European Union Cracks Down on Toxins in Plastic Used for Medical Devices

//European Union Cracks Down on Toxins in Plastic Used for Medical Devices

European Union Cracks Down on Toxins in Plastic Used for Medical Devices

Plastic mesh

Plastic mesh

the graduate plastics

The Graduate, YouTube

Mesh Medical Device News Desk, June 13, 2016 ~ Using Plastic for Permanent Implants Is Not the Ideal Material

Mr. McGuire: I just want to say one word to you – just one word.

Ben: Yes sir.

Mr. McGuire: Are you listening?

Ben: Yes I am.

Mr. McGuire: ‘Plastics.’

Ben: Exactly how do you mean?

Mr. McGuire: There’s a great future in plastics. Think about it. Will you think about it?

Ben: Yes I will.

By the time young Dustin Hoffman was being schooled on his future in the 1967 film, “The Graduate,” the medical industry had discovered plastics.

Derived from the Greek word, “plastikos,” meaning to mold or form, plastics had an advantage over steel, ceramics and glass for medical use. Besides being pliable and implantable, plastics were cheap to produce and easy to dispose of avoiding cross-contamination in hospitals.

Derived from oil refineries generating many units of carbon, oxygen and hydrogen, by midcentury, production techniques allowed plastics to be molded into medical devices including those implantable – heart valves, stents, pacemakers, defibrillators, silicone implants, hip and bone implant components and hernia and pelvic mesh, to name a few.

In 2013, the global market for polypropylene (PP), a cheap commodity plastic, was about 55 million metric tons.  PP has a wide range of applications. In the laboratory is can withstand the heat in an autoclave, so PP was easily adapted as suture material.

But problems with plastics are mounting.plastic medical device from in these times

While tests showed their endurance when interacting with oxygen, there was very little evidence of how they did constantly exposed to liquids, especially bodily fluids.

That’s a problem for 600,000 people worldwide who have pacemakers implanted and the 100,000 patients who receive defibrillators in the US each year.

When researchers in 2012 mimicked conditions inside the human body, they found materials began to break down within three to six years, including plastic used to coat cardiac leads that carry an electrical current from the battery to the heart. Water caused the plastic to age, soften or lose tensile strength, according to a study, published by the American Chemical Society.

Polypropylene has been used as hernia mesh since the 1950s and more recently implanted as a permanent implant in women with urine leakage or sagging pelvic organs. It too is now believed to change in the body in the presence of bodily fluids and heat with dire results for hernia and pelvic mesh recipients.dr donald ostergard

Initially marketed as inert, in 2011, Dr. Donald Ostergard, past president of the American Urogynecologic Society, published an article revealing information accumulating since the 1950s. Mesh is not inert, he wrote, the PP was able to incite an inflammatory response or foreign body reaction. Electron microscopy showed the deep cracks in the PP as it degrades in the body as well as shrinks 30 to 50 percent.

More than 100-thousand defective product lawsuits have been filed by women experiencing mesh complications.

Eto used to sterilize TVT Secur

Eto used to sterilize TVT Secur

What’s equally concerning, PP mesh implants are exposed to ethylene oxide (EtO), a low-temperature sterilization agent. EtO is regarded by the EPA as toxic and a carcinogenic and exposure is regulated by the EPA, and in the workplace, under the rules of the Occupational Safety and Health Administration (OSHA).

Two standards are supposed to assure the implant sterilization is safe for humans and the implants are biocompatible.  But the ISO 10993 and United States Pharmacopoeia USP Class VI only go so far. According to Plastics in Medical Devices, Second Edition, “It would be possible to pass the USP Class VI test while still showing up as cytotoxic, mutagenic, hemolytic, or sensitizing in the biological testing.”

On May 24, 2016, a compromise deal in the European Union promised to step up surveillance of implanted medical devices. The deal, agreed to by the European Parliament and EU Council of Ministers, would limit the use of devices that contain carcinogenic, toxic, mutagenic or have hormone disrupting properties, including plastics.

Any device that is implanted and comes in direct contact with the human body containing those properties will be barred unless the proportions do not exceed 0.1 percent by weight. Consumers and doctors will be informed through strict labeling requirements.

The crackdown comes following a scandal in the EU in 2011 when a French manufacturer used industrial grade silicone in breast implants.

In the EU, a central database will list all devices on the market that are implanted.

The U.S. has yet to establish a national database for adverse events when plastic medical devices go wrong. ##



By | 2016-06-12T20:02:03+00:00 June 12th, 2016|Medical News|8 Comments

About the Author:

I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.


  1. Dottie June 12, 2016 at 8:36 pm - Reply

    Yeah, the snow ball is rolling down the mountain. They may want to rethink using third world countries to make their million’s. Thank you Jane

  2. stopmeshimplants June 14, 2016 at 1:41 pm - Reply

    When all of this mesh implant mess comes out and everyone realizes how many of us passed on due to this plastic material then we might just get the news attention we so desperately sought for years. Settlements or no settlements the pharmaceutical giants greed is to blame and they can never repair the harm done to our lives. Thank you, Jane.

  3. Barbara M June 15, 2016 at 10:45 am - Reply

    I have no trust left as FDA was to protect me allowed me to be used with
    Out my consent as there toxic human lab rat, never telling me plastic was put in side 20 years of illness always being told not the mesh,when mine was recalled they never told me,using 510k law in a curupt way,taking dangerouse recall and putting it back on market!
    Not once in all emergency visits was I told could be the mesh,always me asking if it could be and them saying No!
    Had they taken it out when things first went wrong I’m sure,R.A. Could have been prevented and skin auto immune disease,Contrature pain,severe pelvic pain nerve damage etc the last few years of sepsis,over 2 years fever damaged sex relationship with husband as sex became to painful,and all the years being lied to ,not beleaved causing depression from pain and phycalogical damage,now also have PTSD!

  4. Janis Urban June 17, 2016 at 2:27 am - Reply

    It’s not just the Plastic that is Toxic Poison to our Bodies… How on earth do they all get away with what they have done? They added more Chemicals to the Resin and Bio-materials and who knows what else…Science has never studied this cocktail mix in each one of the meshes as to what reaction our bodies will have? We know the reaction and most of it is tell tale sign of Toxins. And tell us “It’s Not the Mesh”. They have had plenty of time to re-exam study and research us between the Hernia and Pelvic Mesh Injured…Years. I also think the Cocktail of Chemicals & Bio-materials would react differently in Men & Women for many reasons! So much went wrong ….Destroy Human Bodies & Poison them and get a way with it…Tragic! Greed…The World is catching on…to many have been injured…Hang on Everyone…

    • Robin June 29, 2016 at 9:26 am - Reply

      Yeah when is the u.s. going to start taking a stand for women all over the country who are suffering from the harmful effects of trans vaginal mesh. polypropylene being used in women and men is harmful and toxic and the FDA refuses to do anything about it the pharmaceutical companies are making billions off the travesty of women what do we need to do start burning down towns or hurting people to make the news? it’s ridiculous women are nurturers we care we just want to be heard no one seems to be listening maybe we need to take a step a little higher?

  5. Linda Jane Bos August 28, 2016 at 6:34 am - Reply

    Hi i am a Australian born in Tasmania now living in Victoria I had my mesh inserted on my birthday 2007 for a twisted bow around my cervical head {post Hysterectomy.} at the Mercy Hiedlbuerge Victoria .After 5 other hospitals mistook the bow as my uterus .and now this hospital hove lost half the records .only have virginal repair noted .They are looking into it .

  6. Linda J August 28, 2016 at 6:36 am - Reply

    phone )487791011

  7. Linda Jane Bos September 17, 2016 at 8:33 pm - Reply

    Help me to under stand this mesh problem and to get my Gp to listen to me and do some tests to see if i am effectived . i live in Victoria Au. Born in Tasmania Au. My Email is mobil 0487791011 leave a message

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