For women who have had the mesh implanted, the FDA advised that so far the data on possible risks do not warrant removal.

The FDA had "strengthened" its requirements for surgical mesh for transvaginal repair of organ prolapse in January. “These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” said Dr. William Maisel, deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health. “We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.”


The new orders are the result of thousands of reports of complications involving the use of mesh for transvaginal organ prolapse repair received over the last few years, stated the agency.

The recent counterfeiting accusation came about, claimed the law firm, when Boston Scientific ran out of FDA-approved supplies and “started using counterfeit resin from China with no history as to when it was made, how it was made, who made it, no title, and was smuggled out” in a series of transactions “mimicking an international drug deal.”

The company then, apparently, started to search the globe for a source for polypropylene resin pellets, under the brand name Marlex – the product the FDA had approved for making those implants, alleged the law firm.

It found a Chinese supplier, but the Marlex was not documented as coming from the same U.S. manufacturer. In fact, that firm later stated that there was a fake lot number on a bag of pellets from the supplier.

Boston Scientific then shipped 37,400 pounds in four shipments, sent on different dates by air and sea to "avoid detection and limit losses if confiscated by customs agents," the petition claimed.

According to the document, one email from a Boston Scientific employee in China stated that, “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.”

“Desperate [Boston Scientific] staff blindly waved its shoddy product on through,” the petition stated.

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