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Neil urges health boards to suspend use of mesh implants

Health boards have been asked to suspend the use of mesh implants after a campaign by women who have suffered serious side effects as a result of the procedure.

Health Secretary Alex Neil said an independent review will be set up urgently to report on all the issues related to mesh procedures, including complication rates and under-reporting of "adverse events".

Campaigners described the suspension and review as "welcome and unexpected".

Transvaginal tapes and meshes are used in the treatment of pelvic organ prolapse and stress urinary incontinence.

For most patients the implant is effective but a number of women have come forward after experiencing abdominal and pelvic pain, urinary problems, painful intercourse, vaginal scarring and the need for further operations.

Mr Neil has now asked the Acting Chief Medical Officer to write to all health boards in Scotland urging them to suspend the use of mesh until further evidence from both the Scottish Government's independent review and an EU study become available next year.

He said: "The review will report in 2015 taking account of a European Commission report on the devices, due to be published in January 2015.

"I hope to announce the specific remit and chair of the review before the summer recess.

"In addition I have asked the Acting Chief Medical Officer this week to write to all health boards to request them to immediately suspend these procedures... until further evidence becomes available from the two reports next year - the EU report and the independent review I have set up.

"I believe that is the right thing to do, and that we should base any future decisions on the evidence as presented by these two reports."

Mr Neil was speaking at a meeting of Holyrood's Public Petitions Committee, where MSPs were considering a petition by mesh campaigners.

Commenting after the committee meeting, mesh victim and petitioner Olive McIlroy, 57, said: "I just didn't expect that decision today. It was the decision that we were hoping for, and we're very glad that the minister made it, but he could have made it a year ago."

Ms McIlroy is one of the two petitioners who brought the issue to the committee.

She added: "We welcome that there is going to be an independent review and there will be no manufacturers or anyone with a vested interest involved.

"It has been too long. Our alternative evidence has been there for all to see, but nobody has listened.

"The ultimate outcome is that Scottish patients should be protected. They shouldn't have to depend on a European Commission or the Medicines and Healthcare Products Regulatory Agency (MHRA).

"Their regulations are completely flawed, and we have proved that time and time again."

During the committee meeting, Mr Neil said: "I was deeply troubled to hear how women who have been affected have suffered and they have my full sympathy and support, and we will do all we can to improve the situation.

"No-one should have to experience the level of suffering that some of these women have had."

Mr Neil said 1,500 women suffering from stress urinary incontinence and 350 with pelvic organ prolapse have synthetic mesh implant surgery in Scotland each year.

Around 1-3% of women having the procedure for stress urinary incontinence and 2-6% who receive an implant for pelvic organ prolapse suffer complications, according to the MHRA.

"The percentage of complications is probably substantially under-estimated because of the under-reporting of adverse events," Mr Neil said.

"Therefore these figures I would take as not entirely reliable in terms of their accuracy."

New detailed guidance on the risks associated with mesh is due to be published, while the Chief Medical Officer has written to all GPs three times in the last year alerting them to the possibility that women may suffer complications, and that all adverse events should be reported to the MHRA, Mr Neil said.

While he admitted he did not have the authority to withdraw the implants, Mr Neil said: "I would find it highly unlikely and highly unacceptable if they (health boards) didn't agree to this request."

He added: "Where individual women and their clinicians agree on the need for a particular service, this will still be available."

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