lots of Zimmer VerSys heads (often paired with the M/L taper neck and stem products) stating that there was a sub-optimal fit between the head and necks.

In 2013, the Australian Orthopaedic Association National Joint Registry reported that the M/L taper with Kinectiv technology sustained revision rates greater than twice that of conventional hips.

In 2015, Zimmer recalled certain lots of its Zimmer M/L Taper with Kinectiv Technology hip products, citing concerns with cytotoxicity levels found within the product.

These products have been implanted in hundreds of patients. Several dozen lawsuits have been filed by individuals injured by the Zimmer M/L taper hip.

Acetabular Component Failure

An acetabular component failure can also occur due to metal-on-metal wear. This is similar to the neck-stem failure in theory, just involving different parts of the artificial hip component. Specifically, metal pieces of the acetabular system, the cup, ball, and liner, can unfortunately rub together, resulting in metallosis, corrosion, and metal wear. This can cause further damage to the surrounding tissue and muscles.

This type of acetabular failure was alleged to have occurred and the subject of thousands of lawsuits in the DePuy ASR and Pinnacle devices, in the Wright Conserve, Dynasty, and Lineage devices, the Zimmer Durom cup device, as well as the Biomet M2a Magnum product.

Billions of dollars in settlements have been awarded as a result of these acetabular failures.

How Do I Know What Kind of Hip I Have?

There are many different types of hip implant products on the market. The best way to find out what kind of hip you have is to go to the facility where your hip was implanted and ask for the sticker sheet for the barcodes or implant lists associated with the product put in your hip.

What Can Metallosis Cause?

Elevated metal levels indicate that a patient has metallosis, or metal poisoning. Metallosis is a common injury that patients experiencing a metal-on-metal hip replacement failure may suffer. Metallosis occurs because the metal-on-metal hip implants shed cobalt and chromium into the bloodstream. Common symptoms of metallosis include:

  • Increased pain
  • Pain at the hip site
  • Difficulty walking

Metallosis can cause damage to the tissue and muscle around the hip site, long lasting and permanent damage, severe pain, and often results in the need for a revision (removal of the hip device) surgery.

Metal-on-metal wear can unfortunately also lead to dissociation, which is the degradation of the components themselves from metallosis. The prosthesis can then detach from itself, often at the head-neck junction, and result in a collapse of the device components.

Dissociation is another risk inherent in the Zimmer M/L taper hip device.

Can I Pursue a Lawsuit?

Several dozen lawsuits have been filed in state and federal courts throughout the country alleging metallosis and need for revision from the Zimmer M/L taper and M/L taper with Kinectiv technology hip devices. One lawsuit filed in New Mexico for injuries sustained from the Zimmer M/L taper with Kinectiv technology hip resulted in a $2 million award to the Plaintiff after a trial.

The Judicial Panel on Multidistrict Litigation recently ordered that Zimmer M/L taper cases in federal court be consolidated before one Judge, the Honorable Paul Crotty. The Zimmer M/L taper multidistrict litigation is currently ongoing in the Southern District of New York.

If you suspect you require or had to have a revision due to issues with a Zimmer hip device, reach out to GoldenbergLaw. Our experienced team will assess your case and determine if we can move forward with a lawsuit on your behalf.

What Should I do Next?

If you or a loved one is experiencing hip replacement failure and has metallosis, you should look no further than GoldenbergLaw. We have represented hundreds of clients with defective hip replacements. Contact GoldenbergLaw, and we will guide you through this process, fighting to get you the compensation you deserve. GoldenbergLaw delivers the gold standard advocacy you deserve.

Johnson & Johnson Hit With $120 Million Pelvic Mesh Verdict

A Philadelphia jury punished a Johnson & Johnson (J&J) subsidiary with a $120 million verdict over claims its pelvic mesh was defectively designed and left a woman with chronic, debilitating pelvic mesh snippain. The verdict, handed down on April 24, awarded plaintiff Susan McFarland $20 million in compensatory damages while hitting Ethicon Inc. to the tune of $100 million in punitive damages.

McFarland’s claims centered on Ethicon’s TVT-O pelvic mesh device she had implanted in 2008 to treat her urinary incontinence. McFarland alleged that the TVT-O eroded through the tissue in her pelvis and eventually had to be partially removed with a second surgery. As a result, she suffers from chronic uterine tract infections and vaginal pain so severe that she has not been able to have sex with her husband for over 10 years. The jury agreed with McFarland’s claims that the TVT-O’s defective design caused the migration of the mesh and was ultimately responsible for her injuries.

RECORD VERDICT

The verdict marked the seventh plaintiff victory and the largest award yet among the pelvic mesh cases tried in the Philadelphia Court of Common Pleas. The total awarded to plaintiffs across these seven cases now exceeds $270 million.

The verdict also comes just over a week after the Food and Drug Administration ordered the manufacturers of pelvic mesh products to stop selling and distributing the devices after the manufacturers failed to provide evidence of its long-term safety.

If you or a loved one has been injured due to a defective pelvic mesh implant, call the Minnesota defective medical device attorneys at GoldenbergLaw for a free consultation. We have the experience and skills required to help you obtain the justice you deserve.