Physiomesh Surgical Mesh

The FDA has received adverse event reports detailing failures of Ethicon Physiomesh Flexible Composite Mesh. The polypropylene mesh, sandwiched between two layers of polymer film, has been linked to recurring hernias, bowel obstructions, infections, and other complications that have caused the mesh to fail or have required additional surgery to remove and replace these devices.

Physiomesh Problems May Require Revision Surgery

Physiomesh Flexible Composite Mesh is coated on either side with a film designed to be absorbed into the body over time.[1]

You may be eligible for compensation for medical expenses, lost wages, and other costs if you required revision surgery because of a laparoscopic Physiomesh Flexible Composite Mesh failure.

We would feel privileged to assist you. For a free consultation and more information about your legal options, please contact us today.

Weitz & Luxenberg is currently taking Ethicon Physiomesh Flexible Composite Mesh cases in which the mesh was implanted laparoscopically for hernia or other soft tissue repair, and is interested in talking to patients who required revision surgery – or has been advised by a physician that they will need revision surgery – because of complications from their mesh. Weitz & Luxenberg is also interested in talking to people who have suffered pain or other mesh-related symptoms, such as bowel obstructions, infections, or recurrent hernias.

Physiomesh Approval Based on Other Similar Devices

Physiomesh Flexible Composite Mesh received U.S. Food and Drug Administration (FDA) approval in 2010 through the agency’s 510(k) process. Medical device manufacturers using this method do not have to provide safety or efficacy data to the FDA through clinical trials, but only have to show the new product is “substantially equivalent” to another device that the FDA has already approved.

In the case of Physiomesh Flexible Composite Mesh, the manufacturer, Ethicon, declared the mesh substantially equivalent to three other products Ethicon made.[2]

During the 501k process, Ethicon alleged that Physiomesh Flexible Composite Mesh was tested for qualities such as “suture pullout strength, burst strength and tear resistance.” Its application said the mesh “met all testing criteria” and demonstrated “substantial equivalence to its predicate devices….”[3]

But within as little as a few months of that approval, the FDA began receiving multiple reports of the product failing. Adverse event reports described hernias recurring, reoperations to fix multiple adhesions required, and infections requiring reoperation and revision surgeries to remove and replace the mesh.

In 2015, the Polish Hernia Study Group terminated a clinical trial involving Physiomesh Flexible Composite Mesh because of unexpected hernia recurrences. The study was intended to compare two types of mesh and methods of their attachment used in hernia repair, but researchers halted the study when they noticed a higher than expected number of recurring hernias.

The researchers said the “high recurrence rate and the findings during the reoperations were considered as serious adverse events and were the reason for study termination.”[4]

In May 2016, Ethicon issued an Urgent Field Safety Notice and voluntarily withdrew Physiomesh Flexible Composite Mesh for laparoscopic surgeries from the global market. The company claimed the decision was made following analysis of findings by large, independent hernia registries in Germany and Denmark of higher than average rates of hernia recurrence and need for reoperation surgery among patients implanted with Physiomesh Flexible Composite Mesh used for ventral hernia repair.[5]

Ethicon listed 10 different sizes and configurations of Physiomesh Flexible Composite Mesh in its field safety notice.[6]

Physiomesh Complications and Warnings

The FDA began receiving reports of problems with Physiomesh the same year that the mesh was approved, in 2010.[7] By late 2016, there were several hundred adverse event reports regarding Physiomesh in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, a database of mandatory and voluntary medical device reporting.[8],[9]

A review of MAUDE complaints shows repeated references to mesh failures that led to hernia recurrence or other complications, such as bowel obstruction and dense adhesions. The cases frequently required revision surgery to remove and replace the mesh.[10]

In one report to the FDA, a patient’s hernia recurred, among many other complications, after the mesh migrated to the small intestines.[11] This resulted in an enterocutaneous fistula – an abnormal connection of the intestine to the skin.[12] Surgeons had to remove both the faulty mesh and part of the patient’s small intestine.[13]

Another report says the mesh “shrank from the original size,” allowing the hernia to recur in the same spot.[14]

Other complications of Physiomesh listed in the FDA database include:

  • Mesh folding or bunching up[15]
  • Failure to incorporate into the body[16],[19]
  • Painful physical or inflammatory reactions[17]

In June 2016, the FDA’s Canadian and Australian counterparts, respectively Health Canada and the Therapeutic Goods Administration,[18] each posted notifications regarding the voluntary withdrawal of Ethicon’s Physiomesh Flexible Composite Mesh used during laparoscopic ventral hernia repair.

Physiomesh Lawsuits

Lawyers are filing lawsuits on behalf of their clients against Ethicon over the product’s failures, accuses Ethicon of failing to warn of risks associated with Physiomesh Flexible Composite Mesh, negligence, and putting a defective product on the market. These lawsuits assert that using Physiomesh Flexible Composite Mesh during hernia operations has resulted difficult -to-remove mesh adhesions to bowels and abdominal wall, infections in and around the mesh causing intestinal fistulas, and other severe medical conditions.

How Weitz & Luxenberg Can Help

If you have needed or may require revision surgery because of a complication linked to laparoscopic Physiomesh Flexible Composite Mesh, or if you have suffered pain, recurrent hernias, or other mesh-related symptoms, an attorney can help you understand your legal options.

Weitz & Luxenberg can provide you with a free consultation. Contact us at (877) 680-3753 now, or use the online form on this page and one of our representatives will contact you shortly.

  1. FDA.gov. (2010, April 9). 510(k) Summary, Ethicon Physiomesh. Retrieved from https://www.accessdata.fda.gov/cdrh_docs/pdf9/K093932.pdf
  2. Ibid. FDA.gov. (2010, April 9). 510(k) Summary, Ethicon Physiomesh.
  3. Ibid. FDA.gov. (2010, April 9). 510(k) Summary, Ethicon Physiomesh.
  4. Clinical Trials. (2014, September 5). Comparison of Two Mesh/Fixation Concepts for Laparoscopic Ventral and Incisional Hernia Repair. Retrieved from https://clinicaltrials.gov/ct2/show/NCT02233569
  5. Ethicon. (2016, May 25). Urgent: Field Safety Notice; Ethicon Physiomesh Flexible Composite Mesh (All Product Codes) Retrieved from http://www.igz.nl/Images/IT1027122-Ethicon_PHYSIOMESH-algepublic._tcm294-375822.pdf
  6. Ibid. Ethicon. (2016, May 25). Urgent: Field Safety Notice; Ethicon Physiomesh Flexible Composite Mesh (All Product Codes)
  7. FDA.gov. (2010, April 9). 510(k) Summary, Ethicon Physiomesh. Retrieved from https://www.accessdata.fda.gov/cdrh_docs/pdf9/K093932.pdf
  8. FDA.gov. (2016, November 30). MAUDE – Manufacturer and User Facility Device Experience. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/results.cfm?start_search=1&productcode=&productproblem=&devicename=&modelNumber=&reportNumber=&manufacturer=Ethicon&brandname=Physiomesh&eventtype=&reportdatefrom=1%2F1%2F2006&reportdateto=11%2F30%2F2016&pagenum=100
  9. FDA.gov. (2016, November 30). MAUDE – Manufacturer and User Facility Device Experience. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/results.cfm?start_search=201&productcode=&productproblem=&devicename=&modelNumber=&reportNumber=&manufacturer=ethicon&brandname=physiomesh&eventtype=&reportdatefrom=01%2F01%2F2010&reportdateto=01%2F01%2F2013&pagenum=100
  10. Ibid. FDA.gov. (2016, November 30). MAUDE – Manufacturer and User Facility Device Experience.
  11. FDA.gov. (2016, July 11). MAUDE Adverse Event Report: Ethicon Inc. Physiomesh Mesh, Surgical. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5782201
  12. University of California, San Francisco Medical Center. (n.d.). Enterocutaneous Fistula. Retrieved from https://www.ucsfhealth.org/conditions/enterocutaneous_fistula/
  13. Ibid. FDA.gov. (2016, July 11). MAUDE Adverse Event Report: Ethicon Inc. Physiomesh Mesh, Surgical.
  14. FDA.gov. (2016, August 10). MAUDE Adverse Event Report: Ethicon Inc. Physiomesh Oval Mesh, Surgical, Polymeric. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5866762
  15. FDA.gov. (2012, July 23). MAUDE Adverse Event Report: Ethicon, Inc. Physiomesh Mesh, Surgical, Polymeric. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2704678
  16. FDA.gov. (2012, September 28). MAUDE Adverse Event Report: Ethicon, Inc. Physiomesh Mesh, Surgical, Polymeric. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2799300
  17. FDA.gov. (2012, July 25). MAUDE Adverse Event Report: Ethicon Inc. Physiomesh Mesh, Surgical. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2639885
  18. Australian Government, Dept. of Health. (2016, June 9). Ethicon Physiomesh Flexible Composite Mesh. Retrieved from https://www.tga.gov.au/alert/ethicon-physiomesh-flexible-composite-mesh
  19. Healthy Canadians. (2016, June 25). Physiomesh Flexible Composite Mesh (2016-05-25) Retrieved from http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2016/58846r-eng.php

Looking For Legal Help?

We would feel privileged to assist you. For a free case review, please contact us today

Get Yours Now