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March 31, 2016

3 Min Read
Law firm petitions FDA to ban Boston Scientific surgical mesh

The law firm that has sued medical device manufacturer Boston Scientific (Marlborough, MA), alleging that the company used counterfeit materials from China to manufacture surgical mesh devices, has petitioned FDA to recall the products. Houston-based Mostyn Law cites an “urgent need to protect the health of women” as the basis for the petition.

Mostyn Law filed the request on behalf of a West Virginia woman who suffered health problems from a Boston Scientific pelvic mesh implant. The allegations also are the basis of a federal racketeering lawsuit that the law firm filed earlier this year (for more on this, read “Boston Scientific used counterfeit resin from Chinese supplier to make vaginal meshes, lawsuit alleges.”) The suit alleges that Boston Scientific started using counterfeit resin from China when it ran out of the FDA-approved, U.S.-made Marlex brand material. It used a Chinese resin with “no history as to when it was made, how it was made, who made it, no title, and [it] was smuggled out" in a series of transactions "mimicking an international drug deal," writes Mostyn Law in a press release distributed today.

The petition filed with FDA cites “internal, previously undisclosed Boston Scientific e-mails that say the company bought the stock in 2011 and 2012 from a suspected counterfeiter in China without fully testing it or getting FDA approval for its use as a vaginal implant.” It also includes a recent letter that the device manufacturer distributed to customers acknowledging that the devices were made with a non-approved resin.

The petition, based on internal Boston Scientific documents, gives new details on the extraordinary steps the company took to move the resin out of China, notes Mostyn Law. “It split about 37,400 pounds into four shipments, sending them on different dates, by different methods to avoid detection and limit losses if confiscated by customs agents.”

The law firm goes on to describe a process that, as stated, certainly appears shady: “The shipper was instructed to tell Chinese authorities the product was made there, meaning it didn't need certain paperwork for export. The company then switched its story, getting it into the U.S. by claiming the material was authentic American-made Marlex," the petition says.

A Boston Scientific employee in China reportedly said in an email: "For this material, we have lost all of the original paperwork so we can't prove that was legally imported in the country. And if we don't get rid of the original bags or the writing on the bags when we claim they are from China (we have to say they are from China since we don't have the original paperwork attached), if it is caught by custom, we will be in trouble. Therefore the shipper told me it is better to consider to re-pack all of them or find a way to get rid of all of the words/writing on the bags."

Vaginal surgical mesh procedures have been classified as high risk by FDA, possibly resulting in "severe pelvic pain and organ perforation," according to the agency. Thousands of lawsuits have been filed against implant manufacturers who followed FDA rules to the letter. Patients have complained about discomfort, bleeding, infections, painful intercourse, urinary problems and other complications resulting from the implants.

In filing the FDA petition, attorney Amber Mostyn said, "The FDA needs to do its job and ban this outright. We've clearly documented the health risks. Acknowledging there is a problem is not enough. It's a like a firefighter watching a building burn while warning us not to play with matches."

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