Hernia mesh lawsuits involving Ethicon, Inc.’s Physiomesh devices continue to move forward in the U.S. District Court, Northern District of Georgia.
According to a Practice and Procedure Order dated January 16th, plaintiffs with cases currently pending in the litigation are to submit a Plaintiffs’ Profile Form no later than March 1, 2018.
Future Physiomesh lawsuit plaintiffs must file a Profile Form within 60 days of their filing.
Plaintiffs submitting a Profile Form are also to submit, among other things, copies or electronic files of all medical records in their possession, custody, or control (including any medical records in their attorney’s possession) related to the claims and/or alleged injuries, including, but not limited to, records that support product identification.
Signed authorizations are also to be submitted at this time.
Court documents indicate that at least 469 hernia mesh lawsuits are currently pending in the Northern District of Georgia, all of which were filed on behalf of individuals who suffered hernia recurrence and other serious complications due to allegedly defective Physiomesh implants.
Brought to market in 2010, Ethicon’s Physiomesh hernia patches are constructed from non-absorbable polypropylene (plastic) filaments that are woven into fabric. Each side of the mesh is then covered with an absorbable film coating, which is intended to help the patch incorporate into the body and reduce inflammation.
Plaintiffs pursuing Physiomesh lawsuits claim that the product’s multilayer design actually prevents the patch from incorporating into the body, greatly increasing the risk that the device will fail, resulting in:
Like many other hernia mesh products currently on the market, Physiomesh devices were approved via the U.S. Food & Drug Administration’s (FDA) 510 (k) approval program. This program allows a medical device to come to market without the benefit of human testing if a manufacturer is able to demonstrate that the new product is “substantially equivalent” to another device that had previously undergone the agency’s strict pre-market approval process.
Ethicon pulled Physiomesh Flexible Composite Mesh from the global market in May 2016, after unpublished data from two European hernia databases suggested that the product was associated with higher average recurrence and revision rates compared to other meshes used in laparoscopic ventral hernia repair.
The company was unable to determine what factors were behind the Physiomesh problems and has indicated that it would not be returning the affected products to the market.
While Physiomesh recalls were announced in several countries, no such action has been taken in the U.S.