A federal lawsuit filed under the Racketeering and Corrupt Organizations Act (RICO) alleges Boston Scientific conspired to use counterfeit plastic in their transvaginal mesh implant products. Transvaginal mesh is used to treat pelvic organ prolapse and stress urinary incontinence. It has become an increasingly controversial product in recent years due to safety concerns. Thousands of transvaginal mesh lawsuits have been filed against various mesh makers, including Boston Scientific.
According to Qmed, Boston Scientific is accused of smuggling 34,000 pounds of counterfeit material for its transvaginal mesh products. The company is only allowed to use the polypropylene Marlex HGX-030-1 in its transvaginal mesh, since that is the material specified in regulatory documents. The lawsuit, which was filed in West Virginia, alleges Boston Scientific smuggled counterfeit Marlex out of China after unsuccessfully trying to obtain it from their supplier Chevron and Phillips/Sumika in 2011. Allegedly, the device maker worked with “known counterfeiter” EMAI Plastic Raw Materials without testing the products.
The lawsuit alleges Boston Scientific “took extraordinary measures to avoid being caught by U.S. and Chinese authorities, at times acting like a drug dealer to hide multiple overseas shipments” according to Qmed. The company is accused of having counterfeit Marlex resin sent to Belgium, where the counterfeit fibers were produced. The suit says the fibers were then sent to Ireland in order to become shaped meshed and finally to Indiana for knitting and manufacture. An email from plaintiffs’ attorneys allege that the the counterfeit mesh contained selenium levels 10 times allowed in Europe for general plastics. Marlex, which is a trademarked specific brand name and not a generic, does not contain selenium. Allegedly, the selenium can react with hydrogen peroxide, leading to inflammation, tissue damage and plastic degradation.
According to the lawsuit, Boston Scientific lied to Chinese customs, US customs, the FDA and patients through the alleged scheme. The company allegedly tried to conceal their counterfeit plot by claiming to have obtained legitimate Marlex resins in storage from Chevron Phillips Chemical. However, the lawsuit states, the documentation to support this is lacking. The suit points out that Boston Scientific has recalled 793 products since 2003. Recently, the company was involved in a Class I recall, the FDA’s most serious type of recall, over its RotaWire Elite guidewire. Nearly 1,000 units were recalled following a patient death.