Covidien has a long history of manufacturing and distributing a variety of alleged defective medical devices. The latest device to be found potentially faulty is the Parietex hernia mesh product, which has injured an unknown number of patients in recent years.
Covidien’s Parietex hernia mesh uses polyester as a base material and can incite a systemic inflammatory response after implantation. In addition, the Parietex mesh attachment design is made with small barbs that adhere to the patients’ tissue upon implantation.
When issues arise, the Parietex device is very difficult to remove, and secondary surgeries may cause serious damage to the pelvic region and surrounding organs.
As a result, the company has agreed to settle thousands of claims involving its mesh devices which patients allege caused severe and painful side effects after implantation. In the last five years, Covidien has reportedly paid hundreds of millions in lawsuits related to litigation over mesh products.
Joe Lyon is a highly-rated Cincinnati mesh injury lawyer and Ohio mesh recall lawyer representing plaintiffs nationwide in a wide variety of defective medical device and civil litigation claims.
The U.S. Food and Drug Administration (FDA) regularly reports medical device adverse events for hernia operations. The most common patient complaints are pain, infection, hernia recurrence, adhesion, abdominal obstruction, bleeding, and fistula.
There is a high rate of hernia recurrence with mesh devices. When a mesh fails and the hernia reoccurs, many severe complications can occur. Also, the hernia is usually much larger after mesh failure. Abdominal tissue and muscle may adhere to the mesh and must be removed with it. The FDA says it has received reports of complications associated with hernia mesh such as:
• Allergic reactions
• Hernia recurrence
• Bowel Perforation
The FDA notes on its Web site that most defective hernia mesh products that cause serious harm have been recalled and are no longer on the market. However, any defective medical device is a terrible danger to the health community. Covidien also produced other hernia mesh devices including the following:
Covidien’s Parietex hernia mesh uses polyester instead of polypropylene. But like polypropylene, polyester can cause a systemic inflammatory response after implantation.
The Parietex design is similar to Velcro, with barbs intended to adhere to the patients’ tissue upon implantation. Unfortunately, this results in the Parietex being extremely difficult to remove when complications occur.
To remedy this design flaw, Covidien decided to add a coating to the Parietex mesh, much like the manufacturers of other polypropylene hernia meshes. The coating on the Parietex is intended to keep the mesh from adhering to the patient’s bowel.
But over time, doctors and patients have seen that any hernia mesh with a coating is more prone to becoming infected. Furthermore, the mesh is extremely difficult to fully remove once it becomes infected.
Attorneys representing victims of medical device companies claim the manufacturers of hernia mesh products have funded studies to demonstrate that there was a lower rate of hernia recurrence when hernia mesh was utilized. The studies in question do nothing to consider the damage of the variety of serious complications involved with hernia operations.
Patients implanted with mesh many years ago have just recently suffered from the mesh eroding into their bowels. Hernia mesh complications will continue to surface as long as defective mesh devices remain on the market.
Many hernia mesh devices are not properly tested before they are marketed and sold as safe medical instruments. Medical device companies have agreed to pay million to settle lawsuits to victims. The companies currently face thousands of pending lawsuits.
Covidien has faced lawsuits involving their Parietene, Parietex, Surgipro and Permacol devices.
If you have had surgery to treat a hernia using a device and you experience any complications, please consult with the implanting surgeon and a legal expert. The Lyon Firm has experience litigating cases against medical device manufacturers.
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.
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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.
Defective medical device litigation helps to improve patient safety and holds medical device companies accountable when defective products injure plaintiffs and clients.
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.
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.
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:
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:
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
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.