Boston Scientific Responds to ’60 Minutes’ Transvaginal Mesh Report

A Sunday evening 60 Minutes report unveiled emails implicating that Marlborough, Mass.-based global medical device firm Boston Scientific knowingly purchased counterfeit plastic material—specifically Marlex, a brand of polypropylene from a Texas-based subsidiary of Chevron Phillips—from Chinese supplier Emai Plastic Raw Materials to produce its transvaginal mesh devices.
 
In 2005, Chevron stopped selling Marlex to Boston Scientific, citing concerns that the material should not be used for permanent implantation applications. This was troublesome because the company’s FDA approval of its transvaginal mesh products was based on using Marlex to make the devices.
 
A 2016 lawsuit alleged that the company illegally sourced a counterfeit version of Marlex from China from Emai, who claimed to have a large quantity of Marlex imported from Chevron Phillips. Boston Scientific’s quality assurance protocol required that Emai provide documentation confirming the product’s authenticity, but Emai was unable to provide it. The company reportedly confirmed with Chevron Phillips that Emai’s lot numbers were fraudulent and the packaging was fake.
 
Furthermore, 60 Minutes revealed that Boston Scientific conducted a test assessing 11 parameters to compare the two plastics. Only two parameters matched, with four reported as “very different.” The report further alleges that Boston Scientific concluded the materials were identical and purchased enough of the Emai-sourced polypropylene to last 30 years, and Boston Scientific repackaged the material by “over bagging” the product in plain wrappers in order to hide that the product was an imitation. The company also purportedly told Chinese customs officials that the plastic was made in China, and told U.S. customs it was made in Texas.
 
According to 60 Minutes, Boston Scientific declined to be interviewed. However, the company released an open letter disputing these claims in a statement made by Mike Mahoney, Chairman and CEO and Dave Pierce, executive VP, MedSurg and president, Urology and Pelvic Health soon after the episode had aired:
 
“To patients, caregivers, medical professionals and the Boston Scientific community:
 
The CBS network television show “60 Minutes” recently aired an investigative story with completely false claims that suggested that our transvaginal mesh products contain counterfeited and smuggled materials. We want you to know the facts and understand our perspective.
 
The broadcast resurfaced outdated and previously disproven allegations first made by attorneys in 2016. Our rigorous testing and investigation have shown that the resin currently used in our products matches a formulation from the original U.S. produced resin. This information was also reviewed by the U.S. Food and Drug Administration (FDA) and was part of the basis of their conclusions. 
 
We believe that this story was irresponsible and misleading. We provided the show with a statement and are disappointed that our perspective, and those of medical societies and the healthcare community, were not fully reflected in the broadcast.
 
Instead, the show offered a one-sided view and commentary from clinicians and plastic experts involved with litigious actions. It is important to keep in mind that polypropylene-based (plastic) devices have been a mainstay in many medical procedures for more than 50 years, including hernia and tendon repair, sutures, and wound closure. Furthermore, our products meet rigorous internal safety standards, international standards, as well the standards of the FDA and other regulatory bodies. Leading physician societies have issued supporting statements on mesh, and the American Urogynecologic Society recently shared its perspective. 
 
The segment also showed documents and photos that were taken out of context. Numerous communications not shown by “60 Minutes” demonstrated that our employees were committed to making sure that we complied with all import and export regulations in shipping the resin to the U.S. The steps taken by Boston Scientific depicted in this segment were inaccurate. We packaged the materials to prevent them from damage during transportation. This was well-documented and would not have prevented customs officials from opening or further inspecting the bags.
 
Our top priority is providing safe and effective products. We stand firm in our support of women with pelvic floor disorders who continue to need effective treatment options. Nearly one million women have been successfully treated with our transvaginal mesh products.

Our mesh products contribute to only one percent of annual sales to our company. Continuing to provide these mesh products is not about profits. It is about doing what is right for patients. Without these products, women would be left with few treatment options for these debilitating and often embarrassing conditions.
 
Across Boston Scientific, our employees work diligently to bring forward important medical devices that help people around the world to live longer, healthier lives. We remain steadfast in our commitment to patients.”