Hundreds of hernia mesh lawsuits involving Ethicon, Inc.’s Physiomesh Composite Flexible Mesh implants continue to move forward in the U.S. District Court, Northern District of Georgia.
According to an Order dated December 18th, defendants must provide eight exemplar samples for ten different variations of Ethicon Physiomesh within the next 30 days.
Plaintiffs may conduct destructive testing on the samples. However, the Court expects some to be preserved for other purposes.
Once the multidistrict litigation concludes, the Court will return any remaining samples to Ethicon.
Ethicon Physiomesh consists of a lightweight, woven polypropylene layer sandwiched between an absorbable poliglecaprone coating. A polydioxanone film creates a bond between the poliglecaprone and polypropylene.
The U.S. Food & Drug Administration (FDA) approved Physiomesh Flexible Composite Mesh in 2010, via its 510(k) clearance program. This program allows manufacturers to avoid conducting human clinical trials when a new product is “substantially equivalent” to a predicate device cleared through the FDA’s Pre-Market Approval process.
By 2016, the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database had logged several hundred reports involving Ethicon Physiomesh. The most frequently-reported complications included bowel obstructions, adhesions, fistula formation, and mesh migration.
In many cases, the complications resulted in device failure , hernia recurrence, and the need for revision sugery.
Ethicon withdrew Physiomesh Flexible Composite Mesh from the global market in May 2016, after data from two European hernia registries suggested the implants were associated with higher-than-average recurrence and revision rates compared to competitor products.
Although official Ethicon Physiomesh recalls were conducted in Canada and several other countries, this was not the case in the United Sates. Instead, Ethicon merely directed healthcare providers to return any unused implants in their stock.
Nearly 1,600 plaintiffs have since filed Ethicon Physiomesh lawsuits in Georgia federal court.
Among other things, their complaints allege that the defective Physiomesh design increases the potential for infection, adhesions, chronic pain, device failure, and hernia recurrence. They further claim that Ethicon failed to subject Physiomesh Flexible Composite Mesh to adequate pre-market testing and neglected to provide doctors and patients with adequate safety warnings.
The Court previously indicated that bellwether trials would begin in December 2019. Verdicts in these cases could provide insight into how other juries might decide similar Ethicon Physiomesh lawsuits.