Hernia Mesh | Ethicon Physiomesh Lawsuits

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Ethicon Physiomesh Flexible Composite Mesh

Hernia mesh is used during hernia repair surgery to strengthen weakened tissue and to reduce the risk of a hernia re-occurring. Ethicon Inc.’s Physiomesh was introduced in 2010 and was promoted as lowering the risk of hernia repair complications. But the product was quietly removed from the market in May 2016 when unpublished data showed Physiomesh caused higher rates of recurrence and the need for re-operation compared to its competitors. Patients harmed by the defective hernia mesh are now suing Ethicon Inc. for its failure to warn about Physiomesh’s risks.

Ethicon Physiomesh Lawsuits

Did you suffer complications after being implanted with Physiomesh Flexible Composite Mesh during a hernia repair? Did those complications lead to a second surgery to repair or remove the faulty hernia mesh? You may be entitled to financial compensation. There may be significant cash settlements or payouts for those affected by the recalled mesh.

Lawsuits are being filed against Physiomesh’s manufacturer: Johnson & Johnson subsidiary Ethicon Inc. Ethicon pulled Physiomesh from the global market in May 2016, but thousands of people have already been implanted with the faulty mesh.

People who relied on the device for their hernia repair are now suffering injuries like infection, inflammation and the need for a second surgery. They have begun filing lawsuits against Ethicon that accuse the company of numerous legal claims, including negligence and failing to warn the public about the potential risks of the mesh.

Physiomesh lawsuits accuse Ethicon Inc. of several counts, including:

  • Designing and manufacturing a defective product
  • Failing to warn about Physiomesh’s potential risks
  • Negligently designing, manufacturing and selling a faulty hernia mesh
  • Failing to adequately test Physiomesh
  • Strict liability for manufacturing a defective product
  • Breach of express and implied warranties

Physiomesh lawsuits are being filed individually in federal and state courts nationwide. These lawsuits differ from class action lawsuits, which are filed by one or more individuals on behalf of many. Verdicts and settlements that are awarded in these types of personal injury cases are handed down individually, not split equally among plaintiffs like in a class action lawsuit.

Ethicon Physiomesh lawsuits are in their early phases of discovery. No lawsuits have gone to trial and no settlements have been awarded in the Physiomesh litigation as of March 2017.

 

Ethicon Physiomesh MDL

Plaintiffs in Physiomesh lawsuits petitioned the Judicial Panel on Multidistrict Litigation to consolidate theirs and other Physiomesh cases into a multidistrict litigation (MDL). The petition was filed in March 2017 and asked the MDL Panel to coordinate their cases for pretrial proceedings in either Illinois or Florida district court.

The MDL Panel consolidated cases involving a similar hernia mesh device — Atrium Medical’s C-Qur Hernia Mesh — in December 2016. The panel will hear motions for or against centralizing Physiomesh cases in an upcoming hearing.

If the MDL Panel chooses to consolidate, it could affect all Physiomesh lawsuits filed in federal courts nationwide. As of March 2017, there were 18 Physiomesh actions pending in 9 federal courts throughout the country.

First Physiomesh Trial Scheduled for 2018

The first Physiomesh lawsuit to head to trial is scheduled for January 2018. Illinois resident Matthew Huff filed his Physiomesh lawsuit in April 2016 after developing two abdominal abscesses and intestinal fistulas from Physiomesh. Huff required additional surgery because of his complications.

Huff’s will be the first Physiomesh case to go to trial and will be held before District Judge J. Phil Gilbert in the Southern District of Illinois.

Physiomesh Lawsuit Injuries

Hernia mesh lawyers and attorneys have begun filing lawsuits on behalf of people harmed by Ethicon’s now-recalled mesh. People report developing serious and sometimes debilitating injuries as a result Physiomesh and attorneys have documented these injuries in the cases now being filed in state and federal courts.

Physiomesh injuries documented by these attorneys include:

  • Need for revision surgery
  • Recurrent hernia
  • Pain
  • Infection
  • Internal scar tissue
  • Delayed wound healing
  • Inflammation
  • Foreign body response
  • Rejection
  • Adhesion
  • Bowel perforation or erosion
  • Fistula formation

Ethicon Physiomesh Recall

Physiomesh was taken off the market in May 2016. Ethicon Inc. initiated the voluntary global recall of its Physiomesh products with an Urgent Field Safety Notice sent to healthcare providers on May 25, 2016.

The letter advised practitioners to monitor patients who had already been implanted with Physiomesh as they would usually, but any unused products should be returned.

Ethicon said it would not bring Physiomesh back to the global market, citing unpublished data from two European hernia databases that found Physiomesh was prone to certain complications compared to other available devices. The data showed hernia recurrence and re-operation rates after laparoscopic ventral hernia repair with Physiomesh were higher than those of competing mesh.

The company did not determine any one cause for the higher rates of complications, but admitted Physiomesh’s characteristics could have been a factor.

The U.S. Food and Drug Administration (FDA) has not classified the Physiomesh recall and did not include the hernia mesh on its list of recalled products in 2016.

There are also hundreds of thousands of hernia repair patients who still harbor the defective mesh in their bodies. There could be as many as 300,000 people who were implanted with a Physiomesh device, according to a November 2016 estimate.

Physiomesh’s Defective Design

Physiomesh has a unique, five-layer design unlike any other mesh brand on the U.S. market. Ethicon promoted the design as lowering the risk of inflammation and minimizing adhesion, and the product sailed through the FDA’s 510(k) clearance program in 2010.

Physiomesh is a partially absorbable composite mesh made from synthetic materials, including polypropylene, which has been linked to an increased risk of complications. It is believed that when the hernia mesh starts to degrade, the polypropylene layer is exposed and can adhere to surrounding tissues and organs.

What is Hernia Mesh?

Hernia mesh is a type of surgical mesh used in hernia repair surgery. The screen-like device provides support to weakened or damaged tissue and can lower the risk of a hernia re-occurring. Hernias occur when an organ pushes through an opening or weakness in the surrounding tissue.

There are many different types of hernia mesh on the market today and they can be made from synthetic materials or animal tissues. Mesh made from animal tissue is absorbable. It will eventually be absorbed by the body and does not provide longterm support to weakened tissue.

Mesh made from synthetic material, on the other hand, can be either absorbable or nonabsorbable. Nonabsorbable mesh is considered a permanent implant and is intended to remain in the body indefinitely. These synthetic materials have been shown to increase the risk of complications, especially the plastic-like material polypropylene.

Ethicon Physiomesh

Ethicon’s Physiomesh Flexible Composite Mesh is a partially absorbable synthetic mesh designed to stretch and closely match the abdominal wall. A composite mesh is one that contains a coating of some kind.

Physiomesh is made of the synthetic materials polyglecaprone-25 (Monocryl) film, polydioxanone film (PDS) and polypropylene. Its distinct 5-layer design is comprised of 2 outer layers of Monocryl, 2 inner layers of PDS and one center layer of polypropylene.

Hernia mesh attorneys believe that when the outer layers of the mesh begin to degrade, the central polypropylene later is exposed to surrounding tissues and can adhere to organs. Numerous peer-reviewed studies have shown Physiomesh can increase risks for complications. Data from two European hernia repair databases, which Ethicon analyzed before pulling its hernia mesh from the market, also point to an increased risk for complications.

Ethicon’s Physiomesh was first approved by the FDA in April 2010. The agency approved the hernia mesh through its 510(k) Premarket Clearance program. This means Ethicon did not have to test its mesh in rigorous clinical trials to prove it was safe and effective for hernia repair.

To get a medical device cleared through the FDA’s 510(k) program, manufacturers only need to show that their device is as safe and effective as a similar device on the market.

Ethicon said in its application that Physiomesh had “met all testing criteria, demonstrated substantial equivalence to its predicate devices and did not raise any new questions of safety or effectiveness.”

The device was waved through without studies in people to ensure its safety and 6 years later the mesh was pulled from the market because of high complication rates over other mesh products.

Physiomesh Complications & Side Effects

Patients implanted with Ethicon’s Physiomesh allege suffering painful side effects and complications from the mesh. Studies and data have also linked the hernia mesh products to increased rates of complications, including hernia recurrence and the need for revision surgery.

Physiomesh is associated with complications such as:

  • Recurring hernia
  • Need for revision surgery
  • Pain
  • Infection
  • Internal scar tissue

Hernia Repair Surgery

Hernia repair surgery is incredibly common in the United States, with more than 1 million surgeries performed each year. Inguinal hernia repairs are the most common type of hernia repair surgery, making up about 800,000 of the 1 million annual surgeries. Inguinal hernia repairs fix hernias in the inner groin.

Types of Hernia Repair Surgery

There are two main approaches to hernia repair surgery: laparoscopic and open repair.

Laparoscopic

During laparoscopic hernia repair, surgeons make small incisions in the abdomen and use tools to reach and repair the hernia.
Laparoscopic surgery is generally associated with better surgical outcomes over open repair, since the procedure is minimally invasive. Patients typically recover more quickly and experience less pain following laparoscopic hernia repair compared with open repair.

However, some studies comparing the two approaches suggest patients may not experience less pain following a laparoscopic procedure and hernia recurrence rates were comparable between the two groups.

Laparoscopic repair is also more costly to patients and the procedure itself can take much longer than open repair.

The typical recovery time for laparoscopic hernia repair surgery is about 1-2 weeks.

Open Repair

During open repair, surgeons make an incision near the hernia in order to repair it. The incisions are larger than those made in laparoscopic repair.

Patients who choose open repair may have longer recovery times compared to those who choose laparoscopic, but the procedure is typically less expensive. Recovery time for open repair is about 3 weeks compared to 1-2 weeks for laparoscopic.

Hernia Mesh Surgery Complications

There are risks associated with any type of surgery and hernia repair is no exception. However, hernia mesh may increase the risks for complications and injuries.

The FDA conducted a review of adverse events reports and peer-reviewed scientific literature to determine the most common complications of hernia repair surgery.

The most common adverse events — regardless if hernia mesh was used in the repair or not — were:

  • Pain
  • Infection
  • Hernia recurrence
  • Adhesion (scar-like tissue that sticks together)
  • Obstruction (blockage of the large or small intestine)
  • Bleeding
  • Fistulas (abnormal connections between organs, vessels or intestines)
  • Seroma (fluid buildup at the surgical site)
  • Perforation (hole in nearby organs or tissues caused by the mesh)

When mesh was used during the procedure, the FDA found the most common complications were:

  • Pain
  • Infection
  • Hernia recurrence
  • Bowel obstruction
  • Mesh migration
  • Contraction (mesh shrinkage)

Hernia Causes

Hernias occur when an organ pushes through a weakness or hole in the tissue that surrounds it. Hernias can be caused by a number of different factors. Most are caused by pressure pushing on the weakened spot, which then pushes an organ or tissue through the weak area.

Risk factors for hernias include:

  • Muscle weakness present at birth
  • Obesity
  • Lifting heavy objects
  • Diarrhea or constipation
  • Persistent coughing or sneezing
  • Poor nutrition
  • Smoking
  • Overexertion

Types of Hernias

Hernias can occur in different areas of the body. The most common types of hernias are:

  • Inguinal — occurs in the inner groin (most common)
  • Femoral — occurs in the upper thigh or outer groin
  • Incisional — occurs through an incision or scar in the abdomen
  • Ventral — occurs in the abdominal wall
  • Umbilical — occurs at the belly button
  • Hiatal — occurs near the upper stomach or diaphragm

Hernia Symptoms

Hernias are often detected when a bulge appears in the area where the hernia occurred, but other hernia symptoms are possible and may depend on where the hernia is located.

Hernia symtoms include:

  • Bulge in affected area
  • Pain or discomfort in the affected area
  • Burning or aching sensation at the site of the bulge
  • Weakness, pressure or a feeling of heaviness in the abdomen (inguinal hernia)
  • Chest pain, difficulty swallowing, acid reflux (hiatal hernia)

Studies on Ethicon’s Physiomesh

Physiomesh was taken off the market when unpublished data from 2 hernia databases showed there was a higher risk for hernia recurrence and re-operation with Physiomesh compared to other brands on the market.

Several peer-reviewed studies have also been published that suggest Physiomesh could cause significant complications over competing mesh brands.

Surgical Endoscopy, 2016

A study published in the journal Surgical Endoscopy in March 2016 found Physiomesh had a higher rate of recurrence and caused significantly more pain in patients.

The study compared Ethicon’s Physiomesh with Bard Davol’s Ventralight hernia mesh in 100 patients at a single hospital. The study was cut short, however, because of complications in the Physiomesh group.

Roughly 20% of patients in the Physiomesh group suffered from a recurring hernia within 6 months of their initial surgery, and most Physiomesh patients reported significantly higher rates of pain within the first 3 months.

Although researchers ended the trial early, they concluded that Physiomesh was associated with “significantly greater hernia recurrences and postoperative pain” compared to Ventralight.

Animal Studies

A study published in the journal Surgical Endoscopy in August 2015, compared 4 different mesh brands in lab rats. The study found Physiomesh fractured over time and led to an increase in scar tissue formation.

A study published in the Journal of the Society of Laparoendoscopic Surgeons showed Physiomesh caused significantly more inflammation, fibrosis and hemorrhage in female pigs compared to Bard’s Ventralight mesh.

In both animal studies, Physiomesh had significantly less adherence to the abdominal wall, suggesting the mesh was not providing necessary support to strengthen weakened tissue.

Sources

Ethicon Inc. Urgent Field Safety Notice. (May 26, 2016). Retrieved from
https://www.swissmedic.ch/recalllists_dl/13779/Vk_20160525_11_e1.pdf

 

Mass Tort Nexus. “MDL Motion Expected in Ethicon Physiomesh Hernia Repair Product Litigation.” John Ray. (Nov. 2, 2016). Retrieved from
https://www.masstortnexus.com/mass-torts-news/ethicon-physiomesh-hernia-repair-product-recall-and-litigation/

 

Mass Tort Nexus. “Woman Sues Ethicon After Intestines Push Through Hernia Mesh.” Larry Bodine. (Feb. 17, 2017). Retrieved from
https://www.masstortnexus.com/mass-torts-news/woman-sues-ethicon-after-intestines-push-through-hernia-mesh/

 

Connie Franklin et al. v. Johnson & Johnson et al. in the U.S. District Court for the Middle District of Georgia. Filed Feb. 2, 2017. (Case No. 4:17-cv-00031)

 

Mass Tort Nexus. “Plaintiffs Seek MDL in Ethicon Physiomesh Hernia Repair Product Litigation.”  Larry Bodine. (March 24, 2017).
https://www.masstortnexus.com/mass-torts-news/plaintiffs-seek-mdl-in-ethicon-physiomesh-hernia-repair-product-litigation/

 

Huff vs. Ethicon Inc. in the U.S. District Court for the Southern District of Illinois. Filed April 1, 2016. (Case No. 3:16-cv-00368).

 

Johnson & Johnson. Press Release, “Ethicon, Inc. Introduces Two Innovative Devices for Minimally Invasive Hernia Repair during American College of Surgeons (ACS) Annual Meeting.” (October 2010). Retrieved from
http://files.shareholder.com/downloads/JNJ/0x0x407263/c68bdc83-c38a-46d4-85ab-aa22277689b4/JNJ_News_2010_10_4_Financial_Releases.pdf

 

Journal of the Society Laparoendoscopic Surgeons. “Comparison of Laparoscopic vs Open Modified Shouldice Technique in Inguinal Hernia Repair.” Thomas Nicholson et al. (1999).
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3015338/

 

JAMA Surgery. “Laparoscopic vs Open Incisional Hernia Repair: A Randomized Clinical Trial.” Hasan H. Eker et al. (March 2013). Retrieved from
http://jamanetwork.com/journals/jamasurgery/fullarticle/1670366

 

Healthline. What are the Symptoms of a Hernia? Retrieved from
http://www.healthline.com/health/hernia?m=0#symptoms5

 

FDA. Hernia Surgical Mesh Implants. (2016). Retrieved from
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/default.htm

 

Surgical Endoscopy. “Comparison of two different concepts of mesh and fixation technique in laparoscopic ventral hernia repair: a randomized controlled trial.” Pawlak M. et al. (March 2016). Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/26139491

 

Journal of the Society of Laparoendoscopic Surgeons. “Ventralight ST and SorbaFix Versus Physiomesh and Securestrap in a Porcine Model.” Corey R. Deeken et al. (October 2013). Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3866058/

 

Surgical Endoscopy. “Long-term evaluation of adhesion formation and foreign body response to three new meshes.” R. R. M. Vogels et al. (August 2015). Retrieved from
https://www.ncbi.nlm.nih.gov/pubmed/25361655

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