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Ethicon Media Monitoring 09/21/16
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Call for investigation into ‘fake’ implants
Sep 21, 2016 | The Times
By Catriona Webster
Campaigners have called for a criminal investigation into allegations that counterfeit materials may have been used in controversial mesh implants in Scotland. -
CALL FOR INVESTIGATION OVER MESH IMPLANTS ALLEGATIONS
Sep 20, 2016 | Evening Express
Campaigners have called for an investigation into allegations that counterfeit materials may have been used in controversial mesh implants in Scotland. -
*Latest* Scotland Calls for Criminal Investigation into Counterfeit Mesh Allegations Against Boston Scientific
Sep 20, 2016 | Mesh Medical Device Newsdesk
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.
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Call for investigation into ‘fake’ implants
Sep 21, 2016 | The Times
By Catriona Webster
Campaigners have called for a criminal investigation into allegations that counterfeit materials may have been used in controversial mesh implants in Scotland.
Steve Mostyn, an American lawyer, said he had uncovered evidence that the mesh manufacturer Boston Scientific sourced counterfeit polypropylene from China to be used in implants — a claim denied by the company.
Fears have been raised that women in Scotland may have received implants, used for the repair of pelvic organ prolapse and incontinence, made with alleged counterfeit material.
A Holyrood press conference 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.
Neil Findlay, a Labour MSP, is seeking a meeting with police over the “astonishing and deeply, deeply disturbing” claims, while a campaign group, Scottish Mesh Survivors, has called for a suspension on the use of Boston Scientific products.
A Scottish government suspension on mesh implants is in place pending a report by an expert group into their use. However, procedures can take place for women who want to go ahead with surgery after being appraised of the risks. At present there are more than 400 legal cases going through the Scottish courts relating to mesh implants.
Patrick McGuire, at Thompsons Solicitors, which represents mesh victims, said: “There’s absolutely no doubt there is something here that needs to be investigated in Scotland.”
Giving his evidence, Mr Mostyn said: “China is the world’s recycler of polypropylene and there’s a grave concern that the polypropylene that is in these bags. . . is recycled material from around the world.” He said that the main use for polypropylene was in carpet backing.
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 Scottish government spokesman said: “The Medicines and Healthcare products Regulatory Agency (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, we would react immediately and follow any guidance issued.”
http://www.thetimes.co.uk/article/investigation-call-into-fake-implants-jglgmllth
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CALL FOR INVESTIGATION OVER MESH IMPLANTS ALLEGATIONS
Sep 20, 2016 | Evening Express
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.”
https://www.eveningexpress.co.uk/pipe/news/scotland/mesh-implant-campaigners-call-for-criminal-investigation/
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Sep 20, 2016 | Mesh Medical Device Newsdesk
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.
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. ###
http://www.meshmedicaldevicenewsdesk.com/scotland-calls-criminal-investigation-counterfeit-mesh-allegations-boston-scientific/
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