Preview Newsletter
Ethicon Media Monitoring 10/20/2017
-
11th Circ. Upholds $27M Boston Scientific Pelvic Mesh Loss
Oct 19, 2017 | Law 360
By Dani Kass
A Florida federal judge was right to consolidate the cases of four women who say they were injured by Boston Scientific Corp.'s allegedly defective pelvic mesh implants, the Eleventh Circuit ruled Thursday, upholding a jury’s $27 million verdict. -
Woman wins the go-ahead for a High Court claim after she argues a controversial vaginal mesh implant left her with life-changing injuries
Oct 19, 2017 | The Daily Mail
By Alexandra Thompson
A woman has won the go-ahead for a High Court claim over life-changing injuries she suffered after having a controversial vaginal mesh implant fitted that eroded her insides. -
Woman who suffered life-changing vaginal mesh injuries to make High Court claim
Oct 19, 2017 | Metro News
By Oliver Wheaton
A woman has won the right to make a High Court claim over injuries she says she suffered from a vaginal mesh implant. Barbara Wise underwent surgery to treat her urinary stress incontinence at Beneden Hospital in Kent in 2007. -
Mesh Implants Have Hurt Thousands - We Cannot Undo Their Pain But We Can Make Sure This Never Happens Again
Oct 19, 2017 | HuffPost UK
By Emma Hardy
The issue of surgical mesh implants was first brought to my attention when I was visited by a constituent. -
Inquiry into the surgical mesh implant 'scandal' is turned down by UK Government
Oct 19, 2017 | Wales Online
By Mark Smith
Many people in Wales have been left in chronic pain by the plastic implant -
Government change comes as relief to surgical mesh sufferers
Oct 19, 2017 | Newshub
By Gemma Coombe
Surgical mesh campaigners hope the change in government may help prevent the suffering of hundreds of Kiwi women. -
Inquiry into mesh implants rejected by government
Oct 19, 2017 | Medical Plastics News
By Reece Armstrong
The government has rejected calls to ban vaginal mesh implants after MPs debated its use to treat women affected by pelvic organ prolapse and incontinence following childbirth. -
Vaginal mesh implants “a national scandal” says Deeside MP
Oct 19, 2017 | Deeside
Deeside Politicians say they are disappointed with the Governments response to a debate in Westminster Hall yesterday, Wednesday 18th October on the use of controversial vaginal mesh tape.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
-
11th Circ. Upholds $27M Boston Scientific Pelvic Mesh Loss
Oct 19, 2017 | Law 360
By Dani Kass
Law360, New York (October 19, 2017, 9:15 PM EDT) -- A Florida federal judge was right to consolidate the cases of four women who say they were injured by Boston Scientific Corp.'s allegedly defective pelvic mesh implants, the Eleventh Circuit ruled Thursday, upholding a jury’s $27 million verdict.
A three-judge panel said that while each woman may have had different circumstances, their suits came down to the same legal questions: whether the Pinnacle Pelvic Floor Repair Kit was defective and whether the product had sufficient warnings.
The jury awarded a total of $27 million in November 2014, but denied the plaintiffs punitive damages. Plaintiff Mania Nunez received $6.53 million, Juana Betancourt and Amal Eghnayem each received $6.72 million and Margarita Dotres received $6.76 million.
Boston Scientific had asked for four new trials, claiming, in part, that the cases were too distinct to be consolidated and that the jury became confused. For example, the women had different complaints, medical histories and treating doctors, were prescribed the devices for different conditions, and had different complications, including infection, organ perforation, nerve damage, blood loss and chronic pelvic pain.
But the panel said the court didn’t abuse its discretion and made it clear to the jury that each case should be considered separately. The only individual claims that had to be decided were whether the device’s design caused the injury and whether the doctor was sufficiently warned. The difference in awards to the four women proves the women were able to keep the cases separate, the opinion states.
Among a few other rulings tailored to the individual cases, the panel cleared the judge to exclude evidence regarding Boston Scientific’s 510(k) clearance. Under Section 510(k) of the Federal Food Drug and Cosmetic Act, manufacturers must give the U.S. Food and Drug Administration 90 days notice before bringing a new device to market to see if it’s “substantially equivalent” to a device already on the market.
Since 510(k) isn’t a safety regulation, it “does not go to a product’s safety and efficacy — the very subjects of the plaintiffs’ products liability claims,” the panel said.
Plaintiffs’ attorney Clayton Clark of Clark Love Hutson GP said they’re “real happy” with the decision. He said as more cases head to federal court, the courts need to be able to consolidate them to keep the system running efficiently, which this decision laid the grounds for in the Eleventh Circuit.
“I believe that this is the way of the future, in that we’re going to be required to try many multiples of cases at one time, in order to not clog up the court and not leave plaintiffs waiting years and even decades on an adjudication on their case, and not leave defendants paying defense costs for the same period of time,” he told Law360. “It has the Eleventh Circuit affirming what more circuits are affirming: that there are fair and equitable ways to try multiple plaintiff cases in consolidation."
Boston Scientific said in a statement Thursday that it has "reached a confidential settlement with three of the plaintiffs in this case earlier this year and recently with the fourth. We continue to stand behind our products, our practices and our commitment to women's health."
A spokeswoman didn't immediately respond to follow-up questions about how the ruling and settlements will tie together.
U.S. Circuit Judges Frank M. Hull and Stanley Marcus of the Eleventh Circuit and John M. Rogers of the Sixth Circuit, sat on the panel.
The plaintiffs are represented by Clark Love Hutson GP, Andrus Wagstaff PC and Babbitt & Johnson PA, among others.
Boston Scientific is represented by Hildy Sastre, Eric Anielak, Matthew Keehan, Jon Strongman and Robert Adams of Shook Hardy & Bacon LLP and Lindsey Saad and Michael Bonasso of Flaherty Sensabaugh Bonasso PLLC.
The appeal is Eghnayem et al. v. BSX, case number 16-11818, in the U.S. Court of Appeals for the Eleventh Circuit.
The MDL is In re: Boston Scientific Corp. Pelvic Repair System Products Liability Litigation, case number 2:12-md-02326, in the U.S. District Court for the Southern District of West Virginia.
--Additional reporting by Cara Salvatore. Editing by Alyssa Miller.https://www.law360.com/trials/articles/976264/11th-circ-upholds-27m-boston-scientific-pelvic-mesh-loss
-
Oct 19, 2017 | The Daily Mail
By Alexandra Thompson
· Her case against manufacturer Johnson and Johnson was dismissed in 2014
· She also filed against her surgeon who failed to properly explain the procedure
· After being reopened, the surgeon's estate argued it was outside the legal time
· More than 800 women are suing the NHS and the implant's manufacturers
· Mesh manufacturer Johnson & Johnson paid out $57 million last month
A woman has won the go-ahead for a High Court claim over life-changing injuries she suffered after having a controversial vaginal mesh implant fitted that eroded her insides.After Barbara Wise's case against mesh manufacturer Johnson and Johnson and the surgeon who conducted the procedure was dismissed in September 2014 and then reopened in May this year, a High Court judge ruled against the surgeon's family's appeal.
More than 800 women are suing the NHS and the implants' manufacturers after complaining of crippling pain in a scandal that has been compared to thalidomide.
The NHS has even been accused of sweeping complications, such as an inability to walk or have sex, under the carpet in an effort to dodge media attention.
After previously denying their implants were causing women's discomfort, Johnson & Johnson paid out $57 million to a sufferer from Philadelphia last month after a jury found the company to be negligent and its product defective.
Pressure is mounting for a UK ban of the 'gold-standard' treatment for urinary stress incontinence and pelvic organ prolapse.
MPs discussed the impact of mesh implants in a debate in Westminster Hall yesterday.
Surgeon failed to explain the procedure
In January 2007, Ms Wise was fitted with an implant at Benenden Hospital in Kent to treat her urinary stress incontinence.
Although Ms Wise's symptoms initially improved, her incontinence reappeared six months later, alongside excruciating pain as the mesh eroded her insides, it is claimed.
Ms Wise had corrective surgery in September 2011, followed by a hysterectomy in January 2013.
She issued a product liability claim against Johnson and Johnson, as well as a claim against her surgeon Mohammed Mossa, in September 2014, which was dismissed.
Ms Wise claims Mr Mossa failed to adequately explain the operation or inform her of alternative treatments.
Yet, in May this year a judge allowed the claim to continue.
Mr Mossa, who was terminally ill, died without being aware of the case, however, his estate argued the claim could not proceed as it was brought outside the legal time limit.
Today, the High Court dismissed the estate's appeal against this ruling.
A Johnson and Johnson spokesperson told MailOnline: 'Pelvic mesh has helped improve the quality of life for millions of women with serious, debilitating conditions.
'Surgeons, medical societies and regulatory organisations around the world that have conducted independent research on the available data agree that pelvic mesh is an important treatment option for doctors to consider for their patients.
'We empathise with those patients who have had complications following their procedures, but we continue to believe it is important to recognise that their experiences do not speak for the vast majority of women whose lives have been improved through treatment with pelvic mesh devices.'
'A public health scandal'
It was announced on Tuesday Labour is backing a public inquiry into the implants and has called for the procedure to be immediately stopped in England while the inquiry is underway.
Sharon Hodgson MP, Labour's Shadow Public Health Minister, said: 'Mesh implants have left women in permanent pain, unable to walk, and unable to work. This is an ongoing public health scandal and the Government need to do much more to support those affected.
'Ministers have said NICE will publish updated guidance for these products but not until January 2018. Mesh implants should be taken off the market now until we know more about the threat they pose to women's safety.
'The Government have failed to answer big questions about the extent of this public health scandal, including how many women have been affected and why a product with such terrible risks was allowed into the market in the first place.
'Labour is calling for a full inquiry to uncover the extent of the harm done by mesh implants so we can be sure that this never happens again.'
Today's debate was called by Emma Hardy, MP for Kingston upon Hull West and Hessle.
Government rejects a ban
Last month the Government released its three-year investigation into the mesh scandal and rejected calls for a widespread ban on the implants, which can shrink, twist and curl at the edges, leading to nerve damage.
Vaginal mesh has been considered a high-risk device for nearly a decade in the US, with bodies accepting up to 40 per cent of women may experience side effects.
Some studies, published in an array of scientific journals, have shown that pain, erosion and perforation from the surgery can affect up to 75 per cent of women.
The alarming evidence prompted officials in three US states to suspend the practice and saw them call for an urgent review into its safety.
http://www.dailymail.co.uk/health/article-4996820/Woman-wins-High-Court-claim-ahead-against-vaginal-mesh.html
-
Woman who suffered life-changing vaginal mesh injuries to make High Court claim
Oct 19, 2017 | Metro News
By Oliver Wheaton
A woman has won the right to make a High Court claim over injuries she says she suffered from a vaginal mesh implant. Barbara Wise underwent surgery to treat her urinary stress incontinence at Beneden Hospital in Kent in 2007.
A TVT Secur Gynaecare vaginal tape, a product manufactured by Johnson & Johnson, was used by the surgeon during the operation. She initially experienced an improvement, however after six months suffered a relapse which developed into increasing pain along with other further complications and unpleasant symptoms. Investigations revealed that she had suffered erosion of the TVT tape into the vagina and she had corrective surgery in September 2011 before having a hysterectomy in January 2013.In September 2014, she began a product liability claim against Johnson & Johnson. The BBC reported in April this year that more than 800 women in the UK are taking legal action against the NHS and manufacturers. She also issued a claim against Mohammed Mossa, the surgeon who performed her original operation, alleging that he failed to obtain proper informed consent to the procedure.
It is said that he failed to provide adequate information about the TVT product and the procedure used and failed to advise properly as to alternative treatment options. Mr Mossa, who was terminally ill, died without being aware of the case but his estate argued that it could not proceed as it was brought outside the legal time limit. In May this year, a judge said that, looking at all the circumstances, it would be fair to allow the claim to continue. On Thursday in London, Mrs Justice Yip dismissed the estate’s appeal against that ruling. Yesterday Tory MP and chairperson of the Health Committee Dr Sarah Wollaston said that women who have undergone the vaginal mesh procedure ‘deserve an apology‘, saying they were not informed about the risks before the procedure.
http://metro.co.uk/2017/10/19/woman-who-suffered-life-changing-vaginal-mesh-injuries-to-make-high-court-claim-7012702/
-
Oct 19, 2017 | HuffPost UK
By Emma Hardy
The issue of surgical mesh implants was first brought to my attention when I was visited by a constituent. She was advised to have the mesh fitted in her 30s after suffering incontinence following the birth of twins and a hysterectomy. The impact it has had on her quality of life is devastating. She can’t walk very far now, she is unable to work, she is in constant pain and suffering. She is unable to partake in sport and has problems sleeping. I remember listening to her telling me about this life changing experience and being completely shocked.
Mesh surgery is a medical procedure used to treat incontinence and prolapse in women. The surgery, which usually takes less than half an hour, involves inserting a plastic mesh into the vagina to support the bladder, womb or bowel.
Although for most the surgery is successful, at present we have estimates from the Medicines and Health Products Regulatory Authority that around 1% to 3% suffer with complications. But a recent research report for the scientific journal ‘Nature’ showed evidence of around 10% of women suffering from complications after surgery, and other research studies estimate it could be 15% to 20% or even higher.- ADVERTISEMENT -
Mesh surgery was sold to many women as an easy fix to their problem and a quick way to allow them to carry on with their lives. Yet since I applied for the debate in Westminster Hall, my email inbox has been filling up with emails from women across the country telling me their horrific stories after having mesh implanted. Women in their thirties, forties and fifties are telling us they’re struggling to walk, they’ve lost their sex lives and suffer from horrendous pain day in day out. Some are even suffering from post-traumatic stress disorder following the horrific impact the mesh has had on their quality of life.
And I have no doubt that many women are suffering in silence, either too worried or too embarrassed to see their MPs or completely unaware that their symptoms are replicated in other women who have had the mesh fitted.
But this is only part of the problem, women are telling us that they’re going back to their doctors and surgeons after surgery and are being met with blank faces when they describe the complications they’re experiencing.
Our asks of the Government are simple. Leading a debate in Parliament today, I asked the Government to:
· Commit to a full retrospective and mandatory audit of all interventions using mesh followed by a full public enquiry.
· Suspend prolapse and incontinence mesh operations while the audit is being carried out.
· Bring forward the NICE guidelines for mesh in stress related urinary incontinence from 2019 to 2018.
· Commit to raising awareness of the issue with doctors and patients alike.
Yet the Minister’s response was very disappointing. I agree that the majority of women have not suffered complications but with potentially 10-15% of those who have had surgery experiencing devastating, life changing problems, the level of risk is just too high.
The Minister also failed to address the safety of the product itself. She stated that the Medicines and Healthcare products and Regulatory Authority has advised that mesh is the best route to treat stress urinary incontinence. There have, however, been serious concerns expressed by the All Party Parliamentary Group (APPG) on Surgical Mesh and campaigns such as Sling the Mesh over how products are regulated.
Prof Carl Heneghan, who is the Professor of evidence-based medicine at the University of Oxford, argues that manufacturers have to provide little evidence before their product is clinically approved and made available on the NHS. I’d totally agree with Owen Smith, the Chair of the APPG, when he says that the fact many companies have already taken their mesh product off the market should tell us that something is not right with these devices. We have to go to the very core of the issue and investigate the fundamental safety of these products, which needs to be acknowledged by the government.
Mesh implants have affected thousands of people all over the country. For some, the consequences of their operations will be life-changing and devastating. By committing to taking action now, the Government will not be able to undo the suffering and pain these people have endured, but it will go a long way to making sure that nothing like this will happen again.
http://www.huffingtonpost.co.uk/emma-hardy/mesh-implants_b_18314606.html
-
Inquiry into the surgical mesh implant 'scandal' is turned down by UK Government
Oct 19, 2017 | Wales Online
By Mark Smith
Many people in Wales have been left in chronic pain by the plastic implant
Patients who have had surgical mesh implants in Wales have voiced outrage that an inquiry into the “scandal” has been turned down by the UK Government.
A debate was held in the House of Commons on Wednesday which highlighted the plight of thousands of women and men who have been left in chronic pain from the implants.
Surgical mesh procedures are performed on the NHS and privately on around 10,000 UK women each year to treat hernia, pelvic prolapse and incontinence.
But many have experienced major complications and have been left in permanent pain, unable to walk, work or have sex.
Some have even reported feeling suicidal as their quality of life has been lost.
And leading surgeons have admitted that the mesh can prove very difficult to remove completely once it is inserted.
Following the debate, UK Government Public Health Minister Jackie Doyle-Price announced that guidelines by the National Institute for Health and Care Excellence (NICE) would be updated 18 months earlier than planned.
But she dismissed the need for an inquiry and said the health regulator, the Medicines and Healthcare Products Regulatory Agency, advised mesh was “still the best device for treating stress incontinence”.
“The issue is not the product, but clinical practice,” she said. “That’s what’s going wrong.”
Despite women coming forward to complain about their mesh complications, the procedure is still being carried out in hospitals across the UK.
Kath Sansom, of campaign group Sling The Mesh, said: “We welcome moves to publish new NICE guidelines by Christmas which will give the latest information on risks of mesh implants to treat incontinence.
“More than 135 women a week have a mesh tape implant in England alone to treat incontinence or prolapse. That figure is six a week in Wales.
“The refusal to call breathing space on these operations is putting these women at risk – they may well be members of the support group within weeks or months of having their operation.
“This is the only blind operation in the world. All other operations are done open or using a keyhole camera to guide the surgeon.
“For these mesh operations it uses giant hooks to pierce women’s pelvic areas to insert the mesh. Surgeons might as well be blindfolded as they can’t see where it is going and that is a huge problem.
“Also the mesh can shrink, twist or degrade. No amount of training or good surgery can account for this.”
Carolyn Churchill, from Nantgarw, had a mesh implanted six years ago to combat her stress incontinence.
She said she suffered “torture” at the hands of the device and has repeatedly called on the NHS to ban them.
Reacting to the Public Health Minister’s decision, she said: “I’m very disappointed but the fight goes on.
“They just won’t accept that the product is the problem, so now they are prepared to blame surgeons.”
Pauline Inch, from Barry, still has the polypropylene plastic mesh inside her and she claims it is slowly killing her.
The 60-year-old said it is now “embedded” in her bowel, abdomen and surrounding organs – but she says no surgeon will attempt to remove it.
Speaking after the debate, she said: “I was very disappointed in the health minister’s reply.
“I have been a hernia mesh victim in chronic pain for 15 years and I’ve been told this monster inside me can never come out.
“Polypropylene should never have been allowed to get into humans, yet it’s in me and thousands of others throughout the world.”
Peter Corbett, a former supermarket manager from Llwydcoed near Aberdare, said the procedure and subsequent removal of the implant has left him struggling to walk or play with his grandchildren.
He said: “My wife and I both think they should have an inquiry into the use of mesh and that it should not be used until it has been proved to be safe, which I think it will never be.
“No one knows how many people are affected as at the moment, and it’s only women that are coming forward, not men.”
Owen Smith MP, chairman of the Cross-Party Mesh Group, said: “Women who have been treated with mesh, or who are contemplating such treatment will be pleased that the government has agreed to bring forward new guidelines as soon as is possible.
“However, many of the women who attended today’s important first Parliamentary debate on mesh were deeply disappointed to hear the minister declare that ‘the issue is not with the product but with clinical practice’.
“That statement is not supported by clinical evidence which clearly shows that in a significant minority of women the nature and make up of mesh, especially polypropylene mesh, has been responsible for serious and chronic adverse reactions.
“And it is not acceptable for the minister to pass the buck on behalf of the companies who produce mesh to the surgeons who implant their devices. Not least, because almost all clinicians in this debate concede that we still have insufficient evidence about the long-term effects of mesh.
“That is why the government should conduct a full retrospective audit of all patients who have been treated with mesh, and also insist on a prospective registry of any new patients.
“Only then will we have some clarity, in England at least, on how many women have been treated with mesh, and for how many that treatment has caused life-changing complications.
“Until we have that certainty and a clearer sense of the true, long-term risks and benefits of mesh, its use by the NHS should be suspended.”
http://www.walesonline.co.uk/news/health/inquiry-surgical-mesh-implant-scandal-13785438
-
Government change comes as relief to surgical mesh sufferers
Oct 19, 2017 | Newshub
By Gemma Coombe
Surgical mesh campaigners hope the change in government may help prevent the suffering of hundreds of Kiwi women.
Patients from the Mesh Down Under action group met with Ministry of Health officials and medical experts this afternoon to discuss how to reduce the increasing number of injury claims.
Surgical mesh is supposed to change lives for the better, but for thousands of women, it has had a devastating affect.
"I have difficulty sitting, I have difficulty standing and walking, I'm in constant pain," says Carmel Berry of Mesh Down Under.
Ms Berry has been in chronic pain since 2004, when surgical mesh was inserted into her pelvic floor following a hysterectomy.
She says despite an inquiry by the Health Select Committee, not a lot has been done and new statistics appear to support her allegation.
Figures show an alarming increase in claims, from 44 in 2007/2008 to 150 in the past year, and during that time, ACC has paid out more than $13 million.
But after a meeting today between the action group and health officials, change is imminent.
"Everybody wants something to happen," Patricia Sullivan from Mesh Down Under. "It's just a matter of now how quickly we can get those things in place."
The Ministry has agreed to establish a registry to track usage and complications. It also wants new legislation for approving medical equipment, like mesh, that arrives here from overseas.
"With the election of a new government, that potentially makes it a higher priority," says Ministry of Health protection, regulation and assurance director Stewart Jessamine.
Ms Berry says new Prime Minister Jacinda Ardern has also personally promised to get involved.
"She has put it in writing to our group on her campaign trail that there will definitely be change."
Where it sits on the new Prime Minister's list of priorities though remains to be seen.
Newshub.
http://www.newshub.co.nz/home/health/2017/10/government-change-comes-as-relief-to-surgical-mesh-sufferers.html
-
Inquiry into mesh implants rejected by government
Oct 19, 2017 | Medical Plastics News
By Reece Armstrong
The government has rejected calls to ban vaginal mesh implants after MPs debated its use to treat women affected by pelvic organ prolapse and incontinence following childbirth.
Labour MP Emma Hardy led the debate after hearing from women who have been affected by the devices. Hardy first heard about the mesh implants from a constituent who was left unable to work after having the device fitted.
Hardy called the debate ‘crucial’ for those affected and asked the government to do four things:
· Commit to a full retrospective and mandatory audit of all interventions that involved mesh, followed by a full public inquiry.
· Suspend prolapse and incontinence mesh operations while the audit is being carried out.
· Bring the NICE guidelines for mesh in stress-related urinary incontinence forward from 2019 to 2018.
· Raise awareness among the general public and GPs.
Labour MP for Pontypridd Owen Smith who has previously raised awareness over the use of mesh implants, agreed with Hardy and said that issues raised by women over the effects of the implants had been ‘dismissed’ and that ‘women have been patronised by being told that their problems were unique’.
A number of other MPs spoke about how they had been contacted by both men and women who’ve had their lives changed for the worse because of the implants.
Labour MP Sharon Hodgson thanked Kath Samson, the head of Sling the Mesh campaign for uniting women who had been affected by the implants.
She continued, saying: “The NHS and the MHRA say that the risk of complications is low, at 1% to 3%, but a report by nine leading medics put the risk much higher, at 15%. If leading bodies and medical professionals cannot agree, how can patients be expected to make informed decisions?
Hodgson went on to state that Labour are asking for an urgent public inquiry into the implants, specifically into ‘the number of women adversely affected by vaginal mesh implants and into why the safety of so many women was disregarded’.
Kath Sansom of Sling the Mesh campaign said before the debate: “We hope the debate will make the ruling government wake up to the fact that both prolapse and incontinence meshes and tapes pose serious harm to many women with risks rates that are unacceptably high.”
Labour are also urging the NHS and NICE to immediately update the guidance and suspend the use of vaginal mesh.
Responding to the requests, Jackie Doyle-Price, the Parliamentary Under-Secretary of State for Health refused to suspend the mesh and disregarded the need for a public enquiry. She said that the issue is not with the mesh implants and is instead related to clinical practice.
She said women need to be treated properly and that they are given the proper advice, risk assessments and are also able to report any complications.
Doyle-Price continued: “The most important thing we can do—my priority—is to ensure that they get the support, care and treatment they need to alleviate a debilitating condition.”
NICE guidelines on the implants will be made available before the end of 2017, Doyle-Price said. She also said that mesh is the best product for treating incontinence but agreed that the evidence regarding prolapse is more mixed.
Hardy was disappointed with the results, calling the minister’s response ‘simply not good enough’.
She said: “I completely disagree with her: it is about not only the procedure, but the product. I hope that the weight of evidence from all the women involved—all the women who have emailed, all the constituents and all the people who have contacted Sling the Mesh—will be enough to show the Minister that this is more than just procedural; this is about the product.”
https://www.medicalplasticsnews.com/news/inquiry-into-mesh-implants-rejected-by-government/
-
Vaginal mesh implants “a national scandal” says Deeside MP
Oct 19, 2017 | Deeside
Deeside Politicians say they are disappointed with the Governments response to a debate in Westminster Hall yesterday, Wednesday 18th October on the use of controversial vaginal mesh tape.Hundreds of woman have been left in permanent pain, unable to walk, work or have sex because of mesh tape used in operations to cure prolapse, incontinence and hernia.
Alyn and Deeside politicians, Mark Tami MP and Carl Sargeant AM, have been campaigning on behalf of an affected constituent, Maxine Cooper, to suspend the use of Mesh.
Mr Tami spoke in the debate calling the use of mesh a “national scandal”.
The debate brought forward by Labour MP Emma Hardy called for a public inquiry into the use of mesh after it was revealed that more than 800 women are taking legal action against the NHS and the makers of vaginal mesh implants.
During the debate, Conservative MP and GP Dr Sarah Wollaston the health committee chairman paid tribute to the many women who “have been courageous in coming forward and discussing intensely painful and personal experiences, not only with myself but with other Members.
Dr Wollaston also said that a “fundamental absence of data” is at the heart of the issue.
“There has been cavalier practice, and we cannot allow that to continue. The women who have been affected deserve an apology and recognition of the extent of the problem and the delays in recognising and dealing with it.”
There had been “clear failings have been allowed to continue for so long. At the heart of those failings is the inadequacy of clinical trials, recording and consent.” She said.
Elmet and Rothwell MP Alec Shelbrooke said; “I did a lot of work on the thalidomide campaign and I thought this was the next thalidomide scandal.”
Adding; “Suspension [of the implants] and study of the data is vital; otherwise, we could be creating the biggest scandal in years in the NHS.”
The Parliamentary Under-Secretary of State for Health, Jackie Doyle-Price, responded to numerous cases brought forward during the debate, she said the problem lies not with the product, but with the procedure, and failed to commit to a public inquiry or suspension of the product.
Alyn and Deeside AM Carl Sargeant has been campaigning to suspend mesh use in Wales in support of constituent Maxine Cooper from Connah’s Quay.
She has suffered years of excruciating complications after her mesh procedure and is slowly recovering after a removal operation.Carl Sargeant said:
“This debate was an important opportunity to air the truth that women across the UK have known to their cost for years – that mesh can leave women with dreadful, life-changing injuries. Mark Tami, Emma Hardy and Owen Smith did the mesh-injured women proud.
Unfortunately, the health minister’s response was disappointing and we will have to keep fighting for a suspension of mesh procedures.
In Wales Health Secretary Vaughan Gething has written to me with more information on the task and finish group on mesh and reassured me that the group will hear evidence from mesh affected women. I hope in Wales these women will be listened to and their wishes acted upon.”
Maxine was too ill to travel to London for the debate but was pleased Mr Tami was there to represent her.Following the debate Mark Tami said;
“I was grateful that this debate was secured and I am glad so many MPs took the opportunity to speak up on behalf of their constituents.
The number of cases brought forward are a reflection of the clear failings that have happened. The lack of clinical trials and the discrepancies with recordings and consent really is a national scandal.
The Minister’s response was disappointing and shows how out of touch this Government is.
Hopefully women across the country will continue to speak up and put the Government in a position where the evidence can’t be ignored.”
http://www.deeside.com/vaginal-mesh-implants-national-scandal-says-deeside-mp/
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Add recipients
Suggested