With over 100,000 pelvic and other gynecological mesh cases pending in courts around the country, one question that has been on everyone’s mind is much closer to an answer thanks to some investigative reporting that aired earlier this month on CBS’ 60 Minutes.
The question is a simple, yet far-reaching one: what could possibly have gone so wrong with these devices as to cause this level of pain and suffering across so many victims? The answer for one manufacturer, it appears, allegedly combines inferior Chinese materials with a corporate plot to smuggle those materials into the United States.
Boston Scientific is a leading provider of gynecological mesh devices. With $9 billion in sales it is a titan in the medical device manufacturing vertical. It is also the defendant in 48,000 of the mesh lawsuits currently awaiting trial.
The corporation used a type of plastic known as polypropylene in its mesh devices that was sold by a subsidiary of chemicals manufacturer Chevron Phillips and branded under the name of “Marlex.” Marlex is made in Texas and was cleared by the FDA for use in human implantation despite common knowledge among materials scientists that polypropylene is, in one scientist’s words, “oxidatively unstable.” In other words, it breaks down when it’s exposed to oxygen. Oxygen is a key element in the human body and vital to our survival.
According to the 60 Minutes report, Chevron Phillips started doubting the safety of using Marlex in medical applications. In 2004, it issued a warning to its customers that the plastic was not fit for “permanent implantation in the human body.” By that point, however, Boston Scientific was committed to using Marlex in its mesh devices as it was the only plastic that had been approved for use by the FDA. The company appealed Chevron Phillips’ decision to stop supplying it with Marlex and was rebuffed. Chevron Phillips was confident in its assessment of the dangers of Marlex and was ending the relationship, stating that it was “simply not interested in this business at any price.”
Boston Scientific began soliciting other companies for their supplies of Marlex. In the words of Boston Scientific’s director of Global Supply Chain written in an email, Marlex “supports a $120 million in annual revenue.” He goes on to state that he “can not [sic] overstate the importance of getting more.” Suppliers were now actively refusing to sell to Boston Scientific on learning that the company intended to use the material for devices that were to be used for human implantation; something that Chevron Phillips had specifically warned against. BSC even started going through intermediaries to try to disguise itself as the buyer. All of these efforts failed.
The search for more material eventually led it to China where a broker said it had tons of original Chevron Phillips Marlex for sale. The Boston Scientific employee who would be making the deal was instructed not to tell the broker why the company wanted the product, for fear that learning it was to be used in human implantation would torpedo the deal. “Please don’t tell them where we will use it,” wrote BSC’s director of materials management. “It could scare them away.”
As it turns out, it is highly likely that Boston Scientific was sold 30 years’ worth of counterfeit Marlex that was even more unfit for use in people than the real compound. Visual cues like fraudulent lot numbers and blatantly obvious errors and differences between genuine Marlex bags and the Chinese product should have been the first clues. The absence of chain of custody records for the 16 tons of plastic should have caused additional issues. The final nail in the coffin should have been when the Chinese material was tested against genuine Marlex and came back differently on nine of the 11 markers it was tested against. Instead, BSC executives turned a blind eye to every one of these discrepancies and made the purchase anyway.
The lot numbers and other issues with the counterfeit bags posed importation issues, but BSC was not going to lose their mesh sales at any cost. Charles Smith, a director in Boston Scientific’s urology and women’s health division, approved a plan to disguise the counterfeit Marlex and bring it into the United States. “We can over bag,” he wrote. The bags of questionable compound were placed into plain opaque bags, and Chinese authorities were told that the material was Chinese on its way out of China. On arrival to US shores for use in American patients, U.S. Customs authorities were told that the material was made in America.
It would appear that the plan worked. CBS purchased 15 Boston Scientific mesh kits and had them tested by a “leading plastics lab.” Every single one of them came back as the Chinese plastic and not as genuine Marlex.
One can only imagine the chill that must have gone down the spines of the Boston Scientific executives who watched the 60 Minutes report when it aired. Do not assume for a second, however, that any part of that chill was born out of guilt or remorse. Do not assume for a second that they were thinking about the pain and suffering they knowingly inflicted on those who had no choice but to trust them to act in their best interest and produce safe devices that could help them when they were needed the most. The chill more likely came from knowing that their secret was out, and that the American public was now that much more aware of the lengths they were willing to go to put their profits ahead of their victims and their families.
For its part, the FDA appears to be completely unconcerned with the fact that an untested foreign substance that was smuggled into the country is being used as a medical treatment in US patients. The agency refused to speak to CBS for its report but issued a statement saying that the Chinese plastic of completely unknown origin “does not raise new safety or effectiveness concerns.”
We feel safer already.