After spending years in litigation over transvaginal mesh implants, Johnson & Johnson subsidiary is now the target of lawsuits related to is hernia mesh implants. A complex hernia requires surgery to reconstruct the abdominal wall using a mesh patch stitched on the hernia to add support for repair.
Mesh increases the risk of complications for the patient, some meshes used are better than others, but the various types can pose different risks.
Physiomesh, a hernia patch constructed from flexible polypropylene polymer filaments women in fabric, was released by Ethicon midway through 2010. The is laminated in Monocryl, designed to provide anti-adhesion and anti-inflammatory benefits.
The Food and Drug Administration received a large volume of reports claiming serious injuries caused by polypropylene mesh implants used for hernia repair operations.
The FDA and Ethicon began receiving Adverse Event Reports for the Physiomesh hernia implant soon after it was released onto the market. Many complained that the Monocryl laminate’s failure to incorporate, by developing tissue in-growth or adhering to the abdominal wall.
Other incidents cited the Physiomesh becoming detached, shrinking or folding over. Once the patch is detached and free-floating, the migrated mesh can potentially cause a number of life-threatening conditions like organ failure or bowel obstruction.
On May 25, Switzerland issued an urgent field safety notice after European researchers revealed that Physiomesh displayed a higher rate of recurrence and re-operation in comparison to other mesh products. Johnson & Johnson subsequently voluntarily recalled the Ethicon Physiomesh from the global market based on the increased risk of adverse effects.
On June 2, 2017, a number of Physiomesh defective lawsuits were consolidated into the Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation. By May 15, 2018, 24 cases, 12 by the plaintiff and 12 by the defendant, are chosen for the initial discovery pool. There will be 10 more cases added to the initial discovery pool on June 22. By December 2019, the parties select 10 cases in the initial discovery pool to be subjected to expert discovery.
On Sept. 16, 2019, the first Ethicon Physiomesh implant bellwether trial is scheduled to begin. There have already been more 400 of these Physiomesh lawsuits consolidated for discovery and pre-trial motion purposes. Aside from Ethicon, C.R. Bard In. and Atrium Medical Corp subsidiary C-Qur are also facing consolidated actions over their synthetic mesh implant products.