Device maker Boston Scientific has been sued under the Racketeering and Corrupt Organizations Act (RICO) for allegedly orchestrating a conspiracy to sell transvaginal mesh made from counterfeit plastic smuggled from China.
Transvaginal mesh devices are implanted in about 55,000 women each year to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The polymer used to make all of Boston Scientific’s mesh, the polypropylene Marlex HGX-030-1, had been specified in regulatory documents filed for Boston Scientific’s mesh products. No other polymers could be used in its current mesh products, Qmed reports.
In 2011, the company began to encounter difficulties obtaining the material from its supplier, Chevron and Phillips/Sumika in LaPorte, Texas. When Boston Scientific was unsuccessful in its attempt to convince Phillips to produce the material, the company allegedly began smuggling the material out of China. According to Qmed, Boston Scientific worked with a “known counterfeiter,” EMAI Plastic Raw Materials, and ultimately smuggled some 34,000 pounds of counterfeit Marlex material, without verifying the contents. Marlex is a trademarked brand name.
Qmed reports that counterfeit Marlex resin pellets were reportedly sent to Belgium to produce counterfeit Marlex fibers, and then Ireland to fashion the fibers into shaped mesh, and finally to Indiana for final knitting and manufacture. The legal complaint says 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.”
An email from an attorney involved in the case alleges that the counterfeit mesh had levels of selenium 10 times the amount allowed in Europe for general plastics, such as those used in plastic furniture. Selenium is not present in Marlex resin. The attorney claims that the element will react with hydrogen peroxide to cause inflammation, degrading both the plastic itself and the surrounding tissue.
The legal complaint says the smuggling operation required deceiving Chinese customs, U.S. customs, the Food and Drug Administration, and, ultimately, the patients who were implanted with the adulterated products, according to Qmed. The scheme is documented in thousands of Boston Scientific’s own documents, according to the complaint.
The companies claimed they had obtained legitimate Marlex resins in storage from Chevron Phillips Chemical, but lacked the documentation to demonstrate the origin of the material.
Thousands of lawsuits have been filed against Boston Scientific and other makers of transvaginal mesh devices because of injuries and side effects women have suffered. According to the FDA, the most common side effects associated with transvaginal mesh devices include:
- mesh erosion through the vagina (also called exposure, extrusion, or protrusion)
- pain during sexual intercourse
- organ perforation
- urinary problems
Some women have needed additional surgery to attempt to remove the mesh and repair damage to organs.
The FDA has proposed a reclassification of mesh devices from Class II to Class III. This would mean that mesh devices have to undergo a more stringent clearance process, including clinical trials, to determine if the devices are safe and effective.