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Ethicon Media Monitoring 5/9/2019
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Medical devices: FDA ends secret reporting system that hid failures
May 8, 2019 | The BMJ
By Owen Dyer
The US Food and Drug Administration has announced that it will end the “alternative summary reporting” programme that has allowed millions of injuries caused by medical devices to escape public notice over the past two decades. -
FDA grapples with 'living' medical devices
May 8, 2019 | Medical Xpress
By Gopal Ratnam
Imagine a not-too-distant future when medical devices powered by artificial intelligence continuously adapt to new symptoms presented by patients and learn how to make accurate diagnoses much like a well-trained physician would. -
FDA ending controversial 'alternative summary reporting' program
May 8, 2019 | DOTmed
By Thomas Dworetzky
Following the groundbreaking Kaiser Health News report exposing the scope of the little-known FDA “alternative summary reporting” program that let medical device makers “conceal millions of reports of harm and malfunctions from the general public,” the agency has now stated that it will be shutting the program down, according to KHN. -
Meet The Women Protesting Vaginal Mesh: 'It Felt Like Razor Blades Inside Me'
May 9, 2019 | Huffington Post UK
By Rachel Moss
At the age of 38, Joanne Lloyd had vaginal mesh surgery designed to treat the stress urinary incontinence she experienced after the birth of her three children.
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Medical devices: FDA ends secret reporting system that hid failures
May 8, 2019 | The BMJ
By Owen Dyer
The US Food and Drug Administration has announced that it will end the “alternative summary reporting” programme that has allowed millions of injuries caused by medical devices to escape public notice over the past two decades.
Much of the information that has been concealed from public view by the programme will be published within weeks, the agency said.
The programme itself went largely unnoticed for years, until it was unearthed by a Kaiser Health News investigation that reported its findings in March.1 This took “months of questions to the FDA,” Kaiser reported, before the FDA confirmed the existence of reporting exemption programmes and the thousands of incidents listed on secret databases, which in some cases were not shared with FDA expert advisory panels that review devices’ safety.
Even a recent FDA commissioner, Robert Califf, who led the agency in 2016-17, told Kaiser that he had not heard of the programme.Controversial devices
The exemptions covered many of the most controversial devices on the market, such as pelvic mesh, breast implants, and surgical staplers. Even if doctors or the public learnt of such information they were able to obtain it only through a freedom of information request, which can take two years to process.
The most problematic devices were often afforded the most secrecy. Mass litigation against a product is seen by the FDA as grounds for an exemption from public reporting—which will continue even after the alternative summary reporting programme ends, under the “litigation complaint summary reporting” exemption.
Larry Kessler, a former FDA official, told Kaiser that he had started the alternative summary reporting programme in 2000 after several device scandals had brought rule changes that greatly increased the flow of adverse event reporting data to the agency. These reports were often very similar, and reviewing them was “mind numbing” for the 15 staff assigned to the task, he said.
The intention was not to hide the data, said Kessler, but to allow device makers to summarise multiple similar reports on a spreadsheet, allowing easier statistical analysis. The list of exempted devices was short, he said, and it was published. “I don’t know why it’s not now,” he added. “I’m surprised about that.”
The FDA began to wind down the programme in 2017, a year that saw a record 481 000 alternative summary reports filed. In 2018 this fell to 236 000.Individual reports
The FDA will now require individual reports of each serious incident of patient harm involving a device, and these will be posted on its publicly accessible database, MAUDE (Manufacturer and User Facility Device Experience). Minor injuries may still be summarised in spreadsheets. All injuries resulting in death were already reported on MAUDE.
With some devices, the alternative reporting system hid the vast majority of incidents. While only 84 incidents of surgical stapler injuries or malfunction were publicly reported in 2016, more than 10 000 were included in alternative summary reports. Published reports of problems involving the staples themselves surged 10-fold after the alternative reporting route was closed in 2017.
An FDA expert advisory panel looking at transvaginal pelvic mesh this February was told of 476 adverse events that occurred in 2017—but not of 12 000 reports from the same year filed under the litigation exemption. The FDA did, however, later ban these devices on the panel’s recommendation.2
The FDA’s device division draws 35% of its funding directly from the industry. The division’s director, Jeffrey Shuren, was criticised this week in a New York Times editorial3 for describing device makers, not device users, as his department’s main customers, in a presentation touting “90% customer satisfaction” with its “customer service oriented” work.4
Shuren’s four predecessors all left to take up industry posts. An Associated Press investigation found that, under his watch, new device approvals had more than tripled each year, whereas warning letters to manufacturers about product safety and quality issues had fallen by roughly 80%.5
https://www.bmj.com/content/365/bmj.l2097.full
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FDA grapples with 'living' medical devices
May 8, 2019 | Medical Xpress
By Gopal Ratnam
Imagine a not-too-distant future when medical devices powered by artificial intelligence continuously adapt to new symptoms presented by patients and learn how to make accurate diagnoses much like a well-trained physician would.
The Food and Drug Administration is preparing for such a future and weighing how to assess and certify such medical devices, seeing them more like living things that can't be regulated in the same manner as old-fashioned equipment.
The agency is pivoting to new ways of assessing devices driven by machine learning and artificial intelligence because traditional approaches don't apply to the new machines, Bakul Patel, director of the FDA's digital health division, said in an interview.
As technology evolves, "artificial intelligence and machine-learning based devices can be created quickly, and iterations of the product" can be rapidly fielded, Patel said. "It's a living thing to some degree, so having a concept of authorizing it (to) go to market and waiting for things to happen and then doing a review seems to be outdated."
In early April the agency released a white paper outlining a total product lifecycle approach that will focus on processes, quality control, testing and the organizational culture of the maker of such medical devices rather than the typical static assessment of a piece of equipment. The agency is seeking comments and feedback on the proposals.
Such an approach "would provide reasonable assurance of safety and effectiveness throughout the lifecycle of the organization and products so that patients, caregivers, health care professionals, and other users have assurance of the safety and quality of those products," the FDA said in the white paper.
The agency's proposal calls for assessing the device maker's overall culture, starting with an assessment of its machine-learning practices, which include the kinds of data chosen to train and fine-tune algorithms, how the manufacturer intends to turn the training model into a production one, the process used to monitor and evaluate performance of the model once it's deployed, and how the company will take the real-world data to retrain its model.
The FDA's oversight of the medical device approval process has been found wanting in other areas. After a yearlong investigation, the International Consortium of Investigative Journalists last year found that the agency approved implant devices too quickly and failed to stop devices inserted into patients, such as breast implants, mesh and surgical staplers, from being sold and used despite receiving many complaints from patients and doctors.
The investigation cited the FDA's fast-track approval process for devices, known as the 510(K), as one reason the faulty devices were being sold. The FDA's new approach to artificial intelligence-driven devices extends the agency's fast-track process.
The agency is testing the new process, intended to apply to emerging devices that have the capability to evolve, learn and modify their software algorithms to yield better results, said Zach Rothstein, associate vice president for technology and regulatory affairs at AdvaMed, a trade group that advocates for the use of technology in health care. The group is preparing comments on the FDA's proposal, he said.
"Right now under FDA statute and rules, there isn't a mechanism for the agency to let that happen," Rothstein said. "All products that use machine learning and neural networks are locked, in the sense they're not evolving anymore, and the FDA is attempting to come up with a pathway to allow products to learn in a post-market environment."
A so-called locked algorithm used in an artificial intelligence device means that any changes to the algorithm based on new information gathered from real-life use would "likely require FDA premarket review for changes beyond the original market authorization," the agency said in its proposal.
One such locked artificial intelligence-based device the FDA approved last year is called the IDx-DR, which autonomously analyzes images of a patient's retina for signs of diabetic retinopathy—a disease that causes swelling in parts of the retina of diabetic patients and leads to vision loss.
Unlike other artificial intelligence-based devices that require a physician to confirm a machine's diagnosis, the IDx-DR's decision is made autonomously without human oversight, said Michael Abramoff, the founder and CEO of IDx Technologies, based in Coralville, Iowa.
The device is typically installed in primary care practices and can be operated by anyone with a high school diploma, Abramoff said. Using a fundus camera—a low power microscope attached to a camera—the device takes pictures of a patient's retina and sends them to a secure server where the algorithm resides and returns an assessment in less than a minute, according to the company.
Instead of trying to average out multiple doctors' assessments of a given image, the algorithm assesses likely outcome for a patient, Abramoff said. "We look at images of retina, and given that image, assess what's going to happen to the patient if you don't treat, rather than look at whether doctors agree with each other," Abramoff said.
The algorithm employs a series of deep-learning detectors to look for lesions that indicate diabetic retinopathy and recommends referral to an eye care physician if it detects more than mild diabetic retinopathy.
The device was approved by the FDA after it went through a clinical trial involving 900 patients with diabetes at 10 different primary care sites, according to the agency.
The FDA's proposal to find new ways to assess continuously adapting artificial intelligence-based devices is an extension of a process that began nearly five years ago when the agency issued its first guidance on mobile medical applications.
Since then the agency has steadily moved toward assessing the overall quality of a software maker instead of trying to certify each iteration of software.
The FDA already has in place a precertification pilot program that began in 2017 for makers of software that function as medical devices. Software makers who are approved under this process could potentially launch new products without the FDA's premarket review or win approval with a few simple steps.
The FDA's Patel said the approach is similar to the Transportation Security Administration's PreCheck program that allows cleared passengers to go through security without taking off their shoes or removing laptops from bags.
Once the agency is satisfied that a company's culture and organization structure is geared toward patient safety, the software maker is granted the precertification, Patel said.
Nine companies are participating in the pilot program, including Apple, Fitbit, Samsung and Johnson & Johnson.
In September 2018, Apple Watch's Series 4 devices, for example, were cleared by the FDA for two new applications that allow the device to perform an electrocardiogram of a user's heart as well as detect and alert a user to irregular heartbeats.
https://medicalxpress.com/news/2019-05-fda-grapples-medical-devices.html
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FDA ending controversial 'alternative summary reporting' program
May 8, 2019 | DOTmed
By Thomas Dworetzky
Following the groundbreaking Kaiser Health News report exposing the scope of the little-known FDA “alternative summary reporting” program that let medical device makers “conceal millions of reports of harm and malfunctions from the general public,” the agency has now stated that it will be shutting the program down, according to KHN.
FDA cited the decision in a statement about its “new efforts to protect women’s health and help to ensure the safety of breast implants,” especially textured implants, which have been linked to a type of cancer and which the agency now plans to leave on the market as it “does not believe that, on the basis of all available data and information, the device meets the banning standard set forth in the Federal Food, Drug and Cosmetic Act," Amy Abernethy, M.D., Ph.D., FDA's principal deputy commissioner, and Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health, said in a statement.But the announcement also addressed the way in which adverse breast implant events were reported with “alternative summary reporting,” stating that “the FDA has ended all summary reporting of breast implant medical device reports.”
The statement then addressed the controversial alternative reporting issue for devices beyond the implants, as well.
“This is part of a larger effort to end the alternative summary reporting program for all medical devices, which we intend to complete in the coming weeks,” the agency stated, continuing, “this program was established in 1997 to more efficiently review adverse events for well-established risks, but was not allowed for patient deaths and unusual, unique or uncommon adverse events, which, in the case of breast implants, included BIA-ALCL. Alternative summary reports were not previously available in our public database for medical device reports, Manufacturer and User Facility Device Experience (MAUDE) [the FDA public-facing database of device safety reports].
The Kaiser report exposed that the 20-year-old program had 1.1 million reportskept from both public and professional review since 2016.
Former FDA official Dr. S. Lori Brown told KHN that this ending was a “victory for patients and consumers.”
“The No. 1 job of the FDA — it shouldn’t be ‘buyer beware’ — is to have the information available to people so they can have information about the devices they are going to put in their body,” Brown told the investigative news group.
In March, the revelations in the KHN report prompted concern for healthcare professionals.
“The FDA absolutely should be making all of this information available,” Diana Zuckerman, president of the National Center for Health Research, told the news agency.
The numbers of these “alternative summary reporting” (ASR) exemptions, Zuckerman added “takes my breath away," KHN reported at the time.
Former FDA chief Dr. Scott Gottlieb confessed to the news agency at the time that he “wasn’t aware of the full scope of the reports that weren’t going into MAUDE.”
The exemption issue involves hundreds — even thousands — of injury and malfunctioning events. For example, KHN had determined from FDA records that “some cardiac device makers have filed hundreds of death reports under the registry exemption. The FDA confirmed that nearly 12,000 litigation summary reports related to injuries associated with pelvic mesh were filed in 2017 alone.”https://www.dotmed.com/news/story/47179
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Meet The Women Protesting Vaginal Mesh: 'It Felt Like Razor Blades Inside Me'
May 9, 2019 | Huffington Post UK
By Rachel Moss
At the age of 38, Joanne Lloyd had vaginal mesh surgery designed to treat the stress urinary incontinence she experienced after the birth of her three children.
What followed that 2004 operation was more than a decade of pain so intense that Lloyd was forced to leave her job of 16 years as an NHS receptionist.
“It felt like glass or razor blades inside me. It was just horrendous,” Lloyd, now 53, tells HuffPost UK. “My whole life changed. We were keen mountain walkers. We went to Glastonbury... I went from being a very sociable person who was always out to being a recluse.”
On Thursday morning, Lloyd will join other vaginal mesh patients as they protest outside the National Institute for Health and Care Excellence (NICE) annual conference in Manchester. The women, some of whom have been confined to wheelchairs after mesh surgery, say the NICE guidelines ignore patients’ stories and are “not fit for purpose”.
Later in the day, protestors will gather in London outside UCLH (University College London Hospitals), calling for better access to mesh removal treatment.
vaginal mesh implant is a synthetic net material, used to strengthen weak connective tissue or ligaments (often the result of childbirth). The mesh is designed to hold the pelvic organs – the uterus, vagina, bowel and bladder –in place, helping treat incontinence and pelvic organ prolapse – the bulging of pelvic organs into the vagina.
The use of vaginal mesh was paused last year amid safety concerns. But the latest NICE guidelines, released in April, effectively reinstated the treatment, saying it could be used if non-surgical options hadn’t been effective in treatment. NICE added: “There is limited evidence on possible long-term harms of all surgical options.”
This is despite thousands of women worldwide reporting complications, which can occur when the synthetic mesh moves out of place or erodes, breaking down into smaller pieces. Patients’ anecdotes have been echoed in some scientific studies.
After hearing about the Sling the Mesh campaign on TV in 2017, Lloyd went straight to the doctor with her list of symptoms. On previous visits, she says, doctors did not link the problems she was experiencing to the mesh.
She was referred for specialist treatment and underwent two operations – to remove the mesh and to treat her incontinence with an alternative mesh-free operation. Despite the surgeries, Lloyd still experiences nerve pain every day due to the internal damage.
Revealing why she’s joining today’s protest, she said: “I feel like they [NICE] haven’t taken us into consideration at all and our lives and how they’ve been ruined by mesh.
“I don’t want anyone else – my daughters, nieces, family and friends – to go through this in the future.”
Sadly, Lloyd’s story is not unique. HuffPost UK asked four other women joining the protest in Manchester to share their stories.
Beverley Burrows, from Wrexham in North East Wales, had vaginal mesh surgery at the age of 38 due to urinary incontinence after having three children. Now 51, she walks using a stick despite having the mesh removed, takes opioid painkillers to ease her chronic pain, and has to rely on her husband for help completing basic chores like shopping and cooking.
“Living with a chronic condition can be debilitating; both physically and mentally,” she says. “In some ways I feel like it’s robbed me of hope for the future. I can feel worthless and a burden to my family and I can feel sad, because of the realisation that the life I once knew is now different.”
Burrows adds that she feels grief and anger watching other people do everything she should be doing, but connecting with other women in her situation through the Sling The Mesh campaign has helped ease her loneliness.
“I am joining the protest as I want to fight for women’s health for now and in the future,” she says. “I am appalled that the NICE guidelines are no different from what was published in 2003. We have told our stories and NICE have ignored us.”
Mandy Bridge, 52, from Lancashire, was a busy mobile hairdresser before having vaginal mesh inserted in 2015. But now she is unable to walk long distances and has to use a wheelchair on days out or if going uphill.
She claims she experienced a stabbing pain from the mesh immediately after the operation, but it took three years of multiple doctors appointments for anyone to listen.
“I couldn’t put one leg across the other,” the mum-of-two says. “To be crude, if I put my finger inside myself I could feel it, it felt like toothbrush bristles. My husband could feel it during sex. It ripped condoms.” We just want them to explain to us why”
In 2018, Bridge finally had two operations to remove the mesh and treat her stress incontinence using her
own tissue. However, she’s still in pain and has been forced to drastically scale back her business.
“I’ve lost clients and it’s horrible to see them going to other salons and I’m sat here, wanting to do their hair and I can’t,” she says. “It’s made me feel horrendous, I’ve just had two weekends where I literally couldn’t get out of bed. My husband had to pull me.”
Bridge says she can’t understand why the new NICE guidelines allow for the use of mesh when so many women have shared their stories of complications.
“We just want them to explain to us why,” she says. “I’m fighting for my daughter and other women in the future.” ‘I’ve been left with two stomas’
Carol Williams, 51, from Bolton, Greater Manchester, had vaginal mesh surgery in 2007 for stress urinary incontinence. She has experienced multiple complications, including the mesh perforating her bowel and adhering to her rectum. The subsequent emergency surgery left her with two stomas (openings in the abdomen).
“I feel devastated I have had to go through life-threatening emergency surgery caused by vaginal mesh,” she says, noting that she would have probably thought her case was a one-off, had she not discovered the Sling The Mesh support group. “There are thousands of women searching for answers and desperate for an improved quality of life. It wasn’t unlucky, it is real.”
Williams, who works as a health manager, now has to take pain relief medication every day.
“I am protesting for women and friends who cannot physically be here today, but also to raise awareness to our younger generation so they can make informed choices and do not suffer as we have done and are still doing,” she says. “I was diagnosed with anxiety and depression.”
Prior to vaginal mesh repair in 2011, Indira Tailor was “very active and in a full time job”. But soon after surgery the practice nurse from Bolton, Greater Manchester, developed pain in the base of her spine and her vagina.
She’s since experienced health problems, including joint pain and mobility issues and rectal bleeding, which she believes was caused by the mesh. Despite having the mesh partially removed, her side-effects persist.
“Life has not been the same since the initial mesh implant. I have constant vaginal and rectal pain radiating to buttocks,” explains Tailor, now 67.
“The remaining mesh has continued to distort and is shredding fragments, forming rough edges. I have several sharp ends cutting into the vagina wall.”
The mesh and her experiences of living with it has also had a long-lasting impact on her mental health.
“I am constantly tired due to or lack of, and disturbed sleep because of pain and anxiety,” she explains. “I was diagnosed with anxiety and depression and I have had to start taking an antidepressant.”
Tailor says she is joining the protest to echo the message from Sling The Mesh: “Women are been used as guinea pigs and that must stop.”
HuffPost UK contacted NICE for comment in response to criticism on the guidelines. A spokesperson said NICE’s independent committee looked at the “best available evidence” for treating stress urinary incontinence and pelvic organ prolapse in women and recommended non-surgical options should be offered before any procedure.
“The committee had at the forefront of their minds the distressing symptoms that some women experienced because of the adverse effects of mesh surgery,” the spokesperson said. “As such, they recommended that surgery using mesh to treat these conditions should only be considered after non-surgical management and treatments have failed and when a number of conditions are met, including making sure the woman fully understands the benefits and risks of such a procedure.”
The spokesperson added that NICE will review the guidance if new evidence is published, if there is a substantial change in policy or legislation, or if there is a significant safety update from the Medicines and Healthcare products Regulatory Authority.
https://www.huffingtonpost.co.uk/entry/meet-the-women-protesting-vaginal-mesh-outside-nices-annual-conference_uk_5cd14239e4b0e4d75737c065?utm_hp_ref=uk-lifestyle
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