Hernia Mesh Lawsuit Help
The Weinberg Law Firm is currently assisting individuals who have suffered complications after receiving a hernia mesh, including mesh products manufactured by Ethicon, Atrium Medical Corporation, and C. R. Bard, Inc. For a free legal case evaluation and hernia mesh lawsuit information, please call us toll free at 1-877-934-6274. You can also contact our firm online by submitting the easy-to-use case evaluation form found on this page.
Physiomesh Lawsuit and Recall Information
Ethicon, a Johnson & Johnson subsidiary, announced a recall for Ethicon Physiomesh ® Flexible Composite Mesh on May 25, 2016, after data from two European hernia registries revealed higher rates of hernia recurrence and re-operation in patients who received Ethicon Physiomesh ® Composite Mesh when compared to patients who received a similar mesh product for hernia repair.
More About The Ethicon Physiomesh Recall
Ethicon recalled its hernia mesh product after an analysis of data from two independent hernia registries in Germany and Denmark showed higher rates of hernia recurrence and re-operation in patients undergoing hernia repair with Ethicon Physiomesh ® Composite Mesh than in patients receiving comparator hernia mesh products. Ethicon alerted surgical care professionals of these findings and the Physiomesh Recall in May of 2016.
Ethicon advised health care practitioners to follow patients who have received the recalled hernia mesh “in the usual manner.”
Hernia Mesh Complications
According to the U.S. Food and Drug Administration (FDA) the most common adverse events following mesh hernia repair can include:
• hernia recurrence
• additional surgery
• infection
• pain
• adhesion (scar-like tissue that sticks tissue together)
• intestinal blockage or bowel obstruction
• mesh migration
• mesh shrinkage (contraction)
What Is Physiomesh?
Ethicon Physiomesh ® Flexible Composite Mesh was marketed for the repair of hernias and other fascial (connective tissue) deficiencies. The product is composed of a flexible, nonabsorbable, polypropylene (plastic polymer) mesh and biodegradable polymers.
Physiomesh Was Approved Without Clinical Trials
Physiomesh was approved for use in surgical patients via 510(k) Premarket Notification process on April 9, 2010. A 510(k) requires a medical device manufacturer to demonstrate that the new product that they intend to market is substantially equivalent to a similar U.S. legally marketed medical device. Ethicon did not conduct clinical trials to demonstrate that Physiomesh is safe and effective for use in surgical patients, but instead was allowed to market its product by submitting laboratory and animal testing data demonstrating “substantial equivalence” to similar marketed hernia meshes.
Obtain A Free Physiomesh Lawsuit Case Evaluation
Eric H. Weinberg, Esq., has represented thousands of individuals injured by defective drugs and medical devices including for example, Vioxx, Pradaxa, Baycol, contaminated Blood Clotting Factors, and Vaginal Mesh. We have obtained over $800 million on behalf of personal injury victims. If you have suffered complications or required additional surgeries related to the use of Physiomesh, you may be entitled to financial compensation for your injuries. For Physiomesh Lawsuit information, please call The Weinberg Law Firm 24/7, toll free at 1-877-934-6274. To contact our law firm online, please submit the “Free Legal Case Evaluation Form” found on this page.
