Ethicon Physiomesh Lawsuit

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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.

Ethicon Physiomesh Legal Reviews

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.

Hernia Mesh Litigation News

  • November 2016: The U.S. Judicial Panel on Mutidistrict Litigation (JPML) has agreed to centralize all federally-filed hernia mesh lawsuits involving Atrium Medical Corp.’s C-Qur surgical mesh in the U.S. District Court, District of New Hampshire. All of the cases included in the hernia patch litigation similarly allege that C-Qur mesh causes an inflammatory response that promotes the formation of bowel adhesions, impedes proper abdominal wall fixation, and causes additional severe complications. Plaintiffs further allege that Atrium was aware that C-Q suffered from design defects, yet concealed that knowledge and failed to provide appropriate safety warnings to doctors and patients. Read More
  • September 2016: A Florida woman has filed a Physiomesh lawsuit following failed incisional hernia repair. Her complaint claims that Ethicon, Inc.’s Physiomesh Flexible Composite Mesh is made from materials that are not inert and that react to human tissues, placing patients at risk for chronic pain, infection, hernia recurrence, adhesions, intestinal blockage, mesh migration, mesh contraction and repeated surgery. The product code used in the plaintiff’s surgery (PHY2025V) was among the Physiomesh hernia patch withdrawn from the global market in May 2016. Read More

Ethicon Physiomesh: What’s the Problem?

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.

Physiomesh Litigation Update: Hernia Mesh Lawsuit Trial Scheduled for 2018

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

Am I Eligible  to File a Lawsuit

Individuals who may be eligible to file an Ethicon Physiomesh lawsuit include anyone who required revision of a ventral hernia repair due to:

  • Pain
  • Infection
  • Recurrence of the hernia
  • Adhesion and/or scarring
  • Intestinal blockage
  • Migration of a Physiomesh patch
  • Contraction (shrinkage) of mesh

If you would like to discuss a potential case with one of our attorneys, please contact Bernstein Liebhard LLP by calling  (888) 994-5118.

  1. FDA (2010) “Physiomesh 510(k) Summary” http://www.accessdata.fda.gov/cdrh_docs/pdf9/K093932.pdf
  2. FDA (2006) “Class 2 Device Recall” http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=43417
  3. FDA (2014) “Ethicon Physiomesh Open Flexible Composite Mesh Device” http://www.accessdata.fda.gov/cdrh_docs/pdf14/k141560.pdf
  4. Ethicon (2016) “Urgent: Field Safety Notice” https://www.swissmedic.ch/recalllists_dl/13779/Vk_20160525_11_e1.pdf
Last Modified: December 12, 2016

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