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FDA Finds No Prob with Boston Sci Chinese Counterfeit Mesh

Marlex from China

Mesh Medical Device News Desk, November 7, 2016 ~ 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.

###

 

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/

 

 

 

 

18 Comments

  1. daniee says:

    Waooooooo

  2. daniee says:

    FDA = Federal Deceive Administration

  3. Disgusted says:

    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 says:

    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.

  5. Lordhelpus says:

    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 says:

      You make sense, I’m sorry.

      • Lordhelpus says:

        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 says:

    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.

  7. Louise says:

    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 says:

    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.

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