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Physiomesh Flexible Composite Hernia Mesh

Physiomesh Flexible Composite is a brand of hernia mesh. Johnson & Johnson subsidiary Ethicon manufactures it. Ethicon pulled a version of Physiomesh off the market in 2016. High failure rates led to hernias recurring.

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Ethicon Physiomesh
Physiomesh Facts
  1. Uses Surgical hernia repair
  2. Complications Hernia recurrence; mesh folding or bunching up; adhesions; failure to incorporate into the body; pain; inflammatory reactions
  3. Manufacturer Johnson & Johnson subsidiary Ethicon
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Physiomesh Flexible Composite Mesh is a partially absorbable surgical mesh for hernia repair. Ethicon used to manufacture two version of the mesh.

One version used in minimally-invasive hernia surgeries had high failure rates. In 2016, Ethicon removed that version from the global market.

Ethicon’s 2017 product catalog showed that the company still marketed a Physiomesh version for open hernia repairs. Open repairs are traditional surgery techniques.

What is Physiomesh?

Physiomesh is a coated surgical mesh used in hernia repairs. The mesh is made from polypropylene, a type of plastic. It is sandwiched between two thick synthetic film layers. The patient’s body absorbs the laminated film coating over time.

FDA Approval
The U.S. Food and Drug Administration approved Physiomesh in 2010.
Ethicon Physiomesh Open Flexible Composite Mesh Device
An example of Ethicon Physiomesh.

Physiomesh Hernia Repair with Laparoscopic Surgery

The Physiomesh version removed from the market was for laparoscopic surgery. This is a minimally-invasive technique.

A surgeon makes several small incisions. He then inserts surgical tools through the incisions. The surgeon uses the tools to implant and secure the mesh in place around the hernia.

Ethicon designed Physiomesh with a coating to prevent adhesions. The body absorbs the coating over several weeks.

Tissue grows into the mesh’s pores over time. This “ingrowth” should strengthen the repair. But it did not always strengthen repairs. And the mesh sometimes adhered to organs in the body.

Physiomesh Complications

Hernia recurrence was the most common Physiomesh complication requiring surgery. Recurrence is when a hernia comes back after surgery.

Harmed by a Physiomesh hernia repair? Get a Free Case Review

The Polish Hernia Study Group ran a clinical trial with Physiomesh in 2015. The trial included Physiomesh Flexible Composite Mesh for laparoscopic surgery. The group terminated the trial when researchers noticed higher than expected recurrences.

Ethicon then removed Physiomesh’s laparoscopic version from the market. But doctors and patients reported even more complications to the FDA.

Physiomesh Complications Reported to the FDA Include
  • Hernia recurrence
  • Mesh folding or bunching up
  • Adhesions
  • Failure to incorporate into the body
  • Pain
  • Inflammatory reactions

Physiomesh Recalls and Market Withdrawals

Ethicon pulled all units of Physiomesh for laparoscopic surgery off the global market in May 2016.

Ethicon sent out an Urgent Field Safety Notice. The notice explained why Ethicon ordered the market withdrawal. The notice also affected Ethicon Laparoscopic Hernia Kits.

“The 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.”

Ethicon later discontinued laparoscopic versions of Physiomesh.

Physiomesh FDA Actions

The FDA approved Physiomesh in 2010 through its 510(k) process. The process allows for less stringent testing. Ethicon only had to show the mesh was “substantially similar” to a device already on the market.

Ethicon declared Physiomesh substantially equivalent to three other products Ethicon made.

The FDA started receiving reports of Physiomesh failures shortly after the approval. The reports detailed recurring hernias, adhesions and infections.

Physiomesh Lawsuits

Hundreds of people who suffered Physiomesh injuries sued Ethicon. A federal panel combined the first 16 Physiomesh lawsuits in June 2017.

Physiomesh lawsuits
A federal court in the Northern District of Georgia oversees Physiomesh lawsuits.

The presiding judge set the first trial date for Sept. 16, 2019. There were 1,215 Physiomesh lawsuits pending as of June 2018.

The lawsuits accuse Ethicon of failing to warn people about Physiomesh risks. They also accuse the company of negligence and putting a defective product on the market.

Please seek the advice of a medical professional before making health care decisions.

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11 Cited Research Articles

  1. U.S. Food and Drug Administration. (2017, April 4). Hernia Surgical Mesh Implants. Retrieved from https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/default.htm
  2. Brown, C.N. & Finch, J.G. (2010). Which mesh for hernia repair? Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3025220/
  3. Ethicon. (2016, May 27). Urgent: Medical Device Removal Ethicon Physiomesh Flexible Composite Mesh (All Product Codes). http://www.hsa.gov.sg/content/dam/HSA/HPRG/Medical_Devices/Updates_and_Safety_reporting/Field_Safety_Corrective_Action/FSN/2016/May/HSA%206004101-002-16-22_35%20FSN.pdf
  4. U.S. Food and Drug Administration. (2006, January 4). Class 2 Device Recall. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43417
  5. U.S. Food and Drug Administration. (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
  6. U.S. Food and Drug Administration. (2012, September 28). MAUDE Adverse Event Report: Ethicon, Inc. Physiomesh Mesh, Surgical, Polymerci. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2799300
  7. U.S. Food and Drug Administration. (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
  8. Ethicon. (2017). 2017 Ethicon Product Catalog. Retrieved from https://www.ethicon.com/na/epc/pdf/ethicon-product-catalog
  9. Perriello, B. (2016, June 20). J&J’s Ethicon Recalls Physiomesh Flexible Composite Hernia Mesh. MassDevice. Retrieved from https://www.massdevice.com/jjs-ethicon-recalls-physiomesh-flexible-composite-hernia-mesh/
  10. Sherwinter, D.A. et al. (2016). Laparoscopic Inguinal Hernia Repair. Retrieved fromhttp://emedicine.medscape.com/article/1534321-overview
  11. U.S. Judicial Panel on Multidistrict Litigation. (2018, June 15). MDL Statistics Report - Distribution of Pending MDL Dockets by District. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-June-15-2018.pdf
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