Hernia mesh is a medical device that is used to provide additional support to weakened or damaged tissue. Many complications related to hernia repair with mesh have been reported to the FDA. According to the FDA reports, pain, infection, recurrence, adhesion, obstruction, and perforation are the most common complications associated with recalled mesh. Recalled mesh products were a substantial cause of bowel perforation and obstruction complications according to FDA reports. While not all hernia meshes are dangerous, others have been recalled or withdrawn from the market due to concerns.
What is Physiomesh?
Physiomesh is one of those hernia mesh products raising concerns. Ethicon Physiomesh Composite Mesh is a surgical mesh that was used for hernia repairs. It was manufactured by Ethicon, a subsidiary of Johnson & Johnson, and first became available in the U.S. in 2010. The mesh products came in square, oval and rectangle shapes.
Is Physiomesh Dangerous?
Ethicon withdrew Physiomesh from the U.S. market in May 2016. Letters to healthcare providers indicated the decision was made following an analysis of unpublished data from two large independent hernia registries. This analysis found the recurrence and reoperation rates after hernia repair using Ethicon Physiomesh Flexible Composite Mesh were higher than the average rates. Ethicon’s mesh products with the codes PHY0715R, PHY1015V, PHY1515Q, PHY1520R, PHY1520V, PHY2025V, PHY2030R, PHY2535V, PHY3035R, and PHY3050R have been pulled from the market. The Ethicon Physiomesh Open Flexible Composite Mesh device remains available, as do other Ethicon mesh products.
What is C-Qur?
Made by Atrium Medical, C-Qur is another line of mesh products. The products are coated in Omega 3 Bioabsorbable Oil Fatty Acid (O3FA). According to the company’s website the products are “indicated for use in hernia repair, chest wall reconstruction, traumatic or surgical wounds, and other fascial surgical intervention procedures requiring reinforcement with a non-absorbable supportive material.” These products first became available in 2006.
The C-Qur line of products has been under scrutiny throughout nearly all of its decade on the market. For example, the FDA sent a letter to Atrium warning the company of concerns with high infection rates and lax sterilization procedures in 2012. In 2013, one study of C-Qur mesh was called off due to high infection rates. Now, C-Qur lawsuits allege that the fish oil coating may cause an allergic reaction which can lead to severe health complications and, if the hernia patch adheres to the bowel, could lead to the bowel becoming twisted or perforated, causing gastric ulcers or other adverse intestinal problems.
Hernia Mesh Lawsuits
Hernia mesh lawsuits have already been filed by a number of plaintiffs claiming their C-Qur or Physiomesh mesh products have led to serious complications including an inflammatory response from the fish oil coating on the mesh. Some of the injuries include bowel adhesions, organ perforation, or lack of proper abdominal wall fixation resulting in problems after hernia repair.
Ethicon Physiomesh lawsuits have been consolidated into an MDL in the Northern District of Georgia. An MDL consolidating federal C-Qur lawsuits was formed late in 2016 and is pending in the US District Court for New Hampshire.
Don’t Wait if You’ve Been Injured
There are strict time limits for filing a lawsuit. Contact the lawyers of Lopez McHugh, LLP to discuss whether a hernia mesh lawsuit is right for you. Our team is experienced and knowledgeable in evaluating hernia mesh lawsuits and can help determine if a mesh lawsuit is right for you.