FDA Finds No Prob with Boston Sci Chinese Counterfeit Mesh

//FDA Finds No Prob with Boston Sci Chinese Counterfeit Mesh

FDA Finds No Prob with Boston Sci Chinese Counterfeit Mesh

Marlex from China

Mesh Medical Device News Desk, November 7, 2017 ~ It’s been more than a year since it was notified, but now the U.S. Food and Drug Administration (FDA) says there are no worries with the pelvic mesh made from raw polypropylene sourced under questionable circumstances from China by Boston Scientific (BSC), a major mesh manufacturer. 

This update was issued from the FDA in mid-September. (See the 9-19-17  notice here and here.)

What does the FDA do when it finds convincing evidence that a major medical device maker has skirted the rules to source allegedly substandard materials from a known counterfeit smuggler in China?

According to the FDA, “After an extensive review of data and the results of testing the finished product, the FDA has determined that the change in supplier of the polypropylene used to manufacture Boston Scientific’s urogynecologic surgical mesh currently on the market does not raise new safety or effectiveness concerns.”

The FDA was alerted to the questionable raw polypropylene sourced and allegedly smuggled from a known counterfeiter in China with no assurances of authenticity by the Mostyn law firm of Houston, which is representing plaintiffs in a racketeering class action against BSC.

The questionable PP was made into transvaginal mesh implanted permanently in thousands of women who have joined the class.

When a material used to make a medical device is switched, FDA rules say it may not be the same medical device and should spark another application for clearance. That never happened here.

In January 2016, the law firm filed a motion before Judge Joseph Goodwin, overseeing the federal pelvic mesh litigation, to seek an injunction to stop the sale and implantation of the questionable BSC products.

Yimao Plastic Molding, did it sell resin to BSC?

Judge Goodwin then passed the issue onto the FDA for its review,  and the FDA sought the expertise of Boston Scientific to “conduct additional testing relevant to the safety and effectiveness of the finished product,” leaving in limbo the approximately 55,000 women who’ve received the questionable products made by BSC after September 2012.

Mostyn law, in an April 2016 letter, strongly urged the FDA to take notice of the potential for substandard counterfeit raw materials as a violation of federal law and a threat to public health.  It asks:

“Does the FDA believe equivalence is a defense to trafficking of counterfeit raw material in violation of the Trademark Counterfeiting Act?”

 

Polypropylene resin

WHAT ASSURES THE FDA?

The FDA says it has relied on data and information supplied by Boston Scientific and its own testing on the finished pelvic mesh medical devices.

After conducting testing at the facilities involved in the manufacture of its urogynecologic mesh, collecting samples and reviewing mechanical performances,  testing the final mesh devices and reviews of the chemical biocompatible and mechanical performances, the FDA found variability, “but determined, based on the information available to use, that these differences do not present new safety or effectiveness concerns, and do not require submission of a new premarket notification.”

After its own review, Mostyn law reported tests did show  “significant differences” between the Chinese resin and certified Phillips Marlex.

The fibers were weaker and there was more selenium with different molecular strings indicative of substandard manufacturing, according to the racketeering lawsuit filed by Mostyn law on behalf of Teresa Stevens and a class of women implanted with the allegedly substandard mesh after September 2012.

Read the complaint here. 

The FDA says it is not uncommon for a supplier to change the source of raw material used to make a medical device.

There is no mention by the FDA of the alleged attempts to conceal, ship and smuggle the counterfeit resin out of China and into the U.S. and Belgium, as discussed in inner-office emails produced in discovery that show attempts to conceal those activities.

Women implanted with BSC mesh are not recommended to have their medical devices removed, says the agency.

Meanwhile the racketeering lawsuit filed by Mostyn Law alleging trafficking in counterfeit polypropylene continues to add plaintiffs who were implanted with Boston Scientific transvaginal mesh produced after January 2012.

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LEARN MORE:

Read Boston Scientific emails decoded
https://vaginalmeshclassaction.com/toxic-resin-boston-scientific/

MND,  April 1, 2016 FDA Acknowledges Potential for counterfeit Raw Material from China in BSC Mesh
https://www.meshmedicaldevicenewsdesk.com/latest-fda-acknowledges-potential-counterfeit-raw-material-china-boston-scientific-mesh/

MND, January 15, 2016, RICO Suit Accuses Boston Scientific of Faraud in Smuggling Defective Pelvic Mesh from China
https://www.meshmedicaldevicenewsdesk.com/class-action-lawsuit-accuses-boston-scientific-of-obtaining-defective-mesh-from-china/

 

 

 

 

By | 2017-12-31T18:20:12+00:00 November 7th, 2017|FDA News|22 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.

22 Comments

  1. daniee November 7, 2017 at 3:58 pm - Reply

    Waooooooo

  2. daniee November 7, 2017 at 4:04 pm - Reply

    FDA = Federal Deceive Administration

  3. Disgusted November 7, 2017 at 9:36 pm - Reply

    We all knew the FDA was in bed with the pharmaceuticals – we just didn’t know that the sex was that good!

    Please forgive me if I’ve offended anyone.

  4. Kitty November 8, 2017 at 2:48 pm - Reply

    Dr Barbara Levy with in the FDA. She is n advocate of polypropylene mesh…. you dont get poly mesh if you are young and pretty.

    • Jane Akre November 8, 2017 at 3:02 pm - Reply

      please clarify Kitty….. is “an advocate” of mesh…. or not an advocate…

  5. Lordhelpus November 8, 2017 at 4:34 pm - Reply

    Bottom line the fda is gonna say what they’re being paid to say. You know, like they say, one hand washes the other and both hands wash the face. But somebody’s gonna have to clean the whole house at the fda, because it seems that they’re getting way too comfortable with their job to the point of lying for these companies. instead let them all get injected with some polypropylene directly into their bloodstream and let’s see how that plays out for them. If it is so great and so grand and if it really does not cause all types of neurological issues like they claim, then it shouldn’t be a problem for them. Drs are the worst too. You tell them that you’re having all kinds of pains and all they do is turn us away. They all disgust me. I have no trust in any of them anymore. What ever happened to the days when drs looked at the actual X-rays instead of a stupid inaccurate piece of paper?? I don’t even know if I’m making any sense anymore. So sick of all the damn lies….

    • Jane Akre November 8, 2017 at 9:54 pm - Reply

      You make sense, I’m sorry.

      • Lordhelpus November 10, 2017 at 9:24 am - Reply

        Thank you Jane, and thank you for all that you do for us. Have you or anyone else heard of the harm that the contrast they use on MRI’s is and has caused for so long but now is when it’s all coming to light? I tried sharing the link on it where Chuck Norris and his wife are suing these companies who make this lousy substance for $10 million and are now raising awareness for the rest of us. Maybe you can find it and share for all to see..I’m not too computer savvy..apparently this mercury or contrast is clinging to certain organs including the kidneys and the brain. This has always been my question to them before they inject me with it…”Are you guys sure this is safe to use?” Always had a bad, uncomfortable feeling about it…

  6. Kitty November 8, 2017 at 7:00 pm - Reply

    Back in 2007..Dr Levy stated that if she looked at one of her patients and her face looked like it was aging…she would implant mesh vs do a native tissue repair. She has a fairly prominent position with the FDA. In that same journal article Dr Miller suggested that if a woman had autoimmune or fibromyalgia she may not fare well with mesh.

    • Jane Akre November 8, 2017 at 9:53 pm - Reply

      Can you find that reference? Why would an aging face deserve a mesh implant?

      • Kitty November 8, 2017 at 10:28 pm - Reply
        • Jane Akre November 8, 2017 at 10:58 pm - Reply

          This is what i get with that URL… first a 404 message, in other words, not working>

          http://www.obmanagement.com/

          • Kitty November 9, 2017 at 1:22 am

            obgmanagement.com dont forget to put g in there. Give me your address I’ll send u the whole report. KITTY

          • Jane Akre November 9, 2017 at 10:58 am

            Thank you Kitty… you are so right.. forgot the “g”.

  7. Louise November 12, 2017 at 11:40 am - Reply

    WHY ARE CANADIAN WOMEN GETTING LESS MONEY THAN AMERICANS IN A CLASS ACTION ? THEY SAY IT’S BECAUSE CANADA HAS “OHIP INSURANCE ” THAT’S NONSENSE…WE SUFFER PAIN, SYMPTOMS, PHYSICALLY, EMOTIONALY , WE HAVE AUTO IMMUNE DISEASES THAT HAS DEVELOPED SINCE THIS MESH …WE ARE HUMANS JUST LIKE OTHER SUFFERERS ….THAT IS NOT FAIR FOR US, CANADIANS …

  8. Monica November 13, 2017 at 4:08 pm - Reply

    People with this mesh would severely disagree with this. I have had pain and health issues since it was implanted and I was told that it was so much better than the J&J mesh that I had removed. I am doomed to pain and discomfort every day for the rest of my life. I can’t get the doctor to remove it even though I have constant bladder and kidney issues and I can’t enjoy my kids and grandkids like I did before it was implanted.

  9. Sea December 18, 2017 at 8:57 am - Reply
  10. PCFC January 3, 2018 at 1:22 am - Reply

    Couldnt get much less than most of the American women will get, the lawyer gets appropriate 40%. Then we get to repay medical cost. Also some to the court even though it never went to trial. They refuse to accept autoimmune disease as a problem from mesh. They are paying by tiers from level 1-3 , 3 is the highest means the patient has had 3 or more surgeries. Now many women in the US implanted early on and complications from the Mesh occured no one would diagnose. Trust me most of the women im the US are being treated unfairly, dont think it’s because your from another country.
    Our files sit in attorneys offices 6 yesrs then were forced into taking nothing or having our case dropped. What new attorney is going to pick up a case where surgery took place 8-12 years ago. There not. The system destroyed us in every direction

  11. Way2Be May 16, 2018 at 2:49 pm - Reply

    I’m confused about this: FDA say what it said. Mostyn et al., and CBS chemical guy says something else. All leading to either denial or findings that indicate the Chinese mesh was not only counterfeit unregulated imported illegally – isn’t there a freedom of information rule that would allow a citizen, group, legal rep or news media access to all the results. I was implanted with a BS product in Sept of 2012. I have no idea if that polyprolene was the illegal resin. If so, I might be interested in joining the action related to this issue. I’m sure most of us don’t even know if we were implanted with this resin made into mesh. Certainly, the lawyers aren’t telling us. How could we join that lawsuit if we don’t know if the batch they used came in from China.
    Secondarily, the fact that the FDA overlooks how this stuff got here should be of very much concern to all of us. What entity in government is standing up to investigate this with transparency. I think we have a right to seek this information.
    When my sons plane went down over Lockerbie in 1988, Bush the father and government agencies, treated us just the way we as injured patients are being treated now. Absolutely the same deaf, blind and dumb behavior with thinly veiled lies. Just as in the AUGS response. With every effort to reach the truth they fluffed us off. The deeper it got the dirty it got. But we didn’t quit. Never. We wanted to know every detail of why that plane blew up over Scotland. We had only ourselves – just as now. And then a few media people began to follow the miserable lack of security and the lies and fabrications. As in Boston’s again thinly veiled response.
    It can be done. Especially, now that CBS did this expose. We had to meet with our representatives in Congress and begin demanding answers to some of the questions. In this case, a good question would be centered on the FDA’s findings which stand in direct contradiction to what appears to be valid science. There are people behind these memos. We ultimately had them so scorched they had to testify in DC in open hearings. I don’t think this is an inappropriate goal. If the fluff that the are passing off continues there will be countless lives destroyed. As well as, the fact that they practice this way on every level related to the safety of patient consumers. If we just take our little allotment and go home the story will end.
    In my sons death and the case of Pan Am 103, we were able to uncover what circumstances enabled his place to carry a bomb, who was most likely responsible both in foreign and domestic venues. The way that the State Dept. handles families and the injured after an event at this time has radically changed since 1988.For the most part, the plane was filled with college aged children coming home from study abroad. All of the entities could not conceive the degree of rage and what they were up against with their little piss ass lies. That incident destroyed our children. And in that manner us.
    These people in DC, big pharma, manufacturers, have no idea of the force they are up against – yet. It will not happen unless we make it happen. To refuse to accept their lies. All the incongruouencies they are offering up. We must get political support. It’s absolutely necessary. No politician jumped into our boat without being confronted with his constituency making themselves aware.
    This is certainly as heinous a crime as the downing of that plane. And it deserves the respect, retribution, outing of the truth as in that case. We were a bunch of seriously injured families who had lost many if the most significant people in our lives to the same kind of profit, greed, petty power, and callousness.
    I’ll ask again as when I began this overly long missive. Aren’t all those discrepancies available through the freedom of information act? And wouldn’t it be in our interest to continue exposing AUGS, BS and the others for what they have done? All of those memos they sent back and forth indicating that they knew they were acquiring resin that had to be brought in illegally – is. Noose around their neck.
    Please tell me what you think?

    • Jane Akre May 16, 2018 at 4:41 pm - Reply

      I think your words are powerful, so much so, that Congress should hear what you have to say. Can you paste what you wrote here to CBS, 60 Minutes, your congress rep and your senators? Absolutely, it starts with the citizens who are mad as hell and have had enough. I’m so sorry you are a Lockerbie mom…. I had no idea, though of course I remember that story. my ex husband reported on it. There were many questions government didn’t want answered and I’m sorry to hear you were treated so poorly… once again. Your energy is infectious….. Go!!!

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