FDA Ups Enforcement After Pelvic Mesh Counterfeit Resin Allegations

Mostlyn Law alleged that Boston Scientific smuggled counterfeit resin containing toxic selenium and used it in mesh products after 2010. The FDA responded  January 5, 2017 by requiring BSC to prove that the material is safe for human use and to analyze the contents of their own mesh.
In its response, FDA doesn’t recommend removal of the suspected counterfeit material claiming the removal surgery is more risky than keeping the selenium in your body.

Counterfeit Class Actions:
“In addition to the mass tort docket, Boston Scientific said it also faces two class action lawsuits by plaintiffs who allege that the company used counterfeit or adulterated resin from China to make the mesh in its pelvic mesh devices and not brand-name, American-made mesh as specified in regulatory approval for the devices. It said one case was stayed to allow the Food and Drug Administration to issue a determination about the counterfeit allegations.The company said the U.S. Attorney’s Office for the Southern District of West Virginia has also requested information about resin used in the company’s pelvic mesh devices.” — Lexis Legal News Boston Scientific Has Pacts To Settle About 37


Peggy Day is working on a book to combine all these stories. This is an excerpt from Pelvis in Flames: Your Pelvic Mesh Owner’s Guide. Your input is welcome to help make Pelvis in Flames the book you need to read.

If you’d like to join an online support group and learn about erosion, partial removals, surgeons, or just find out that you are not alone, join my group, Surgical Mesh or check the list of support groups here.

Subscribe to PelvicMeshOwnersGuide.com to learn more about pelvic mesh. I’d like to hear from you if you are helped by what you read here or if you need to know more about any particular topic. Comment below or email me privately at daywriter1@gmail.com..


2 responses to “FDA Ups Enforcement After Pelvic Mesh Counterfeit Resin Allegations

  1. If I didn’t wish I was a wealthy person before, I certainly do now. I would take this company through every court in the land, at what they have down to myself and probably thousands of females world wide. I was a pretty healthy older female always looked after myself health ways, and worked hard all my life, probably what kept me young. I now find myself feeling like an old woman. Every day I wake the first thing that comes to my mind how am I going to feel today, and is there going to be fresh complaints and pain for me to endure yet again. I can’t even look to a supportive family to be concerned for me, as they are to busy looking after themselves that’s what sort of nice people they are. Friends are more supportive of me.

    • So sorry this happened to you. Hope you are finding help to deal with it and to have the product taken out.

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