Filing an Ethicon Physiomesh lawsuit may be an option for patients who experienced recurrence and revision related to a 2016 market withdrawal. Ethicon, Inc. pulled the Physiomesh Flexible Composite Mesh device from the global market after data suggested that it was associated with higher rates of recurrence and revision compared to other hernia mesh products following laparoscopic ventral hernia repair.
Bernstein Liebhard LLP is offering free legal reviews to Ethicon Physiomesh Flexible Composite Mesh recipients who experienced recurrence and revision surgery following minimally-invasive (laparoscopic) ventral hernia repair. If you would like to learn more about your available legal options, please call (888) 994-5118.
Ethicon’s Physiomesh Flexible Composite Mesh device was brought to market in 2010, and received regulatory clearance via the U.S. Food & Drug Administration’s (FDA) 510(k) program. This program allows medical device manufacturers to forego human clinical trials if they can demonstrate that a product is “substantially equivalent” to a previously approved device. One of the predicates for Physiomesh was another Ethicon product called Proceed Mesh. Certain lots of that surgical mesh product had been the subject of a Class II medical device recall five years earlier, due to issues that could lead to an increased risk of adhesions and bowl fistulization.
Physiomesh Flexible Composite Mesh consists of flexible, non-absorbable polypropylene (plastic) filaments that are woven into fabric. The structure is then laminated. The patch is used to strengthen the abdominal wall during minimally-invasive repair of ventral hernias. This is a type of hernia that sometimes occurs after abdominal surgery.
In May 2016, Ethicon announced a global market withdrawal of Physiomesh Flexible Composite Mesh products, after its analysis of unpublished data contained in two European databases indicted that the hernia patch was associated with higher rates of recurrence and revision compared to similar patches when used in laparoscopic ventral repairs. Ethicon was unable to determine the cause of this issue, but noted that it could be due to product characteristics, as well as operative and patient factors. The company said it would not be returning Physiomesh Flexible Composite Mesh to the worldwide market.
Doctors who have used the affected Physiomesh have been advised to follow their patients in the usual manner.
In April 2016, a lawsuit was filed in Illinois federal court on behalf of a man who was forced to undergo hernia revision surgery following implantation of the Physiomesh Flexible Composite device. The plaintiff claims that the hernia patch he received was defective and unreasonably dangerous, and caused him to suffer severe complications that included two abdominal abscesses and an intestinal fistula. His hernia mesh lawsuit is scheduled to go to trial January 2018. (Case No. Case 3:16-cv-00368-JPG-PMF, U.S. District Court, Northern District of Illinois) Read More
Individuals who may be eligible to file an Ethicon Physiomesh lawsuit include anyone who required revision of a ventral hernia repair due to:
If you would like to discuss a potential case with one of our attorneys, please contact Bernstein Liebhard LLP by calling (888) 994-5118.