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Now we know the dangers of mesh implants... but are the alternatives any safer?
May 6, 2019 | Daily Mail
By Lois Rogers
After more than two decades of almost constant misery, Debbie Dowd has a new career and a fresh outlook on life. ‘My whole existence has been transformed,’ she says. And the reason for this is an incontinence treatment that has been available for years. ‘I have so much confidence compared with how I was before. What I can’t understand is why no doctor ever thought to offer me this treatment years ago.’ Like vast numbers of women, Debbie underwent an operation in 2002 to insert a plastic ‘mesh’ tape, meant to treat the post-childbirth bladder leakage experienced by an estimated two in five women. -
Lessons from Inside the Implant Files
May 6, 2019 | ICIJ
By Ben Hallman and Emilia Diaz-Struck
The largest cross-border health care investigation in history began in the produce section of an Amsterdam grocery store. Jet Schouten, a reporter for Dutch public television, had heard from dozens of women who suffered bleeding, pain and other life-altering complications after they were implanted with a medical product called transvaginal mesh, commonly used to hold reproductive organs in place. Her reporting led her to question how these problematic mesh products were approved for sale in Europe — and to the supermarket. To show that implants are often approved without safety testing, she created a bogus application for a mesh product with photos she took of a polypropylene bag used to hold mandarin oranges. -
As Pelvic Mesh Plaintiffs See The Light at the End of the Tunnel, Hernia Mesh Patients are Left Suffering
May 6, 2019 | The Legal Examiner
By Mike Daly
Recently, a number of plaintiff verdicts and group settlements have marked a promising trend of holding large pharmaceutical companies accountable for the harm that their pelvic mesh devices cause. While this is undeniably good news, these same companies continue to turn a blind eye to the dangers of their nearly identical hernia mesh products. -
FDA to end program that hid millions of reports on faulty medical devices
May 6, 2019 | Fierce Biotech
By Christina Jewett
The FDA announced it is shutting down its controversial “alternative summary reporting” program and ending its decadeslong practice of allowing medical device makers to conceal millions of reports of harm and malfunctions from the general public. -
Mesh device inventor denies knowingly misleading NSW health regulator
May 7, 2019 | The Herald
By Joanne McCarthy
A DOCTOR who knocked back "lucrative" American offers to buy his pelvic mesh device in 2008 is accused of knowingly misleading health regulators nearly a decade later after women implanted with the device were left with serious and permanent injuries. -
India must stop blind reliance on US-cleared medical devices: Patient groups
May 7, 2019 | DNA India
By Cheena Kapoor
With a report on flawed clearance of medical devices and implants garnering global attention, patient groups have sought stricter foreign regulatory nods for such products before their entry into the Indian market. -
FDA grapples with ‘living’ medical devices
May 7, 2019 | Roll Call
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.
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Now we know the dangers of mesh implants... but are the alternatives any safer?
May 6, 2019 | Daily Mail
By Lois Rogers
After more than two decades of almost constant misery, Debbie Dowd has a new career and a fresh outlook on life.
‘My whole existence has been transformed,’ she says. And the reason for this is an incontinence treatment that has been available for years.
‘I have so much confidence compared with how I was before. What I can’t understand is why no doctor ever thought to offer me this treatment years ago.’
Like vast numbers of women, Debbie underwent an operation in 2002 to insert a plastic ‘mesh’ tape, meant to treat the post-childbirth bladder leakage experienced by an estimated two in five women.
As Good Health has highlighted, while the tape worked for many women, thousands have suffered crippling permanent injury, caused by the disintegration of this internal tape, which is used to help prop up pelvic organs.
In Debbie’s case the tape worked for only a short time before the leaking returned, but it was a further 15 years before she was offered a less risky alternative: an injectable ‘bulking agent’.
Here, collagen tissue or gel is injected into the walls of the bladder neck. This reduces its diameter and creates greater resistance to the pressure from the urine filling the bladder. And it can be done in minutes under local anaesthetic.
For Debbie, who is 59 and has three grown-up children aged 32, 27 and 25, it has proved life changing. ‘I had suffered with incontinence ever since I had my third child,’ she says. ‘I had tried everything, but nothing worked.
‘At first, the tape seemed to have worked, but after a couple of years, I was back worrying about incontinence,’ says Debbie, who lives in South Croydon with her husband, Trevor, 50.
‘I saw a gynaecologist and asked if the mesh could be taken out, but was told it would be impossible as it was embedded in tissue.’
She was lucky in that it didn’t cause her any pain.
‘I was given a drug called tolterodine, which is meant to reduce the urge to go to the loo by blocking the nerve signals, but it didn’t really work either.
‘In October 2017, I finally went back to the GP, who suggested a treatment called Bulkamid.
‘It’s been amazing. Since I had it I have changed jobs and have so much more confidence.
Bulkamid, an organic injectable gel, has been in use since 2006. Its main drawback is that the effects last only a few years.
Potential side-effects include the risk of the material being incorrectly placed and blocking the urethra, the tube that carries urine from the bladder.
Debbie, however, is delighted with its effects.
‘I could have literally cried with relief when I finally got something that works,’ she says. ‘I’ve been on walking and climbing holidays, and stayed in a tree house in the Costa Rican rainforest — all things I could never have done before.
‘If only I had known this treatment was available before.’
Bulkamid has been available on the NHS for seven years, and has been used on 60,000 women worldwide. The manufacturer reports no adverse events, and if it doesn’t work the first time, patients can be given a top-up injection.
However, updated guidance from the National Institute for Health and Care Excellence (NICE) on treating post-childbirth injuries and incontinence said there is little evidence to support the use of bulking agents.
Insisting there is ‘limited evidence on the long-term adverse events [from mesh]’, and continuing to recommend its use in some cases, the document has outraged campaigners representing more than 6,000 mesh-injured women. Steve Foley, a consultant urologist at the Royal Berkshire Hospital in Reading, said it is equally infuriating that women are not offered other solutions for incontinence, such as bulking agents.
‘I think, if they were given this option, most people would choose an injectable bulking agent first,’ he told Good Health. ‘They have been around for more than 15 years and have got better and better, but NICE bases its opinion of them on data from ten years ago.’
Data from 224 Finnish women in a Helsinki University study comparing bulking agent success rates with mesh repair, reported last year that the former cured incontinence in 92 per cent of cases.
The study results, discussed at the European Urogynaecological Association meeting in Milan in October, showed that, while 100 per cent of women receiving mesh were cured of incontinence, 5 per cent suffered internal injuries, 5 per cent experienced extreme pain and 9 per cent could not empty their bladder normally.
Now, another option, an experimental laser treatment to stimulate collagen tissue regeneration, is gaining attention.
The Fotona laser has been studied across Europe, Asia and the U.S. for up to a decade, producing good results in reducing incontinence. It works by ‘remodelling’ collagen in the pelvic area. The laser is inserted into the vagina and burns away collagen, which is the body’s tissue
This triggers new collagen production, which tightens and narrows the vagina so it is better able to support the adjacent bladder. However, the need for rigorous data on its safety and efficacy means it is not expected to be available to NHS patients for some years.
‘The situation over mesh surgery shows that the rapid introduction of a new treatment without proper evaluation can lead to poor outcomes,’ says Professor Christian Phillips, a specialist at Basingstoke Hospital, Hants, who has been involved in a Fotona research project for four years. ‘Most lasers work by damaging, then remodelling collagen in the tissues. During my research, I discovered that Fotona has the ability to cause tissue remodelling simply by promoting new collagen production.’
However, some specialists are worried about this new treatment.
‘The concept of vaginal laxity has not been precisely defined,’ says Chris Harding, a consultant urologist at the Freeman Hospital, Newcastle, and a spokespersonman for the British Association of Urological Surgeons.
‘The vagina is in folds, so it can expand to accommodate a baby. I would be a bit sceptical about it regenerating enough collagen to make a difference. Theoretically, it’s possible, but you would have to regenerate it in a precise area and it’s not clear that can be done.’
In the U.S., there have been reports of women suffering vaginal damage and lacerations following treatment with other lasers, prompting the U.S. Food & Drug Administration (FDA), which regulates healthcare, to issue a warning.
The use of energy-based devices to perform vaginal ‘rejuvenation’, cosmetic vaginal procedures, or non-surgical vaginal procedures to treat symptoms related to menopause, urinary incontinence or sexual function may be associated with serious adverse events, the FDA said in a statement.
Mayoni Gooneratne, a private plastic surgeon in North London, offers Viveve radiofrequency laser treatment for vaginal laxity and incontinence, at a cost of £1,500, and points out that the Viveve system was not included in the list of named devices attached to the FDA warning, and insists the treatment is safe and effective.
‘I have treated 40 women aged between 35 and 72 over the past 18 months, and it has only failed in two of them,’ she says.
Dr Gooneratne said Viveve’s Colorado manufacturer had told her its system is due to be trialled for future NHS use by specialists at Imperial College, London.
However, in a statement to Good Health, the manufacturer subsequently said the conversations were at a ‘conceptual’ stage. Despite its claim that ‘it is designed to treat women experiencing urinary incontinence’, they also said they would never recommend it for that purpose.
Swati Jha, a consultant gynaecologist at the Royal Hallamshire Hospital in Sheffield, is cautious about these innovations: ‘Radio frequency devices emit focused electromagnetic waves which stimulate production of newer collagen leading to tissue tightening and formation of new blood vessels,’ he says.
‘However, this does not equate to a cure of stress urinary incontinence or improved sexual function. To prove this we need longterm follow-up studies.’
https://www.dailymail.co.uk/health/article-6998765/Now-know-dangers-mesh-implants-alternatives-treat-incontinence-safer.html
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Lessons from Inside the Implant Files
May 6, 2019 | ICIJ
By Ben Hallman and Emilia Diaz-Struck
The largest cross-border health care investigation in history began in the produce section of an Amsterdam grocery store.
Jet Schouten, a reporter for Dutch public television, had heard from dozens of women who suffered bleeding, pain and other life-altering complications after they were implanted with a medical product called transvaginal mesh, commonly used to hold reproductive organs in place. Her reporting led her to question how these problematic mesh products were approved for sale in Europe — and to the supermarket. To show that implants are often approved without safety testing, she created a bogus application for a mesh product with photos she took of a polypropylene bag used to hold mandarin oranges.
Among other obvious flaws, her application said 30 percent of women receiving the product would be permanently injured. Three notified bodies — for-profit entities that device companies pay to evaluate new products in Europe — reviewed the application, but none flagged any safety concerns. (Formal approval would have required proof of a factory to produce the devices, which of course didn’t exist).
Schouten came to the International Consortium of Investigative Journalists in late 2016 with an idea to build on her reporting: a cross-border examination of the medical device industry, the government authorities charged with overseeing it and the ramifications of medical-product mishaps for real people.
ICIJ is a newsroom and a network. We utilized both roles to assemble an investigative team that grew to include more than 250 journalists in 36 countries.
Unlike our past global investigations — the Panama Papers and Paradise Papers — where we started with millions of leaked files, the Implant Files was built from the ground up. Over the course of nearly a year, we filed more than 1,500 public records requests and spent countless hours collecting and analyzing data obtained from the U.S. Food and Drug Administration and other health authorities.
We didn’t always get what we wanted. In the European Union, regulators claimed disclosing raw patient harm reports would give away confidential commercial information. Reporters in Mexico submitted 964 requests that produced only 44 responses.
But the work paid off: Our partners at the Canadian Broadcasting Corporation obtained, for the first time, data on “adverse events” — injuries, deaths and other device-related problems — from the national regulatory agency after two years of fighting. In Finland and Spain, ICIJ’s partners obtained device recall and safety alert data that were not previously available to the public.
The reporting team eventually gathered more than 8 million records, which form the bedrock of our investigation. The greatest trove was 5.4 million reports sent to the FDA over the last decade on suspected device-associated deaths, serious injuries and malfunctions.
ICIJ data journalists deployed machine-learning algorithms to screen millions of adverse event records and identify 500,000 reports that described an “explant” — the potentially deadly removal of a defective device.
Again and again, our reporting turned up examples of implants pulled from sale in some countries for safety reasons, even as they continued to be sold in others. Because no global resource for recalls and safety notices exists, ICIJ decided to build one. The International Medical Devices Database gathered records — more than 70,000 so far — into a searchable portal that allows anyone to discover whether a device was flagged for official concern.
ICIJ journalists and our partners examined dozens of medical devices. Some, we explored in depth: implantable pain pumps that can malfunction, triggering cycles of overdose and withdrawal; breast implants that leak, rupture and cause hidden agony; spinal cord stimulators meant to treat back pain that can shock and burn.
But with thousands of products on the market, many with seemingly endless iterations that stretch back a decade or more, we only scratched the surface. We want other journalists to build on our reporting. Here are some lessons we learned along the way.There’s no such thing as a risk-free medical implant.
Manufactured products may break, or malfunction. Doctors can make mistakes implanting them. Once inside the body, a device may trigger an allergic reaction or autoimmune response. None of these outcomes is necessarily evidence of a systemic problem.Some devices break, rupture, misfire or otherwise fail to work as intended more often than they should.
ICIJ’s investigation focused on devices identified by researchers, regulators, patient advocates, or manufacturers as posing an outsized risk of harm. A question that dogged us throughout the investigation: How to quantify that harm?
For a variety of reasons — balkanized healthcare systems, spotty oversight and poor reporting practices — a definitive number of people injured or killed by any individual device simply cannot be determined. But adverse events collected by the FDA can help give a sense of the scope of the harm, and point to newsworthy stories.
Anyone can file an adverse event report, though most come from device makers. These reports describe has experienced a potentially harmful malfunction of is suspected to have caused or contributed to a serious injury or death. The FDA cautions that conclusions about a device’s safety or role in an injury or death cannot be made from adverse events alone.
But the agency itself uses the reports to help it identify potentially dangerous problems, and ICIJ’s analysis of the data generated two whopping numbers: more than 1.7 million suspected injuries and nearly 86,000 deaths linked to medical devices over the last decade.
The reports can also identify patterns and trends, which spurred us to examine implants associated with high numbers of injury reports that we might have otherwise overlooked.Data can help explore the story systematically.
One of the sources with the largest number of data linked to medical devices in the U.S. is the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. It contains millions of reports — more than 5.4 million sent to the FDA over the last decade — on suspected device-associated deaths, serious injuries and malfunctions. Most are from the U.S., but the FDA also receives foreign reports.
It is possible to search for reports online for brand name or manufacturer over a period of time. Unfortunately, the online system has a limit of showing 500 results at a time. Downloading the entire database is the best way to explore and analyze it.
Keep in mind:Devices and companies are listed under a variety of spellings and names.A report key number serves as a unique identifier for events. It is required to avoid double counting.To link events to a specific company, check all of its subsidiaries and the events linked to them.Event descriptions in a narrative format may contain rich details that are not always reflected in the structured data.
Approval and recall data is also available. And we used the Centers for Medicare & Medicaid Services “Open Payments” search tool to research payments from device companies to physicians.Machine learning can help explore millions of records in a different way.
ICIJ used machine learning to identify devices that were later explanted as well as death reports that were not categorized as such by the reporters of an adverse event. The process involved refining and also manual checks done by journalists to verify the results.
ICIJ found 2,100 cases where people died, but their deaths were classified as malfunctions or injuries. Of these, 220 reports showed that devices may have caused or contributed to the deaths. The other reports did not include enough information to determine conclusively if the device played a role in the patients’ deaths.Recalls can be evidence of a serious problem, but not all recalls are equal.
Recall data and other safety notices — easily searched using ICIJ’s new database — can also point to medical devices with life-threatening flaws.
One example: In 2016, St. Jude Medical issued a global recall for an implantable defibrillator with a defective battery that affected nearly 350,000 patients. In the U.S., this was deemed a “class one” recall by the FDA, the most serious kind.
The agency reserves this rating for defects deemed to pose a “reasonable chance” of “serious health problems or death.” Some class one recalls can be easily remedied — through software updates, for example. Other class one recalls are far more serious and spur some patients to have an implant removed in procedures that pose risks of their own. Our analysis of adverse event reports, which are mostly from the U.S., indicate that the St. Jude recall led to at least 12,000 explant surgeries.
Recall data can help you unearth strong public interest stories — but remember: Not all Medical literature can identify alarming trends that doesn’t attract wide notice.
In 2007, a Minnesota cardiologist published a study showing a defibrillator called the Sprint Fidelis was failing at a higher-than-expected rate. Its maker, Medtronic, recalled the device a few months later, citing five deaths that may have been caused by fractured wires that connect to the heart.
Two years later, the company bumped up the death toll to 13. After that, the device all but vanished from the news — but remained in more than 200,000 patients.
An ICIJ literature review pointed to harm that far exceeded what Medtronic had acknowledged. A French study of 1,000 patients, for example, showed that the connectors on more than one in five devices fractured after five years, and that younger, more active patients were especially vulnerable.
An ICIJ analysis of FDA adverse event reports in the last decade linked Sprint Fidelis models to more than 8,000 injuries and 2,000 deaths.Lawsuits can also point the way. But a 2008 Supreme Court decision means there are fewer than you might expect.
It is much harder to successfully sue a medical device company than it used to be. In 2008, the U.S. Supreme Court ruled that if the FDA has ok’d a product through a pathway called premarket approval, people who claim harm can’t sue in a state court, shutting down untold numbers of lawsuits.
Even so, a basic legal search may reveal dozens or even hundreds of cases against manufacturers that can lead you to sources and stories.Medical devices also provide tremendous benefits.
Most implants work as intended. They improve lives, and save them, in enormous numbers. But we found failures in how devices are approved and monitored that have harmed patients at a global scale.
https://www.icij.org/investigations/implant-files/lessons-from-inside-the-implant-files/
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May 6, 2019 | The Legal Examiner
By Mike Daly
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Recently, a number of plaintiff verdicts and group settlements have marked a promising trend of holding large pharmaceutical companies accountable for the harm that their pelvic mesh devices cause. While this is undeniably good news, these same companies continue to turn a blind eye to the dangers of their nearly identical hernia mesh products.
Pelvic mesh is a net-like sheet that is surgically implanted in patients with a weakened bladder neck, urethra, or vaginal wall. It is used in individuals with pelvic floor conditions such as stress urinary incontinence (SUI) and pelvic organ prolapse (POP), both of which are commonly seen in women after childbirth. There are about 200,000 inpatient surgical procedures done in the U.S. annually on individuals with POP.
Hernia mesh is used even more commonly. Approximately one million hernia repairs are done each year in the United States, over 90 percent of which use surgical mesh. A hernia is when an organ bursts through a weakened cavity wall. The most prevalent type of hernia involves an intestine protruding through the abdominal wall, commonly known as an abdominal or ventral hernia. Hernia mesh holds the weakened wall in place so that the tissue can grow into the mesh’s pores and form a stronger wall of support.
Tens of thousands of individuals have suffered from detrimental health consequences caused by surgical mesh. Mesh erosion, infections, bleeding, pain during sex, organ perforations, and urinary problems can result from pelvic mesh. Hernia mesh patients see many of the same complications, often resulting from a dislodging or contraction of the mesh product. The contraction of the mesh can cause severe and chronic pain that may not be cured until the mesh product is removed. Hernia mesh products are also susceptible to increased inflammation, infection, poor or lack of healing, buildup of fluid or warmth at the incision sign, flu-like symptoms including vomiting, chills, and fever, chronic pain or discomfort, scarring, and abscess or fistula formation.
Pelvic mesh plaintiffs have been seeing some big wins lately: on April 10, a Superior Court panel voted unanimously to uphold a $13.5 million verdict against Johnson & Johnson (J&J) after a plaintiff was injured by their pelvic mesh device implantation. Just two weeks later, on April 24, a Philadelphia court jury awarded another plaintiff $120 million in damages after her pelvic mesh led to chronic pain, incontinence, and lack of consortium. Both of these successes came after a New York Times article revealed that seven device manufacturers are paying nearly $8 billion to settle more than 100,000 pelvic mesh cases.
Despite the undeniable similarities between pelvic and hernia mesh and the FDA’s nationwide ban on pelvic mesh sales due to safety concerns, most hernia mesh products remain available to consumers. While there have been FDA-issued recalls for some hernia mesh products, mesh implantation continues to be the standard for hernia treatment. On a more positive note, however, big pharma manufacturers including J&J, Gore, Atrium, and C.R. Bard will all be facing new litigation and/or bellwether trials for hernia mesh cases in 2019. Hopefully, upcoming verdicts succeed in holding these manufacturers responsible for the pain and suffering hernia mesh causes.
https://southeastpennsylvania.legalexaminer.com/health/as-pelvic-mesh-plaintiffs-see-the-light-at-the-end-of-the-tunnel-hernia-mesh-patients-are-left-suffering/
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FDA to end program that hid millions of reports on faulty medical devices
May 6, 2019 | Fierce Biotech
By Christina Jewett
The FDA announced it is shutting down its controversial “alternative summary reporting” program and ending its decadeslong practice of allowing medical device makers to conceal millions of reports of harm and malfunctions from the general public.
The agency said it will open past records to the public within weeks.
A Kaiser Health News investigation in March revealed that the obscure program was vast, collecting 1.1 million reports since 2016. The program, which began about 20 years ago, was so little-known that forensic medical device experts and even a recent FDA commissioner were unaware of its existence.
Former FDA official S. Lori Brown, Ph.D., said ending the program now is 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 said.
FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and the agency's device center director, Jeffrey Shuren, M.D., J.D., announced the decision to terminate the program in a statement on increasing transparency about the safety of breast implants.
The agency has for years allowed makers of breast implants to report hundreds of thousands of injuries and malfunctions out of the public eye, federal records show.
“We believe these steps for more transparent medical device reports will contribute to greater public awareness of breast implant adverse events,” Abernethy and Shuren said in a Thursday statement. “This is part of a larger effort to end the alternative summary reporting program for all medical devices.”
FDA spokeswoman Angela Stark said the agency will also end alternative summary reporting exemptions still in place for makers of implantable cardiac defibrillators, pacemakers and tooth implants. The FDA has said the program was originally designed to allow for more efficient internal review of well-known risks.
The agency said it began winding down the program in mid-2017, revoking many reporting exemptions, including those for saline breast implants and for balloon pumps used inside patients’ blood vessels.
At that point, the agency required devicemakers with ongoing exemptions to file quarterly reports in its public device-harm database known as MAUDE, short for the Manufacturer and User Facility Device Experience.
Still, FDA data provided to KHN show that during the first nine months of 2018 the FDA continued to accept more than 190,000 injury reports and 45,000 malfunction reports under the hidden alternative summary reporting program.
Ronni Solomon, vice president and chief policy officer of the ECRI Institute, which studies device safety, said the staff uses the FDA’s open data on a daily basis to look for signals that might show heightened risks with a particular device.
“We think it’s really vital for the sake of transparency, for the sake of policy, for the sake of science,” she said. “We’re really glad to see this, the sooner the better.”
The agency said its forthcoming data release will be for the alternative summary reports filed before mid-2017. The FDA for years reached agreements with makers of about 100 devices allowing them to cease public reports of certain types of problems. The agency previously said the agreements and resulting records were available only by filing a Freedom of Information Act request, a process that can take months or even years.
Going forward, devicemakers will be required to file individual reports describing each case of patient harm related to a medical device.
The FDA has not said it will stop allowing devicemakers to file other types of device-harm exemption reports that are withheld from the public, such as when there is mass litigation over a device or when a company is submitting reports from an independent device-tracking registry. Nor has a plan been announced to open those records, which contain reports of harm related to pelvic mesh and surgical robots and reports of deaths related to several cardiac devices.
The FDA had granted Covidien, now a division of Medtronic, a long-standing “alternative summary reporting” exemption for its surgical staplers, a device used to cut tissues and vessels and quickly seal them during a variety of surgeries.
In 2016, when just 84 reports of stapler-related harm were disclosed in the FDA’s MAUDE database, almost 10,000 more malfunction reports were sent directly to the FDA’s in-house database, the agency acknowledged.
The device has been subject to numerous lawsuits over patient deaths and grave harm.
Doris Levering alleged in court that a stapler malfunction during liver surgery caused profuse bleeding that left her husband, Mark, 62, with serious brain damage and unable to walk. She applauded the agency’s decision to open the database. “It’s just wonderful to know that this information is going to be out in the open and not covered up,” she said. “Now doctors who need to find the information will be able to find it.”
The surgeon, hospital and devicemaker have all denied wrongdoing in an ongoing legal case.
The FDA has announced a May 30 advisory board meeting to review the agency’s oversight of surgical staplers.
The FDA will leave in place a newer summary-reporting program that allows makers of more than 5,500 types of devices to send the agency spreadsheets logging device malfunctions. Unlike the alternative summary reporting program, devicemakers will not be allowed to report serious injuries using that approach.
Over the years, the FDA has had an uneven record of disclosing its “exemption” reports to advisers who review the safety of individual devices.
In February, FDA officials presented an advisory panel on gynecological devices with data showing 476 adverse events in 2017 related to a certain type of pelvic mesh. That panel was not briefed on nearly 12,000 reports filed by eight mesh makers in 2017, under a special exemption for lawsuit-related reports, according to an agency spokeswoman and a review of public records.
FDA spokeswoman Deborah Kotz said in an email that those “litigation” summary reports did not contain enough detail for the FDA to determine whether they shed any light on the safety question at hand.
The FDA ultimately took decisive action, though, ordering makers of the type of mesh under review to stop marketing those products, which were used to support sagging pelvic organs.
In late March, after KHN’s investigation landed, the FDA convened another panel to review breast implant-related injuries and a rare form of lymphoma. For that meeting, the agency did provide a full tally of previously unreported injury and malfunction reports related to breast implants.
As of May 2, though, the agency said it would leave the textured breast implants linked to a rare lymphoma on the market.
Matt Baretich, a Denver-area biomedical engineer who advises health systems on device safety, is eager to examine the hidden reports as they’re released by the FDA.
“I’m really interested to see what information has been hidden so I can go back,” Baretich said. “I may have been looking for that information and not found anything and thought there was not a problem.”
https://www.fiercebiotech.com/medtech/fda-to-end-program-hid-millions-reports-faulty-medical-devices
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Mesh device inventor denies knowingly misleading NSW health regulator
May 7, 2019 | The Herald
By Joanne McCarthy
A DOCTOR who knocked back "lucrative" American offers to buy his pelvic mesh device in 2008 is accused of knowingly misleading health regulators nearly a decade later after women implanted with the device were left with serious and permanent injuries.
Dr Peter Petros is accused of giving misleading evidence to the NSW Health Care Complaints Commission on four matters, including retaining a significant financial stake in his Tissue Fixation System (TFS) pelvic mesh device after denying a financial interest, and failing to disclose nearly $2 million in loans to the device manufacturer, a tribunal was told on Monday.
Dr Petros is also accused of failing to fully disclose his financial interest in TFS to Sydney Private Hospital before a hospital medical committee in 2013 prioritised the device's use in surgery on more than 100 women patients where Dr Petros supervised another doctor.
The hospital's decision was "effectively a slam dunk the TFS was going to be used" in any surgery where Dr Petros supervised gynaecologist colleague Dr Richard Reid, who was found guilty of professional misconduct in September, 2018 after more than 20 years of serious complaints by women patients in Australia and America.
While Dr Petros told the hospital he invented the TFS, he did not disclose he retained the right to sell the device under a deed of agreement with Adelaide-based TFS Manufacturing, owned by former Newcastle Falcons basketballer Paul Zadow, the NSW Civil and Administrative Tribunal was told on Monday.
"Partial disclosure is just as misleading as no disclosure at all," barrister for the HCCC Christopher Mitchell told the tribunal at the end of a public hearing where Dr Petros denied misleading investigators, but made admissions where he conceded his financial stake in the device.
His continuing financial interest in TFS meant there was an incentive for him to help increase its use, including by making loans to the manufacturer, the tribunal was told.
Dr Petros was charged with multiple breaches of the national health practitioner law after a woman complained to the HCCC after she was implanted with TFS without her consent by Dr Reid at Sydney Private Hospital in 2013 and suffered serious and permanent injuries.
The woman's complaint to the HCCC in early 2014, which included asking why Dr Petros's name appeared on her hospital records and questions about his financial interest in the TFS device, prompted Dr Petros to direct his accountant to remove him as a beneficiary from a family trust, the tribunal was told.
The move allowed Dr Petros to respond that he no longer had a financial interest in the device, but it failed to acknowledge he did have a financial stake when the woman was implanted with TFS, Mr Mitchell said.
An earlier pelvic mesh invention by Dr Petros, the Intra Vaginal Sling (IVS) device, which was developed in Western Australia in the late 1980s after experimental surgery on 13 large dogs, was sold to American firm Tyco in 2001.
The IVS was approved by American regulators to treat prolapse, a complication after childbirth, only months after Australian reviewers in February, 2001 found no "good quality evidence to determine the safety and efficacy" of the device procedure.
The American IVS approval allowed multiple prolapse device kits on the global market without clinical trials over the following decade under the FDA's controversial device approval system, including at least one Johnson & Johnson device cited in a class action by 1000 Australian women against the company.
In early April Dr Petros gave evidence to the tribunal about receiving two "lucrative" offers by American companies in 2008 to purchase his TFS device, which was invented in the period after the IVS sale.
The TFS device was one of the first pelvic mesh devices in the world to be cancelled by Australian regulators in November, 2014 after TFS Manufacturing failed to substantiate safety and efficacy claims.
TFS surgery was restricted to Sydney Private Hospital by 2014 after a majority of Australian gynaecologists declined to accept Dr Petros's "integral theory" that underpinned both TFS and IVS devices.
The tribunal was told Dr Petros was under an even greater obligation to disclose his full financial interest in the TFS device to other doctors after it was cancelled, but during a period when it continued to be implanted in women at the hospital.
While Dr Petros did not have an obligation to disclose his financial interest to patients, he had an obligation to ensure surgeons who used the device after its cancellation advised patients.
Barrister Patrick Griffin, SC, for Dr Petros said his client's retirement was a consideration for the tribunal if it found him guilty of professional misconduct.
While deregistration is a penalty available following a professional misconduct finding, a reprimand "would be appropriate" because Dr Petros had already retired and the allegations against him were "at the mid to lower end of seriousness", Mr Griffin said.
The HCCC told the tribunal the allegations against Dr Petros were at the high end of objective seriousness.
Mr Griffin urged the tribunal to "think long and hard before reaching a conclusion" Dr Petros "set out to deliberately mislead, provide false information or knowingly cause the HCCC to be misled". The tribunal reserved its decision.
https://www.theherald.com.au/story/6109470/slam-dunk-mesh-decision-while-women-kept-in-the-dark/
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India must stop blind reliance on US-cleared medical devices: Patient groups
May 7, 2019 | DNA India
By Cheena Kapoor
With a report on flawed clearance of medical devices and implants garnering global attention, patient groups have sought stricter foreign regulatory nods for such products before their entry into the Indian market.
The report claims 80,000 deaths and 20 lakh injuries in the last decade in the US alone. Citing the case of Johnson & Johnson, involving faulty implants, the groups say India should not blindly rely on foreign approvals to medical products as it has no information system for patients in case of a device failure.
After the US Food and Drug Association said last month that there was no guarantee for the long-term safety of the 'vaginal mesh' products, which have existed for decades and are implanted to hold pelvic organs to reinforce the weakened vaginal wall, investigations showed that the synthetic nettings alone have caused 80 deaths till 2018 and over 1 million claims, said a report by the New York Times.
The report has triggered concerns in India as FDA-approved devices don't need any clinical trials in the country. "In India if a product is registered in the US or Europe, there is no need to conduct clinical trials in India but if no predicate is available in the US or European market, clinical trials are required," reads an article published in the 'International Journal of Drug Regulatory Affairs' on Medical devices and their approval procedure in India.
The best example for the need for stricter laws in India on the import of medical devices is the Johnson & Johnson hip implants, where of the 4,700 surgeries involving faulty Articular Surface Replacement hip implants, only 1,000 patients have been traced so far.
The groups say over 66 per cent with faulty ASR had been reached out in the US within a year and the number remained less than one per cent in its first year of fault detection in India.
According to Malini Aisola, health researcher, co-convenor of the All India Drug Action Network, the US government constantly monitors cases involving medical products, while no such mechanism exist in India. She said, "Once a person is implanted with a faulty device, we may not have a way to reach out. We need urgent reforms for patient safety, including- abolishing the blind reliance on regulatory approvals of the US, EU etc. for granting licences in India."
https://www.dnaindia.com/india/report-india-must-stop-blind-reliance-on-us-cleared-medical-devices-patient-groups-2746704
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FDA grapples with ‘living’ medical devices
May 7, 2019 | Roll Call
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 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.Troubled history
The FDA’s oversight of the medical device approval process has been found wanting in other areas. After a year-long 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.Approval on the fly
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://www.rollcall.com/news/policy/fda-grapples-with-living-medical-devices
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