FDA Acknowledges Potential for Counterfeit Raw Material from China in Boston Scientific Mesh
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 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.
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.
”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.
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.” #
Mostyn Law Court Documents, Citizen Petition
Mesh News Desk, Jan. 15, 2016 – RICO Suit Accused Boston Scientific of Fraud in Smuggling Defective Pelvic Mesh from China
RICO Complaint Jan 12, 2016