Preview Newsletter
Ethicon Media Monitoring 3/6/2019
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Pelvic and hernia mesh patients will confront politicians and bureaucrats in April over the medical device industry
Mar 6, 2019 | Newcastle Herald
By Joanne McCarthy
A "perfect storm of systemic failures" has left an unknown number of pelvic and hernia mesh surgery patients with severe complications that confirm the need for urgent health system reforms, including how medical devices are approved for use in Australia, a study has found only months after a global investigation concluded device approval processes can put patients' lives at risk. -
Mesh victims make emotional plea for help to Scottish Government
Mar 5, 2019 | Herald Scotland
By Alistair Grant
Women whose lives have been ruined by surgical mesh implants have issued an emotional plea for a specialist US surgeon to be allowed to treat them in Scotland. -
Call for US expert to operate on mesh implant victims
Mar 5, 2019 | BBC News
Campaigners have called for a specialist surgeon from the US to be allowed to help people with problems caused by vaginal mesh implants. -
Call for US expert to operate on mesh implant victims resisted
Mar 5, 2019 | Press Association (In The Sunday Post, Swindon Advertiser)
The Health Secretary has resisted campaigners’ pleas to invite a specialist surgeon from America to remove vaginal mesh implants and train Scottish doctors. -
Live: Scottish and Welsh parliaments pass joint Brexit motion
Mar 5, 2019 | BBC News
By Louise Wilson and Craig Hutchison
Labour MSP Neil Findlay will now lead a member’s debate expressing disappointment that the government has apparently declined the offer from a mesh implant removal expert from St Louis to come to Scotland. -
These 2 medical devices have sparked controversy
Mar 5, 2019 | Mass Device
By Danielle Kirsh
The history of clinical research is filled with unfortunate examples of drug and device trials that involved serious ethical violations, injured patients or even resulted in death. -
FDA Commissioner Scott Gottlieb to step down in a month
Mar 6, 2019 | MedTech Dive
By David Lim
FDA Commissioner Scott Gottlieb will resign effective in one month, HHS Secretary Alex Azar said in a statement Tuesday.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Mar 6, 2019 | Newcastle Herald
By Joanne McCarthy
A "perfect storm of systemic failures" has left an unknown number of pelvic and hernia mesh surgery patients with severe complications that confirm the need for urgent health system reforms, including how medical devices are approved for use in Australia, a study has found only months after a global investigation concluded device approval processes can put patients' lives at risk.
Hernia patients were subject to the "gross minimalization of the severity of their symptoms", were not told mesh devices would be used, and resorted to alternative medicine treatments after losing trust in the health system, leading Australian consumer health group the Health Issues Centre said in a report released on Wednesday based on the experiences of 183 people.
It recommended major health system reforms less than a year after a Senate report into the pelvic mesh scandal identified long-standing serious system failures that compromise patient safety, and called for a review of doctors’ relationships with device manufacturers “to prevent the payment of inducements”.
The Senate report followed a Newcastle Herald pelvic mesh campaign and Senator Derryn Hinch's call for an inquiry into "one of the greatest medical scandals and abuses of mothers in Australia's history".
In October Federal Health Minister Greg Hunt apologised to pelvic mesh women for the "historic agony and pain" of their surgery.
A judgment in Australia's largest class action case, brought by more than 850 women against mesh manufacturer Johnson & Johnson, is expected in coming months.
Wednesday's Health Issues Centre report into hernia mesh found surgical complications are exacerbated when doctors "minimise the impact of adverse outcomes, deny responsibility, invalidate the lived experiences of their patients and seek to blame them for their circumstances".
"There appears to be an unwillingness or inability by a section of the medical profession to countenance that their own best efforts may sometimes result in life-ruining outcomes," report author and Health Issues Centre chief executive Danny Vadasz found.
"There is clearly a dissonance between their best intentions to 'do no harm' and the reality of their patients’ experience. It would seem that physicians, like the rest of the community, have a problem dealing with inconvenient truth."
Mr Vadasz said he believed the extreme experiences of the 183 hernia patients could be "the tip of a very large iceberg", with the lack of data about how many Australians have received hernia and pelvic mesh an indictment of the health system.
"If you don't have the data about how many people have been implanted with devices then you can't determine risk," Mr Vadasz said.
The centre will hold a forum in April where pelvic and hernia mesh patients, device regulator the Therapeutic Goods Administration, health bureaucrats and politicians from around Australia will be brought together for the first time to discuss reforms that consumer health groups say are urgently needed, including the need for a health watchdog willing to prosecute to improve public safety.
In 2017 the TGA confirmed it had not pursued the prosecution of a single manufacturer for failing to report serious pelvic mesh injuries to women despite thousands of known serious injury cases linked to mesh, criminal sanctions if a manufacturer fails to report, and a 2013 TGA report acknowledging it “only receives 10-20 per cent” of all adverse events.
"Does Australia have a strong watchdog in the TGA? Clearly not," Mr Vadasz said.
The Health Issues Centre and the Consumers Health Forum of Australia have called for an inquiry into the responsibilities, operations and funding of the TGA, saying the current model of funding by industry rather than government was failing the public.
"It is a regulator captured by industry," Mr Vadasz said.
The Health Issues Centre report includes statements from hernia mesh patients saying they had considered suicide because of chronic pain, the failure of doctors to respond, the inadequacy of the health system to deal with complex complications after failed surgery, and the lack of clear treatment pathways.
"I almost bought a wheelchair in 2015 but I realized if I sat down in a wheelchair I was going to die with my multiple issues, so I do all I can to stay on my feet," one hernia mesh patient told the centre during the four-week survey.
Mr Vadasz said the drive for innovation prioritised in the health system meant too many in that system had lost sight of patients as human beings.
"At a time when the health system extols patient-centred care as a pillar of good health care delivery, it is ironic that the most fundamental aspects of patient-centredness are found wanting when put to the test, as is the case with pelvic and hernia mesh," he said.
Australian Medical Association NSW president Kean-Seng Lim acknowledged the existing system in NSW provided "a very fragmented approach to managing complex conditions" which left women experiencing serious pelvic mesh complications "not getting the best outcomes".
"Under the current system you could honestly spend your whole day travelling from one specific service to another for each individual consequence of the mesh surgery," said Dr Lim, who completed part of his training as a general practitioner at Lake Macquarie.
"We really need to have a much more patient-centred, coordinated approach to the management of complex cases like pelvic mesh. There does need to be a rethink about the more coordinated, appropriate approach that puts the patient at the centre, that provides a better recognition of multi-morbidities which now represent a very significant number in the community," he said.
He acknowledged that the pelvic mesh scandal where lack of transparency, accountability and informed consent were issues meant "we run the risk of losing trust in the system".
On Monday Dr Lim expressed reservations about a NSW Labor promise to provide $10 million for robotic surgery at St George Public Hospital at the request of doctors, after reputable reviews questioned whether it produced better outcomes for patients in urology and gynaecology.
Australian Medical Association spokesperson and gynaecologist Dr Steve Robson said the TGA aimed to prioritise patient safety but "like many organisations, it is dealing with multiple priorities".
"Patient safety should be the foremost priority when any medical device or therapy is considered. Systems that don't have this priority are destined to fail patients," Dr Robson said.
He said few health systems in the world, including Australia, were "equipped to adequately respond to patient safety in an era where multiple and complex morbidities (different conditions) are becoming very common".
The TGA was contacted for comment.
https://www.theherald.com.au/story/5939419/perfect-storm-the-health-system-that-has-failed-thousands-of-australians/
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Mesh victims make emotional plea for help to Scottish Government
Mar 5, 2019 | Herald Scotland
By Alistair Grant
Women whose lives have been ruined by surgical mesh implants have issued an emotional plea for a specialist US surgeon to be allowed to treat them in Scotland.
Sufferers insist St Louis-based Dr Dionysios Veronikis would help rid them of the debilitating pain they have suffered for years – and allow them to lead normal lives again.
It comes after Scotland’s health boards were last year told to “immediately halt” the use of mesh implants to treat pelvic organ prolapse and stress urinary incontinence.
The use of mesh was suspended in all but "exceptional circumstances" in 2014, but hundreds of procedures were still carried out despite fears over painful side-effects.
Speaking in Holyrood, Lorna Farrell, 53, from Glasgow, said she was in “constant chronic pain”.
Fighting back tears, she said: “I’m disgusted and excited in one, because I just can’t see an argument why this doctor can’t come to Scotland. He has to come. We deserve to get our lives back.”
She made the comments at a press conference hosted by Scottish Labour MSP Neil Findlay, who has spent years campaigning alongside victims.
He pleaded with the Scottish Government and NHS bosses to pay for Dr Veronikis to fly over to Scotland and carry out his pioneering surgery.
The calls attracted cross-party support, with former SNP Health Secretary and long-standing mesh campaigner Alex Neil insisting Dr Veronikis could help train Scottish surgeons in his "micro-surgery" technique.
Dr Veronikis, a world-leading mesh expert, has offered to come to Scotland if the NHS pays his costs and covers his earnings.
Responding to the pleas, Health Secretary Jeane Freeman told MSPs her "mind is not closed" to the offer.
But she added: "It is not entirely my decision. I have not refused Dr Veronikis' offer. It is not for me to accept that offer. It is for me to discuss with the clinical community how their learning and techniques could, in their opinion, be improved and enhanced and we will do that."
Mesh sufferer Dr Mary Rose McGlaughlan earlier told how Dr Veronikis had changed her life after she paid £15,000 to travel to the US from Belfast.
She said doctors in the UK had performed multiple internal investigations, but told her they would only ever be able to remove up to 11cm of mesh. Dr Veronikis eventually removed the full 28cm.
Mr Findlay said it would be “fairly straightforward” to get Dr Veronikis registered as a specialist in the UK, allowing him to treat woman and train other surgeons.
Mesh implants were commonly used to relieve incontinence and pelvic prolapse, particularly after childbirth.
But many women have been left in excruciating pain as a result of the procedure, which often cannot be fully reversed.
https://www.heraldscotland.com/news/17477892.mesh-victims-make-emotional-plea-for-help-to-scottish-government/
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Call for US expert to operate on mesh implant victims
Mar 5, 2019 | BBC News
Campaigners have called for a specialist surgeon from the US to be allowed to help people with problems caused by vaginal mesh implants.
Hundreds of women say the procedure has ruined their lives.
Dr Dionysios Veronikis has offered to come to Scotland and operate on women who have suffered severe pain since the implants.
The Scottish government said it was open to discussions with health boards on the funding of additional training.
Mesh implants are used by surgeons to treat conditions which some women suffer after childbirth, with the synthetic substance used to repair damaged or weakened tissue.
The use of mesh in Scotland was suspended in all but "exceptional circumstances" in 2014 after it emerged some women had suffered painful side-effects but the procedure has still been used hundreds of times since.
Campaigners are calling on the Scottish government to allow Dr Veronikis, who has successfully removed hundreds of implants, to be allowed to operate on Scottish women.
Irish mesh campaigner Mary McLaughlin was operated on by Dr Veronikis in January after paying about £5,000 for the procedure. She said it had transformed her life.
"I don't like the word miraculous but the day after surgery I was able to stand up and was able to walk with a normal gait to the bathroom," she told the BBC's Good Morning Scotland programme.
"Since then I wake up every morning to see if the pains in my legs come back and they don't.
"There is no longer a wobble when I stand up, I can bend down to get stuff out of a cupboard which I couldn't do and I am driving again, which i couldn't do."'The ball has been dropped'
Law lecturer Ms McLaughlin, from Belfast, said she found out about Dr Veronikis on the internet and claimed that his kind of surgical expertise is not available on the NHS.
She added: "The government has had 20 years for tea and sympathy conversations with patients with mesh, and it has to be admitted that the ball has been dropped.
"There are no full removals in Scotland, England, Wales or Northern Ireland
"The surgeons use a small piecemeal approach where they take a little bit of the mesh out, see how the patient fares and then take another little bit of the mesh out.
"Dr Veronikis does this operation in one."
Mesh campaigners say thousands of Scottish women are suffering the effects of mesh implants and almost 600 are taking legal action over the procedures.
Last year a Scottish government-commissioned report was critical of the way a previous review of the procedure was carried out, saying it suffered "systemic" failings and potential conflicts of interest.
NHS England has recently curbed the use of mesh on safety grounds, although it is still available as a treatment of last resort for some.
If Dr Veronikis was going to operate in this country he would have to be registered with the General Medical Council as is the case with all British surgeons.
A Scottish government spokeswoman said: "We know there are many patients who have suffered pain and life-changing complications following mesh implant procedures - and we sympathise hugely with them and their families.
"Health boards are aware that Dr Veronikis has been reported as being willing to visit Scotland. While boards are directly responsible for surgical staff and their development, we would be happy to discuss with both boards and professionals funding of additional education and training where a specific need is identified.
"Full mesh removal, where this is the correct course of action, has already been provided by specialist staff working here in Scotland. The decision to remove mesh will be made by the patient in consultation with her clinician and will take into account her particular circumstances."
https://www.bbc.com/news/uk-scotland-47456278
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Call for US expert to operate on mesh implant victims resisted
Mar 5, 2019 | Press Association (In The Sunday Post, Swindon Advertiser)
The Health Secretary has resisted campaigners’ pleas to invite a specialist surgeon from America to remove vaginal mesh implants and train Scottish doctors.
Hundreds of women have suffered chronic pain due to mesh implants inserted by surgeons to treat bladder and bowel conditions, repairing weak or damaged tissue often suffered during childbirth.
Campaigners say that only partial mesh removal is available in Scotland, but that the pioneering American doctor Dionysios Veronikis has carried out over 2,000 full removals of the damaging implants using new techniques he developed.
Dr Veronikis has offered to come to Scotland to carry out operations and train Scottish surgeons how to do it.
As mesh sufferers watched on in the Scottish Parliament, Jeane Freeman said that, while she had not rejected the specialist’s invitation to work in Scotland, it was not for her to decide what training doctors receive.
Ms Freeman said she would discuss the issue with the Chief Medical Officer and “look at whether there is additional training, expertise, learning that can be provided – by Dr Veronikis or others.”
Scottish Labour MSP Neil Findlay pleaded with the Health Secretary and said: “We have a small window of opportunity to act. An opportunity that if we don’t take it will be lost.
“Take up the very genuine offer from Dr Veronikis to come to Scotland, to work up to 6 days a week to carry out full mesh removal procedures but critically to also train Scottish surgeons in his techniques.
“This is a serious and a genuine offer that I urge the Cabinet Secretary to take.”
After pointing out some victims of mesh implants watching the debate at the Scottish Parliament, Mr Findlay said: “I implore Ms Freeman to do the right thing and do the right thing: give these injured women the best treatment available – these women have already lost so much- they should not, as some are, have to travel to the US and elsewhere.
“The Cabinet Secretary has the chance to act; the opportunity to change lives. Cabinet Secretary, you have the chance to do the right thing.
“The alternative is these women left living a life of pain, a life of misery, careers and relationships lost and a lifetime of medical costs which will collectively far outstrip the costs of bringing this surgeon to Scotland.”
In response, Ms Freeman said: “Nobody needs to implore me, nobody needs to beg me. I completely understand that the women involved want to have the best possible response to the situation they find themselves in and for many of them that will be full mesh removal.
Ms Freeman continued: “My mind is not closed to this, it is not entirely my decision.
“I have not refused Dr Veronikis’ offer; it is not for me to accept that offer, it is for me to discuss with the clinical community how their learning and techniques can be improved and we will do that.”
At a press conference before the debate, Mr Findlay introduced Dr Mary McLaughlin, a law lecturer from Northern Ireland who had a full mesh removal carried out by Dr Veronikis in January.
“I can walk again without pain. I can sit without excruciating pain,” Dr McLaughlin said.
The trip to the United States for the operation cost her £15,000 and she added: “I don’t think anyone should have to pay for this operation.
“Mesh women were injured. We trusted doctors and we’ve been let down.
“It’s not right to say that partial removal is good enough.”
Sufferer Lorna Farrell, 53, said: “Mary is just the perfect argument of why Dr Veronikis has to come to Scotland – eight weeks ago she was like we are all now – in constant, chronic pain.”
Ms Farrell, from Eaglesham near Glasgow, explained how she was told that doctors in Scotland could not fully remove the mesh and her partial removal “has done so much damage”.
“My nerve damage has become 100 times worse since they have gone in and cut this mesh inside of me.”
Fighting back tears, she added: “I just can’t see an argument why this doctor can’t come to Scotland.
“We deserve to get our lives back.
“It’s wonderful to see Mary and to hear how bad she was and how good she is now – nobody has the right to deny us that.
“We got these implants in Scotland, the damage was done in Scotland, and it’s only right that experts should come to Scotland and repair what they’ve done.”
After being told that the Scottish Government claimed full mesh removals were already taking place, campaigner Karen Neil said: “We are being lied to.”
The 52-year-old from Glasgow added: “I know just about all 635 Scottish mesh survivors personally, and I haven’t met or spoken to one yet who’s had a full removal.”
Ms Freeman acknowledged a dispute about whether full mesh removals do take place in Scotland and said she would discuss the issue with Mr Findlay and other MSPs.
https://www.sundaypost.com/news/scottish-news/call-for-us-expert-to-operate-on-mesh-implant-victims-resisted/
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Live: Scottish and Welsh parliaments pass joint Brexit motion
Mar 5, 2019 | BBC News
By Louise Wilson and Craig Hutchison
Scottish government declines help of mesh expert.....
Labour MSP Neil Findlay will now lead a member’s debate expressing disappointment that the government has apparently declined the offer from a mesh implant removal expert from St Louis to come to Scotland.
Dr Dionysios Veronikis, an obstetrician-gynaecologist, had offered to help remove transvaginal and other mesh implants from people in Scotland and to train other surgeons how to do this safely.
Mr Findlay will urge the government to reconsider their decision and accept the offer of help.
'The reality is that full mesh removal is not available in Scotland'
Labour MSP Nel Findlay says for the last seven years he has been campaigning alongside women who have suffered due to mesh implants.
Mr Findlay adds: "Some of these remarkable women are in the gallery tonight and I salute your determination to be here today."
Mr Findlay says there is now finally hope for these women and they are rightly calling for it to be fulfilled.
"They want and expect full mesh removal."
"The reality is that full mesh removal is not available in Scotland."
Background: Call for US expert to operate on mesh implant victims
Campaigners have called for a specialist surgeon from the US to be allowed to help people with problems caused by vaginal mesh implants.
Hundreds of women say the procedure has ruined their lives.
Dr Dionysios Veronikis has offered to come to Scotland and operate on women who have suffered severe pain since the implants.
The Scottish government said it was open to discussions with health boards on the funding of additional training.
Dr Dionysios Veronikis has developed "pioneering methods" which allow mesh implants to be removed carefully and in one piece, Mr Findlay says.
He highlights the Scottish patients who were sent to a London doctor, Dr Suzy Elneil, to have mesh removed previously, but her lists are now closed.
Registration is not a barrier to Dr Veronikis coming here the Labour MSP insists.
He suggests the money set aside for waiting times reduction could be used to cover his costs, given the women have been waiting years for treatment.
Mr Findlay highlights Irish mesh campaigner Mary McLaughlin underwent successful surgery under Dr Veronikis two months ago and is now well enough to join the public in the gallery today.
I don't beg government ministers ever, but I implore you to do the right thing he says.
Campaigners are calling on the Scottish government to allow Dr Veronikis, who has successfully removed hundreds of implants, to be allowed to operate on Scottish women.
Irish mesh campaigner Mary McLaughlin was operated on by Dr Veronikis in January after paying about £5,000 for the procedure. She said it had transformed her life.
"I don't like the word miraculous but the day after surgery I was able to stand up and was able to walk with a normal gait to the bathroom," she told the BBC's Good Morning Scotland programme.
"Since then I wake up every morning to see if the pains in my legs come back and they don't.
"There is no longer a wobble when I stand up, I can bend down to get stuff out of a cupboard which I couldn't do and I am driving again, which i couldn't do."
SNP MSP Alex Neil says everyone in this chamber is united to make sure the NHS does the right thing by these women whose lives have been so blighted by mesh implants or devices or both.
Many of these women believe that the only way forward is to remove the mesh, Mr Neil adds.
The former health secretary says for many women the removal of the mesh is the last chance saloon to improve their health.
The SNP MSP tells the chamber of the pioneering work of Dr Dionysios Veronikis on full mesh removal.
Whether Dr Veronkis operates in Scotland or not, the important thing is he trains Scottish surgeons in the new techniques, Mr Neil insists.
Tory MSP Miles Briggs says we need to make sure the Scottish NHS can build the capacity to achieve full mesh removal.
He hopes the cabinet secretary will respond to Dr Veronikis's positive offer at the end of the debate.
We need to see significant improvements in how we provide help to mesh victims and families, he insists.
Green MSP Alison Johnstone begins: "I'll never forget meeting the mesh survivors who came to the parliament in 2017."
Ms Johnstone says the women shared the personal impact of mesh implants and their stories cannot fall on deaf ears.
She insists, in relation to bringing Dr Veronikis to Scotland, "we must act".
"The Scottish government must step in and help."
Lib Dem MSP Tavish Scott tells the chamber about Bobbie, a woman who lives in Shetland and has suffered from the impact of a mesh implant for 20 years.
Women with the implant face both physical and psychological pain.
On the latter, he questions why patients are sent to the same doctor in the same the hospital where the procedure was undertaken.
We need some leadership from the government, Mr Scott concludes.
In September two patient representatives quit the independent review group looking at the safety of mesh implants.
Olive McIlroy and Elaine Holmes, who both suffered severe complications following mesh implant surgery, claimed the final report had been watered down.
It followed claims that an entire chapter had been removed from the report ahead of its publication.
The then Health Secretary Shona Robison said she would meet with the women to discuss their concerns.
Health Secretary Jeane Freeman recognises women suffer a considerable amount of pain and a deterioration of the quality of their lives due to mesh implants.
Ms Freeman praises the tireless work of the Mesh Survivors Group and fellow MSPs who have campaigned on this issue.
"I remain convinced my decision to halt the use of transvaginal mesh for pelvic organ prolapse and stress urinary incontinence was and remains the right one.
"I am also convinced that a great deal of the evidence to make that decision came from the women themselves."
She says: "Let me repeat full mesh removal is available in Scotland and photographic evidence is used in that procedure."
The health secretary accepts there is dispute around this and pledges to show the evidence she has to support that to Neil Findlay, Alex Neil and Jackson Carlaw, the main mesh implant campaigners.
Last September we reported that Scotland's health boards had been ordered to "immediately" halt the use of vaginal mesh implants in surgery.
The controversial implants were listed as an underlying cause of death of a woman in August, sparking calls for an inquiry and an outright ban.
Health Secretary Jeane Freeman said NHS boards had been told to stop using mesh in cases of pelvic organ prolapse and stress urinary incontinence.
This will continue until a new "restricted use protocol" is drawn up.
Ms Freeman says the specialist centres offer a range of treatments, which are considered on a case by case basis.
The staff at these specialist centres are highly trained and the clinicians are continually developing new skills, she adds.
The health secretary says there is a process to go through to ensure skills are learned across borders and she insists it is not her decision what clinical practice or clinical learning should take place.
"My job is, that where that is considered by those clinicians to be the right thing to do, my job is to help make that happen."
She adds: "I have not refused an invitation from Dr Veronikis."
Nobody needs to implore or beg me, Ms Freeman says, adding she understand the women involve want the right response which may require full mesh removal.
That's all from Holyrood Live on Tuesday 5 March 2019.
Scottish and Welsh politicians joined forces to urge the prime minister to change her position on Brexit.
The Scottish Parliament and the Welsh Assembly voted to pass identical motions calling for the planned exit date of 29 March to be put off.
MSPs and AMs also reiterated their opposition to the UK government's plans and to leaving the EU without a deal.
MSPs backed the first minister's motion on EU withdrawal negotiations, with 87 MSPs backing it, while 29 voted against and with one abstention.
https://www.bbc.com/news/live/uk-scotland-scotland-politics-47440451
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These 2 medical devices have sparked controversy
Mar 5, 2019 | Mass Device
By Danielle Kirsh
The history of clinical research is filled with unfortunate examples of drug and device trials that involved serious ethical violations, injured patients or even resulted in death.
It’s a sobering reminder of the many risks medical devices can pose to patients and the importance of compliance in clinical trials. Although many of these events occurred decades ago, medical devices still have the potential to cause harm.
These issues are documented in the FDA’s annual list of medical device recalls and (in some rare cases) even make headlines. Here are two examples of more recent medical devices that have hurt patients.Pelvic mesh treatments
Pelvic organ prolapse occurs when the tissue and muscles of the pelvic floor no longer support pelvic organs, causing them to drop. This can cause bulging, pain, urinary incontinence or sexual difficulties. Pelvic organ prolapse can be caused by childbirth or age.
Many physicians have used plastic surgical mesh to treat pelvic organ prolapse. However, the FDA has identified serious complications with the use of surgical mesh for this purpose. An FDA review of adverse events from 2005 to 2010 identified at least three deaths directly associated with pelvic mesh procedures (two bowel perforations and one hemorrhage), as well as nearly 4,000 reports of injury and malfunction. The most frequent complications included:Vaginal mesh erosionInfectionUrinary problemsBleedingOrgan perforationRecurrent prolapseVaginal scarring
The FDA has not seen conclusive evidence that using transvaginal mesh in pelvic organ prolapse repairs improved outcomes more than traditional pelvic organ prolapse procedures, and it may expose patients to greater risk.
Complications from pelvic mesh treatments have resulted in a number of lawsuits.
In March 2018, the U.S. District Court for the Northern District of Indiana awarded one couple $35 million in damages after the woman suffered from severe pain and other injuries related to pelvic mesh treatment.
Pelvic mesh treatments are still in use today, although the FDA encourages healthcare providers to recognize that many instances of pelvic organ prolapse can be treated without mesh. Scientists have also developed a new mesh made of softer polyurethane material, although it still needs to undergo rigorous clinical trials before it will be approved.The Essure birth control device
Bayer recently made the decision to discontinue the sale and distribution of Essure, a permanent, non-surgical birth control device implanted into the fallopian tubes, after a number of women reported painful complications.
In a news release, Bayer stated it stands by the product’s safety and efficacy, which it says is demonstrated by research involving more than 200,000 women over the past two decades. However, Bayer cited increased permanent contraception options, declining sales and “inaccurate and misleading publicity” among its reasons for discontinuing the device.
Since the FDA approved the device in 2002, it has received more than 26,770 reports of complications, including:Abdominal, pelvic or back painTearing or perforation of the uterus or fallopian tubesUnintended pregnancyUnexpected movement of the device to the abdominal or pelvic cavityHeadachesFatigueWeight changesHair lossMood changes, including depression
One patient’s painful experience with Essure led her on a crusade to warn others about the dangers of the device. She started a Facebook group called Essure Problems, which has more than 42,000 members to date and was featured in a recent Netflix documentary, The Bleeding Edge.The importance of real-world evidence in medical device trials
Even the most well-controlled and rigorously conducted clinical study is limited in its ability to determine definitively how the device will function out in “the real world.” Limited by sample size, patient selection criteria, and the fact that there is a closer level of oversight and training of clinical personnel in a controlled clinical trial setting, clinical trials, while absolutely critical to the process, may not always be able to tell the full story. The serious complications these two medical devices have caused illustrate the importance of continuing to study the safety and efficacy of medical devices by collecting ample real-world evidence after regulatory approval.
When mesh products were initially introduced for pelvic repair in the 1990s, they were not required to undergo the FDA’s pre-market approval (PMA) process to demonstrate safety and effectiveness. In 2016, the FDA reclassified pelvic mesh as a high-risk medical device, and manufacturers are now required to submit premarket approval applications.
The Essure birth control device was always classified as a high-risk medical device and did undergo the pre-market approval process prior to its release. Following reports of adverse events, the FDA ordered the original manufacturer, Conceptus, and Bayer (the company that later acquired Conceptus) to conduct additional post-market studies.
Post-market data collection is important because long-term side effects may not always be evident during clinical trials. For this reason, the FDA has announced plans to increase post-market data collection and surveillance of medical devices.
IMARC Research has helped many medical device companies conduct compliant trials and ultimately secure approval. We also have extensive experience in collecting real-world evidence after a device has been approved.
To learn more about the history of clinical research and our role in it, explore our interactive timeline.
https://www.massdevice.com/these-2-medical-devices-have-sparked-controversy/
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FDA Commissioner Scott Gottlieb to step down in a month
Mar 6, 2019 | MedTech Dive
By David Lim
FDA Commissioner Scott Gottlieb will resign effective in one month, HHS Secretary Alex Azar said in a statement Tuesday. The Washington Post first reported the news.
The regulator, who took office May 11, 2017, has been a relatively steady figure at the agency throughout President Donald Trump's tenure. He has garnered bipartisan support for balancing protection of public health while pushing efforts to encourage medical product development. Just two months ago, he tweeted he was not planning to leave.
Gottlieb has overseen FDA's reaction to a spate of criticism of its regulation of medical devices. The agency is in the process of trying to encourage manufacturers to utilize the De Novo pathway for new medical devices and lessen reliance on older 510(k) predicate devices.
Gottlieb’s efforts to oversee the pharmaceutical industry may be more high profile, but device safety and effectiveness has emerged in recent months as a contentious topic in its own right. Under his regime, FDA has made efforts to rejigger approval pathways, including the De Novo and 510(k) processes.
Approval standards have also been under a spotlight after a hard-hitting Netflix documentary and a series of investigative reports took aim at the agency and industry, putting FDA on defense.
During Gottlieb’s tenure, FDA’s Center for Devices and Radiological Health put out its Medical Device Safety Action Plan aimed at ramping up post-market surveillance, real-world data collection and cybersecurity efforts. Scrutiny of controversial devices like transvaginal mesh and breast implants, both the subject of FDA advisory committee meetings, also rose.
Gottlieb, who did a stint during the administration of President George W. Bush at the agency, also oversaw the ramping up of the FDA’s Pre-Cert Program. That effort seeks to update how the agency reviews software as a medical device amid the rise of wearables and other hybrid products. Nine companies including Apple, Fitbit and Johnson & Johnson are part of the pilot program.
Senior Democrats in Congress have expressed concern about FDA’s ability to maintain safety and hold companies that skirt the rules to account. Both lawmakers and industry have also called into question the legal authority of the agency to implement the idea.
On the device side, Gottlieb was largely seen as industry friendly. Public interest groups such as Public Citizen have complained the device approval process is still too lenient, especially compared to the drugs side.
"His tenure as commissioner was marked by regulatory decision-making regarding drugs and medical devices that tilted further in favor of industry’s financial interests rather than the interests of public health," Mike Carome, director of Public Citizen’s Health Research Group, said in a statement.
In his March 5 resignation letter, Gottlieb touted the record number of medical devices cleared in 2017 and 2018.
AdvaMed CEO Scott Whitaker praised Gottlieb’s service, saying he was committed to patient access to new treatments and diagnostics.
"During his tenure as FDA commissioner, Dr. Gottlieb has been a tireless advocate for improved patient care and for promoting innovative solutions to our most pressing health challenges, including greater use of medtech to combat the opioid crises," Whitaker said.
https://www.medtechdive.com/news/fda-commissioner-scott-gottlieb-to-step-down-in-a-month/549791/
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