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.
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?"
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.
Read Boston Scientific emails decoded
MND, April 1, 2016 FDA Acknowledges Potential for counterfeit Raw Material from China in BSC Mesh
MND, January 15, 2016, RICO Suit Accuses Boston Scientific of Faraud in Smuggling Defective Pelvic Mesh from China