A large number of patients throughout the United States have reported severe and debilitating problems following hernia implantation with Atrium C-Qur mesh or Proloop Mesh products. Common complications include chronic pain, infection, device rejection and hernia recurrence.
But rather than issuing a recall for the ProLoop or C-Qur devices, Atrium instead elected to quietly remove certain devices from the market and failed to warn consumers of their serious risk.
Atrium Medical embarked on what lawyers are calling a “stealth” recall of their C-Qur mesh products due to allegations that the device increased the risk of hernia mesh complications and Atrium mesh injuries.
Atrium knew or should have known about the potential risks of their products. However, information was withheld from patients and the medical community. Many surgeons and hospitals have recently stopped implanting the C-Qur hernia mesh due to high rates of infections, bowel obstructions, and allergic reactions.
Joe Lyon is a highly-rated Cincinnati product liability lawyer and Ohio mesh recall attorney representing plaintiffs nationwide in a wide variety of defective medical device and Atrium mesh injuries linked to ProLoop or C-QUR defects.
The Atrium C-Qur mesh failure rates are unreasonably high, potentially resulting in the need for revision surgery and leaving patients with permanent and debilitating health problems.
The C-Qur mesh is made from polypropylene, the polymer plastic that is known to shrink, cause a foreign body reaction, become infected and erode. These mesh injuries are often life-changing, due to the pain and loss of function related to the faulty products,
If the hernia mesh adheres to the bowel, it could lead to a twisted and perforated bowel, causing gastric ulcers or other intestinal problems, including infections like sepsis and gangrene. Some reports also suggest that patients may suffer from the following:
• Device rejection
• Organ Perforation
• Adverse foreign Body Response—inflammation and allergic reactions
• Revision Surgeries
• Bowel Obstruction
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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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Despite signs of potential problems with the Atrium C-Qur mesh, the manufacturer continued to release products for use in hernia repair. All of the listed products are constructed out of an Atrium polypropylene mesh, with an outer coating of gel made from omega 3 fatty acids, called the O3FA layer. Surgeons utilize several types of C-Qur mesh for various abdominal procedures, including the following:
• C-Qur Edge (officially recalled)
• C-Qur V-Patch
• C-Qur Tacshield
• C-Qur FX
• C-Qur CentriFX
• C-Qur Mosaic
• C-Qur Film
On October 11, 2012, the FDA issued a warning letter to Atrium Medical, noting that the company was failing to address serious complaints related to infections associated with their C-Qur hernia mesh product. The letter also revealed that Atrium Medical appeared to be ignoring sterility complaints.
In August, 2013, the FDA announced a recall of the C-Qur Edge mesh because the Omega 3 fatty acid coating on the mesh could adhere to the inner packaging liner due to exposure to high humidity. The recall affected over 1,500 C-Qur hernia mesh units.
Atrium warned physicians to inspect the C-Qur mesh device, but did not pull any of the C-Qur products off the shelf. Attorneys believe that the coating of the C-Qur mesh has peeled off in patients once implanted, and has resulted in significant injuries.
Many lawsuits have been filed against Atrium after patients allegedly suffer from a variety of ProLoop and C-Qur mesh injuries. One particular plaintiff underwent surgery for a hernia in which Atrium C-Qur mesh was used, and roughly two years post-operation, the patient noticed an onset of severe stomach pain.
The hernia also recurred, and the patient underwent surgery again to remove the Atrium C-Qur mesh. Surgeons found the C-Qur mesh crumpled in her abdomen, where it had caused scar tissue, making it impossible to replace the C-Qur with new mesh. The patient’s attorneys argue that the C-Qur fish oil coating resulted in her body rejecting the hernia mesh.
Other patients who are implanted with similar Atrium devices have alleged similar foreign body reactions. Physicians have reported to the FDA experiences of the coating peeling off during implantation or within a week after implantation.
Atrium’s C-Qur hernia mesh is among many devices on the market that have not been proven safe through extensive testing for Pre-Market Approval. As a result, an increasing number of claims against Atrium Medical have been filed in the courts.
The lawsuits contend that Atrium knew or should have known about both the risks of rejection, and other associated complications. Medical device companies like Gore, Covidien, Aspide, Atrium, Ethicon and Bard have agreed to pay million to settle lawsuits. The companies currently face thousands of pending 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.
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.