Hernia mesh recipients in recent years have reported severe and debilitating problems following implantation with Atrium C-Qur mesh products. The most common complications include chronic pain, infection, device rejection and hernia recurrence.
Atrium was warned years ago about such results, but elected not to recall their mesh device and failed to warn consumers of the risks. Only after allegations and lawsuits began surfacing did Atrium Medical remove some of their C-Qur mesh products from the market.
Lawyers claim Atrium knew or should have known about the potential risks of their mesh products. Rather than prevent further injuries to patients, Atrium went forward and sold questionable devices. Many medical professionals stopped using the C-Qur hernia mesh due to high infection rates, bowel obstructions, and systemic allergic reactions.
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.
In October, 2012, the FDA issued a warning to Atrium Medical, urging the company to address serious complaints related to infections caused by the C-Qur mesh product. Atrium Medical did not properly manage the issues and the FDA responded in 2013 by announcing a recall of the C-Qur Edge mesh.
The recall stated that the Omega 3 oil coating on the mesh could adhere to the packaging due to humidity exposure. Attorneys believe the same C-Qur coating in question has peeled off in patients’ bodies once implanted, and resulted in severe injuries requiring further operations.
The Omega 3 oil coating was originally designed to assist in the patient’s healing process and reduce the chance of the mesh attaching to internal tissues. Results, however, show the gel coatings simply led to further injuries.
The FDA has received serious post-op reports regarding the ProLoop and C Qur mesh devices. The Atrium mesh failure rates are unacceptably high, and allegedly leave patients with permanent and debilitating medical conditions. The mesh, made from polypropylene, is known to shrink, cause foreign body reactions, become infected and erode. Patients implanted with a C-Qur mesh device may suffer from the following:
Infection—the Omega 3 fatty acid gel of C-Qur was designed to create a cleaner mesh implant, less likely to attach to organ tissue, but in many cases patients have suffered from serious infections. There is clear indication that the mesh is unsuitable to be used inside the body. If the hernia mesh adheres to the bowel, it can cause gastric ulcers and infections like sepsis and gangrene.
Chronic Pain—discomfort is the most common side effect after a hernia mesh operation. This is understandable, considering the invasiveness of the surgery, but some patients have suffered severe allergic reactions and other patients have experienced pain so severe they are unable to go to work or perform daily chores. Persistent groin pain affects quality of life in every way.
Rejection—mesh rejection is most commonly caused by an allergic reaction. The body in many patients is unable to accept the makeup of the mesh material, namely the Omega 3 oil.
Organ Perforation—this may be caused by the mesh migrating in the body. Organ perforation is extremely serious and can cause long-term health issues.
Bowel Obstruction—if a mesh device has perforated an organ, it can cause an obstruction of the bowel. This will in turn require an additional surgery.
Patients may also suffer from other side effects including:
• Adverse foreign body response—inflammation and rashes
• Additional Surgeries
• Abnormal Liver Function
• Nerve damage
• Neurological changes
Doctors have reported to the FDA certain cases where the oil coating on the mesh peels off during implantation or very soon after implantation. Despite such issues with the C-Qur mesh, Atrium continued to release products made of polypropylene mesh with an outer coating of Omega 3 fatty acid gel.
Atrium has authorized and sold the following types of mesh for use in hernia abdominal procedures:
• C-Qur Edge (officially recalled)
• C-Qur V-Patch
• C-Qur Tacshield
• C-Qur FX
• C-Qur Mosaic
• C-Qur Film
• C-Qur Centrifix
• C-Qur Lite
Atrium currently faces thousands of pending lawsuits. Medical device companies like Atrium have previously paid millions to settle lawsuits when they market and sell failing medical devices, and plaintiffs expect that trend to continue.
Atrium’s hernia mesh was not proven safe through testing and as a result an increasing number of claims against Atrium have been filed by injured patients and attorneys. Pending lawsuits allege that Atrium should have known about the risks of dangerous ProLoop and C Qur complications, and properly warned patients.
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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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.
The Lyon Firm aggressively, professionally, and passionately advocates for injured individuals and families against companies due to a defective product or recalled product to obtain just compensation under the law.