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Ethicon Media Monitoring 11/22/2018
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TVMIs no longer first-line treatment for pelvic prolapse - report
Nov 21, 2018 | RTE
By Fergal Bowers
The use of Transvaginal Mesh Implants for treating pelvic organ prolapse is no longer regarded as appropriate first-line treatment internationally, a report from the chief medical officer at the Department of Health concludes. -
Report warns women should be informed of potential risks of controversial vaginal mesh implants
Nov 21, 2018 | independent.ie
By Eilish O'Regan
Controversial vaginal mesh implants should only be offered to women following assessment and detailed discussion about the associated risks and benefits as well as alternative treatment, a Department of Health report said today. -
Vaginal mesh devices should not be first treatment for prolapse in women, report finds
Nov 22, 2018 | The Irish Times
By Paul Cullen
Vaginal mesh devices should not be used as a first-line treatment of prolapse in women, according to a report by the chief medical officer of the Department of Health. -
Changes to vaginal surgeries as Minister praises women for 'making public their private suffering'
Nov 21, 2018 | thejournal.ie
By Michelle Hennessy
THE MINISTER FOR Health has praised the bravery of women affected by vaginal mesh complications as he confirmed today that a suspension of these surgeries will remain in place until the HSE implements a number of recommendations. -
FDA TURNS TO 'ACTIVE' MONITORING ON WOMEN'S HEALTH DEVICES
Nov 21, 2018 | Politico- Morning eHealth
By Arthur Allen
The agency on Tuesday announced a break from its current post-market surveillance system that largely relies on device users to report problems and sometimes results in underreporting. -
FDA commits to rapid device safety responses using real-world data and active surveillance
Nov 21, 2018 | Fierce Biotech
By Conor Hale
The FDA has set itself a new goal: to become the international leader in medical device safety through better use of big data. -
FDA outlines measures to improve medical device safety plan
Nov 21, 2018 | Medical Plastics News
The Food and Drug Administration (FDA) has announced “several key actions” to update its Medical Device Safety Action Plan with the aim of creating a more robust medical device safety net through better data. -
FDA details ramp-up of postmarket device oversight
Nov 21, 2018 | Medtechdive
By Susan Kelly
The FDA released a lengthy statement Tuesday laying out plans to increase postmarket surveillance of medical devices and set a new goal to be “consistently first” among global regulators to respond to safety signals from those products.
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TVMIs no longer first-line treatment for pelvic prolapse - report
Nov 21, 2018 | RTE
By Fergal Bowers
The use of Transvaginal Mesh Implants for treating pelvic organ prolapse is no longer regarded as appropriate first-line treatment internationally, a report from the chief medical officer at the Department of Health concludes.
It follows concerns raised about the frequency and severity of complications linked with the use of TVMIs.
These have been widely used for the surgical treatment of stress urinary incontinence and pelvic organ prolapse.
The report from Dr Tony Holohan says there is an evidence base to support the use of mid-urethral sling mesh devices in the treatment of stress urinary incontinence and the use of abdominally placed mesh in the management of pelvic organ prolapse.
It says that all TVMIs should only be offered, following assessment and after detailed discussion with the patients about the associated risks and alternative treatment options.powered by Rubicon Project
The report makes 19 recommendations, including the need to develop patient information and informed consent material.
https://www.rte.ie/news/health/2018/1121/1012464-transvaginal-mesh-implants-health/
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Report warns women should be informed of potential risks of controversial vaginal mesh implants
Nov 21, 2018 | independent.ie
By Eilish O'Regan
Controversial vaginal mesh implants should only be offered to women following assessment and detailed discussion about the associated risks and benefits as well as alternative treatment, a Department of Health report said today.
They are devices used by surgeons to treat pelvic organ prolapse and urinary incontinence in women.
Usually made from synthetic polypropylene, a type of plastic, the implants are intended to repair damaged or weakened tissue in the vagina wall.
Other fabrics include polyester, human tissue and absorbable synthetic materials.
Some women reported severe and constant abdominal and vaginal pain after the surgery. Infections, bleeding and even organ erosion has also been reported.
The report was carried out from Dr Tony Holohan, chief medical officer, on the clinical and technical issues associated with the use of the treatments..
A key conclusion of the report is that there is evidence base to support the use of mid-urethral sling (MUS) mesh devices in the treatment of stress urinary incontinence and the use of abdominally placed mesh in the management of pelvic organ prolapse.
The report also concludes their use for treatment of pelvic organ prolapse specifically is no longer regarded as appropriate first line treatment internationally.
It recommends that the HSE develop protocols to ensure its use is restricted to the management of complex prolapse cases, where other treatment options have failed or are not appropriate, and where patients are fully informed.
The Report makes 19 recommendations in all, including the necessity to develop patient information and informed consent materials; surgical professional training and multi-disciplinary expertise in units carrying out mesh procedures, and ensuring timely, appropriate and accessible care pathways for the management of women with complications.
Minister Harris said: “The bravery, commitment and dignity shown by these women in sharing what were harrowing, deeply personal experiences are acknowledged and appreciated. The telling of their stories makes public what heretofore was often a private suffering.
“Their stories and their courage caused me to act and I want to thank the Chief Medical Officer for his work in addressing the understandable public and patient anxiety about this issue.
“A pause remains on the use of mesh procedures, pending confirmation by the Health Service Executive that the key recommendations have been implemented. I have already committed to meeting again with mesh survivors Ireland to discuss the report and I look forward to doing that in the coming weeks.”
https://www.independent.ie/irish-news/health/report-warns-women-should-be-informed-of-potential-risks-of-controversial-vaginal-mesh-implants-37552289.html
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Vaginal mesh devices should not be first treatment for prolapse in women, report finds
Nov 22, 2018 | The Irish Times
By Paul Cullen
Chief medical officer says mesh devices associated with significant and severe complications in minority of women
Vaginal mesh devices should not be used as a first-line treatment of prolapse in women, according to a report by the chief medical officer of the Department of Health.
Mesh devices are associated with significant and severe complications in a minority of women, and this is of concern given the difficulties of removing them, the report by Dr Tony Holohan states.
Dr Holohan was asked by Minister for Health Simon Harris to draw up the report last July after British authorities enforced a pause on the use of vaginal mesh devices and groups representing women who used the product alleged painful and chronic complications.
A similar pause ordered by the Minister in Ireland is to remain in place until the recommendations in Dr Holohan’s report are implemented, according to Mr Harris.
“A pause remains on the use of mesh procedures, pending confirmation by the Health Service Executive that the key recommendations have been implemented,” he said when publishing the report on Wednesday.
“I have already committed to meeting again with Mesh Survivors Ireland to discuss the report and I look forward to doing that in the coming weeks.”
Transvaginal mesh implants (TVMIs) have been widely used in the surgical treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP) in women.
Dr Holohan’s report finds there is an evidence base to support the use of mid-urethral sling (MUS) mesh devices in the treatment of incontinence and, separately, the use of abdominally placed mesh in the management of prolapse.
“A significant majority of patients benefit greatly from these procedures, with reduced long-term complications and improved functional outcomes compared to non-mesh procedures,” the report states.Assessment
The report says mesh implants should only be offered following assessment and after detailed discussion with the patient about the associated risks and benefits and alternative treatment options.
“The use of TVMIs for the treatment of POP specifically is no longer regarded as appropriate first line treatment internationally,” the report states, adding that that the HSE should develop protocols to ensure their use is restricted to the management of complex POP cases, where other treatment options have failed or are not appropriate, and where patients are fully informed.
The report makes 19 recommendations on the development of patient information and informed consent materials; surgical professional training and multi-disciplinary expertise in units carrying out mesh procedures; and ensuring timely, appropriate and accessible care pathways for the management of women with complications.
A significant number of these recommendations are already underway by the HSE, according to Mr Harris.
Members of the Mesh Survivors Ireland group met the minister last June to call for a suspension of the mesh device and to discuss how the treatment of women suffering from SUI or POP could be improved.
On Wednesday, Minister Harris said: “The bravery, commitment and dignity shown by these women in sharing what were harrowing, deeply personal experiences are acknowledged and appreciated. The telling of their stories makes public what heretofore was often a private suffering.”
Surgical mesh is a medical device made from a synthetic material has been in use since the 1950s to repair abdominal hernias and since the 1990s in treating male and female SUIs, female POPs and bowel disorders.
POP, which affects women who have given birth, is when one of more of the organs in the pelvis slips down from their normal position and bulge into the vagina. SUI is the unintentional loss of urine and occurs when the muscles that support the bladder weaken.
The report says it is widely accepted that for many women suffering incontinence, the use of mesh devices has provided a more effective and less invasive form of treatment than traditional surgical procedures.
https://www.irishtimes.com/news/health/vaginal-mesh-devices-should-not-be-first-treatment-for-prolapse-in-women-report-finds-1.3705954
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Changes to vaginal surgeries as Minister praises women for 'making public their private suffering'
Nov 21, 2018 | thejournal.ie
By Michelle Hennessy
THE MINISTER FOR Health has praised the bravery of women affected by vaginal mesh complications as he confirmed today that a suspension of these surgeries will remain in place until the HSE implements a number of recommendations.
Thousands of women across the world have reported complications after procedures involving the use of vaginal mesh. In Ireland, a support group for affected women has more than 400 members and around 100 patients are taking legal action either against the State or their consultants.
Vaginal mesh devices are used in operations to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP); two conditions women can suffer from after natural childbirth or in their later years.
Irish women who have had surgeries using these implants have reported complications like chronic pain, reduced mobility and recurrent infections. Many have spoken of an inability to be intimate with their partners and some have had to have multiple surgeries to remove parts of the mesh after it eroded or moved inside them.
In November last year, Minister Harris asked the Chief Medical Officer (CMO) Tony Holohan to compile a report on the use of these medical devices. Harris today published the report, which found there is an evidence base to support the use of mesh in some circumstances:The use of a mid-urethral sling for stress urinary incontinenceThe use of abdominally placed mesh for management of prolapse
However the report states that devices known as transvaginal mesh implants (TVMIs), used for the treatment of pelvic organ prolapse, are no longer regarded as appropriate as the first line treatment.
Holohan said these devices should only now be used in the management of complex cases, where other treatment options have failed or are not appropriate and where patients are fully informed.
Complications
In his report, he notes that it has been reported in a number of international safety reviews that complications relating to mesh devices may be “severe and life-altering” in a minority of women.Mesh complications can be extremely difficult to treat in some patients because of the unique characteristics of mesh devices, which are designed to be permanently implanted.
Complications reported with mesh implants used in the treatment of both stress urinary incontinence and pelvic organ prolapse include pain, erosion through the vagina or surrounding tissue, infection, urinary problems, pain during intercourse, bleeding, organ perforation and neuro-muscular problems.
These complications risks apply to all mesh procedures, not just the TVMIs that Holohan has recommended restrictions on. He noted in his report that all of these complications also occur following non-mesh procedures to treat these conditions, except for mesh erosion.Mesh erosion (for example through the vaginal wall) is one of the complications most highlighted in recent media reports. All synthetic meshes are associated with some risk of mesh erosion, reported by different studies in the reports in the footnotes below to occur in 2-4% of SUI procedures and 4- 19% of POP procedures.
Holohan in his report stated that many women who have undergone these procedures have had satisfactory outcomes and he highlighted the fact that a number of women suffering from these conditions have had their procedures postponed.
Informed consent is one issue many of the affected women have raised as part of their campaign. Members of the Mesh Survivors Ireland group have said their surgeons did not tell them beforehand that there was a risk – even a small one – that they could experience longterm pain or other complications after their procedures.
The report found some affected women were not even told that these devices had been used in their surgeries.
And Holohan said a significant source of distress was the difficulty in accessing timely and compassionate aftercare. For some women, the response of clinicians to their concerns greatly added to their distress. Many women were of the opinion that they were not believed, that clinicians minimised or did not understand the severity of their complications, and there was a lack of confidence on the part of women that their treating clinicians had the expertise to assess and treat complications.
Women who suffered complications have previously described how their doctors rejected suggestions afterwards that their pain, discomfort or infections were related to the mesh device.
Among the 19 recommendations in the report is the necessity to develop patient information and informed consent materials and ensuring “timely, appropriate and accessible care pathways” for women with complications.
A number of women have travelled to the UK at their own expense for specialised scans and removal surgeries. Holohan has recommended the HSE ensure surgical professional training and multi-disciplinary expertise in units carrying out mesh procedures.
The Department of Health said a significant number of these recommendations are already underway by the HSE and the pause on all mesh procedures that was put in place on 24 July will not be lifted until key recommendations are in place.
‘Harrowing, deeply personal experiences’
Solicitor Melanie Power, who set up Mesh Survivors Ireland and who is representing many of the women affected, said the report recognises that concerns they raised in their campaign were valid.
“It recognises that the consent procedures and pathways were lacking and the HSE did not take heed of warnings of the device. It recognises under reporting by clinicians, a lack of readily available data on the number affected due to failings in the HSE system which all beg the question; how can complications rates as provided by Irish consultants be calculated?”The suspension must continue until the science behind the device proves it is safe. Irish women deserve quality independent research before a lift on the suspension is considered.
Today Minister Harris paid tribute to the women affected by complications who had shared their personal stories and pushed the government on this review.
“The bravery, commitment and dignity shown by these women in sharing what were harrowing, deeply personal experiences are acknowledged and appreciated. The telling of their stories makes public what heretofore was often a private suffering,” he said.
“Their stories and their courage caused me to act and I want to thank the Chief Medical Officer for his work in addressing the understandable public and patient anxiety about this issue.
“A pause remains on the use of mesh procedures, pending confirmation by the Health Service Executive that the key recommendations have been implemented. I have already committed to meeting again with Mesh Survivors Ireland to discuss the report and I look forward to doing that in the coming weeks.”
https://www.thejournal.ie/vaginal-mesh-report-4351988-Nov2018/
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FDA TURNS TO 'ACTIVE' MONITORING ON WOMEN'S HEALTH DEVICES
Nov 21, 2018 | Politico- Morning eHealth
By Arthur Allen
FDA TURNS TO 'ACTIVE' MONITORING ON WOMEN'S HEALTH DEVICES:
The agency on Tuesday announced a break from its current post-market surveillance system that largely relies on device users to report problems and sometimes results in underreporting. Instead, it will focus on what it calls real-world evidence — especially with regard to vaginal mesh, long-term birth control devices, certain breast implants and other products for women.
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FDA commits to rapid device safety responses using real-world data and active surveillance
Nov 21, 2018 | Fierce Biotech
By Conor Hale
The FDA has set itself a new goal: to become the international leader in medical device safety through better use of big data.
The agency pledged to consistently place first among the world’s regulatory agencies in identifying and reacting to device safety issues by transitioning to an active surveillance system built on real-world evidence and by seeking new authority to take faster actions for postmarket safety.
The effort also includes plans for modernizations of the 510(k) review process—with details to be released next week—as well as targeted measures related to devices for women’s health, such as surgical mesh for transvaginal repair.
“We’re evolving beyond our current post-market surveillance system—which is largely passive and relies on device users to report problems to us, sometimes resulting in underreporting,” FDA Commissioner Scott Gottlieb and CDRH Director Jeff Shuren said in an agency statement outlining the first new steps of the plan.
“We’re moving to an active surveillance system that relies on real-world evidence and timely receipt of robust safety information,” they wrote. “We have long recognized the systemic weaknesses of the passive system—a challenge faced by other countries—and we prioritized this area for regulatory reform efforts.”
The moves build upon the FDA’s unique device identification initiative, which tags each device with a code that can be tracked across its distribution and use in patients. Its public database now contains more than 1.5 million records, the agency said, to help it link adverse event reports with specific devices.
“We believe that including the device identifier in electronic data more broadly, including in insurance claims, will advance FDA’s efforts to leverage real-world data to support the development of more effective post-market surveillance tools,” Gottlieb and Shuren wrote.
In addition, the agency is committing new resources to rapidly enable its National Evaluation System for health Technology, or NEST, for the analysis of real-world data from patient registries, Medicare claims and electronic medical records.
NEST will also provide information to medical device manufacturers developing improvements for their devices, the agency said.
Its independent governing board is run from a public-private coordinating center, dubbed NESTcc, that is comprised of industry and community stakeholders as well as patient and provider representatives. FDA provided the seed funding for NESTcc and secured partial industry funding through the latest iteration of the agency’s user fee legislation.
NESTcc has entered agreements with 12 organizations—representing more than 195 hospitals and nearly 4,000 outpatient clinics with access to more than 495 million patient records—to help build out its data network.
The agency allocated $3 million to NESTcc in September, in addition to the annual funding allocated by the latest user fee agreement. The Trump administration has also requested an additional $46 million for fiscal 2019 to support NEST.
Earlier this month, NESTcc announced eight real-world data demonstration projects, exploring the use of patient registry and claim data in evaluating total joint replacement and spine fusion surgeries, as well as the effectiveness of different tissue closure techniques following surgery.
In women’s health, the FDA has scheduled an advisory committee meeting for February 2019 to discuss surgical mesh intended for transvaginal pelvic organ prolapse repair and to consider additional regulatory actions. Two years ago, the FDA reclassified surgical mesh devices from Class II to Class III, requiring manufacturers to submit them for premarket approval and leaving only three products on the market for the indication.
The agency also pointed to its National Breast Implant Registry launched in September following public concerns that implants may be linked to health conditions such as chronic fatigue, cognitive issues and muscle pain, though the FDA has not yet found evidence of a direct association.
The agency is also continuing to monitor energy-based devices which may be inappropriately marketed for vaginal rejuvenation and symptoms related to menopause, urinary incontinence or sexual function. This past summer, the FDA publicly warned seven manufacturers of its concerns—since then, all seven have made changes to their websites to remove those unapproved claims.
https://www.fiercebiotech.com/medtech/fda-commits-to-rapid-device-safety-responses-using-real-world-data-and-active-surveillance
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FDA outlines measures to improve medical device safety plan
Nov 21, 2018 | Medical Plastics News
The Food and Drug Administration (FDA) has announced “several key actions” to update its Medical Device Safety Action Plan with the aim of creating a more robust medical device safety net through better data.
The regulator has outlined new steps to improve data available when it comes to devices for women’s healthcare, including on breast implants, “vaginal rejuvenation” devices and gynaecologic surgical mesh.
It says it is investing in new tools, policies and resources to enhance post-market safety, and trying to move to an active surveillance system that “relies on real-world evidence and timely receipt of robust safety information.”
The Administration added it is putting more resources into the new national system for gathering real world evidence through the National Evaluation System for health Technology (NEST), saying that the FDA has evidence that NEST will “help improve the breadth and quality of real world evidence (RWE)” they can access and analyse.
In September, an extra $3 million in agency funding was allocated to the project to support demonstration projects and building out active surveillance capabilities. Eight test case projects using real world data began this month undertaking work such as: testing the feasibility of using patient registries and claims data to evaluate the safety and effectiveness of total joint and knee replacement surgeries, comparing safety and effectiveness of different tissue closure techniques, and to evaluate the safety of intervertebral body fusion devices used to treat spinal conditions.
Part of that $3 million funding is being used to focus on addressing clinical questions on device therapies unique to women, such as treatment of uterine fibroids, pelvic floor disorder, female sterilisation and long-acting reversible contraception.
The organisation has heard from patients who are concerned their breast implants may be linked to other conditions, with the aim of a partnership with the National Breast Implant Registry (NBIR) may help to identify risk factors for complications.
On “vaginal rejuvenation” devices, the statement read: “This past summer, we warned women and health care providers about a growing number of manufacturers marketing “vaginal rejuvenation” devices to treat conditions and symptoms related to menopause, urinary incontinence or sexual function – even though the FDA has not received evidence that these devices are safe or effective to use for these indications.
"We’re announcing that after reaching out to the seven manufacturers marketing their devices for unapproved or uncleared uses, all of them have made significant changes to their websites to remove claims associated with vaginal rejuvenation and other unapproved treatments. Our efforts to address these safety concerns is part of our broader work to improve our analysis of data and generation of RWE concerning the safety and effectiveness of health technologies in clinical areas that are unique to women.”
The FDA also said the advisory committee will seek “expert opinion” regarding the available evidence of the benefits and risks of mesh and transvaginal pelvic organ prolapse (POP) repair – as well as providing an opportunity to hear from the public, including patients, about their experiences.
The Advanced Medical Technology Association (AdvaMed) appeared to welcome some of the content of the statement.
An AdvaMed statement read: “Patient safety is the number one priority of the medical technology industry, and we are always willing to look at new ways of ensuring patient safety -- whether on the regulatory end with FDA, or on the manufacturing and distribution side with new tools for monitoring and preventing adverse events.
“This is a collective effort, and one we can continually improve when we work together. FDA’s latest updates to its Medical Device Safety Action Plan are another positive step in this collective effort, and we’re ready to work with the agency and other stakeholders on ways to support the continued safety and effectiveness of medical devices.
“While we’re still reviewing the details of FDA’s updated Safety Plan, industry has long supported many of the programs highlighted, including development of the National Evaluation System for health Technology (NEST) to more efficiently generate better evidence on device performance and deployment of a unique device identification (UDI) system to ensure companies can effectively identify their products through their distribution and use while ensuring patient access to the most innovative, life-saving technologies.”
The FDA will announce further aimed at modernising the process for medical device review next week.
https://www.medicalplasticsnews.com/news/fda-outlines-measures-to-improve-medical-device-safety-plan/
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FDA details ramp-up of postmarket device oversight
Nov 21, 2018 | Medtechdive
By Susan Kelly
Dive Brief: The FDA released a lengthy statement Tuesday laying out plans to increase postmarket surveillance of medical devices and set a new goal to be “consistently first” among global regulators to respond to safety signals from those products. Specific actions include improving the safety net for women’s health, including holding a Feb. 12, 2019 advisory committee meeting on transvaginal surgical mesh. The agency will follow up next week with more details on its plans to modernize the premarket review of medical devices, especially the 510(k) process, FDA Commissioner Scott Gottlieb and device center chief Jeff Shuren said. FDA reiterated that it will work to secure additional funding for the National Evaluation System for health Technology (NEST), an initiative to improve real-world data collection about medical devices by connecting clinical registries, electronic health records and medical billing claims. Dive Insight:
The statement follows the agency’s release in April of a Medical Device Safety Action Plan, as it moves to adopt a less-burdensome approach to device regulation intended to accelerate the speed at which medtech innovations are brought to market.
FDA said it plans to announce a series of “important new actions” to improve the postmarket surveillance system and encourage advances that lead to safer medical devices. The agency said it has carefully considered public feedback in formulating the changes.
The current postmarket oversight system is passive and prone to underreporting because it relies on device users to report problems, FDA noted. Shifting to a system based on real-world evidence would better protect patients by increasing access to large data sets for evaluation and by improving the link between adverse events and specific devices, the agency said.
FDA is also committing new resources to NEST. The governing board for NEST’s public-private coordinating center, known as NESTcc, includes patients and healthcare providers.
NESTcc has forged agreements this year with 12 organizations that represent nearly 195 hospitals and 4,000 outpatient clinics with access to more than 495 million patient records as it builds the early data network, FDA said. Development in recent years of a unique device identification system for tracking products through distribution and patient use will support the effort, the agency said.
Earlier this month, NESTcc announced eight post-market surveillance test cases using patient registries and claims data, including projects to evaluate knee replacement surgeries, wound closure techniques and spinal fusion devices. J&J and Abbott are among the big players taking part.
Partial funding for NEST will come from industry as part of the latest Medical Device User Fee Agreement. In September, FDA allocated an additional $3 million to the program. The president’s budget for fiscal year 2019 includes a request for an additional $46 million to support NEST and conduct FDA-sponsored post-market studies that address device-specific safety concerns. FDA said it will work with stakeholders to help make NEST financially self-sustaining long term.
Part of the $3 million MDUFA funding will go toward addressing clinical questions on devices unique to women’s health. The agency will hold an advisory committee meeting on Feb. 12, 2019 to review the safety and effectiveness of surgical mesh intended for transvaginal pelvic organ prolapse repair.
Efforts are under way to establish a national breast implant registry and to monitor a set of energy-based devices. And the agency has successfully pressed seven manufacturers into removing marketing claims promoting their energy-based devices for unapproved uses such as vaginal rejuvenation.
https://www.medtechdive.com/news/fda-details-ramp-up-of-postmarket-device-oversight/542787/
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