Free Case Evaluation
Connect
With Us

FDA Acknowledges Potential for Counterfeit Raw Material from China in Boston Scientific Mesh

Yimao plastic molding, Guangdong Province China

Yimao plastic molding,
Guangdong Province China

Mesh News Desk, April 1, 2016 ~  FDA says it will rely on Boston Scientific tests of its own mesh!

Citizen Petition shows Toxic selenium in polypropylene pellet samples. 

FDA does not recommend pelvic mesh removals at this time. 

The U.S. Food and Drug Administration (FDA) acknowledged today it is aware that some of Boston Scientific’s (BSC) urogynecologic surgical mesh may be made from counterfeit raw material.

This is the first time the agency has responded to a federal racketeering lawsuit filed by Mostyn Law of Houston, alleging Boston Scientific was involved in a “scheme” to defraud regulators in both China and the U.S. by smuggling 37,000 tons of raw polypropylene resin into the U.S. without any oversight from regulators.

The composition of any surgical mesh made from that counterfeit polypropylene resin remains unclear to the FDA which will rely on Boston Scientific to test its own mesh products.

Steve and Amber Mostyn

Steve and Amber Mostyn

Steve Mostyn tells Mesh News Desk, “While we are happy they put out an advisory, the fact is that allowing Boston Scientific to test its own products, something we have solid evidence they faked the first time, is insanity.

He is referring to the company’s previous assurances to the FDA that its sourced resin was Marlex, the company’s trade name for its polypropylene.

CITIZEN PETITION

The FDA warning comes one day after the Mostyn Law firm filed a citizen petition which contained previously sealed documents laying out how Boston Scientific allegedly brought the resin into the country.

The evidence shows Boston Scientific sought distributors of raw polypropylene through a website called Alibaba.com, not unlike an ebay for raw materials. The company feared a shortage of
Marlex, its polypropylene mesh, would cost $120,000,000 in annual profits after U.S. supplier Phillips said it was not interested in doing business with BSC at any price and would no longer supply raw polypropylene pellets used to be fashioned into a mesh material for implantation in the pelvic floor for support.

Included in the petition is a lab report from Cambridge Polymer Group of Boston, Mass. completed for Boston Scientific October 13, 2011. It compared three samples of polypropylene pellets. Using Plasma Spectroscopy it found the samples contained high levels of selenium.

Polypropylene raw resin pellets

Polypropylene raw resin pellets

”As this is a rare and toxic element, this result is unusual and should be verified by using another technique, such as SEM-EDS.” ~ says the lab report.

Selenium is a trace element essential in small amounts but toxic at high levels, according to the Linus Pauling Institute (here). Selenium toxicity has been noted in China. Symptoms include hair and nail brittleness and loss, gastrointestinal disturbances, skin rashes, garlic breath, fatigue irritability and neurologic disorders.

The samples differed in trace minerals as well as debris of small fiber particles on some resin pellets.

The sealed documents were just released last week and the defendant company “fought us every step of the way,” Mostyn says.

The FDA says it’s not aware of any complications that have occurred as a result of raw polypropylene resin. It will review the findings of Boston Scientific when it finishes its evaluation of the composition of its mesh made from the counterfeit polypropylene resin, which should take several months to complete.

In the interim, the FDA says the public should be aware of this investigation.

Mostyn believes sourcing raw polypropylene from China may extend beyond Boston Scientific, though he would not elaborate.  In March 2010, the FDA issued a warning that counterfeit surgical mesh marketed by C.R. Bard was in the marketplace. See the FDA warning here. 


RICO LAWSUIT

On January 12, 2016, West Virginia resident Teresa Stevens filed a class action lawsuit alleging Racketeer Influenced and Corrupt Organizations Act (RICO) and filed a motion asking Judge Goodwin to stop the sale of Boston Scientific pelvic mesh.  Judge Goodwin denied the motion and requested the FDA to look at the issue citing the Doctrine of Primary Jurisdiction (here).

Stevens was implanted with a Boston Scientific Advantage pelvic mesh as are about 55,000 other women every year, says the plaintiff complaint.

During a meeting with FDA regulators in Washington D.C. on February 19th, Mostyn says they laid out the entire “scheme” to the FDA but “it was like talking to a blank wall.”  #

 

LEARN MORE:

FDA Notice, April 1, 2016
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm493784.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Mostyn Law Court Documents, Citizen Petition
https://vaginalmeshclassaction.com/exhibits/

Mesh News Desk, Jan. 15, 2016 – RICO Suit Accused Boston Scientific of Fraud in Smuggling Defective Pelvic Mesh from China
http://www.meshmedicaldevicenewsdesk.com/class-action-lawsuit-accuses-boston-scientific-of-obtaining-defective-mesh-from-china/

RICO Complaint Jan 12, 2016
https://s3.amazonaws.com/static.mostynlaw.com/wp-content/uploads/sites/4/2016/01/RICO-Complaint.pdf

70 Comments

  1. Debi says:

    Unbelievable! !!!!! So if I robbed a bank the FBI will rely on ME to check and see if the finger prints are mine….. total B.S.

  2. dee says:

    I feel like I a slowly dieing from the bard mesh sling and no one cares or will help me

  3. Lynne Ruth Dwyer says:

    I find this article extremely disturbing as I sit here and read this information. I wrote in, a day or two ago that my polyprolene was from Boston Scientific. It’s too dangerous to remove. I am in constraint pain. Limited in energy and stamina. With a prognosis of who knows what since these pieces of plastic can take years to show themselves. The FDA is letting the scam artist check their scammed material to decide whether there is a potential problem over the course of months. Why isn’t there mention of legal action against the company for importing this stuff if the evidence is correct. The FDA is putting out a notice to warn the public. Shouldn’t my surgeon, the one that put it in be contacting me to assess whether his patient (me) might be having adverse effects from the possible counterfeit product. Just how am I, the patient, being protected or cared for in this instance. Or the other, 55,000 women, per annum, that potentially received this material. I have to chase after medical people. Who either offer to see me weeks later, or not at all. The side effects of this implant are quite something to live with. Then there is the question of how does all of this shake out over the years to come? Since it may take a few years for the material to become troublesome in some – where will the gatekeepers be for the victims in five, ten, plus years in the future. Right now it’s a struggle to get the little attention the issue is getting. After the big pharmaceuticals cross this bridge – what then for the survivors? This is like a big toothache that they want to make go away. It seems to me, that the FDAs handling of this matter is emblematic of their lack of concern for any of us and the seriousness of just how protective that agency is of the companies involved. I found it interesting in the report, that the lawyer cited kept referring to the FDA as They. What a weird point of reference. As though the FDA entity were a corporal human body. “The FDA said”. What? Was that someone speaking to me? Now that I have this little piece of information and my body is racked with weird and painful sensations, how well will I sleep tonight? My doctor thinks he will kill me if he removes it. I fear it will kill me if it remains inside of me. Even more so, now that I fear the material may have been contaminated or high in an element such as selenium and may shred more rapidly than usual. I’m not sure how to end this post…maybe someone else can help clarify where all of this is going. How can we be just left out here in the dark?

    • Jane Akre says:

      Sounds like you need an expert if you choose a removal. An expert will help you make an educated assessment as to your situation.

    • Bev says:

      Go see Dr. Raz. Google him for details.
      He can safely remove all of it.

      There are very few Drs. That can safely remove. I know of four. But none as good as Dr. Raz.

      • Lynne Ruth Dwyer says:

        I am 68 and have no family. Do you have any suggestions on how IC get there and back. How do I go alone and return. I’m on my last nerve here. Bordering on hysteria. I just found out it was poly last wk. now it’s bootleg Chinese? I feel sick from the implant. My body isn’t well. I can’t just make an appt with someone in California I get sick if I go out of my house to the store for too long. I’m just going to die here. How is this happening?

        • Jane Akre says:

          Lynn- Are you represented? Do you want to use your full name here… please advise. Also where are you located? There may be folks locally who can help… also, many women are flying to UCLA and they gather in a community at the Tiverton house, so you may be able to connect to someone in advance of going. If you put out the word and your date, others will respond… also on the facebook page

          • Nameless says:

            My email is my name. I live in NYC. I’m really upset right now. I can’t type and cry. I’ll get back in the morning. I can’t believe this happening.

          • Jane Akre says:

            Dr. Jerry Blaivas, New York City Urology, 212-772-3900
            Dr C. Y. Liu, gynecologic endoscopic surgery, private practice, NYC 212-988-1444

          • Nameless says:

            Thank you. I will give Dr. Blaivas a call. About changing my name. Ok. How about Nameless. After I signed the contract on line my so called lawyers office never spoke with me again. Whenever I phoned them, I never got beyond the person answering the phone. There isn’t any way I sound know that they would not like me posting using my own name. Apparently, I am a nameless to them.

          • Sea says:

            You might wish or at least consider the following:
            Mostyn Law firm who seems to be the leader of Mesh Injuries ….While they are located in Texas, they can work with any law firm in any state to represent you. Their office number/address is HOUSTON, Texas
            3810 W. Alabama Street
            Houston, Texas 77027
            Phone: (713) 714-0000
            Fax: (713) 714-1111
            I highly recommend you ask for Larissa Westbrook to talk too. I don’t live in Texas either, but I called them searching for answers, thus, they won over my trust while directing me accordingly. Just a suggestion for you to consider. I called many a attorney office and did not like they way I was addressed by phone, thus, I called Mostyn Law firm with a list of many questions …..they answered all my questions including about evidence of their case now in court over China shipments to US with Boston S. They were professional, they listened, answered all my questions with great knowledge, and I posed SERIOUS questions, thus …They can work with any attorney in any state for co-ornated efforts…SO ….I decided to have them to become my team players since they have become the leading law firm with doing what is right while uncovering major unjust/illegal actions of major medical devices manufactures ….helping me to fight my battles with this MESH MESS. Hope this helps … The old saying that cream always rises to the top of milk is true….thus, I decided to go with the best I could for my life has forever changed …However, the decision is always yours … so , take your time, hang in there, because there many of us holding on to one another …..With kind regards from your wounded mess mesh sister, Sea

          • Sea says:

            As I have searched deeply day after day in my dazed brain over this mess mesh while doing my best in keeping up with daily news on this subject along with searching for answers, I pose a few simple questions:
            Since all the companies are making this mesh product, it appears our (women with some men with mesh hernia problems) our personal problems seem to have many similarities in common nature , and there is only ONE manufacture of this resin in the US which has recently denied Boston Scientific of selling them this product, because Phillips (the company) said something like this mesh is not for human consumption, …..so my simple question is ….ARE ALL THE MANUFACTURES MAKING THE MESH PRODUCT OUT OF THIS RESIN or WHAT IS THE DIFFERENT COMPOSITES OF THEIR PRODUCT > ?? Or, are (J&J, BS, plus the rest of the companies )_they all getting China/other 3 world company products too ??? /COULD THIS BE THE REASON or at least ONE OF THE REASONS we are all suffering serious similar medical problems ????
            The reason I pose this question is the concern we all have for the ruling of the JUDGE OVERSEEING THE JUDICIAL SYSTEM IN THIS MESH MESS? Or, what is the different in each recipe of the mesh from each different manufacturer? My simple equation is like making homemade biscuits ….they won’t rise if you don’t use baking powder or buttermilk ? So, what is the difference in each recipe (formula) of each mesh manufacturer and what do they have in common ? RESIN? BAKING POWDER? BUTTERMILK? OR ????
            Sea

          • Jane Akre says:

            Yes they are all made out of polypropylene, a cheap plastic. My understanding ,thre is no medical grade of PP, so yes are the other manufacturers also denying the use by mesh makers. We know Bard also had a material Safety Data Sheet which also said not to be used for human implants. What did Bard do? They created a dummy company to cover their tracks and continued buying from Phillips. Do they still? It is entirely possible and very probably in my opinion, that others have been forced to source cheap PP from China. That is a good question to delve into for some investigative reporter…. LOL with the time and support to delve deeper….. peddling as hard as I can.

          • Nameless says:

            That is a brilliant question and reasoning out part of the complexity. If Boston Sci’s vendor bailed why didn’t they go to the vendor supplying the rest of the manufactures. Why China? Or did the others take part in the buy and they had a piece of the stock. Boston bought a huge amount of resin and it was conjecture that some was still in the warehouse. Could they have been vending it to other companies? How did the other companies supply themselves? Why would Boston be driven outside with all the sly dealing if they could get it here. Unless the price was so low. In that case, it would be a magnet for the other companies to follow. These are questions that we may never find answers to. Personally, I’m going to have blood work soon to check for high selenium or any other toxic substance in my blood. That’s an area not investigated Asa far as I know. The door opens wider when this Chinese stuff shows up. That would be a marker since that is one of the agents noted different from the original mesh. I also wonder if chelation would be of any use.

          • Jane Akre says:

            If you find a lab to do blood work or have protocol for testing, could you please share. Others may want to do the same thing.

          • Nameless says:

            One of the barriers in pursuing this issue is that a long as the FDA denies auto immune illness associated with mesh implantation it’s impossible to get a study going to differentiate the chemical composition of each manufacturers stock. There job is to keep this simple, ignore our suffering and protect the manufacturers profit margin.

          • Sea says:

            Suggestion: Seems we need to start up support groups nationwide to help one another and also MAKE A STATEMENT ….TERRIBLE what we are going throughout …..Sea

          • Adrianne says:

            I want in also. I had the same default mesh put in and I need to know how to get it out without dying. I am having symptom after symptom

    • Wendy F says:

      When are governments going to realize that being in bed with pharmaceutical companies is not just about paying too much for medications. The side effects from these types of mesh on women is life threatening. Yes its killing people or they kill themselves because they cant take the pain anymore. All this is done alone.surgeons who put this in in a majority of cases dont want to even see the patient they mutilated. They have been lied to yelled at told its all in their head. The world will look back at this as the biggest medical scandal since thalidomide. There is a Senate inquiry into these device being heard now in Australia. When the results of that finding come out (as long as the pharmaceutical industry keeps its snotty nose out of their pockets) and lets the inquiry be free and fair) then maybe the world may listen. Shame on you all.

  4. jade says:

    Why do we (the victims) have to play by the rules in these legal proceedings when it is transparent that the FDA and BSC are NOT required to do the same! This is NOT JUSTICE – it’s a JOKE. And, we the victims have NO recourse, but to sit and wait and wait and wait. Testing their own materials – that’s ridiculous – BSC has lied, conspired, cheated for the sake of the Almighty Dollar. They DO NOT deserve any more chances – where are our so-called lawyers?????

    • Jamie says:

      OMG I cannot stand this anymore I see the whole world going to hell in a hand basket and we have to be quite about all this & sit back & wait to Die !!! I really feel like this is never going to happen for me AMS, what the heck is the hold up I call my attorny every month I have been told since june 15 that I will be getting an awards letter as this mesh erodes into my bladder causing me to have UTI pissing glass shards because I have that nerve damage & Intestines are backing up and leaing into my kidneys and I’m doubled over other than being throwing up cuz I’M impacted !!! All of this crap is a joke and all these lawyers are too, saying that it’s pending ? Pending on what? When I die or can’t walk it’s sickning,no one is a professional medical adviser not even the medical professionals themselves & I read that if you did not know that you were inserted with this mess mesh that it’s even better & that was my biggest complaint 5yrs & waiting & waiting lawyer time 11 yr vet of this & it’s gotten worse no matter what I’ve tried I was doomed from the begining an sitting behind a key board complaining is ludicrist this is why the world is the way it is I’m making some =thing happen here weather it be for myself or others I’m mad as hell & I’m sick of taking it anymore !!!! i’ll be dead before I see a dime or in prison & then dead because of all the In Eptt Idiots of this country !!!!

  5. iim says:

    Someone needs to start getting these poor mesh ladies lawyers to push the issue. They have all these adds about find a lawyer and you file with them then they ignore you. These lawyers seem to not have any regard for these poor mesh injured women. Their seem to care until your their clients then they ignore these women until their pay day comes. It’s seriously said the service they women get from their lawyers. And the judges aren’t any better. I watched this stuff ruin my mother’s life. I wish the best for all of you poor women

  6. dottie says:

    University of Michigan teaching hospital has a whole setup to remove mesh from your body. Beleive me when I tell you that they understand all about mesh and the problems it causes. I had Dr Cameron (female) & Dr Morgan do my removal. Jane has interviewed the Drs and can vouch for them. If Michigan is too far, look into teaching hospitals in your own state, starting with urology. Hope this helps those trying to find sympathetic caregivers.

  7. Don't give up says:

    This is unreal that the FDA is letting BS do there own testing for this,it would be like me taking a silent fart walking with a bunch of people and someone saying eew did you fart? Who me Nooooo!,,
    Something really stinks here once more but it doesn’t surprise me with what’s been going on and on and on with the FDA and the mesh issues.
    It’s nice to see Avis Favero has picked this story up for the CTV National News though on Twitter.
    Let’s hope that the testing done will also be ordered done by an outside firm as this needs to be done,and if BS is saying it didn’t do this with there mesh then they have nothing to worry about if that’s the case.

  8. Denise Schrader says:

    can’t find lawyer to take case of hernia mesh and human mesh, have been turned down for all, hurt so like I have a steel corset on. Have another hernia coming out above human mesh and was told by cleveland clinic to wear a elastic band, well being squeezed so much from human mesh wouldn’t be able to breath with belt on, some one has to help us :/

  9. Lynne Ruth Dwyer says:

    Please I mean no disrespect. But what expert is that? Where does the $30,000 come from to for travel, lodging, bringing someone either you (if you have someone). Medical fees. The one guy mentioned over and over. Who doesn’t pick up the phone if you are sick after his removal. I’m afraid this situation has to be called out for what it is. Because, there are a lot of us out here that are in jeopardy. The previous poster was saying the truth. Who cares about us? I signed a contract and never heard another word from the lawyer. Shouldn’t there be some question regarding Boston Scientific/Bard and maybe others related to us – the people with this potentially poisonous material in us. Why isn’t there any over sight into our care? If someone fed us arsenic They would be guilty of attempted murder. If someone’s product was poisonous and it was implanted internally, with foreknowledge of its toxicity what do you call that? Profit? I want an expert to remove this toxic product from my body. Anyone have any ideas other than Dr. R., Dr. V., Dr. H? An expert that will take Medicare? Be within reasonable distance to my home. And will not kill me on the OR table because the procedure is too dangerous? Or should I just wait silently for the lawyers to throw a few crumbs my way as I deteriorate? I can feel the mesh ache with every breath. Who cares about that? The FDA, BS, the undertaker? AUGS has a lot to say. Maybe They should take responsibility and over see our return to health.

  10. Lynne Ruth Dwyer says:

    Maybe teams of experienced urogyn’s should be taught the best procedures for removal then set up counseling locations to facilitate decision making to begin the removal process for those that want it out. With appropriate post removal follow up. Just saying – u know????. That would be a society that cared about victims of corporate greed.

  11. Dixie says:

    Yeah sure Boston is going to give positive results for their mesh’s. Why can’t someone other than Boston do the testing? Sounds fishy to me. We all know Boston is going to say; in their own defense they didn’t find a problem in “their” testing. Duh !!! Yep, Boston is going to come through this smelling like a rose.

  12. Barbara Melling says:

    Insane FDA protect us! Did you become corrupt ? Do you have mothers wife’s daughters grandchildren is this there future because of greed!
    Please do your job ! We did not deserve to have septic deaths because of wrong doing ! We are suffering! Some in hosp being killed by biofirn ! Please have you no heart?

  13. Janis Urban says:

    Reading my medical records just the other day. All my organs seem to have scaring, hardening, lesions, small cysts,inflammation, ulcers up and down the esophagus and lining stomach etc. Each and everyday waken to severe nausea that never goes away. Bouts with diarrhea vomiting hair loss, teeth loss etc etc open sores, skin rashes….inner body tremors. Body is trying to rid the toxins. Doctors run the standard tests and they can only see what they know. Blood work levels are always in the higher than normal range. Until it turns into disease. Nothing can be done. I feel like I have been poisoned. Body so swollen. I can’t move or talk without feeling overwhelmed with nausea, vertigo, nerves quivering it takes my breath away! Speech becoming impaired, brain fog. What else could it be? I call it The 21st Century Holocaust. Is History repeating itself? We will see? Monsanto comes to mind. I had another manufacturers mesh. Eat clean non over processed foods and flush your body with pure water and pray.

    • Still Standing says:

      Janis, bless your heart. I, too, have developed ulcerations post mesh. Started within a month or so. It started in mouth and skin, but now is vaginally. Multiple biopsies settled on erosive vaginal lichen planus. It is horrible, just cant keep any skin on vaginal wall. Have your ulcers been biopsied? Two other potential diagnoses for me were
      Bechet’s disease and desquamative vaginitis. Treatment is with vaginal cortisone suppositories. Not working very well at times. Also have cysts. Do you have any in your nail beds? Mine are at my cuticle and break open and ooze. Pretty gross. I do know that keeping on an anti-inflammatory diet helps a great deal. I can definitely tell when I am not disciplined about my diet. Id like to talk to you more about your ulcers. I have not heard that mentioned too much.

  14. Linda says:

    Jamie,
    I read your post and understand BACKED UP” I had removal @ UCLA 3 years ago and then reconstruction @ UCLA a year later. In every x ray they noted that my bowels are full. Following reconstruction, the surgeon order a Cat-Scan because he thought I had a bowel blockage. no blockage just can’t evacuate. Never had a problem before mesh. What helps me is Miralax, 2 capfuls every single day. I put it in hot tea. If I skip even a day I swell like I’m 7 months pregnant. I tried Lizness/ new drug that is supposed to be very effective and very expensive. It did not do a thing for me. a month ago I started the non- inflammation diet and it has helped with the abdominal swelling. Even after removal, Ii push to get through the work day and get home and lay on my heating pad. I did not find increasing fiber as helpful and then my primary said it can make it worse because it is already so difficult to evacuate it expends in there. Sorry I don’t have better news but if I do it daily it allows a small BM daily.

  15. Linda says:

    The reason the FDA is not aware of negative effects is because nobody I studying us! All the orders are for the company to study their products. Of course they will not present accurate findings. I would like to know how they discovered the imported resin and if they will be able to prove other companies used it as well. Even after removal I am having fatigue, joint pain, and I have to be careful not to over-do activity or I end up immobilized for long period of time. The removal did make life more tolerable and I would do it again. I was ready to call it quits before removal. I also do myo-facial massage regularly. It does not feel good but again, I believe it keeps me able to function for work. It’s a day to date fight.

  16. Disgusted says:

    Ridiculous!! We need someone who is able and in the right position to stand up to this nonsense. This is in the same vein as Love Canal in NY, the toxic dumping of the chemical company that Erin Brockovich successfully brought to accountability, etc. We are so harmed, sick, immobile, in pain that it makes it hard for any of us to do the leg work and we’re talking world wide assault. Those who are responsible for this charade need to go to jail. Inexcusable.

    • Lynne Ruth Dwyer says:

      Yes ma’am. We are the canal. I thought the very same thing. This lack of accountability and being left yo bounce from one possible disaster to another without proper counseling that includes a clear definition of what exactly us wrong with each and every one of and how best to regain health through whatever means necessary. Not alone and on our own. We are the human love canal. Disgusting lack of concern for all us and our families. Disgusting behavior !

  17. Susan says:

    I have a solyx mesh implant made by Boston Scientific and my attorney for some reason is saying my hospital nor my dr. Knows the batch number. So according to them I don’t have a claim. I have many more problems than are written here my life went to hell on 12/23/11 because of the implant. How do I find the batch number I need help.

    • Jane Akre says:

      Was it implanted transvaginally? Did insurance pay for it? What information was submitted to insurance? The medical records should contain the information on your Boston Sci mesh….May be time for another attorney…..

    • Carol, S.C. says:

      Susan, you are entitled to get a copy of
      your surgery report from Medical Records where the surgery took place. it is protocol for the attending nurse in surgery room to remove a sticker from the box mesh came out of with lot number, batch number, and name of mesh, all info pertaining to this one mesh for recording purposes. You may be asked to pay $1.00 per copy. If you need more, go to Office Depot & save one for yourself. Worked for me. Good luck & God Bless!

  18. Ellen says:

    Susan, I would think that the hospital’s purchasing department and/or accounts payable department would have an invoice from the supplier of the mesh, just like they would have filed away for other medical supplies. That invoice could possibly list batch, lot, or other identifying numbers. There should also be a packing slip in those records which generally include even more detail.

  19. Sea says:

    Been reading this site plus any other site on the web about this nightmare. For those who need help, look into teaching hospitals in your area/state/county. Vanderbilt seems to be leading in taking out the vaginal mesh implants along with other medical hospitals across the USA. However, be sure to make an appointment with the HEAD UROLOGY SURGEON and have a list of questions to ask before anything is done. Vanderbilt is in Nashville, Tennessee. Hope this helps in some sort of way. And, if you are in the USA, you can all the law firm who seems to be leading all others in Houston, Texas for legal help. That law firm is Mostyn Law firm which is mentioned many times on this site. I’m in this mesh mess too. We have to help one another and hang in there together also …..Sea

  20. Nameless says:

    If you reread the FDA paper closely it is clear that the extreme suffering of the mesh receivers is not recognized (on purpose). Any validation is negated. The company was given months to answer. Not a definitive date but a squssy referral to months. That’s not a point in time, that would lead to an answer. That’s an agency that is invested in covering up. It’s time to give up the FDA as a genuine factor that protects anyone but themselves and (you guess who). The underlying tone is that we will look into it. With our eyes and ears closed. Sometime in the future. There is no real proven correlation that the mesh does anything but what the Drs and manufacturers say it does. We know nothing about anyone suffering from this product. And, in any case it should not be removed because the removal may kill you. Leading all physicians to cite the FDAs position whenever they would like to excuse them self from this task. In fact, if a dr chooses to remove he/she is doing that in opposition to the FDA guidelines. So, you can’t pick and choose among the FDA rulings. For example, the fact that they upgraded to high risk is something you want the medical community to pay attention to. But, not the negation of auto immune disorders. Which they have quite plainly negated. So, those of us with symptoms serious enough, and that are damaging our bodies cannot depend on any physician that unilaterally accepts FDA statements. High risk, yes, auto immune no. Even if the material is found to be rife with contaminants – that does not prove it made anyone sick. Read it again. Because if this is the way things fall out – a lot of us are going to suffer unrecognized illnesses to our grave. I remain truly yours, nameless. P.S. I support the statement made by Sea for nation wide services – counseling and medical. Because right now our lives are in the hands of the FDA and the companies. Please reread the FDA paper and judge how valued your life really is. As well as mine.

    • Jane Akre says:

      Please add your comments to the autoimmune registry if it applies to you, that is, if your autoimmune issues occurred some time after your implant.

  21. Nameless says:

    Would like to suggest blood work to test for toxin exposure. Heavy metal. Aresenic, Mercury and definitely selenium. Maybe this will go no where but might be helpful if we are caring toxins that can discovered in the blood.

  22. Sea says:

    I am gathering my medical reports step by step ….and …I also say….I would rather “hand deliver” my medical reports to so and so doctor than have you send them over your computer since I have many doctors. And, it seems, I always get my medical reports, read them, see all the false wording or not true statements in them and correct them with my own hand writing and then take them to my next doctor. I am finding a whole new world out there by reading my own medical reports and seeing for myself what doctors are writing that is absolutely not true. Just sharing for you to look into my window of life step by step. Sea …..

    • Jane Akre says:

      Wow- Ive heard this before….. good advice. check your medical report after each meeting… In fact, could you take notes during the meeting and have the doc read them and have him/her sign what your wrote? That would be turning the table but I can’t imagine they would have a problem with it… if you were friendly and the information was accurate. In other words “I told doctor x my pain radiated down my right leg.” If that is true and you write it in “your” report, why would the doctor have a problem with it? Just a thought, I’ve not had this experience personally.

      • Still Standing says:

        Jane, I am doubtful that a physician would sign a handwritten page of notes bacause it would not be an acceptable medical record. However, patients do have rights. First of all, you have the right to see your medical records. You can request all of your records. However, you may have to pay for the copies. If records are released to another medical provider or facility, they dont charge, but they can charge you the legitimate costs for copies. Most medical providers have a form for patients to request correction of their files. Many now have patient portals where you can view your test results and visit summaries. Get the form, indicate your disputed information, submit the form, then do a follow-up 60 days after you submit your challenge. Doctors are not required to make the changes than you submit so there would be a need to have more conversations if he/she does not agree with your side of the story. This will be the best way to get permanent changes to your records.

  23. Sally says:

    Is there anyone out there who has had the mesh implanted for 10 yrs or so and had it successfully removed? My sisters has done it’s job of meshing into and growing with the tissue of several organs and the dr.s she has consulted have left her with the impression it would probably kill her to try to remove it all. Also if it is that toxic and hard to remove even missings one shred of it could leave her with the same symptoms. She was one of the earlier patients to receive it. Over the course of the years, she had pieces come out her stomache, her hair fell out, her teeth rotted, her energy wained, She went from being a high energy, productive, 2 job professional active woman to an 80lb bed ridden now for 3 yrs, can barely think, has to work up the energy just to get to the bathroom a couple times a day, slowly dying woman. She’s been to countless dr.s the few even remotely willing to help want tens of thousands of dollars up front, I understand the need for lawsuits, but besides that part… Has anyone out there had success in any way? Can one person say they found a solution to get their life back? If so can you tell us the steps you took?

  24. Sea says:

    Better yet, take a tape recorder and tell your doctor you sometimes can’t remember all his directions so you brought a tape recorder to help you remember. Sea PS …and of course, ask your doctor to have his OK … for the tape recorder playing …. 🙂

  25. Sea says:

    Here is a list of labs for your consideration ….I highly recommend the lab in Wisconsin ….of course, this should always be a personal choice ….Sea …..LINK and LISTS …
    AccuChem Laboratories
    990 North Bowser, Suite 800
    Richardson, Texas 75081
    (214) 234-5412
    They provide blood and urine testing for chemicals.
    Aeron LifeCycle Clinical Labs
    1933 Davis St., Suite 310
    San Leandro, California 94577-1259
    (800) 631-7900
    Saliva testing for hormone evaluation, includes DHEA, testosterone, estrogen, progesterone, and cortisol.

    Advanced Metabolic Imaging
    Theodore Simon, M.D.
    12200 Preston Road
    Dallas, Texas 75230
    (214) 490-0536
    They perform single photon emission computerized tomography (SPECT) brain imaging tests.

    Anderson Laboratories
    773 Main Street
    West Hartford, Vermont 05084-0323
    (802) 295-7344
    fax (802) 295-7648
    They provide bioassay testing on carpets and other common household items, by exposing mice to the fumes and monitoring their neurological effects.

    Antibody Assay Laboratory
    1715 East Wilshire, Suite 715
    Santa Ana, California 92705
    (800) 522-2611
    They do various blood antibody, auto-antibody, immune system, and chemical detection testing.

    Citizens Environmental Laboratory
    160 Second Street
    Cambridge, Massachusetts 02142
    (617) 876-6505
    They test carpets for toxic chemicals.

    Diagnos-Techs, Inc.
    P.O. Box 38138-0662
    Tukwila, Washington 98138-0662
    (800) 878-3787
    They do adrenal and sex hormone testing.

    Doctor’s Data
    170 West Roosevelt Road
    West Chicago, Illinois 60185
    (800) 323-2784
    They do nutrient testing, amino acid testing, and urine and hair analysis testing for toxic metals.

    Environmental Testing and Technology
    P.O. Box 369
    Encinitas, California 92024
    (619) 436-5990
    They conduct indoor environmental building evaluations, are very familiar with chemical sensitivity, and test for indoor air quality, mold problems, and electromagnetic fields.

    Genova Diagnostic Laboratories
    18A Regent Park Boulevard
    Asheville, North Carolina 28806
    (800) 522-4762
    They test for intestinal parasites, yeast, and digestive problems by comprehensive stool exam. They also offer tests for amino acids, food allergies (IgG &IgE), amino acid levels, vitamin and mineral levels, and hormone testing.

    Parasitology Testing Center, Inc.
    403 S. Rural Rd. #101-318
    Tempe, Arizona 85281
    (480) 777-1078
    Stool testing for bacteria, fungus, and parasites.

    SpectraCell Laboratories
    515 Post Oak Boulevard, Suite 830
    Houston, Texas 77027
    (800) 227-5227
    They provide functional testing for vitamin and mineral levels and anti-oxidant function.

  26. Still Standing says:

    Im curious to know if all of these tests require a physicians order. I have done the Genova lab test and comprehensive bloodwork for vitamin and mineral deficiency and food sensitivities and they required an order. However, it is important to have these interpreted by a physician as the results are complicated to analyze for a non medical person. I have an integrative health doctor who ordered and interpreted the tests for me. This leads to another question….if you get a doc to order them, you need to ask how the results will be used in your treatment plan. Be aware that this testing is very expensive and insurance doesnt pay. So, my initial consult with the integrative medicine doctor was $400; the tests were a little over $1000.00 and the follow up visit to have him go over the results was $300., then his treatment in the form of infusions and supplements run about $150/week. It adds up fast. Just want you all to ask your doctor how the testing would impact your treatment and what it will demand financially.

  27. Nameless says:

    I know these tests are incredibly expensive and they may not be useful for the seekers. I can say though, I had an between 2008 and 2010. I was seriously ill. Bedridden and in a lot of pain. I went to every well hospital in NYC. Flew to the Mayo in Phoenix, Rush medical in Chicago. All the docs repeated the same endoscopies and blood works over and over. Until I went to an integrative little known doc in Manhattan who suggested a heavy metal test. I thought, ok, why not. I didn’t believe it would be of any value. Just one more vial of blood. I had arsenic 3xs the allowable upper limit. The doc said that was really rare. I found the source – within six wks of blood work every two wks when the source was removed the arsenic level slowly dropped to well within range. It took about six months for my body yo start feeling normal. Pain diminished. Vegan sleeping normally. Could finally eat healthy food again. Depression lifted. The mesh is an entirely different story. Whether it shows in blood work or mot we already know the source. However, if an values are abnormal there is one more concrete proof of the meshes ongoing harm. I can tell you this, I felt much worse with the arsenic poisoning but there are some days when whatever is wrong with me us flaring I do feel poisoned. And I can say that from direct experience. I can’t fix it as quickly though. Very frightening feeling yo know you are being poisoned. It’s not just the pain. This stuff is slowly killing healthy tissue. I worry about “a point of no return”. So many of us will perish. Unproven with the medical community snubbing their filthy, greedy selves at us. The doctors I saw that couldn’t think outside the box, labeled me crazy. I wound up getting medicated because I was “crazy”. I kept saying, no, I’m sick. I know, I’m sick. I could see it on their faces. In their voices. They couldn’t figure it out, do, it had to be me – their tests were the wrong tests. The problem was there but the right discovery had to e done. Finally, this one doctor, just stop the right time, find the right test. I will tell you, I feel poisoned again. And the feeling increases as time goes on. Not everyone can afford the work up – but some can. Maybe it will show nothing. That’s not so terrible – who wants to find out you are bring poisoned. Kept me just leave you with a piece of infornation that doesn’t come from me but the information about the Chinese mesh. They suspect high selenium. I have no more information than that for myself. I need to know.

    • Still Standing says:

      Nameless, you arent prying. That is the beautiful thing about this site…we can share , teach and learn. Yes, I had quite a few abnormalities. I will dig out the 20 page report and give you some details this week. My copper to zinc ratio was very skewed. Many effects from that imbalance. Google it and you can see what they are. The way to bring it down is to take more zinc. I read an interesting research article that talked about adding copper to mesh to bring down biofilm development. Not sure if copper is part of our meshes. Also, my homeocystine and C-Reactive Protein were extremely high. This are indcators of inflammation and my integrative doctor believes it is a direct result of my body trying to rid it of mesh. Of course chronic inflammation leads to many health issues and it is the primary driver of pain. We currently focus on an anti- inflammatory program of medication (Low dose Naltrexone, this has been found to have an impact on lowering inflammation…at regular doses, it is the drug that is given to addicts who are morphine addicted, at very low doses, it has a paradoxical effect. My urogynecologist is very interested in how this works for me, he sees lots of benefits, and there are relatively no side effects. It is compounded at a pharmacy and costs about $50/month.), anti inflammatory diet ( I have acquired so many food sensitivities since mesh…egg whites, egg yolks, wheat, oats, all dairy, rice,potatoes, beef, pork, peanuts, yeast..eating is a challenge to say the least. I had no allergies before, and I also use stress reduction techniques that are helpful. I teach mindfulness for chronic pain management so I have some personal tools that help reduce pain and inflammation. My integrative doctor looks at this from a cellular level. When all of these levels are out of balance, it changes cellular functions. They can get stuck in the fight or flight mode and prevent the cellular process of rest and digest. Fascinating. It can have dramatic impact on our bodies. Well, way too long post, but I think it is important to understand not just what we can see or feel ( such as pain) but how the mesh impacts those body functions we cant see.

  28. just me says:

    Have any of you seen your sticker page? The sticker page I received was Boston Scientific manufactured in China. This was implanted in 2007.

  29. Connie says:

    Just started to get very sick…first thought it was UTI then vaginal infection, then GI all normal except bacteria in colon, slightly elevated WBC and nitrites in urine. Now I feel tingly all over with muscle weakness nausea and brain fog. Burning pain when urinating and poking pain in groin/urethra. I have bipolar so a lot of it is chalked up to “anxiety” and psychosomatic symptoms. Was in ER three time in past week. CT showed nothing abnormal. I wake up daily just sick, weak and tingly with something poking me in the vaginal/urethral area. Getting bladder checked Friday, but no one will consider the sling and that my pain is exactly where it lays inside and has hurt me from the beginning (I guess because it isn’t as inert as we were told). I’m scared as I have two young kids. For some reason I had diarrhea 5 days straight then vomiting. I tasted sulphur as well as poop in my mouth! CT had contrast so that could of been it they said. Two days later the diarrhea was back. I’m on antibiotics for both UTI and bacteria in colon. I also have pain meds. I don’t know but I do know I am growing sicker by the day. No one I know in Ohio will help me. Plan on going out of state to get mesh out but who knows what is going on now!

    • Jane Akre says:

      Connie it sounds like you need immediate help. If anyone knows a doctor in Ohio this would be the time to speak up. Otherwise the closest might be dr. veronikis in st . louis. If you can travel there are others… I will send you privately… I’m sorry

  30. In making the ruling Judge Highberger ruled, “If the product is equivalent chemically but counterfeit in terms of its actual producer source, that raises legitimate questions as to why a manufacturer of products intended for human implantation would resort to such ruses to obtain needed raw material.”

    • Jane Akre says:

      Thank you for this. I’d love to see the source. The FDA in defining defective says on its own website that if a product does not conform to the device that was approved (one would assume that means in material and design), then it is defective. Why then did the FDA not crack down on this and instead let BSC investigate itself? I guess I know the answer to that question.

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.