The Problems with Polypropylene

Jane Akre
|
November 15, 2021
Degrading Mesh from Lewis trial

Mesh Medical Device News Desk, November 15, 2021,

The Problems with Polypropylene

 

When this site started ten years ago, its focus was on the injuries caused by polypropylene pelvic mesh. 

Polypropylene or PP is a polymer that emerged from the petroleum industry. PP is THE material that has been used to make most pelvic and hernia meshes for decades.

Recipients claim it incites an inflammatory response, hides biofilm infection, can shrink and erode. A surgeon can unintentionally trap a nerve during placement, causing unrelenting pain.

Although it's debated, complications with PP mesh are see in upward of 30% of recipients from mild to life-altering.

PP is one of the dominant polymers used in the medical device industry alongside polyvinyl chloride (PVC) and polyethylene (PE). Because the price-to-performance ratio is very high, the market for PP is predicted to grow exponentially in the future. 

We know from the many pelvic mesh trials that PP, used by manufacturers Johnson & Johnson, Boston Scientific, American Medical Systems, and C.R. Bard, is accompanied by a warning not to use polypropylene to make an implanted medical device. 

The warning is contained in the Material Safety Data Sheet (MSDS) that accompanies the polymer.  That warning is required by the Occupational Safety and Health Administration (OSHA) to protect workers in the manufacturing of any material.  

It says specifically  - “MEDICAL APPLICATION CAUTION:  Do not use this Phillips Sumika Polypropylene Company material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.”

It couldn’t be clearer.

What’s disturbing is that polypropylene mesh naturally will come into contact with both bodily fluids and tissues for the rest of that patient’s life.

Mesh makers have contended that “mesh is inert” and does not change once placed in the body, but experts at trial have shown with the help of an electron microscope, that PP continues to degrade and crack in the body.

In the upcoming January 10, 2022 trial in Ohio trial of hernia mesh recipient, Antonio Milanesi, naming defendant Bard, the Complaint lists the many complications alleged to accompany a PP hernia mesh. (Antonio Milanesi v. Bard 2:18-cv-01320, Do District of Ohio)

 They include:  

 ·        Biofilm, a bacteria encasing slime that encases bacteria protecting it from destruction by white blood cells and macrophages.

·        Polypropylene impurity – containing about 15 additional compounds which can leach from the PP and incite an inflammatory response. There is no pure polypropylene

·        Mesh is not inert- In other words it changes once in the body demonstrated through electron microscopy, which can lead to the release of toxic compounds and cause inflammation and fibrotic reactions.

·        PP Mesh shrinkage of 30-50% was known by 1998.

·        Allergic reactions can be seen after polypropylene implantation.

·        Small mesh pore size of 1mm effectively. The pore size should be at least 3 mm to allow for tissue ingrowth otherwise fibrotic bridging can occur.

·        PP migrates in lymph nodes where there is a foreign body giant cell reaction.

·        The ePTFE patch shrinkage rates are the largest among microporous mesh.

·        The Complaint says that mesh material is “biologically incompatible with human tissue and promotes an immune response in a large subset of the population.

  

From Lewis trial, PP mesh eroding, cracking

LEARN MORE:


Mesh News Desk, September 28, 2021 What Do We Know About Polypropylene


Mesh News Desk, November 20, 2017, Do You Think it Might be the Polypropylene?


Mesh News Desk, January 6, 2017, Polypropylene Resin Not Meant for Human Implants


Mesh News Desk, A Guide to Polypropylene or PP, August 22, 2017


Mesh News Desk, Day Three: Lewis v. Ethicon ~ Polypropylene Under the Microscope

Milanesi Case Text

About Lawsuits -Milanesi Complaint


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