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Health chief: Mesh implant issues ‘not widespread’
Mar 1, 2015 | The Scotsman
By Scott MacNab
Dr Neil McGuire of the Medicines and Healthcare Products Regulatory Agency (MHRA) was heckled by angry campaigners, -
Scottish Parliament: Scottish Petitions Committee Minutes
Feb 25, 2015 | Scottish Parliament Public Petitions Website
Minutes from the Scottish Parliament Public Petitions Committee -
Report: C.R. Bard to Settle W. Va. Pelvic-Mesh Case
Feb 24, 2015 | Mass Device
By Val Kennedy
...The remainder were filed against Johnson & Johnson (NYSE:JNJ) and Boston Scientific (NYSE:BSX)...
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Health chief: Mesh implant issues ‘not widespread’
Mar 1, 2015 | The Scotsman
By Scott MacNab
Dr Neil McGuire of the Medicines and Healthcare Products Regulatory Agency (MHRA) was heckled by angry campaigners, many wheelchair-bound from mesh side-effects, as he told MSPs there are no plans to withdraw them from use.
Health boards in Scotland have continued to use the devices to treat organ prolapse and urinary incontinence, despite former health secretary Alex Neil calling for them to be banned.
Dr McGuire said: “If we had a higher level of reporting that showed that there were more complications than we are seeing then we’re always prepared to change our view.
“So if we had thousands and thousands of reports to say this was an issue, that wasn’t in the complication rate that was deemed acceptable by the clinical community, then we would change our stance.
“But we can’t act without information – and that information does not appear to be out there.”
Greater Glasgow and Clyde, Borders, Fife and Grampian are among the health board areas which still carry out procedures and have used the MHRA as the basis for this. This is despite former health secretary Alex Neil calling for a moratorium, while further work is carried out into the safety concerns.
Dr McGuire, a consultant in intensive care and anaesthesia, was asked if Mr Neil was being “irresponsible” in calling for the ban.
“I think that would be probably be a question I wouldn’t answer,” the clinician added.
Tory committee member Jackson Carlaw said: “I’ll take that to mean Yes.” The medic added that the Scottish Government has imposed the moratorium without any new evidence being provided.
But Elaine Holmes of the Scottish Mesh Survivors campaign group, who attended yesterday’s meeting, branded Dr McGuire “dismissive and evasive”.
She said: “We’ve been going through this for years. They say there’s a lack of evidence to support a mesh suspension or even issue a warning. What more evidence does he need?”
MSPs at Holyrood have been investigating the issue, following a number of harrowing examples of women suffering infections and bleeding following the surgery, and long-term side effects.
Campaigners say many are left with chronic pain, permanent disability and the need for wheelchairs and walking aids or even the loss of a kidney or bladder.
The Scottish Government’s review into the use of mesh implants will report in a couple of months.
CASE STUDY
Suky Mann once led an active life as a swimming instructor and keen skier. She is now largely wheelchair bound after suffering a mesh nightmare three years ago.
The 47-year-old lives in Gosport, Hampshire, and travelled with nine-year-old son Jakob to hear experts give evidence at Holyrood yesterday.
She suffered ongoing problems after giving birth in 2005 and eventually got a mesh implant eight years later.
Doctors told her at the time it would be a “simple, half-hour operation”.
She added: “I woke from surgery and was only able to move the toes in my left leg. I was in extreme pain.”
She can now only walk with crutches and suffers “24/7 pain” in her legs and bladder. Surgery to remove the mesh was attempted, but proved “too complicated” to extract it fully.
Ms Mann added: “This first started when my son was seven and it’s turned our lives about completely.
“We used to ski, kayak, cycle but he has to spend time with me on the sofa or bed. Our lives have just crumbled.”
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Scottish Parliament: Scottish Petitions Committee Minutes
Feb 25, 2015 | Scottish Parliament Public Petitions Website
PUBLIC PETITIONS COMMITTEE MINUTES
5th Meeting, 2015
(Session 4) Tuesday 24 February 2015
Present: Jackson Carlaw Kenny MacAskill Angus MacDonald Hanzala Malik John Pentland (Convener) David Torrance (Deputy Convener) John Wilson
Also present: Neil Findlay.
The meeting opened at 10.05 am.
1. Consideration of a current petition:
The Committee considered— PE1517 by Elaine Holmes and Olive McIlroy, on behalf of the Scottish Mesh Survivors - "Hear Our Voice" campaign, on polypropylene mesh medical devices and took evidence from—
- Dr Neil McGuire, Consultant in Intensive Care and Anaesthesia, Clinical Director Devices, and
- Sally Mounter, Senior Medical Device Specialist, Biosciences and Implants Devices Division, Medicines and Healthcare Products Regulatory Agency;
- and then, via videoconference, from— Adam M Slater, Mazie Slater Katz & Freeman, LLC.
The Committee agreed to write to the Scottish Government to seek its assurance that the evidence of the Medicines and Healthcare Products Regulatory Agency and Mr Slater would be taken account of by the Independent Review of Transvaginal Mesh Implants.
The Committee also agreed that the evidence sessions with the Cabinet Secretary for Health, Wellbeing and Sport, the Chair of the Independent Review and the European PPC/S4/15/5/M Commission would take place after publication of the Independent Review's findings. The meeting closed at 12.08 pm.
Anne Peat Clerk to the Public Petitions
Committee Room T3.40
The Scottish Parliament Edinburgh
Tel: 0131 348 5186 Email: Anne.peat@scottish.parliament.uk
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Report: C.R. Bard to Settle W. Va. Pelvic-Mesh Case
Feb 24, 2015 | Mass Device
By Val Kennedy
C.R. Bard (NYSE:BCR) is reportedly close to settling a suit filed in West Virginia federal court by a woman who claimed she was injured by the company's pelvic-mesh device, Avaulta Plus.
According to Law360, recent court papers indicate the two parties have a settlement pending in the case, which has been removed from the active docket. A trial had been slated to begin in February.Sign up to get our free newsletters delivered straight to your inbox
About 70,000 cases involving pelvic-mesh devices have been compiled before a federal district court in Charleston, W. Va. Bard is the defendant in approximately 10,000 of the cases. The remainder were filed against Johnson & Johnson (NYSE:JNJ) and Boston Scientific (NYSE:BSX).
Earlier this month, U.S. District Judge Joseph Goodwin, who is overseeing the litigation in W. Va., urged the parties to settle, stating that it would take decades for all of the cases to reach trial. The judge likewise praised device maker Endo International, which faced roughly 10,000 cases, for settling last year.
Goodwin reportedly advised Bard to settle its cases during a court hearing in December.
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