Hernia Mesh Lawsuits
Ethicon, a Johnson & Johnson company, denies that it recalled its Physiomesh for safety concerns. Ethicon maintains that it simply voluntarily withdrew Physiomesh from the US market in May of 2016. Looking closer, Ethicon company officials may be living in a parallel universe built on “alternative facts.”
Ethicon withdraws Physiomesh
Ethicon “voluntarily withdrew” its Physiomesh after independent studies revealed high rates of complications associated with it. Previous high rates of patient and surgeon complaints had failed to convince Ethicon that Physiomesh needed to be removed from the market.
Physiomesh Plastic for Hernia Repair
Physiomesh for hernia repair is made from polypropylene / plastic. Ethicon has already been fighting back lawsuits for years involving its transvaginal or pelvic mesh products. These are also made of polypropylene / plastic. Ethicon continues to deny the life-threatening complications that polypropylene / plastic can cause in the human body.
FDA Clearance of Ethicon’s Physiomesh
The FDA originally cleared Ethicon’s Physiomesh on April 9, 2010, via the FDA’s 510(k) approval process. This truncated program allowed Ethicon to avoid rigorous pre-market research and studies. Ethicon claimed its Physiomesh was substantially similar to the company’s Proceed hernia patch. Ethicon submitted a modified version of the Physiomesh for FDA 510(k) approval June 12, 2014. The FDA approved a second model of the Physiomesh on October 23, 2014. However, FDA noted 510(k) approval did not mean that the Physiomesh complied with any Federal statutes, regulations, acts, the FDA or any other regulatory agencies. Consequently, a company using 510(k) “approval” (really only clearance, in this case) does not have the liability protection afforded by the 1976 Device Act. That Draconian legislation continues to give most medical device makers virtual immunity from liability when they make defective or dangerous medical devices that hurt people.
Polypropylene / Plastic
Ethicon uses polypropylene / plastic for the base layer of the Physiomesh. This plastic is the same stuff Ethicon uses for its troublesome transvaginal mesh and bladder slings. Ethicon has faced thousands of lawsuits over its plastic transvaginal mesh and bladder slings. Ethicon added an absorable film coating to each side of the plastic to create the Physiomesh. This coating, made of different compounds, is meant to prevent the destruction plastic causes when it contacts human tissue. Human tissue and plastic don’t naturally “mesh,” however. There has never been a plastic made that doesn’t offgass chemicals and break down. Everything in this world eventually breaks down and/or disintegrates to its base elements.
Physiomesh Market Withdrawal
Ethicon released an urgent field safety notice May 25, 2016. The company advised doctors to stop using the Physiomesh for hernia repair. However, Ethicon and Johnson & Johnson continue to deny Physiomesh was recalled. The FDA website today still does not list Physiomesh as recalled.
Medical Studies Underway
Medical studies in progress are investigating the rates of hernia recurrence and additional surgeries following Physiomesh surgery. These studies have likely found high rates of Physiomesh complications. Why else would Ethicon have withdrawn the Physiomesh from the market?
Ethicon Admits Physiomesh Problems. . . sort of
Ethicon admitted in the withdrawal notice that complications associated with the Physiomesh were possibly related to its specific characteristics, though the company claimed it could not identify any specific problem with the Physiomesh. Ethicon also admitted it was unable to instruct doctors in how to prevent hernia recurrences and complications when they used Physiomesh.
C-Qur Hernia Mesh Problems
After Ethicon withdrew Physiomesh, the Getinge Group (parent company of Atrium Medical Corporation) sent a letter to doctors to promote their the use of Atrium’s C-Qur Hernia Mesh. Atrium has already faced several lawsuits from the FDA and consumers regarding the C-Qur hernia mesh.
Physiomesh Defective Design
Ethicon has been aware from the beginning that its Physiomesh was defectively designed and dangerous to implant. Physiomesh’s coating, thick on both sides, is supposed to prevent the bowel from being exposed to the plastic / polypropylene. Plastic will essentially stick to any tissue in the human body. If the polypropylene sticks to the bowel, it can cause severe injuries. However, if no polypropylene is exposed, the mesh will not properly incorporate or “mesh” into the abdominal wall. When it fails to properly “mesh,” the plastic material floats and migrates in the patient’s abdomen.
Physiomesh also uses a lighter weight plastic than Ethicon’s previous hernia meshes. A “lightweight” polypropylene mesh means less plastic was used to make the product. Mesh makers started using less plastic in hopes of cutting down complications. But the “lightweight” polypropylene / plastic is much weaker than the old “heavyweight” mesh material. As a result, the Physiomesh has torn apart inside of many patients.
The Physiomesh has been linked to high rates of bowel obstructions, seromas, infections, mesh failures. The hernia recurrence rate is high with the Physiomesh due to poor incorporation and mesh tearing too easily. Subsequent surgeries are often required due to complications from the defective Physiomesh, according to lawsuit petitions filed against Ethicon.
Ethicon Physiomesh Device Tag
Ask for device tags and operative reports when requesting your own medical records from the hospital. The device tags are needed to prove which hernia mesh was implanted in you. The operative report often uses a more generic name for the hernia mesh. So many new hernia meshes constantly hit the market that many surgeons can’t even recall which one they are implanting. Device tags can consequently be difficult to find.
Device tags are also known as the “Product Traceability Label.” The device tags note that Ethicon is the maker of the Physiomesh.
Ethicon withdraws Physiomesh
Johnson and Johnson’s subsidiary Ethicon withdrew all LOT numbers of the Physiomesh from the market. Matthews & Associates Law Firm Physiomesh recall lawyers are reviewing injuries associated with all Physiomesh LOT numbers.
Scientific Articles on Ethicon’s Physiomesh:
August 2016: Tissue Integration and Inflammatory Reaction in Full-Thickness Abdominal Wall Repair Using an Innovative Composite Mesh.
Cmpared with two other composite hernia mesh products, Physiomesh resulted in the development of more seromas and less tissue integration than the other studied hernia mesh products.
June 2016: Outcomes of Bridging Versus Mesh Augmentation in Laparoscopic Repair of Small and Medium Midline Ventral Hernias.
A study comparing various techniques to close a hernia defect with Physiomesh. Many patients experienced hernia recurrence regardless of the implanting technique.
March 2016: Comparison of Two Different Concepts of Mesh and Fixation Technique in Laparoscopic Ventral Hernia Repair: A Randomized Controlled Trial.
25 patients implanted with Physiomesh were compared with 25 patients implanted with Ventralight. Within six (6) months of hernia mesh implantation, 20% of those implanted with Physiomesh had experienced a hernia recurrence. None of those implanted with Ventralight experienced a hernia recurrence.
August 2015: Long-Term Evaluation of Adhesion Formation and Foreign Body Response to Three New Meshes.
Physiomesh was compared with two other new hernia mesh products. Physiomesh demonstrated significantly lower incorporation strengths than the other hernia mesh products. Fractioning of the the Physiomesh coating was also observed over time, which lead to scar plate formation, but little to no abdominal wall adherence.
October 2014: Biaxial Analysis of Synthetic Scaffolds for Hernia Repair Demonstrates Variability in Mechanical Anisotropy, Non-Linearity and Hysteresis.
The mechanical properties 13 hernia mesh products were evaluated, including Physiomesh. Significant differences were observed depending on which mesh was implanted and how it was secured. The authors noted that hernia mesh materials are currently utilized as if they are uniform and interchangeable, when that is simply not the case. Additional instructions and training from Ethicon could have resulted more successful hernia repairs.
October 2013: Ventralight ST and SorbaFix Versus Physiomesh and Securestrap in a Porcine Model.
Five (5) animals were implanted with Physiomesh and five (5) animals were implanted with Ventralight. Animals implanted with Physiomesh exhibited significantly more inflammation, fibrosis, and hemorrhage.
Physiomesh: Ethicon Hernia Mesh Lawsuit
Please call us to speak to one of our trained hernia mesh team members. An attorney and a medical professional will look over your Physiomesh case and let you know what they believe the best course of action is for you. Matthews & Associates prosecutes each hernia mesh claim on an individual lawsuit, not as a class action. The specific facts of your lawsuit will determine if your lawsuit is compensable and to what amount. Matthews & Associates represents hernia mesh victims nationwide. All case evaluations and consultations are Free and Confidential. Call (888) 520-5202 or email us for an Ethicon Physiomesh lawsuit evaluation.
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