Ethicon Physiomesh Hernia Product

physiomeshIn May 2016 Ethicon initiated a voluntary recall of its Physiomesh Flexible Composite Mesh (for laparoscopic use) following an analysis of unpublished data from two (2) large independent hernia registries. The recurrence/reoperation rates after laparoscopic ventral hernia repair using Ethicon Physiomesh were higher than the average rates of the comparator meshes among patients in these registries. 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. Consequently, Ethicon recalled Physiomesh from the global market. This is a 510(k) device.

Ethicon Voluntarily Recalls Physiomesh Hernia Product (6/1/16)

In a Field Safety Notice issued May 25th, and posted online by the UK’s drug and device regulator, Ethicon states that it has initiated a voluntary recall of its Physiomesh Flexible Composite Mesh (for laparoscopic use). Ethicon is recalling the product following an analysis conducted at the request of the Ethicon Medical Safety Team of unpublished data from two (2) large independent hernia registries. The recurrence/reoperation rates 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. 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. Consequently, Ethicon has 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. According to the notice, this voluntary recall has been communicated to the U.S. FDA and the European Competent Authorities.

HGD is presently looking at claims from individuals who may have suffered harm from the use of Physiomesh Hernia products. IF you or a loved one underwent an abdominal (belly) hernia repair since 2010, and have been experiencing problems, please call us for a free consultation.

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