Revelations suggesting a major medical device manufacturer in the US used counterfeit Chinese plastic in surgical mesh products has reignited concerns in New Zealand.
US current affairs programme 60 minutes took manufacturer Boston Scientific to task in a special report aired this week. Through court documents and interviews with plastic and gynaecological experts, the programme raises serious concerns over the company’s move to source “Marlex” resin from a Chinese supplier. According to the report, the switch was prompted after Marlex producer Phillips Sumika – a subsidiary of Texas petrochemical company Chevron Phillips – cut off its supply to Boston Scientific.
Boston Scientific, which raked in US$9 billion in sales last year, is a supplier of surgical mesh products in New Zealand. The mesh is mainly used to strengthen weak abdominal and pelvic muscles. Last year, Boston Scientific was one of four suppliers issued a special notice by regulatory agency Medsafe over safety requirements for its surgical mesh products used in urogynaecological procedures. After that notice, the company discontinued three of its products. Eight are still available – of which six are used in procedures performed where tissue have been weakened after childbirth (urogynaecological use).
In the 60 minutes report, documents show that Chevron Phillips stopped supplying Boston Scientific with the Marlex resin in 2005. A year earlier, the petrochemical company had already warned Marlex was not to be used for “permanent implantation in the body”. Despite that, it had been approved by the US Food and Drug Administration (FDA) as a component in surgical mesh. Switching to an unapproved resin would have likely created significant delays in production and sales for Boston Scientific, as extensive tests and procedures are needed for FDA approval.
The company then identifies a solution in the form of a broker in China, known as EMAI. According to the 60 minutes report, EMAI tells Boston Scientific it has “tonnes of Marlex imported from Chevron Phillips in Texas”. To get things underway, one of the company’s staffers in China emails his bosses in the US asking whether he needs to tell EMAI the resin is for “medical implantable”. The response from his bosses:
“Please don’t tell them where we will use it. It could scare them away.”
Next, Boston Scientific take steps to get the Chinese-sourced Marlex into the US for manufacturing in its surgical mesh products. However, a series of red flags are identified in the company’s own, internal checks as this happens. First, EMAI is unable to produce documents verifying the Marlex is authentic. Chevron Phillips also confirms three times over that the lot numbers on the bags from EMAI’s Marlex resin are fraudulent. The Texas company also points out the bags from China are the wrong colour and have the incorrect city of production on them. A product analysis of the Chinese-sourced resin also shows that nine out of 11 parameters are different.
Despite this, Boston Scientific concludes the Chinese-sourced resin is a match, and buys enough of it to satisfy its supply-needs for 30 years. Fast-forward to today, and the company is now being sued by 48,000 people over its surgical mesh products. It has also issued a strong denial in response to the 60 minutes report.
“Our rigorous testing and investigation have shown that the resin currently used in our products matches a formulation from the original US produced resin,” the company states on its website.
Charlotte Korte, of New Zealand surgical mesh advocacy group Mesh Down Under, says the latest 60 minutes revelations add further disappointment and heartbreak for hundreds of mesh-injured locals. So far, at least 900 injury claims associated with the products have been lodged with ACC. Injury payouts have cost about $13 million.
The situation could have been avoided, and should have been addressed years ago, Korte says.
“In 2014, we were one of the first ones in the world to submit evidence to our Government and Health Select Committee regarding a written caution from the plastics company Phillips Sumika [the Chevron Phillips subsidiary], which stated that its Marlex material should not be used in the human body.
“We included documentation – a 2008 Material Safety Data sheet which had a detailed warning that clearly stated: ‘Do not use this Phillips Sumika Polypropylene Company material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues’.”
Korte says the group also alerted Medsafe to the resin issue in 2016, “but nothing came of it”.
Medsafe, which is unable to confirm the number of Boston Scientific devices in New Zealand, says allegations like those outlined in the 60 minutes report are always concerning.
The agency checked with Boston Scientific two years ago over the allegations surrounding its mesh products.
“Boston Scientific’s response provided comprehensive information about the testing of the polypropylene material that had been used to make mesh the company had distributed,” spokesman Chris James says.
“Information included physical and chemical testing which was aimed at ensuring the material met or exceeded the specifications of previous batches of material and that it was safe to use. ”
In total, five adverse event reports involving Boston Scientific mesh products have been logged with Medsafe.
Korte, who as part of Mesh Down Under continues to lobby for an official surgical mesh register, points out any official figures are unlikely to provide a comprehensive picture of what is happening.
“There are no systems in place for the Ministry of Health to identify who has been implanted with a surgical mesh device, so it is not possible to know which patients will be affected,” she says.
“The fact that patients cannot be identified or monitored more closely when problems surface is extremely worrying, especially if these devices are designed to be permanent and in the case of surgical mesh, difficult to remove.”