ETHICON
HERNIA MESH RECALL


Product Liability Lawyer reviewing Ethicon Hernia mesh injury lawsuits for plaintiffs nationwide
Nationwide Success

Ethicon, a subsidiary of Johnson and Johnson, is currently the target in numerous lawsuits nationwide because thousands of patients have been allegedly injured by hernia reparation devices, including the Proceed Ventral Patch.

Ethicon states on its Web site that the Proceed Patch model enables patients “to heal strongly, naturally, and comfortably.” But that claim has been discounted by thousands of hernia patients who have undergone surgery and had an Ethicon mesh device implanted. Infection, bowel obstruction, and other complications have been reported after the Ethicon patch disintegrated inside the bodies of patients.

Attorneys claim Ethicon knew that the polypropylene used to make the Proceed hernia mesh was not fit for human implantation. In fact, Ethicon added a coating to the Proceed in an attempt to mitigate injuries caused by the polypropylene. However, over time the coating disintegrates and only bare polypropylene remains.

The company claims a hernia recurrence rate of less than 10 percent, though patient reports suggest a much higher rate. The Proceed device has been recalled in the past after post-surgery complications, though the Ventral Patch continues to be implanted and cause serious health issues to patients.

Joe Lyon is a highly-rated Cincinnati product liability lawyer and Ohio recall attorney representing plaintiffs nationwide in a wide variety of defective medical device and civil litigation claims.  

FDA Recalls Ethicon Proceed 

Thousands of Proceed hernia mesh units have been recalled in the last decade. All recalls initiated by the U.S. Food and Drug Administration (FDA) were due to the device coating delaminating, or peeling off of the polypropylene base material.

The FDA noted, “The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination.”

In their recall statements, Ethicon admitted that there was a higher risk of adhesions and fistulas when the Proceed delaminates. They said the defective devices “could increase the risk of adhesions and bowel fistulization.”

These are serious complications that may lead to permanent injury or even death. However, the Proceed hernia mesh is still on the market and continues to be implanted in patients nationwide.

The first Proceed Patch recall was initiated in 2006, and over 18,000 units were affected, many of them already implanted in hernia patients. Further FDA recalls were announced in 2010, and another in 2014. Incredibly, the patch remains on the market and is sold as a safe mesh product.

Ethicon Hernia Device Complications

Mesh and patch devices are commonly used to strengthen weakened or damaged tissue in hernia repair procedures. Hernias are a relatively common problem that may require surgery to alleviate persistent pain, discomfort and other symptoms.

However, patients who selected Ethicon’s Proceed Ventral Patch may risk potential infections, hernia recurrence and secondary surgeries. Patients and doctors have reported severe complications including the following:

•    Severe abdominal pain
•    Redness of skin
•    Bowel Blockage
•    Abdominal abscess
•    Adhesions
•    Bowel obstruction
•    Intestinal fistula
•    Mesh migration
•    Bacterial infection
•    Hernia recurrence
•    Revision surgery

Ethicon Hernia Mesh Injury

The Ethicon Proceed Ventral Patch is facing scrutiny over its effectiveness and poor safety record, though it is only one of Ethicon’s hernia products that have been potentially unsafe. The other models of hernia devices include the following:

•    Proceed Ventral Patch
•    Physiomesh
•    Prolene 3D Patch
•    Ultrapro Comfort Plug

Hernia Mesh Lawsuits

Attorneys claim Ethicon’s hernia-related products, first approved in April, 2010, were not properly tested before they were marketed and distributed as a safe hernia solution. The Proceed Ventral Patch was approved by FDA 510(k) clearance, meaning it did not require FDA review or clinical trials to properly deem it safe or unsafe.

A number of settlements have been reached over Ethicon mesh litigation. If you have had surgery to treat a hernia using a mesh and you experience any signs or symptoms of recurrence or complications, talk to medical and legal experts.

The Lyon Firm has experience litigating cases against Ethicon and other mesh device manufacturers including Gore, Aspide, Covidien, Atrium and C.R. Bard.

photo of attorney Joe Lyon
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Questions about Hernia Mesh Injury

Can I file a hernia mesh lawsuit?

Attorneys claim several hernia mesh devices were not properly tested before they were marketed and distributed as safe medical instruments.

The companies currently face thousands of pending hernia mesh injury lawsuits. If you have had surgery to treat a hernia using a device and you experience any signs or symptoms of recurrence of the hernia, please consult with a medical and legal expert. The Lyon Firm has experience litigating cases against medical device manufacturers.

Attorneys contend that some hernia mesh devices are not properly tested before they are distributed to the public as safe products. Device companies like Gore, Aspide, Ethicon, Bard, Covidien and Atrium have settled hundreds of lawsuits and currently face countless more injury claims.

If you are unsure about the mesh manufacturer and product used in your surgery and have questions about your hernia repair, contact your Ohio surgeon to obtain medical records. Contact a Cincinnati hernia mesh lawyer to discuss potential hernia mesh injury lawsuits and settlement.

What hernia mesh products have allegedly caused injury?
  • Gore DualMesh
  • Aspide Surgimesh
  • Ethicon
  • Physiomesh
  • Proceed
  • Prolene
  • Covidien 
  • Parietex
  • Parietene
  • Permacol
  • Surgipro
  • Atrium
  • C-Qur
  • ProLoop
  • Bard/ Davol
  • Visilex
  • Composix
  • Marlex
  • Ventralight
  • Spermatex
  • 3D Max
  • Sepramesh
  • PerFix Plug
  • Ventralex
  • Kugel
How common is hernia recurrence?

Regardless of treatment, hernias have a high rate of recurrence, and surgeons often use surgical mesh to strengthen the hernia repair recurrence rate. The use of meshes is thought to reduce dramatically the incidence of hernia recurrence.

However, up to 50 percent of hernias may reoccur with an implanted device. This is commonly due to inadequate fixation during the original operation or shrinkage of the mesh. Light-weight meshes may have a higher risk due to their increased flexibility and movement.

Two-thirds of recurrences occur after three years. It is not clear if the type of mesh used has any effect on durability. All mesh products appear equally limited in effectiveness.

what are the different types of hernias?
  • Inguinal: occurs in the inner groin. The most common of abdominal hernias. Sometimes muscles that attach to the pelvis leave a weakened area and if there is a stress placed on that area, the weakened tissues can allow a portion of small bowel to slide through that opening, causing pain and producing a bulge. Inguinal hernias are more likely to occur in men.
  • Femoral: occurs in the upper thigh/outer groin. Femoral hernias tend to occur more frequently in women.
  • Incisional: occurs through an incision or scar in the abdomen. Incisional hernias occur as a complication of abdominal surgery, where the abdominal muscles are cut to allow the surgeon to enter the abdominal cavity to operate.
  • Ventral: occurs in the general abdominal/ventral wall
  • Umbilical: occurs at the belly button and are very common in newborns and often do not need treatment unless complications occur. Some umbilical hernias enlarge and may require repair later in life.
  • Hiatal: occurs inside the abdomen, along the upper stomach/diaphragm
  • Obturator: the least common hernia of the pelvic floor, mostly found in women who have had multiple pregnancies or who have lost significant weight.
What is a fistula?

Repair of hernias are done by either suture repair or prosthetic mesh repair. The latter is associated with a lower recurrence rate but a higher incidence of complications. The most serious complication is the development of fistula.

Fistula is a late complication of prosthetic mesh repair and is usually due to chronic erosion of bowel by mesh placed in direct contact with intestinal loops both in open and laparoscopic repairs. Symptoms of fistulas may include the following:

  •  Persistent pain—throbbing and worse when sitting down.
    •    Skin irritation around the anus, including swelling, redness and tenderness.
    •    Discharge of pus or blood.
    •    Constipation or pain associated with bowel movements.
    •    Fever
Does hernia mesh cause adhesions?

Hernia mesh adhesions are scar tissue resulting from hernia mesh operations and the healing process. Following hernia repair surgeries, adhesions may form in the abdomen or peritoneum. The mesh repairs usually heal quickly but when adhesions form, organs connected by the scar tissue may not function properly.

The popularity of hernia mesh operations has led to increasing concern regarding mesh-related adhesions. Adhesions result from the fibrin exudates that follow any kind of trauma.

These exudates form temporary adhesions until the fibrinolytic system absorbs the fibrin. Absorption is delayed in the presence of inflammation or foreign bodies such as mesh devices. In these situations, they develop into tissue adhesions.

All mesh implants produce adhesions, though their extent varies. Abdominal adhesions are a common complication, occurring in a majority of people who undergo abdominal or pelvic surgery. Adhesions cause the majority of small bowel obstructions in adults, and are believed to contribute to the development of chronic pelvic pain.

X-rays do not reveal potential mesh issues or diagnose the presence of adhesions. An additional surgery is usually needed to diagnose or treat hernia mesh adhesions. However, revision surgeries carry risks and can lead to further health problems, including infection, bowel blockage, bowel perforation and chronic pain.

Adhesions may begin forming long before they are noticed by patients or doctors. Depending on the location, adhesions from defective hernia mesh devices may cause pain and affect the bowel in different ways. Even removing a defective hernia mesh product may not completely solve all health issues.

Symptoms of adhesion and hernia mesh injury may include:

  •  Severe abdominal pain or cramping
    •    Vomiting
    •    Bloating
    •    Loud bowel sounds
    •    Swelling of the abdomen
    •    Constipation
How is a Medical Device Defined as Defective?

Ohio Definition of Defective

Under Ohio law, a medical device is  defective if it is unreasonably dangerous for its intended use. A legal cause of action can be based on several types of medical device product defects. Most jurisdictions a version of one or more of these cause of actions. 

(1)  Manufacturing/ Construction Defect of the medical device:

(2) Defective design and/or formulation of the medical device:

(3) Failure to warn or inadequate warning or instruction associated with the medical device:

(4) Misrepresentation on the Safety or Efficacy of the Medical Device:

(5) Fraud Related to the Safety or Efficacy of the Medical Device

(6) Negligent Distribution or Testing of the Medical Device

 

Why should I hire The Lyon Firm?

Our Firm will help you find the answers.  The Firm has the experience, resources and dedication to take on difficult and emotional cases and help our clients obtain the justice for the wrong they have suffered. 

 Experience:  Joe Lyon is an experienced Cincinnati Defective Device Lawyer. The Lyon Firm has 17 years of experience and success representing individuals and plaintiffs in all fifty states, and in a variety of complex civil litigation matters. Defective device lawsuits can be complex and require industry experts to determine the root cause of an accident or injury. Mr. Lyon has worked with experts nationwide to assist individuals understand why an injury occurred and what can be done to improve their lives in the future. Some cases may go to a jury trial, though many others can be settled out of court.

Resources/Dedication: Mr. Lyon has worked with experts in the fields of accident reconstruction, biomechanics, epidemiology, metallurgy, pharmacology, toxicology, human factors, workplace safety, life care planning, economics, and virtually every medical discipline in successfully representing Plaintiffs across numerous areas of law. The Lyon Firm is dedicated to building the strongest cases possible for clients and their critical interests.

Results:  Mr. Lyon has obtained numerous seven and six figure results in medical device cases.  He has litigated cases successfully against some of  the largest companies in the world including:  Johnson & Johnson, Biomet, Ethicon, Stryker, Coloplast, Smith & Nephew, American Medical Systems, Boston Scientific, Medtronic, Guidant, Bard, & Bayer. 

Your Right to Safety

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Defective products on the market present safety and health hazards for adults and children. Cheap and defective products may pose fire and burn risks; electrocution, strangulation and choking risks; and severe health risks. The manufacturers of consumer products have a duty to foresee potential injury and properly design and test products before they are released.

Companies must also properly warn consumers of any risks associated with their products. Any failure to protect consumers that results in accidents and injury can lead to lawsuits filed by plaintiffs and their Cincinnati product liability lawyer


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