Boston Scientific is accused of scheming to sell adulterated transvaginal mesh products. According to Qmed, a federal lawsuit filed in West Virginia alleges the company obtained counterfeit plastic materials from China. The device maker is being sued under the Racketeering and Corrupt Organizations Act (RICO). Boston Scientific cited polypropylene Marlex HGX-030-1 as the material in its transvaginal mesh products, and is therefore limited to this material when producing mesh. According to the lawsuit however, the company smuggled 34,000 pounds of counterfeit material when it was unable to obtain the legitimate substance from their supplier Chevron and Phillips/Sumika in 2011.
Transvaginal mesh is a device used to provide additional support to sagging pelvic organs and muscles. It is approved to treat pelvic organ prolapse and stress urinary incontinence. Due to rising safety concerns and thousands of lawsuits, the devices have become more controversial in recent years.
According to the lawsuit, Boston Scientific received the adulterated material through “known counterfeiter” EMAI Plastic Raw Materials without testing the products. 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” the lawsuit states, according to Qmed. Allegedly, counterfeit Marlex resin was sent to Belgium where the counterfeit fibers were produced. The suit says the fibers were then sent to Ireland in order to become shaped mesh and finally to Indiana for knitting and manufacture.
The levels of selenium in the adulterated product exceeded levels allowed in Europe for general plastics by ten-fold, according to an email by plaintiffs’ attorneys. Marlex, which is a trademarked specific brand name and not a generic, does not contain selenium. The email asserts the selenium can react with hydrogen peroxide, leading to inflammation, tissue damage and plastic degradation.
The lawsuit alleges Boston Scientific deceived Chinese customs, US customs, the FDA and patients by engaging in their counterfeit plot. The device maker allegedly tried to conceal their actions by claiming to have obtained legitimate Marlex resins in storage from Chevron Phillips Chemical. According to the suit, however, there is inadequate documentation to support this claim.
Boston Scientific has recalled 793 products since 2003, according to the suit. The company recently recalled nearly 1,000 units of its RotaWire Elite guidewire following a patient death. The recall was designated as Class I by the FDA, meaning that exposure to the recalled device can present reasonable risk of serious injury or death.