Free Case Evaluation
Connect
With Us

Mesh Survivor on the FDA’s Oversight of Chinese Boston Scientific Mesh Controversy

Plastics recycling in Guandong Province

Plastics recycling in Guandong Province

Mesh News Desk, February 26, 2016 ~Written by an anonymous woman in response to the story about Chinese mesh smuggled in by Boston Scientific from China.

Judge Goodwin has asked the Food and Drug Administration (FDA) to weigh in as to whether the mesh falls within the regulatory approval Boston Scientific received to sell its mesh products.  The FDA also has the authority to see  if the Chinese mesh contains selenium, a metal, or any other  contaminants, as research obtained by the Mostyn law firm of Houston, Texas alleges.  

Mostyn First Amended Complaint  alleges RICO violations by Boston Scientific, filed Jan 29, 2016. 

Jane,

I am a mesh victim.  I follow your site regularly and receive your newsletter.  Like many victims, I hesitate to reply due to litigation, and wish to remain anonymous.  However, I felt compelled to forward my opinion on the BSC (Boston Scientific) litigation hold.

By sending this case to the FDA for review, Judge Goodwin has given all of us a voice within the FDA.  Records pertaining to device compliance, medical, product safety and manufacturing for these devices could potentially be reviewed.  This is a good thing.

Steve and Amber Mostyn

Steve and Amber Mostyn

By including them in this process, Judge Goodwin has given the FDA the charge to identify any infractions and to potentially fully  investigate BSC medical device compliance. In their role of federal oversight, any ramifications from raw material safety violations fall under their jurisdiction. It is the FDA that has the authority and the expertise for this review.

Will the FDA examine the supply chain and production processes for BSC?  Will they review the supply chain and safety precautions implemented by other pelvic mesh producers?   Unknown, but the process of completing their investigation would include a paper trail that could provide a clearer picture of the manufacturers regarding product safety and regulatory control.

Judge Joseph R. Goodwin, overseeing bellwether mesh trials

Judge Joseph R. Goodwin, overseeing bellwether mesh trials

Manufacturers are required to establish procedures that identify and track product components throught the manufacturing process and guarantee their safety.  Non-compliance could result in an audit or other regulatory event.  Compliance to FDA standards is paramount to the device system.  The FDA has the authority to evaluate whether these devices were produced in compliance with GMP (good manufacturing practices) and proceed accordingly.

Under the FDA regulations for GMP, manufacturers are required to track raw material purchases, production lots, and finished product quality and consumer safety information for every device.  They are required to maintain these records in accordance to FDA policies and procedures…legal hold or not.

I think Judge Goodwin has opened the door for direct oversight of the supply chain and manufacturing processes, establishing accountability from the defendants in these cases.  State and Federal policy makers, insurers and other stakeholders will be able to review the outcomes of any procedural review undertaken by the FDA.  Any review will be an additional source of oversight and compliance. The attorneys and advocates will have additional references to apply to their review of each case.  These are all good things.

Below are links to some of the device regulations.

The following from the FDA website – www.fda.gov: 

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm

Device Advice: Comprehensive Regulatory Assistance

Regulations, guidances, and other information for regulated industry.

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/

Overview/GeneralandSpecialControls/default.htm

11 Comments

  1. mary babb says:

    Hello,Jane i want to thank you for giving us info. on all the cases it means a lot to us every time we hear about another case it makes us a little closer to know what is going on and so glad for the ones that has got a settlement now they can move on hopeful in the near future we can to bless all the women that is going through the pain as i am …mary

  2. Tami Holmes says:

    In 2009, I was implanted with a sling manufactured by Boston Scientific. I’m having many issues, and my drs. And ob/gyn are acting like nothing is wrong. I don’t know what to do, or where to go.

    • Jane Akre says:

      Hi Tami- You need competent medical help and probably a lawyer if you are having complications. Please contact us with your location and you will need your medical records. janeakre@meshnewsdesk.com They likely are acting like nothing is wrong because they do not know what to do. We’ve heard this many times, again unfortunately.

  3. Emmie says:

    Thank you Jane!!!

    You gave us a source of info that has meant a world of difference to us mesh victims.

    You give us hope and a source for us to know others who share our same problems.

    I am going to see Dr. Hibner in Phoenix the first week of May. I’ve talked to others whom have chosen other doctors and to victims that have also chosen Dr. Hibner. I feel Dr. Hibner has the most experience with pudendal nerve damage which is my main source of plain. I’ve probably would have not heard of Dr. Hibner without your Mesh Medical Device News Desk.

    I sincerely consider Jane an earth angel and God sent to us mesh victims. If I had millions of dollars and that money could give me my per life mesh life back to me…I give it up in a heart beat!

    If I win my lawsuit…dead or alive, I want to share some with Jane. My husband is aware of my wish and I hope I can be living the day justice is served to myself and my family.

    Jane….you made a difference in many mesh victims lives and we are forever thankful to you!

    Our spirits have been brighten on our dark days when you reported any news that gave us hope.

    Your website is a daily read for me….sometimes more than a one time read.

    Thank you!!

  4. I try to be hopeful that the FDA will create a paper trail with its authorities. Unfortunately, my trust of The FDA is at an all time low. Who investigates the FDA when they are heavily influenced by the very affluent manufacturing and drug producing companies? Who will point out the FDA panel members who thought it reasonable to classify permanent implant materials and devices as class 2 along with tampons, condoms and needled and bandages, none of which come into permanent contact with blood and tissue, and bodily fluids? Never, ever, would any person with a minimum education and a good dose of common sense agree that permanent implant materials and devices be lumped in a category that does not demand testing each product on its own merit. I was aghast, disillusioned when I learned about the 510k process allowed permanent implant products to be cleared for sale. I pray there are enough honorable FDA panel members who will review the FDA’ policies which enabled a gross harm to be committed to patients implanted with cleared, rather than approved products. I respect Judge Goodwin, but my trust in the FDA almost non-existent.

  5. anna says:

    There has been so much cover up with this manufacturers, that it would no surl

  6. anna says:

    I was trying to say that it would not be a surprise for me to know that this is not properly done by the FDA. After all they didn’t do the right thing from the beginning, which was to research this products more thoroughly. There are thousands of women who’s life’s have been destroyed, and they still refuse stop this mesh madness.

  7. Gracel says:

    Hi Jane,
    I hope you can give me some advise.
    I had the Boston Scientific sling placed in 2010.
    I had surgery to trim the mesh that was causing pain. I still have pain if I have sex, aback pain and painful bloating. I filed a claim and now was offered a settlement. However I have another consult with a doctor to either remove this or see what’s going on. I was told by the settlement attorney I would need to deny my settlement in order to add any other medical claim. If I accept this settlement, I lose all my rights. I am beside myself.

    • Jane Akre says:

      Grace, as you know I’m not an attorney and you should probably follow the advice of your attorney. It sounds as if adding claims to your case will raise the settlement dollars. Once you settle you will be forever closed from any other claims AND you must not speak of the settlement amount…. thats the theory anyway.

Post a Comment

Your email is never published nor shared. Required fields are marked *

*
*

© 2016 - 2017 Mesh Newsdesk. All rights reserved.
This news website is designed by NextClient.com.