Counterfeit Used For Boston Scientific Surgical Mesh

48,000 lawsuits face medical device manufacturer.

May 23, 2018, Los Angeles, CA – A common surgical mesh implant has generated the largest multi-district litigation since asbestos.

Boston Scientific Corp. ("BSC"), with $9 billion in medical device sales, is one of the largest gynecological surgical mesh manufacturers. Now 48,000 lawsuits claim the mesh causes life altering pain and injury. Boston Scientific states they "have extensively tested the [plastic] resin to confirm its composition, safety and performance" and that "The American Urogynecologic Society says the mesh is safe and effective."

In 2004, the FDA issued a report that mesh supporting organs after pregnancy, had resulted in nearly 4,000 "reports of injury, death, and malfunction" and complications including "pain, infection, urinary problems, bleeding and organ perforation." "Serious adverse events," the FDA said, "are not rare."

Last week's CBS 60 Minutes report provides compelling evidence that the polypropylene mesh used in Boston Scientific's product is fraudulent and substantially altered in its architecture from the original authentic Marlex product;

Duane Priddy, Ph.D, a plastics engineer and Fellow of American Chemical Society reported the "I can't in my wildest imagination, imagine anybody knowledgeable in the science of plastics ever deciding it is appropriate to use polypropylene in the human body. It's well known that its oxidatively unstable."

In 2004, Chevron Phillips, the manufacturer of the Marlex® mesh became concerned about the medical use of Marlex and issued a warning that the polypropylene mesh must not be used for permanent implementation in the human body.

In 2005, Chevron cut of Boston Scientific's supply of Marlex "We are simply not interested in this business at any price" said Chevron.

Boston Scientific's, George Vialle, director of BSC's Global Supply Chain responded that "Marlex supports $120 million in annual revenue, I cannot overstate the importance of getting more." A second supplier also refused to provide Marlex for use in medical device to Boston Scientific in 2010.

Important is was.

Boston Scientific Corp. turned to an independent plastics broker in China (EMAI), with no direct link to Boston Scientific. BSC's China representative inquired "do we need to ask [EMAI] if this material is supposed to be used in Medical Implantables?" receiving a reply from BSC's Director of Materials Management "please don't tell them where we will use it, it could scare them away."

BSC's own procedures required documents and import records (that EMAI did not have) that proved the plastic was Marlex from Texas. BSC went on to confirm three times with Chevron Phillips that the lot numbers on the China Marlex bags were fraudulent. Chevron Phillips confirmed the counterfeit bags had errors in printing, color and even the city where authentic Marlex was made.

(Photo: CBS 60 Minutes)

BSC ordered tests analyzing 11 parameters to compare the fraudulent product with original authentic Marlex. Nine parameters were different (four very different), two were the same. Inexplicably, BSC concluded the China product was the same material.

BSC's China representative wrote "if we don't get rid of the original bags, if it is caught by custom(s), we will be in trouble." An email plan to hide the bags ("over bag") in plain wrappers was obtained by 60 Minutes, along with pictures of the over-bagging distributed to BSC company directors for approval. Conflicting Customs Declarations prepared the China product were included in the 60 Minutes report.

Despite the red flags, a BSC staffer concluded "I believe this tis the right material." BSC purchased enough product to last 30 years.

Boston Scientific provided a written response to the 60 Minutes investigation; "any allegations continuing to question the integrity or legitimacy are false and irresponsible."