Hernia revision surgery is performed when a hernia recurs, or when other complications cause a hernia repair to fail. In 2016, Ethicon, Inc. announced a worldwide market withdrawal of Physiomesh Flexible Composite Mesh, after data from two European registries suggested that it was associated with higher rates of recurrence and revision following laparoscopic ventral hernia repair.
Bernstein Liebhard LLP is offering free, no-obligation legal reviews to individuals who were forced to undergo revision of a laparoscopic ventral hernia repair that involved the use of Ethicon’s Physiomesh Flexible Composite Mesh. To learn more, please contact our office by calling (888) 994-5118.
Hernia revision surgery is required when the initial procedure is not successful. Complications that may result in the need for a revision procedure include:
Hernia revision surgery is very similar to initial hernia repair. However, the procedure is usually more complex because of scar tissue that can develop around the initial repair site.
Ethicon’s Physiomesh Flexible Composite Mesh product is used in laparoscopic ventral hernia repair. The device is manufactured from polypropelene fibers that are woven into fabric and then laminated. During hernia repair, a Physiomesh patch is stitched over the hernia to reinforce the abdominal wall.
In May 2016, Ethicon issued an Urgent Field Notification announcing a worldwide market withdrawal of its Physiomesh Flexible Composite Mesh.
Ethicon said it was pulling the Physiomeh product from the market “following an analysis conducted at the request of the Ethicon Medical Safety Team of unpublished data from two (2) large independent hernia registries (Herniamed German Registry and Danish Hernia Database-DHDB). The recurrence/reoperation rates (respectively) after laparoscopic ventral hernia repair using ETHICON PHYSIOMESH™ Composite Mesh were higher than the average rates of the comparator set of meshes among patients in these registries.”
Healthcare providers who treated patients with the affected Physiomesh products were advised to follow patients in the usual manner. Ethicon’s customers were asked to return all unexpired and unused Physiomesh Flexible Composite Mesh products.
The notice indicated that Ethicon would not be returning the withdrawn Physiomesh products to the market.
A study comparing Physiomesh Flexible Composite Mesh to another hernia patch called Ventralight found that patients implanted with the Ethicon product during minimally-invasive ventral hernia repair were more likely to experience recurrence. At six month post-op, 5 of the 25 Physiomesh patients involved in the study had suffered a recurrence, while none of the 25 Ventralight patients had. The authors of the study also observed a significantly higher pain rate in the Physiomesh group after 3 months and no difference after 7 days. The pain intensity decreased significantly over time and was significantly higher in the Physiomesh group. The study was terminated early due to safety concerns. Read More
Individuals who underwent ventral hernia revision surgery due to complications allegedly associated with Ethicon’s Physiomesh Flexible Composite Mesh patch may be entitled to compensation. To learn more about filing an Ethicon Physiomesh revision lawsuit, please contact Bernstein Liebhard LLP today by calling (888) 994-5118.
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