Hernia mesh has been an important medical device for thousands of patients, and at the same time, some defective mesh products on the market have caused unthinkable injuries and serious complications.
According to a 2016 study published in the Journal of the American Medical Association (JAMA), the use of hernia mesh to reinforce an incisional hernia repair is associated with a lower risk of hernia recurrence over five years. But thousands of hernia mesh injuries have many patients and surgeons questioning a number of products on the market.
If you have suffered complications or side effects due to a Bard Visilex mesh implant, please contact The Lyon Firm to discuss your legal options. Hernia mesh companies have been targeted in recent years in hernia mesh recall lawsuits, and injured plaintiffs may have a viable claim to compensation.
If any patient has experienced an infection, adhesion, bowel perforation, mesh erosion, chronic pain, or revision surgery, they may be eligible for a large settlement.
Joe Lyon is a Cincinnati, Ohio medical device defect attorney reviewing hernia mesh injury and Visilex mesh products. Following hernia mesh surgery complications, settlements are likely.
Surgery with defective hernia mesh can lead to health complications. The most common complaint is chronic pain, although other more serious injuries are a rick, including infections, hernia recurrences, adhesions, and bowel obstructions.
Medical professionals warn that mesh migration and mesh shrinkage are also possible. Hernia mesh patients regularly report the following:
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Bard Visilex mesh is the first polypropylene mesh designed for laparoscopic hernia repair. Bard states the Visilex mesh device directly addresses critical issues associated with laparoscopic procedures, and “delivers maximum visibility, enhanced maneuverability and retains a flat profile after insertion.”
While the company touts the potential benefits of the hernia mesh, they may downplay the risks to surgeons and patients. The Visilex mesh has a reinforced edge that assists the device to return to its flat shape after insertion.
Visilex patches come with what Bard calls a “significant advantage,” which is a monofilament polypropylene. The marketing available notes the mesh discourages infection, and promotes tissue growth. Oxygen may erode the polypropylene, however, causing it to shrink and cause pain and injury.
Bard’s Visilex Mesh is also supposed to be superior to other hernia implants in that the pores in the mesh are larger than in other hernia implants. But plaintiffs have said the materials may be very cheap and compromise patients.
Inguinal hernias are pockets of intestinal tissue that push through weakened muscles in the abdominal wall. This is potentially a serious condition in males that can lead to infertility.
Inguinal hernias often require surgery to correct. Laparoscopic surgery uses a tiny incision near the navel, in which a surgeon inserts a laparoscope through the incision and to the location of the hernia. Mesh implants are passed through the instrument and onto the abdominal wall to cover the hernia.
The plastic Visilex mesh is designed to create scar tissue on the abdominal wall which is meant to grow into the pores of the mesh, fusing mesh and tissue, strengthening the abdominal wall and preventing future hernias.
No recall has been issued for the Visilex Mesh, although many other Bard hernia mesh products have been recalled. Most of Bard hernia mesh implants were eligible for an FDA 510(k) shortcut, which allowed Bard to skip clinical trials.
The medical device manufacturer was allowed to claim that the products were very similar to other products on the market, and very quickly, Bard hernia mesh was introduced for use in hernia mesh repair operations. In addition to Visilex, Bard has marketed and distributed the following mesh products:
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.
Nationwide Consolidation in U.S. District Court, Northern District of Ohio. The Depuy ASR Hip design was plagued with problems related to premature loosening and metallosis, caused by chromium and cobalt entering the blood stream. The resulting injuries were a result of the metal-on-metal friction inherent with the design of the product. Depuy recalled the ASR and entered into a global settlement valued at $2.5 Billion to cover an estimated 8,000 patients. The Lyon Firm represented several clients in the original settlement and continues to be active in this litigation. The settlement funds provided compensation for the revision surgeries, including compensating for medical costs, lost wages, and pain and suffering.
Nationwide Consolidation in U.S District Court, Northern District of Indiana. Similar to the Depuy ASR, the Biomet metal-on-metal hip design allegedly contributed to premature hip failures and metallosis due to the metal friction. Biomet entered into a global settlement valued at $56 million to cover a few thousand claims. The Lyon Firm represented several plaintiffs in the original settlement and continues to be active in this litigation.