Surgical Mesh Ban Scandal in Scotland

http://www.dailyrecord.co.uk/news/politics/former-snp-health-secretary-alex-4915651

Former SNP Health Secretary Alex Neil accused of lying over suspension of mesh implant

Jan 04, 2015 09:32

By Marion Scott

FORMER Health Secretary Alex Neil has been accused of lying over the suspension of mesh implants blamed for crippling thousands of women.

Neil banned the controversial surgeries in June and promised they would not resume until a major investigation into the procedures and their side-effects.

But, months after the announcement, he wrote in secret to a surgeon who supports mesh, promising to reinstate the use of implants before the results of a European Commission safety inquiry.

Campaigners yesterday voiced anger and said Neil was claiming credit for launching the investigation while secretly prejudicing the outcome.

He wrote to Aberdeen-based Dr Mohamed Abdel-fattah and pledged to ask the Independent Review – a probe he launched claiming to be proud that Scotland was leading the way in investigating concerns about mesh safety – to reintroduce the use of standard mid-urethral slings (SMUS).

Consultant gynaecologist Abdel-fattah is at the centre of a probe into a trip to Brazil and laptops being offered to the medical team who sign up the most mesh patients.

The surgeon, who has accepted “travel sponsorships” from mesh manufacturer Ethicon, a subsidiary of medical giant Johnson & Johnson, had written to Neil demanding he lift the suspension, claiming it would affect a research programme worth £4million.

In his response, Neil wrote: “I acknowledge the difficulties you highlight as a result of boards’ decisions to suspend the use of SMUS and the impact this is having on patients and on research.

“It is clear from the summary that there is significant evidence to support the use of SMUS in the treatment of stress urinary incontinence.

“What I intend to do is ask the Independent Review for their view about how quickly they can update the evidence base you have summarised in relation to the use of SMUS to consider if they are content to recommend that the use of SMUS can be reinstated ahead of the expert opinion being published from the European Commission.”

Neil was forced to take action against mesh implants last June after a Sunday Mail campaign led to him being called before the Public Petitions Committee.

He was ordered to explain what he was doing in light of mounting evidence of injuries to women being treated for bladder problems and pelvic organ prolapse.

Mesh manufacturers have already pledged payouts of more than £1.5billion in the US and the NHS are braced for an avalanche of negligence claims, with more than 400 cases in Scotland alone. As a result, Neil announced he was suspending mesh procedures across Scotland pending an independent safety review and introducing new patient consent forms spelling out all the possible dangers, including permanent nerve damage and life-changing injuries.

Neil told the Public Petitions Committee: “We should all be very concerned to hear how these implants have affected the lives of some women in Scotland and elsewhere.

“I’ve personally met with women who’ve been adversely affected and I was deeply troubled to hear how they have suffered.”

Campaigners say they feel badly let down by Neil, now Secretary for Social Justice, Communities and Pensioners’ Rights.

Elaine Holmes, of the Scottish Mesh Survivors’ Hear Our Voice campaign, said: “To say we feel betrayed is an understatement. We trusted Alex Neil to do the right thing. To find he was saying one thing in public and something else in private is awful.”

Neil’s successor Shona Robison has assured campaigners she has no plans to reinstate mesh procedures before the report is published.

She said: “All efforts are being made to ensure as much evidence is collected as swiftly as possible. This includes work to gather evidence regarding use of SMUS.

“The Independent Review will be asked for an update prior to the next meeting in January.

“There are no plans for any pronouncements prior to the final report.”

A spokesman for Neil said that he did not wish to comment.

Surgical Mesh: Scandal Deepens in Scotland

Mesh surgeryscandal: Doctor hired to lead mesh probe used to work for manufacturers

         Jun 15, 2014 12:33

         By Marion Scott  Daily Record  FiDA highlight

        

MESH victims have become concerned over the news that Dr Fred Milani, who worked for one of the mesh manufacturers will be investigating safety issues.

A doctor who was once a consultant to one of the world’s biggest mesh manufacturers has been appointed by the European Commission to investigate safety issues.

The appointment of Dutch urogynaecologist Dr Fred Milani has sparked concern among mesh victims, who say they would have preferred someone with no ties to the industry that they blame for their injuries.

We can reveal that, less than two years ago, Dr Milani stated in medical papers that he had a “consultancy agreement” with Ethicon, the Johnson & Johnson company who produce mesh implants to treat pelvic organ prolapse and bladder problems.

The firm also manufactured the TVT-O mesh implant device which was ruled as defective in a US court of law two months ago.

Milani co-authored a number of medical studies and papers with some of Ethicon’s high-profile management team including Dr Piet Hinoul, former medical director of Ethicon’s Gynecare women’s health and urology.

He has also written medical papers with Ethicon’s clinical director in Scotland, Judi Gauld, and Vanja Sikirica, another ex-associate director at Ethicon.

And in his report to Holland’s Health Care Inspectorate into mesh complications last year, it was noted Milani’s research was partially financed by Ethicon.

Campaigner Olive McIlroy, 57, of Scottish Mesh Survivors, said: “This investigation will have a huge influence across European countries in how they deal with the emerging mesh injury crisis.

“We already feel let down by doctors because so very few of them bothered reporting adverse incidents, allowing the mesh industry and medical watchdogs to continue saying the benefits outweigh the risks. It is vital that the victims have complete confidence in what happens from now on.”

Despite 328 women having repeat surgeries to correct damage, just 12 cases were reported by Scottish doctors.

Dutch health experts have delivered new guidelines on mesh surgery but said a ban on products was not in the best interests of patients.

However, mesh will only be used in patients where traditional methods fail.

A spokeswoman for European Commissioner for Health Tonio Borg said: “Strict rules are in place to assure an independent, excellent and transparent 

Safety or Secrecy: Implanted Medical Devices

New rules to end secrecy oversafety of medical implants

By Laura Donnelly, Health Correspondent, The Telegraph

7:50AM BST 09 Sep 2012  (FiDA blog highlight added)

The changes will mean that for the first time the public will be able to access details of the clinical research behind the products, and their safety record since coming on to the market.

The rules are being drawn up by the European Commission in the wake of the PIP breast implant fiasco and the scandal of metal-on-metal hips, which were found to poison the body and suffer failure rates of up to 50 per cent.

Under the current system, the clinical evidence to support devices, and the records of adverse incidents linked with them are kept behind closed doors.

Manufacturers must share some information with a "nominated body" of their choice, which authorises their products for use, yet it cannot be seen by the public, nor by independent scientists because of draconian European Union regulations.

British regulators run a voluntary system so surgeons can report concerns about medical devices, yet the EU confidentiality rules mean their data is not published, with patients and doctors told nothing - unless the situation deteriorates so badly that a safety alert is issued.

Last December it emerged that more than 40,000 British women received substandard breast implants, made by Poly Implants Protheses (PIP), with some made from industrial silicone, instead of the medical substance which had been authorised.

In January, The Sunday Telegraph disclosed that thousands of Britons had been given metal-on-metal hip implants which were found to poison the body, with some devices having failure rates of up to 50 per cent.

Weeks later, regulators the Medicines and Healthcare products Regulatory Agency (MHRA) issued a warning that 49,000 people with the implants should undergo checks throughout their lifetime and undergo further operations to replace the devices if problems were found.

The new proposals from the European Commission, due to be published within weeks, are expected to recommend that three directives on medical devices, passed during the 1990s, are rewritten.

Under the plans, a duty of confidentiality which is currently placed on all organisations which handle clinical data would be erased, in a bid to make the system more transparent.

The current rules were intended to protect the commercial interests of manufacturing companies, but safety campaigners and regulators believe they have gone too far in putting the interests of business ahead of patient safety.

Professor Sir Kent Woods, chief executive of the MHRA, which has called for the change, said: "The evidence should be out there – so that scientists can look at it, so that patients can look at it and so the public can look at it."

He said it had now become "widely accepted" in the pharmaceutical industry that companies had to make the data from their clinical trials public after drugs were licensed, and that reports of adverse reactions to drugs were documented and published.

Medical devices and implants should follow the same direction, he said.

Because of the single European market, devices used in this country can be manufactured elsewhere, then authorised by a "notified body" in any of the 27 EU member states.

That meant that in the case of the PIP implants, a company in Germany was responsible for the quality of devices produced in France and imported for use in 300,000 women around the world, including Britain.

British regulators the MHRA accredit the six notified bodies which operate in this country and can audit them to check their processes – but have little control over the quality of checks done abroad.

The MHRA has urged the European Commission to change the system, so that accreditation is done by representatives from several countries, in order to ensure that all countries are working to the same standards.

Prof Woods said he felt confident about the expertise of the organisations it inspects but said: "I can't be confident that notified bodies in every one of the 27 countries are working the same way".

He said the rules of a single market in Europe meant it was not possible for British regulators to check all the devices used in this country.

The MHRA is also calling for more rigorous standards to ensure that the clinical evidence to support the application for a licence is more consistently and robustly scrutinised.

The commission is considering how information should be better shared across EU member states, which Prof Woods said could have helped regulators to detect the PIP scandal sooner.

"If we had been able to easily share adverse incident data across Europe I think we would have picked up an increased signal about rupture rates – though not that the filler was fraudulent," he said.

The Commission is also considering whether an "implant card" should be given to all patients who receive an implant, with details of the date, name of device, batch, lot and serial number.

The MHRA said it became clear when problems arose over breast implants and metal-on-metal hip replacements that most patients given implants were not aware what type of device they had.

Sir Bruce Keogh, the Department of Health medical director, is leading a review of cosmetic surgery which is considering whether details of all operations should be held on a central register, to help detect problems with particular types of implants.

FiDA blog comment: 

Tomorrow 9/10/12 the US FDA is conducting a webinar/public meeting on the issue of unique device identifiers UDI's for implanted medical devices.  The US government is liberating a substantial amount of 'big data' from Medicare for research.  Patient harm will be reduced and safe and effective implanted medical devices will be identified so that consumers can make informed decisions.  "Proprietary" information that endangers public health will be exposed.