As early as December, 2005, Davol, a subsidiary of C.R. Bard, initiated a series of recalls for its Composix Kugel mesh due to problems with the “memory ring” minimally-invasive surgery.
Following several reports of the plastic memory ring splintering and migrating away from the surgical site, Davol recalled the mesh. Another recall was initiated in 2007 for similar issues with the mesh devices.
The recall was classified as a Class 1 recall, the highest level of recall observed by the U.S. Food and Drug Administration (FDA), indicating how potentially dangerous the implanted devices can be to personal health.
The Composix Kugel mesh patches were designed with a “memory recoil ring” that allowed the patch to be inserted through a small abdominal incision. However, that ring was found to buckle or break after placement, causing painful and potentially fatal complications.
Attorneys and victims have argued for over a decade now that hernia Bard’s mesh devices, including the Composix Kugel Mesh patches are not properly tested before they are used in patients who expect safe and effective medical care.
As a result, C.R. Bard and other mesh manufacturers have paid millions to settle injury lawsuits. The company still faces thousands of pending Composix Kugel Mesh lawsuits.
If you have had surgery to treat a hernia using a device after January 1, 2006, and you experience any signs or symptoms of recurrence of the hernia, consult with medical and legal experts to investigate. The Lyon Firm has experience litigating cases against mesh device manufacturers.
Joe Lyon is a highly-rated Cincinnati product liability attorney and Ohio Bard mesh injury lawyer representing plaintiffs nationwide in a wide variety of defective medical device and civil litigation claims.
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.
Based on the U.S. Food and Drug Administration’s (FDA) analysis of medical device adverse event reports and scientific literature, the most common adverse events for all hernia repair operations are pain, infection, hernia recurrence, adhesion, bowel obstruction, bleeding, fistula, seroma, and tissue perforation.
Other common adverse events following mesh hernia repair include the following:
• Chronic pain
• Hernia recurrence
• Bowel obstruction
• Mesh or ring migration
• Mesh shrinkage (contraction)
• Abdominal abscess formation
• Pelvic inflammatory disease
Symptoms associated with hernia mesh complications:
• Abdominal tenderness
• Distended abdomen
• Fluid in abdomen
Bard recalled over 100,000 Composix Kugel Mesh devices, and the FDA received reports of 34 memory rings breaking, 21 of which caused serious injuries.
The Bard recall notice was expanded several times, classified by the FDA as Class I, the highest level of recall for medical products considered to be dangerous or defective and may cause serious health problems or death.
Bard surgical mesh products intended for hernia repair did not undergo the usual FDA approval process required for Class III devices because they passed under the 510(k) Premarket Notification, as they were similar devices the FDA has already approved.
Studies showed the mesh effective at preventing hernia recurrence, but were ultimately recalled after patients reported suffering from complications including infections, bowel obstructions, and mesh removal surgery.
Bard has a poor safety record for its medical devices, and has faced legal trouble in the past. A California state court jury awarded $3.6 million to a woman who claimed Bard’s Avaulta Plus implant injured her. The Avaulta inserts were subsequently pulled off the market.
But many of Bard’s devices still exist on the market, even as dangerous as they may be. Attorneys say CR Bard Inc. has sold mesh devices in the past that were made of a plastic that its manufacturer warned wasn’t suitable for human implantation.
Internal e-mails from 2004 and 2007, filed in federal court, show an executive warning colleagues not to tell Chevron Phillips or other resin makers that the company was using the material in medical devices placed in humans.
Despite the warning, Davol/Bard used the material as the base for hernia-repair and vaginal-mesh devices because the mesh was cleared through the FDA 510(k) system, which allows medical devices to reach the market without human testing.
By 2005, C.R. Bard, knew of potential complications and patient risks involved with the Composix Kugel mesh device. After a string of negative port-op reports of the plastic memory ring splintering and migrating away from the surgical site, the company issued a recall, followed by more reported injured and another recall in 2007 for similar revision surgeries and complications.
The Composix Kugel Mesh patches were originally designed with a “memory recoil ring” that allowed the patch to be folded, inserted through a small abdominal incision and open to cover a wider surface. Unfortunately, the ring had risks of buckling and breaking, leading to a number of painful and serious complications.
Attorneys claim several of Davol/Bard’s hernia mesh devices were not properly tested before they were marketed and distributed as safe medical instruments. Medical device companies like Bard and others 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. Joe Lyon is a Hernia Mesh Injury Lawyer with experience litigating cases against several large 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.