Ethicon, Inc., a subsidiary of Johnson & Johnson, make a large number of different types of hernia mesh and transvaginal mesh products. Both of these have been the subject of large scale litigation with tens of thousands of cases filed in MDL 2327, In re: Ethicon, Inc., Pelvic Repair Systems Products Liability Litigation pending in the United States District Court for the Southern District of West Virginia and in a coordinated proceeding in New Jersey State Courts.
While the transvaginal mesh litigation is in its later stages, the and the hernia mesh cases are in the earlier stages. In 2017, MDL 2782, In Re: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation was created to oversee all federal lawsuits relating to the Physiomesh products. MDL 2782 was established in the United States District Court for the Northern District of Georgia and assigned to the Hon. Richard Story.
Currently there are over 1,600 Physiomesh cases pending in MDL 2782. There are also a number of Physiomesh lawsuits pending in the New Jersey State Court Physiomesh MCL which was created in July of 2018 Physiomesh , the Ethicon Physiomesh Flexible Composite Mesh and the Physiomesh Open Flexible Composite Mesh.
Unlike the transvaginal mesh MDL 2327, which encompassed almost all synthetic mesh products made by Ethicon used to treat incontinence and pelvic organ prolapse, MDL 2782 is limited to only lawsuits relating to Ethicon’s Physiomesh products and not other Ethicon hernia mesh products that have also been the subject of lawsuits such as Proceed Hernia Mesh, Ultrapro and Prolene Hernia Mesh products.
Ethicon Physiomesh Products
Ethicon manufactures two different Physiomesh products, the Physiomesh Flexible Composite Mesh (“Physiomesh FCM”) and the Physiomesh Open Flexible Composite Mesh (“Physiomesh Open FCM”).
The current litigation involves only the Physiomesh Flexible Composite Mesh version. The Physiomesh product is a composite mesh composed of non-absorbable, light-weight polypropylene mesh (Prolene) laminated with an absorbable coating of poliglycaprone outside.
Physiomesh is unusual in that the coating is placed on both sides of the mesh instead of one like most composite meshes. Theoretically, the coating is supposed to prevent the inner polypropylene core from adhering or organs or creating fistulas by acting as a barrier.
The difference between the FCM and Open FCM products is the latter is designed for open procedures only. Whereas the Physiomesh FCM was designed for laparoscopic procedures.
The Physiomesh FCM was released in 2010 through the FDA’s controversial 510(k) approval process. The Open FCM was also released by the 510(k) process in 2014.
Physiomesh Voluntary Recall and Market Removal
Unlike Proceed mesh, Physiomesh FCM has not been the subject of an FDA recall although Proceed mesh was one of the predicate devices used by Ethicon in getting Physiomesh FCM to the market under the flawed 510(k) process.
While never recalled by the FDA but Ethicon did pull Physiomesh FCM from the market in 2016 under a “voluntary” recall.
In May 2016, Ethicon issued an Urgent: Field Safety Notice notifying all surgeons and operating room supervisors to stop using the Physiomesh FCM products immediately due to higher recurrence/re-operation rates that other hernia mesh products on the market.
The voluntary recall was initiated after two unpublished studies, one in the Danish Medical Registry and the other in the German Medical Registry, found the failure rate for the Physiomesh FCM in laparoscopic ventral hernia surgeries was higher than the other meshes used on patients in these registries.
The studies note, “The recurrence/reoperation rates (retrospectively 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.”
These studies suggested the cause of the failures is degradation of the polypropylene which allows the hernia to recur or result in infections or inflammatory reactions at the surgery site leading to another surgery.