CE-Mark For Sale
“Undercover investigation by Dutch television program Radar expose how the EU regulation of medical devices is so lax that mesh packaging for fruit could be approved as a medical device to be implanted in peoples bodies.”
Please go to link to see full movie: http://www.imdb.com/video/wab/vi3882135065/
This movie is about an hour long, and is not just about mesh, but definitely has a lot of content pertaining to mesh and is a real eye opener. Produced and directed by Linda StoltenbergIt, it is by Dutch television, and about the EU regulation of medical devices. However, in the US, the FDA has the 510K process which is allowing the same kind of thing. Products, untested, on the market. Unbelievable? Well, believe it. It is happening.
It is good to see Erin Brockovich involved with this.
She appears in this film throughout it, and makes some very good points.
She actually breaks down at about 33:00 minutes in as she talks about what is happening to so many:
Reporter: “You’re crying?”
Erin Brockovich: “It bothers me. And, I’ve heard, like I said, the women’s stories and I think it’s a shame. It’s a tragedy. And, it does disturb me. And you know we read these things, you think it happens in other countries and we run to their aid. Yet when it happens in our own backyard we stand down and do nothing for them.
And they are suffering. And they’re losing their relationships… and they’re losing their sexuality, and they’re losing their job and their self-esteem has been damaged, and they feel “less than”. And, I just don’t think that anybody in this world should be put in a position where they feel less than anything… because they are a human being and they do matter”.
Yes! We DO matter. Thank you Erin Brockovich!
Then there’s this at 37:30 minutes in:
Erin Brockovich: “You’re not protecting your people. You’re using people as guinea pigs. For a CE mark that has no validity… that nobody knows anything about.. that you’re putting in a human body.You can kill people that way. You ARE killing people. You are ruining people’s lives, and yet nobody knows.”
Prof. Carl Heneghan (w/Evidence-Based Medicine University of Oxford): “When I first realised this is the system, I came on camera and said, what’s happening is that patients are acting like guinea pigs. Because they have these devices and they actually are the experiment. That was about five years ago, and when I said it I was a bit concerned that maybe I wasn’t saying the right thing, but when I see this, we’re realising that if these devices are implanted in people, they ARE acting as the experiment, because nobody knows if it’s beneficial or safe enough.“
Adam Slater, the American lawyer that is representing many women against Johnson and Johnson also appears throughout this film.
This is from 15:35 minutes in:
Reporter: “The erosion rate of our mesh turns out to be an impressive 30 percent. We show this to Adam Slater, an American lawyer. For seven years he has been taking on Ethicon, a Johnson and Johnson subsidiary. He is representing 300 women.
Adam Slater: “30% means you bring in 10 women into the room and say, “We’ll put this into your body. Three of you are going to have the mesh not sit safely in your body. It will damage the tissue and erode of through the surface of the vagina and now you’re going to need – for most women – surgery to try to remove it”. For many women, it’s not just one surgery, but it will happen again and again… and they have complex mesh erosions that can be devastating and go on for life.”
Prof. Carl Heneghan (w/Evidence-Based Medicine University of Oxford) also plays a big role in this documentary.
Towards the end, at about 51:45 minutes in, they mention the car industry and recalls.
Prof. Carl Heneghan (w/Evidence-Based Medicine University of Oxford): “Think about the car industry. Many manufacturers had to do a recall. And they said, “My gosh, there is a problem with the brakes”. They can trace every single car around Europe, send an alert around to the garages, call everyone back in and do those brakes. They know it’s important to solve the brakes. Because they have high-quailty and high-quantity manufacturing, they want to ensure they do that. The system with the medical devices is just about the opposite. You won’t know who these devices go into if there is a problem. Nobody does.”
My husband has made that exact same comparison so many times. It is mind boggling that they do NOTHING to track/notify/recall known faulty medical devices, yet they can (and do) track and recall a whole fleet of cars for a faulty part that potentially could cause damage!?
Again, Please watch and share this important and poignant documentary:
I know there are many more involved in this… and I hope to add/highlight more clips.
If there is a complete transcript of this film someplace – please let me know! I’m also happy to add any other links that are affiliated with this.
Thank all of you so much to those who were responsible for the making of this film!
- March 22, 2012: Victims Speak Out about Dangerous Loophole, Unsafe Medical Devices on the Market by RepMarkey (Re: 510K process)
- More Videos on Mesh: https://meshmenot.wordpress.com/videos-regarding-mesh-complications-information/
- Top 10 Things to Know About Mesh BEFORE Having Surgery for POP or SUI:https://meshmenot.wordpress.com/top-10-things-to-know-about-mesh-before-surgery-for-pop-sui/
- FDA warns there is NO evidence that mesh provided any greater clinical benefit than non-mesh surgeries: https://meshmenot.wordpress.com/2015/04/02/fda-warns-there-is-no-evidence-that-mesh-provided-any-greater-clinical-benefit-than-non-mesh-surgeries/
- See the comment on this post: https://meshmenot.wordpress.com/2014/04/16/augs-addressing-mesh-complications-and-helping-patients-or-just-defending-mesh/#comment-770
- A brochure on hernia mesh: https://www.facebook.com/groups/meshproblems/987402747957336/
- Are you a GOOD mesh? Or a BAD mesh? https://meshmenot.wordpress.com/2015/05/31/are-you-a-good-mesh-or-a-bad-mesh/
Perhaps even more helpful than articles, is talking to a variety of others who are suffering from mesh complications, and are in various stages of treatment. Three of the larger support groups I found helpful are:
- Women’s POP/SUI TVMesh Complications Support (Closed Group)
- Fighters And Survivors of All Transvaginal Mesh And Hernia Mesh/Plugs (Closed Group)
- Mesh Problems (PUBLIC/OPEN TO ALL, including doctors, etc)
- More resources listed on the footer/main page of this blog!