Hernia Mesh Market Withdrawal

In May 2016, Ethicon, Inc. issued an Urgent Field Safety Notice announcing a voluntary market withdrawal for its Physiomesh Flexible Composite Mesh hernia patch. According to the company, data had suggested that the hernia mesh was associated with comparatively high rates of recurrence and revision.

Ethicon Physiomesh Lawyers

The attorneys at Bernstein Liebhard LLP are offering free legal reviews to hernia surgery patients who may have suffered complications related to the Physiomesh market withdrawal. To learn more about the available legal options, please call (888) 994-5118.

What is Physiomesh?

Ethicon’s Physiomesh products are a line of hernia patches that include the Physiomesh Flexible Composite Mesh product, as well as Physiomesh Open Flexible Composite Mesh. The May 2016 worldwide market withdrawal only involved the Physiomesh Composite Mesh device, which is used in minimally invasive ventral hernia repair to strengthen the abdominal wall.

Physiomesh Composite Flexible Mesh was cleared for sale under the U.S. Food & Drug Administration’s (FDA) 510(k) program. This program allows a medical device to come to market without undergoing human clinical trials as long as it can be shown that the new product is “substantially equivalent” to another device that has already been approved by the FDA. The predicate product for Physiomesh was a surgical mesh called Proceed, which was once the subject of a recall.

Physiomesh is manufactured from polypropylene, polyglecaprone 25 film, polydioxanone film and filaments, and comes in various sizes and shapes.

Physiomesh Market Withdrawal

On May 25, 2016, Ethicon issued an Urgent Field Safety Notice announcing that the Physiomesh Composite Mesh device was being pulled from the global market, and advised doctors to stop using the patch. According to the notice, unpublished data from two European registries indicated that “recurrence/reoperation rates (respectively) after laparoscopic ventral hernia repair using ETHICON PHYSIOMESH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.”

The company was not able to determine the reason for these issues, and said that the higher rates seen with Physiomesh could be due to product factors, as well as operative and patient characteristics.

Doctors who have implanted Physiomesh composite mesh were advised to monitor their patients in the usual manner.

Did Your Hernia Recur After Physiomesh Surgery? Contact an Attorney Today.

Patients who experienced hernia recurrence following laparoscopic ventral hernia repair with Physiomesh Flexible Composite Mesh should contact an attorney today to ensure their legal rights are protected. To learn if you are eligible to file a Physiomesh lawsuit, please call (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. Ethicon (2016) “Urgent: Field Safety Notice” https://www.swissmedic.ch/recalllists_dl/13779/Vk_20160525_11_e1.pdf
Last Modified: September 15, 2017

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