Lawsuits have been filed and many more are expected to be filed resulting from injuries alleged to be caused by Physiomesh, sold by Ethicon, Inc./Johnson & Johnson, and C-Qur, sold by Atrium Medical Corporation. The lawsuits alleged that these hernia mesh products are defective and that Ethicon and Atrium failed to warn patients and their physicians about the allegedly increased risk of danger to patients, including inadequate repair, adhesions, infections, hernia recurrence, bowel obstruction, sepsis, and even death.
Indeed, on May 25th 2016, Ethicon issued an URGENT: FIELD SAFETY NOTICE admitting:
“Ethicon has initiated a voluntary product recall of ETHICON PHYSIOMESH™ Flexible Composite Mesh (for laparoscopic use) (“ETHICON PHYSIOMESH™ Composite Mesh”). Ethicon is recalling the product following an analysis conducted at the request of the Ethicon Medical Safety Team of unpublished data from two (2) large independent hernia registries (Herniamed German Registry and Danish Hernia Database-DHDB).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. 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 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.”
This warning and recall, however, does not help the thousands of individuals already implanted with the allegedly defective hernia mesh product.
Borgess Law, LLC is currently evaluating hernia mesh cases involving inadequate repair, adhesions, infections, hernia recurrence, bowel obstruction, sepsis, other complication, injury, or death following hernia surgery. You can contact Medical Device Attorney Pamela A. Borgess of Borgess Law, LLC at (567) 455-5955 or toll-free at (844) LAW-9144. You can also contact Borgess Law by submitting an online inquiry. Borgess Law never charges a fee for an initial consultation.