Lawsuit Accuses Boston Scientific of Racketeering and Use of Counterfeit Plastic in Mesh DevicesJan 20, 2016
A lawsuit filed against Boston Scientific accuses the company of racketeering under the Racketeering and Corrupt Organizations Act (RICO) law. The suit alleges Boston Scientific orchestrated 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 in Boston Scientific’s mesh, Marlex HGX-030-1, was specified in regulatory documents filed for Boston Scientific’s mesh products, therefore no other polymers could be used in its current mesh products, Qmed reports.
In 2011, the company encountered difficulties obtaining Marlex from its supplier, Chevron and Phillips/Sumika in LaPorte, Texas. When Boston Scientific was unsuccessful in convincing Phillips to produce the material, the company allegedly began smuggling counterfeit Marlex out of China. Qmed says Boston Scientific worked with a “known counterfeiter,” EMAI Plastic Raw Materials, and smuggled some 34,000 pounds of counterfeit Marlex, without verifying the contents. Marlex is a trademarked brand name and is not available in generic form.
Qmed says the trail of the counterfeit Marlex resin pellets went from China to Belgium, where counterfeit Marlex fibers were produced, and then Ireland where the fibers were fashioned into shaped mesh, and finally to Indiana for final manufacture of the devices. 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 attorney involved in the case alleges that the counterfeit mesh contains levels of the mineral selenium 10 times the amount allowed in Europe for general plastics, such as those used in plastic furniture. Selenium is not present in true Marlex resin. The attorney claims that the selenium will react with hydrogen peroxide to cause inflammation, degrading the plastic and the surrounding tissue.
The legal complaint says Boston Scientific’s conspiracy deceived Chinese customs, U.S. customs, the Food and Drug Administration, and, ultimately, the patients who were implanted with the adulterated products, according to Qmed. Thousands of Boston Scientific’s own documents demonstrate the conspiracy, the complaint alleges.
Boston Scientific claims it obtained genuine Marlex resins from Chevron Phillips Chemical’s storage, but the company did not have documentation to show the origin of the material. Transvaginal devices have proved problematic and thousands of lawsuits have been filed against Boston Scientific and other makers because of injuries and side effects women have suffered. The FDA says 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
Many women have undergone additional surgery to remove the mesh and repair organ damage, but they are often left with permanent damage.
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.