Mesh Medical Device News Desk, September 20, 2016 ~ Scottish campaigners call for a criminal investigation into pelvic mesh made with polypropylene from China. Thanks to Scottish reporter Marion Scott for supplying the stories.
Mesh campaigners in Scotland are calling on a criminal investigation into allegations that substandard counterfeit raw material was used to make pelvic mesh implants used on Scottish women.
At a press conference today at the Scottish Parliament building in Holyrood, Houston attorney Steve Mostyn told those in attendance that at least 82 women in Glasgow have been implanted with Boston Scientific products made between 2012 and 2013, the years the company says it used polypropylene resin it obtained from China.
Mr. Mostyn told reporters the concern is China is the word’s recycler of polypropylene, used primarily as a backing for carpets.
“There’s a grave concern that the polypropylene that is in these bags, that has now been permanently implanted inside these women, that is not reversible, is recycled material from around the world.”
The company sourced 37,000 lb. of the raw material for mesh implants from China after its U.S. supplier refused to continue to sell to the major manufacturer.
Boston Scientific supplied National Health Service (NHS) hospitals in Scotland with its Advantage, Obtryx and Pinnacle products used to treat incontinence and prolapse in women. The total number of women in Scotland who may have been implanted with the counterfeit material is unknown. What’s also unknown is how many products could still be in use in Scotland.
Boston Scientific claims the Mostyn documents have been “taken out of context,” and its products are rigorously tested. In response to an inquiry by the Evening Express, a spokeswoman from Boston Scientific said: “These allegations are simply not true. We stand by our products, our testing and verification of the Marlex used in our products, and we continue to reject any allegations that this resin is counterfeit or adulterated. We are working on a number of fronts to ensure the public and the medical communities have accurate information. We are deeply committed to patient safety.”
Scottish Mesh Survivors, a group of women injured by pelvic mesh, is calling for a suspension on the use of all Boston Scientific Products. Elaine Holmes told Bauer Media (here) “Survivors of mesh feel that the government should put an immediate suspension on Boston Scientific products, all Boston Scientific mesh products … until we have proof, until there’s been an investigation and these allegations have been looked into.”
Labour MSP Neil Findlay is asking for a meeting with law enforcement over “astonishing and deeply, deeply disturbing claims.”
“If these allegations prove to be true, Boston Scientific have misled hundreds of thousands of patients across the world and may have defrauded the NHS by selling a fake product that is not fit for purpose and potentially extremely dangerous.
“I am now calling on the police and Crown Office to get involved and investigate these allegations to ensure the integrity of Scotland’s NHS is not compromised,” he told the Evening Express.
Unlike the U.S. where media coverage of the pelvic mesh injuries has been relegated to jury verdicts, at least five papers made the story the evening news including the Herald Scotland and the Evening Times.
The MHRA (Medicines & Healthcare Products Regulatory Agency), Scotland’s version of the U.S. Food and Drug Administration, said it will investigate any complaints but was not aware of any evidence to justify the claims of counterfeit mesh materials.
Scottish lawyer Patrick McGuire, a partner at Thompsons Solicitors, urged women who have had pelvic mesh surgery to obtain their medical records and find out if they’ve been implanted with Boston Scientific mesh.
He calls is a public health issue.
“We don’t know what’s in there, we don’t know what level of contaminants are present, so this isn’t about scaremongering, it’s about finding answers and getting the correct treatment if that’s possible.”
The Scottish government has decided to suspend mesh procedures until a government investigation is completed. Women still wanting mesh however, can obtain it.
Boston Scientific sourced the material from EMAI Plastics through the website Alibaba.com, research by Mostyn Law has revealed.
In the U.S., Mostyn asked for a judicial order to stop the sales of the Boston Scientific mesh products made after 2012 but Judge Goodwin, overseeing consolidated cases in West Virginia, denied the request. Instead, the FDA has allowed Boston Scientific to investigate its mesh to determine if it is the same material it received clearance to sell.
Mostyn Law has filed a RICO suit alleging fraud and conspiracy by the company over the counterfeit mesh.
There are about 400 defective product lawsuits filed in Scotland and more than 100,000 suits filed in the U.S. against seven manufacturers alleging the pelvic mesh is defective and doctors were not warned of the dangers. ###