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Ethicon Media Monitoring 12/19/2018
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Justice Secretary apologises for botched review of vaginal mesh scandal
Dec 19, 2018 | Press Association (In Aol.)
The Justice Secretary has apologised to the victims of the botched review into the transvaginal mesh scandal while also facing calls to open a public inquiry into the murder of Craig McClelland. -
Gold Coast to host service dedicated to women affected by pelvic mesh
Dec 19, 2018 | Mirage News
The Palaszczuk Government will open Australia’s first specialised service for women with pelvic mesh complications on the Gold Coast in the first half of 2019. -
Toxic Baby Powder; NIH Stiffens Funding Rules; Child Psychiatrist Probe Continues
Dec 18, 2018 | Medpage Today
By Vicky Stern
.... Earlier this year, The Guardian, in partnership with the International Consortium of Investigative Journalists (ICIJ), began exploring how poorly medical devices are regulated and what happens when medical devices fail. -
Medtech’s year of living dangerously
Dec 18, 2018 | Plastics Today
By Norbert Sparrow
.... The Bleeding Edge catalogued complications with the Essure birth control device from Bayer, metal-on-metal hip implants and vaginal mesh implants.
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Justice Secretary apologises for botched review of vaginal mesh scandal
Dec 19, 2018 | Press Association (In Aol.)
The Justice Secretary has apologised to the victims of the botched review into the transvaginal mesh scandal while also facing calls to open a public inquiry into the murder of Craig McClelland.
Mesh implant procedures were temporarily banned in Scotland after incidents where the net-like implant was found to erode and disintegrate, damaging organs, vaginal walls and, in some cases, have been linked to deaths.
A bungled investigation into the scandal lasting three years incensed many victims and was branded a “whitewash” by politicians, so a review into public inquiries was commissioned by the Scottish Government.
I am deeply, deeply sorry for the suffering of those women affected by the mesh has been compounded by what went wrong with the process of the reviewHumza Yousaf, Justice Secretary
Professor Alison Britton, of Glasgow Caledonian University, found that the original mesh review was “ill-conceived, thoughtlessly structured and poorly executed”.
Responding to the report in Holyrood, Justice Secretary Humza Yousaf said: “I am deeply, deeply sorry for the suffering of those women affected by the mesh has been compounded by what went wrong with the process of the review.
“I am determined that future inquiries and reviews learn the necessary lessons and ensure those who have suffered harm and the country at large are confident that a fearless, independent and robust investigation has taken place.”
The report by Prof Britton cleared any individual of deliberate wrongdoing, saying: “We were satisfied that no one involved in the mesh review was acting in bad faith.”
It added: “We found no evidence to support the claim that evidence was deliberately concealed.”
In September, a pause on all trans-vaginal mesh procedures was announced, and Mr Yousaf promised: “The temporary halt will be lifted only once all the restricted-use protocol is developed and in place.”
“It will be informed by new evidence-based guidelines from the National Institute for Health and Care Excellence and will ensure that in future trans-vaginal mesh will only be used in the most limited of circumstances, subject to rigorous process,” he added.
Mr Yousaf also announced that the Scottish Government would use the report to create guidance to be be issued in situations where a review or inquiry is being considered in Scotland.
However, Labour’s Neil Findlay MSP – who has been an active campaigner on behalf of the women affected – said that the Cabinet Secretary’s intentions did not go far enough.
He said: “I think today’s statement is pretty pathetic. We don’t want Government-written guidance, what we want is the full recommendations – all of them – of Professor Britton’s report implemented.”
Professor Britton’s report has caused discomfort for Ministers but they should implement it in its entirety. Anything less is an insult to the mesh victimsNeil Findlay MSP
Speaking after the statement on the conduct of reviews and inquiries, Mr Findlay added: “The mesh review was a complete whitewash.
“The Britton review was passed to the Government in the summer and still the Government could not say how many of the 46 recommendations it will accept.
“It is clear that Professor Britton’s report has caused discomfort for ministers, but they should implement it in its entirety.
“Anything less is an insult to the mesh victims.”
Scottish Conservative MSP Liam Kerr quoted Mr Yousaf’s comments about full public inquiries sometimes being the only way to restore people’s trust, and urged him to launch an inquiry into the murder of Craig McClelland.
The Paisley father-of-three was stabbed to death by a killer with 16 previous convictions who was initially released from prison on curfew with electronic tag, but was at liberty illegaly when he killed Mr McClelland.
James Wright, 25, was sentenced to life imprisonment for the murder in June this year.
Mr McClelland’s family have demanded a public investigation into how his killer was allowed to be free, but Mr Yousaf has resisted and said he does not believe a full public inquiry is the “appropriate” response at this time.
He added that he has written to the family with responses to their questions, with answers from the Scottish Prison Service, Police Scotland and the Scottish Government.
A Scottish Government spokesman added: “While nothing can take away their grief, the Cabinet Secretary has met the McClelland family on a number of occasions to listen to their concerns and to help assemble information from relevant agencies outlining a better understanding of the circumstances of Craig’s death, while also ensuring wider lessons are learned and improvements made.
“The Scottish Prison Service (SPS) and Police Scotland, as well as the Scottish Government, have accepted all 37 recommendations made by the two independent Inspectorate reviews that have already examined the Home Detention Curfew (HDC) scheme, including looking at the circumstances of James Wright’s release and subsequent breach of HDC.
“The Cabinet Secretary has now written to Craig’s family providing further information from SPS and Police Scotland in direct response to questions the family had, which acknowledges where issues have been identified to them in light of this case and what actions were taken.
“We are now focused on ensuring there is real and demonstrable progress in implementing the independent recommendations, which is why the Cabinet Secretary has asked both Inspectorates to review progress next spring.”
https://www.aol.co.uk/news/2018/12/18/justice-secretary-apologises-for-botched-review-of-vaginal-mesh/?guccounter=1
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Gold Coast to host service dedicated to women affected by pelvic mesh
Dec 19, 2018 | Mirage News
The Palaszczuk Government will open Australia’s first specialised service for women with pelvic mesh complications on the Gold Coast in the first half of 2019.
Health Minister Steven Miles said the Queensland Pelvic Mesh Service would comprise a team of medical, nursing and allied health specialists, offering expertise in surgery, continence care, chronic pain management and counselling.
“This is the first service to be co-designed with clinicians, Health Consumers Queensland and consumer representatives to ensure it meets the needs of affected women.
“There are many women who are experiencing significant health problems caused by pelvic mesh devices, and their stories have been heart-wrenching,” Mr Miles said.
“The Queensland Pelvic Mesh Service will include an initial comprehensive interdisciplinary assessment, resulting in a plan developed for each woman that meets her needs and recovery goals.
“This care may include medical and nursing treatment and procedures, continence care, chronic pain management, counselling, psychology, social work support and physiotherapy.”
Member for Gaven Meaghan Scanlon said the specialist team would be based on the Gold Coast but that women from across the state would have access.
“This highly specialised interdisciplinary service will be delivered here on the Gold Coast, meaning all the expertise in caring for and treating women with pelvic mesh complications is available at the one site.”
“The Palaszczuk Government is committed to providing specialised care and treatment for women, whether they live in rural, remote, regional or metropolitan Queensland. Which is why the Queensland Health Patient Travel Subsidy Scheme will subsidise travel and accommodation costs for eligible women across the state.”
“Due to the complexity of mesh complications, each woman will have very different needs.”
“Based on the interdisciplinary assessment and in consultation each woman, care and treatment will be offered relevant to their personal recovery needs,” Ms Scanlon said.
Queensland Health will provide $3.14 million annually to the Gold Coast Hospital and Health Service to operate the new service.
In 2018, the Therapeutic Goods Administration (TGA) restricted the sale of transvaginal mesh products designed solely for the treatment of pelvic organ prolapse and single incision mini-slings used to treat stress urinary incontinence.
The action was taken after a TGA review determined the risks of using transvaginal mesh for pelvic organ prolapse outweighed the benefits to women.
Queensland Health’s Clinical Excellence Division Deputy Director-General, Dr John Wakefield, said the new state-wide service will partner with women to develop individualised care and recovery plans.
“The co-design with consumer representatives and clinicians has been central to the development of the Queensland Pelvic Mesh Service,” Dr Wakefield said.
Melissa Fox, Chief Executive of Health Consumers Queensland said, “Mesh affected women have been strong advocates for the care that they need. We are pleased that Queensland Health has listened and co-designed a service that we hope will be responsive to their needs.”
Ms Fox said, “Health Consumers Queensland look forward to continuing to support the ongoing partnership between Queensland Health and consumers.”
Dr Wakefield said, “Acknowledging the impacts of mesh complications in daily life is essential, as is responding to the needs of women suffering from pain.”
“We offer our sincerest sympathies to these women and their families.”
“We understand each of these women has different complications and health needs, so our services will be holistic and personalised to ensure each patient receives the precise care they require.”
The Queensland Pelvic Mesh Service is anticipated to open the first half of 2019.
Women seeking to access the service will require a referral from their general practitioner.
https://www.miragenews.com/gold-coast-to-host-service-dedicated-to-women-affected-by-pelvic-mesh/
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Toxic Baby Powder; NIH Stiffens Funding Rules; Child Psychiatrist Probe Continues
Dec 18, 2018 | Medpage Today
By Vicky Stern
Welcome to the latest edition of Investigative Roundup, gathering some of the best investigative reporting on healthcare each week.
J&J Hid Knowledge of Tainted Baby Powder
Darlene Coker wanted to understand why she was dying of cancer. Coker, along with her personal injury lawyer, suspected Johnson & Johnson's Baby Powder was to blame.
Two decades ago, Coker sued the company, alleging that the talc powder she'd used on herself and her babies was tainted with asbestos, a known carcinogen. But, throughout the lawsuit, J&J denied the allegations. The company was not compelled to disclose internal documents and, without sufficient proof to back her claim, Coker had to abandon the suit.
Now, two decades later, J&J's baby powder has come under renewed scrutiny. Internal documents from J&J, obtained by Reuters, tell a different story about the product's safety -- showing that, although most test reports did not find asbestos, "the company's powder was sometimes tainted with carcinogenic asbestos and that J&J kept that information from regulators and the public."
The first mention of needle-like contaminants occurred as early as 1957, and a J&J scientist's lab notes from 1972 cites "incontrovertible asbestos." Now, 11,700 plaintiffs are claiming the company's talc caused their cancers.
New Probe for Disgraced Child Psychiatrist
Regulators in Illinois are investigating a once-prominent psychiatrist who resigned her post at the University of Illinois at Chicago in June after the school's investigation found she had committed research misconduct.
In August and September, the state issued three subpoenas to the university regarding Mani Pavuluri, MD, and her research examining the effects of the lithium on children and teens with bipolar disorder, according to reporting by Propublica, The Chronicle of HigherEducation and the Chicago Sun-Times. One subpoena, from the state's medical disciplinary board, ordered the university to provide records related to the clinical trial on children with bipolar disorder and will evaluate whether complaints against Pavuluri require disciplinary action. The two other subpoenas seek Pavuluri's "complete and unredacted personnel file" and her "application and credentialing file," which includes background check information.
The university has already been dinged for Pavuluri's misconduct. Last April, ProPublica Illinois reported that the National Institute of Mental Health demanded the university repay $3.1 million in grant money Pavuluri received for her research. Since leaving the University of Illinois at Chicago, Pavuluri has opened her own medical practice.
NIH Upgrades Policies after Alcohol Study Debacle
In June, the National Institutes of Health halted a study evaluating the benefits of moderate drinking after uncovering that the researchers had solicited funding from industry.
Now, the NIH is cracking down on similar practices that could compromise the integrity of its research, The New York Times reported. Last week, the NIH announced its new policies and recommendations to prevent corporate donations and interests from affecting the credibility of future research projects. The NIH report said that its "27 institutes must evaluate all current research projects that receive private donor support for conflicts of interest of the kind that compromised the alcohol trial."
Francis Collins, MD, director of NIH, told the Times, "We have to do everything we can to ensure the integrity of the NIH grants process and the quality of our research is above reproach, which means worrying about conflicts."
Some experts, however, do not believe the new policies go far enough. "These recommendations are weak and will not prevent industry influence," said Adriane Fugh-Berman, MD, a professor at Georgetown University and founder of the industry watchdog group Pharmed Out.
Poor Device Regulation Laid Bare
"We have been shocked by the lack of transparency" when researching issues with medical devices, The Guardian said.
Earlier this year, The Guardian, in partnership with the International Consortium of Investigative Journalists (ICIJ), began exploring how poorly medical devices are regulated and what happens when medical devices fail. The international team has "ploughed through pages and pages of court documents and data released through freedom of information requests, spoken to surgeons and specialists around the world, and heard -- often heartbreaking -- stories from those who have suffered when things have gone wrong."
As part of this effort, The Guardian reported that Johnson & Johnson (yes, again) sold vaginal mesh implants even after evidence emerged that the mesh could shrink and harden inside the body. The ICIJ team has also created an International Medical Devices Database to document recalls and safety alerts related to medical devices.
https://www.medpagetoday.com/publichealthpolicy/ethics/76993
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Medtech’s year of living dangerously
Dec 18, 2018 | Plastics Today
By Norbert Sparrow
The medical device industry went through a rough patch in 2018, at least in the public eye. Historically, it has been relatively sheltered from the sort of opprobrium directed toward sectors such as Big Pharma and the plastics industry. That shifted this year, as the Netflix documentary The Bleeding Edge and the Implant Files report were released.
The Bleeding Edge catalogued complications with the Essure birth control device from Bayer, metal-on-metal hip implants and vaginal mesh implants. These are not new controversies and have been the target of countless lawsuits, but the 90-minute documentary, which gave voice to people who have been harmed by these devices, renewed public interest.
The filmmakers argue for more rigorous regulatory oversight to prevent incidents of this kind in the future. Sister brand MD+DI, a business-to-business publication for the medical technology industry, produced an online poll asking its audience for feedback on the documentary. I found it interesting that the readers generally did not lambaste the film. Even some who found it “one-sided,” noted that they “agreed with many things in the film” and that it “brought out some issues we need to address.”
The Bleeding Edge started streaming on Netflix in the summer. Then in November came the Implant Files report. More than 250 journalists from dozens of media outlets across the world conducted a yearlong investigation of adverse events involving medical implants. The report noted that FDA has collected 5.4 million adverse event reports over the past decade, which included 1.7 million reports of injuries and almost 83,000 deaths. I was critical of the way in which some medical device associations, speaking on behalf of industry, punched back. We’re painfully familiar with the when-they-punch you, counterpunch-harder technique, but I don’t think it’s a winning strategy in the long run.
Both The Bleeding Edge and the Implant Files report called out FDA’s 510(k) program as being an antiquated tool for regulating medical devices. FDA’s 510(k) process lets low- to medium-risk devices on the market as long as the manufacturer can show “substantial equivalence” with an existing device, which may be decades old. The agency itself has tacitly acknowledged that it can do a better job regulating medical devices and has proposed a modernization of the approval process. In a statement issued the day after media outlets began reporting on the Implant Files, FDA recognized that allowing medical device manufacturers to rely on comparative testing against “predicate” devices that may be more than 10 years old is not advancing medical technology. “That doesn’t mean the products are unsafe,” FDA stressed in the statement. “But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.”
Enough sturm und drang, though—in 2018, as in every year that I’ve been alive, there were countless examples of the medtech industry applying advanced technologies to saving lives and improving quality of life. For the purposes of this article and because, well, we are PlasticsToday, I will limit the scope to advances in the world of medical polymers.
A peak year for PEEK
It was a very good year for polyether ether ketone (PEEK) in medical applications. As Len Czuba noted in an interview with PlasticsToday, “this unique material can be sterilized by any of the most commonly used methods of sterilization and is virtually inert when exposed to solvents and any natural fluids found in the human body. These properties make it an ideal material for long-term implant devices, whether they are orthopedic hardware, such as bone pins, plates and screws, or components of a joint-replacement device. For this reason, the variety of specialty products made with the ketone polymers have grown dramatically while the range of polymers offered for these applications has also grown.”
For example, a micro-porous hydrophilic PEEK technology developed by medical polymers company DiFusion Inc. (Austin, TX) was named one of the top 10 spine technologies of 2018 by Orthopedics This Week. ZFUZE PEEK Composite received the recognition because it supports bony in-growth in orthopedic implants while retaining the mechanical properties and imaging capabilities of traditional PEEK. Described as a new biomaterial capable of being injection molded, 3D printed or machined, ZFUZE is currently being scaled up for commercial launch in early 2019.
Solvay Specialty Polymers (Brussels) announced this year that China-based artificial joint manufacturer Okani Medical Technology has developed an all-polymer knee implant using Solvay’s Zeniva PEEK. Okani’s novel ORGKnee implant reportedly offers a longer service life at a lower cost than traditional metal-based implant systems.
PEEK also made news in the medical 3D printing space, when Evonik (Essen, Germany) announced the development of an implant-grade PEEK filament for 3D printing in November. Formulated for fused filament fabrication technology, the material is based on Vestakeep i4 G, which has a long history of use in spinal implants, maxillofacial surgery and sports medicine.
More broadly, the 3D printing materials portfolio expanded significantly this year.
Sabic (Riyadh, Saudi Arabia) introduced two medical-grade materials at NPE2018: Ultem AMHU1010F, a polyetherimide product that provides inherent high-heat resistance, and Lexan AMHC620F, a biocompatible polycarbonate filament that withstands gamma and EtO sterilization.
Solvay (Brussels) added the first medical-grade additive manufacturing (AM) filaments suitable for contact with bodily fluids and tissue for less than 24 hours to its high-performance materials portfolio. The new materials are a neat KetaSpire PEEK AM filament, a 10% carbon-fiber-reinforced KetaSpire PEEK AM filament and a neat Radel polyphenylsulfone AM filament.
Digital manufacturing company Carbon (Redwood City, CA) achieved a milestone this year when it introduced its first medical-grade material. The Medical Polyurethane 100 (MPU 100) resin combines mechanical strength, biocompatibility and sterilizability, making it suitable for the fabrication of medical components used in skin- and drug-contact devices and single-use applications.
What’s next? That is a question we will endeavor to answer after the holidays in our annual medtech forecast. In the meantime, stay healthy.
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