SEPRAMESH


Product liability attorney investigates defective hernia mesh products for injured plaintiffs nationwide
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Sepramesh Injury Lawsuits

investigating hernia mesh injury cases 

C.R. Bard’s Sepramesh IP composite hernia mesh device was acquired from another medical device outfit, specifically for the Sepra® technology and to use in future mesh products of its own. Bard’s Sepra Technology (ST) is still used in the Ventralex ST, Ventrio ST, and Ventralight.

The Sepramesh IP composite mesh was approved by the FDA in 2000 through the agency’s 510(k) clearance program, similar enough to another mesh product already on the market, and was distributed widely to patients. Sepramesh IP, approved in 2004, is a modified version of the original device (Sepramesh IP Composite is made of the plastic-like materials polypropylene (PP) and polyglycolic acid (PEG).)

Regardless of new and “improved” designs, Sepramesh IP and other Bard mesh products have reportedly injured thousands of recipients with implanted mesh.

Victims and attorneys argue that Bard should have initiated better clinical testing programs and offered warnings of health risks before they marketed their products as safe.

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

Sepramesh Safety Issues & Complications

Bard’s Mesh devices have been associated with many common injuries and complications. 

At least 50 adverse event reports relating to Sepramesh have been submitted to the FDA by doctors and patients. Sepramesh IP has been shown to adhere to surrounding tissues and organs, including at least one patient’s colon.

Another reported an implant had created a holes in their bowel and eroded a small intestine. Other reported mesh complications and side effects linked to hernia mesh products include:

  • Bowel Blockage
  • Infection
  • Adhesion
  • Chronic pain
  • Hernia recurrence
  • Allergic reaction
  • Granuloma
  • Hematomas
  • Fistula formation
  • Bowel Perforation
  • Mesh erosion
  • Need for revision surgery

Sepramesh IP Composite Mesh Lawsuits

Sepramesh has been targeted for being manufactured with alleged defective materials. The implant is made of a lipid coating that may incite high levels of inflammation, and can slow wound healing and create chronic infection. In one study, after the mesh was implanted for only 8 days, postoperative peritoneal adhesions occurred at the extremities of the mesh where bare polypropylene was exposed.

Adhesions also formed where fixation sutures exposed the polypropylene. Lawyers involved in cases argue C.R. Bard is negligent and failed to warn the public about the potential risks of the mesh. Lawsuits also claim the following:

  • Bard is liable for designing and manufacturing a defective product
  • Bard failed to warn consumers of potential risks
  • Bard is liable for strict liability for manufacturing a defective product
  • Bard breached express and implied warranties

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ABOUT THE LYON FIRM

Joseph Lyon has 17 years of experience representing individuals in complex litigation matters. He has represented individuals in every state against many of the largest companies in the world.

The Firm focuses on single-event civil cases and class actions involving corporate neglect & fraud, toxic exposure, product defects & recalls, medical malpractice, and invasion of privacy.

NO COST UNLESS WE WIN

The Firm offers contingency fees, advancing all costs of the litigation, and accepting the full financial risk, allowing our clients full access to the legal system while reducing the financial stress while they focus on their healthcare and financial needs.

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A Voice for Those who have suffered

Why are these cases important?

Defective medical device litigation helps to improve patient safety and holds medical device companies accountable when defective products injure plaintiffs and clients.

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Hernia Mesh Litigation

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. 

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