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Johnson & Johnson’s Ethicon unit has removed a popular hernia repair mesh product from the market worldwide, after it was linked to a high rate of problems and revisions, and the manufacturer failed to identify what is causing the complications.
The Ethicon Physiomesh recall was issued in several countries, and announced last month in an Urgent Field Safety Notice sent to operating room managers, materials management personnel and surgical chiefs at hospitals worldwide.
While the FDA has classified the action as a “Market Withdrawal”, the manufacturer is requiring medical providers to return unexpired products and indicates that Ethicon Physiomesh Composite Mesh will not be returned to the market.
The notice lists product codes for Ethicon Physiomesh Flexible Composite Mesh impacted by the recall, which was issued after an analysis of unpublished data found that the products have higher than average recurrence and reoperation rates following laparoscopic ventral hernia repair. The data came from the Herniamed German Registry and the Danish Hernia Database (DHDB).
“Based on the currently available data, Ethicon believes the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but has not been able to fully characterize these factors,” the field notice warns. “Consequently, Ethicon have not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and have decided to recall ETHICON PHYSIOMESH Composite Mesh from the global market.”
The action affects the Ethicon Physiomesh Composite Mesh product line. The product codes affected include PHY0715R, PHY1015V, PHY1515Q, PHY1520R, PHY1520V, PHY2025V, PHY2030R, PHY2535V, PHY3035R, and PHY3050R. The mesh products came in square, oval and rectangle shapes. The recall does not affect the Ethicon Physiomesh Open Flexible Composite Mesh device or other Ethicon mesh products.
Ethicon is calling on its customers to examine their inventories to determine if they have affected mesh products, and to complete a Business Reply Form attached to the field notice even if they do not have the product being recalled. The company indicates that customers are required to return the recalled, unexpired Ethicon Physiomesh devices immediately. It is only reimbursing those who return unexpired mesh products by September 16, 2016.