Campaigners have called for an investigation into allegations that counterfeit materials may have been used in controversial mesh implants in Scotland.
Fears have been raised that an unknown number of women in Scotland could have received implants with the alleged materials.
US lawyer Steve Mostyn alleges that manufacturer Boston Scientific sourced polypropylene from an area of China notorious for counterfeit materials to be used in implants, a claim denied by the company.
Labour MSP Neil Findlay is seeking a meeting with police over the “astonishing and deeply, deeply disturbing” claims, while campaign group Scottish Mesh Survivors has called for a suspension on the use of Boston Scientific products.
However, a spokeswoman for 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.”
A press conference at Holyrood heard that while the total number was not known, 82 women in Glasgow were implanted with Boston Scientific products between 2012 and 2013, and the products could still be in use in Scotland.
A Scottish Government suspension on the use of mesh implants is currently in place pending a report by an expert group into their use, but procedures can take place for women who want to go ahead with surgery.
Currently there are more than 400 legal cases going through the Scottish courts relating to mesh implants, used to treat prolapse and bladder problems.
Patrick McGuire, a partner at Thompsons Solicitors – which represents mesh claimants, said: “There’s absolutely no doubt that there is something here that needs to be investigated in Scotland.”
Mr Mostyn said: “China doesn’t make a lot of polypropylene, but China is the world’s recycler of polypropylene and 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.”
Elaine Holmes, from the Scottish Mesh Survivors group, said many women were unaware of what device had been implanted in them and some were left ” distraught and terrified” by the allegations.
Ms Holmes said she and fellow campaigner Olive McIlroy had written to Health Secretary Shona Robison in April to raise the issue of potential counterfeit products.
She criticised the Scottish Government’s response as “unacceptable and not particularly helpful”, and the response from the Medicines and Healthcare products Regulatory Agency (MHRA) as “ridiculous” – accusing both of not listening to the concerns.
She said: “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.”
Mr Findlay added: “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.”
Chief Inspector Mark Leonard, Police Scotland’s lead officer for counterfeit goods, said: “I would be happy to meet with Mr Findlay to discuss this issue and gather any information to share with the Scottish anti illicit trade group.
“This is a collaborative group including the MHRA (Medicines & Healthcare Products Regulatory Agency), the respective industries and enforcement agencies. If Police Scotland receives a complaint, we will investigate it.”
An MHRA spokesman said it was “not aware of any evidence to justify these claims”.
He added: “We have listened to and understand the concerns that many women have, for the majority the users of vaginal mesh implants is safe and effective and can greatly help in dealing with upsetting conditions such as urinary stress incontinence and pelvic organ prolapse.
“We are aware of allegations that Boston Scientific’s urogynaecologic surgical mesh devices may contain counterfeit raw material. We have contacted Boston Scientific and are not aware of any evidence to justify these claims.
“Manufacturers are responsible for ensuring that any ingredient used within the manufacturing process of their device meets the required specification. We are not aware that any changes in raw material have contributed to reported adverse events associated with Boston Scientific mesh devices.”
A Scottish Government spokesman said: “The MHRA regulates medical devices across the UK, and has not issued an alert regarding the implants concerned.
“The MHRA has responsibility for monitoring and evaluating the safety and performance of these devices. If the agency were to highlight any concerns with these products, then we would react immediately and follow any guidance issued.”