Boston Sci rejects claims it used fake plastic in med devices

One of the manufacturers of the controversial vaginal mesh device has been accused on TV of knowingly using counterfeit plastic from China to produce the product.

Boston Scientific was singled out in a 60 Minutes report that aired in the US on Sunday evening, exploring the controversy around vaginal mesh devices, an implant that supports weakened pelvic muscles and organs.

The broadcast claimed documents suggested the manufacturer had knowingly bought counterfeit plastic from a Chinese supplier to make the implant and that the material was repackaged to hide its dodgy origins.

60 Minutes claimed that Boston Scientific had allegedly bought enough of the fake plastic to last 30 years.

The company allegedly declined to be interviewed for the report but has since released a statement slamming the programme’s claims as “completely false”.

Boston Scientific’s stock dropped 2 per cent on the back of the 60 Minutes report, according to SeekingAlpha.

Vaginal mesh devices are net-like implants made of a type of plastic known as polypropylene. The implants were developed to hold up pelvic organs to treat conditions such as incontinence and prolapse but thousands of women around the world have experienced painful complications where the mesh has cut into tissues.

More than 48,000 lawsuits from 100,000 women have been filed against Boston Scientific alone.

According to 60 Minutes, Boston Scientific allegedly took the decision to use counterfeit plastic after it’s original supplier Chevron Phillips stopped selling the Marlex brand of polypropylene to the company in 2005, citing concern that the plastic should not be used in medical implants in humans for safety reasons. Another supplier also refused to sell the plastic to the manufacturer.

Boston Scientific’s vaginal mesh gained US approval based on the use of the Marlex brand in the implant device.

“Boston Scientific’s global sourcing division decided to use a middleman with no direct link to Boston Scientific, so the plastic makers wouldn’t know the true buyer,” 60 Minutes alleged in its report.  

According to 60 Minutes, Boston Scientific was in contact with a Chinese supplier called Emai Plastic Raw materials, which allegedly told the manufacturer it had “tons” of Chevron Phillips Marlex, although the authenticity of the product could not be verified.

Based on documents obtained by the programme, the report said: “Boston Scientific’s man in China wrote his superiors: ‘Do we need to ask Emai if this material is supposed to be used in medical implantables?’ Boston Scientific’s director of materials management replied: ‘Please don’t tell them where we will use it, it could scare them away’.”

Allegedly, Boston Scientific initially checked the Emai plastic with Chevron Phillips, which deemed the product and packaging to be fake. Despite this finding Boston Scientific allegedly performed a further 11 tests comparing the Emai plastic with authentic Marlex, discovering similarities for just two of the parameters.

60 Minutes alleged that Boston Scientific concluded the findings were sufficient to class the two materials as the same and proceeded to purchase a large amount of the plastic from Emai.

The report also made further claims against the manufacturer, alleging it aimed to deceive customs officials as to the true nature of the material by repackaging it and providing false information on the customs declaration forms.

People interviewed by the programme also suggested the company was unable to provide sufficient supply chain information, including manufacturer, packaging and shipping details.

Boston Scientific has denied the allegations, claiming the 60 Minutes report was “inaccurate”, “irresponsible” and “misleading”, adding that the information in the broadcast with taken out of context and failed to include other relevant and non-biased information to provide the full story.

In a statement the manufacturer said: “The broadcast resurfaced outdate and previously disproven allegations first made by attorneys in 2016,” referencing a racketeering lawsuit that accused the firm of smuggling fake Chinese-made Marlex into the US, which was not approved for use in human implants. In that case, the federal judge gave the US Food and Drug Administration jurisdiction over the case, which sided with the manufacturer.

Boston Scientific added: “Our rigorous testing and investigation have shown that the resin currently used in our products matches a formulation from the original US-produced resin.”    

In a statement to the Boston Globe, the FDA said it had carried out an “extensive investigation” when the manufacturer changed suppliers. “The FDA conducted its own testing of the finished product for specific mechanical properties and physical characteristics and determined that all samples met the appropriate specifications.”

Boston Scientific said: “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.”

“Our mesh products contribute to only 1 per cent 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.”