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Ethicon Media Monitoring 23/03/15
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Patients in Disbelief as Mesh Company Sales Reps were Allowed in Theatre While Surgeons Carried Out Intimate Operations
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Patients in Disbelief as Mesh Company Sales Reps were Allowed in Theatre while Surgeons Carried Out Intimate Operations
Mar 23, 2015 | Daily Record
By Marion Scott
A spokesman for one of the biggest manufacturers of mesh products, Ethicon, admitted their staff had been in theatre in Scottish hospitals. The firm, a subsidiary of Johnson & Johnson, have twice had their TVT-O device declared “defective” by a US court. -
Do the FDA’s Regulations Governing Medical Devices Need to Be Overhauled?
Mar 23, 2015 | Wall Street Journal
By Thomas M. Burton
These devices cannot be removed without significant risk of serious morbidity or death, as has been learned by the many women who received pelvic mesh, or had their uteri removed with the aid of morcellators, for just two of many possible examples. -
The Natural Product Transforming the Lives of Cancer Patients After Surgery
Mar 23, 2015 | The Telegraph
By Cherrill Hicks
Calf skin has been used to repair the abdominal wall of musician Caroline Brown after surgery to remove a rare 'silent' tumour.
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Mar 23, 2015 | Daily Record
By Marion Scott
IT has been revealed that sales reps have been present during controversial mesh implant surgery, leading to questions over whether or not patients had given their consent.236 SharesIT has been revealed that sales reps have been present during controversial mesh implant surgery, leading to questions over whether or not patients had given their consent.">ShareIT has been revealed that sales reps have been present during controversial mesh implant surgery, leading to questions over whether or not patients had given their consent.">TweetIT has been revealed that sales reps have been present during controversial mesh implant surgery, leading to questions over whether or not patients had given their consent."
SALES reps from the makers of controversial mesh products were allowed in theatre while surgeons carried out intimate operations on patients.
Health boards across Scotland have admitted staff members from firms were present during intimate procedures as advisers to NHS medics.
The reps were merely required to complete a £250 theatre access course on protocol and infection control.
Yesterday victims of botched mesh ops questioned whether women were fully informed – though health boards said consent had to be given from patients.
Olive McIlroy, of campaign group Scottish Mesh Survivors, said: “While it’s clear this has been happening across Scotland for quite some time, none of the hundreds of victims we’re in touch with says they’ve ever been consulted.
“It’s such a sensitive, intimate problem they’re seeking help with, I can’t think of anyone who’d wish to have a salesman present, especially one with no medical qualifications and profits on their agenda.”
More than 300 patients have suffered complications during mesh operations to treat bladder and pelvic organ disorders.
After we compiled a dossier with the help of mesh victims, then health secretary Alex Neil ordered a suspension of the use of the products in June last year. But several health boards have continued to use them.
It’s unclear exactly when private reps were given theatre access as some health boards said they did not keep detailed records.
A spokeswoman for NHS Greater Glasgow & Clyde said: “There is a clear policy on experienced medical and technical representatives providing support to clinical staff on the use of new devices.
“These representatives will be invited in on an ad hoc basis at the request of theatre teams as new products and equipment are introduced.”
Dr Crawford McGuffie, associate medical director at NHS Ayrshire & Arran, said: “Medical representatives stand away from the surgical field and, if required, communicate with the surgical team to troubleshoot the functioning of a device or the insertion technique.”
NHS Lothian medical director Dr David Farquharson said: “They are shadowed at all times and can help advance medical technology and improve patient safety by offering technical guidance.
“During these occasions they are obliged to follow strict theatre protocol.”
The Scottish Government say NHS boards are required to seek the consent of patients before medical sales reps attend procedures.
A spokesman said: “They are only allowed into theatre under very strict criteria and we would expect all health boards to first seek the consent of the patient.
“The Scottish Parliament are currently considering a petition on declarations of interest by healthcare workers in relation to industry and commerce.
“The Scottish Government have made clear that we are happy to consider any recommendations from that petition.”
Medics say reps from private firms can be called to assist in theatre even when patients are under general anaesthetic.
Ian Ritchie, president of the Royal College of Surgeons of Edinburgh and a consultant trauma and orthopaedic surgeon, said: “The sales and adoption of medical technology is a highly regulated area subject to stringent guidelines, similar to those applied to the pharmaceutical sector.
“While reps can be present in the operating theatre, this is in a technical advisory role for the apparatus or device being used.
“They are entirely under the direction of the consultant surgeon, whose ultimate responsibility it is to ensure the procedure goes smoothly and uphold patient safety. Reps do not come in contact with the patient.”
A spokesman for one of the biggest manufacturers of mesh products, Ethicon, admitted their staff had been in theatre in Scottish hospitals. The firm, a subsidiary of Johnson & Johnson, have twice had their TVT-O device declared “defective” by a US court.
Their director of public affairs, Lucinda Macari, said: “For any surgery involving a medical device, surgeons may request that a company representative be present during a procedure to provide technical information related to the device. This assistance is provided only at the request of the surgeon and is done in compliance with hospital policies, guidelines and procedures.”
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Do the FDA’s Regulations Governing Medical Devices Need to Be Overhauled?
Mar 23, 2015 | Wall Street Journal
By Thomas M. Burton
Medical devices can save lives, but in recent years it has become clear how hazardous they are when they malfunction: metal hips that fail; bloodstream filters that fracture and prove lethal; defibrillator wires that break down.
The Food and Drug Administration works at striking the proper balance between insisting on safety but not standing in the way of innovative products that promote health and well-being. In doing so, it’s dealing with increasingly complex products of the software and digital age, including some aimed directly at consumers, such as medical apps.
The vast majority of medical devices still get to the U.S. market through an abbreviated pathway, called 510(k), in which companies need only show that a new device is substantially the equivalent of a device already legally marketed.
Joining our round-table discussion on medical-device safety are Scott Gottlieb, former FDA deputy commissioner and a resident fellow at the American Enterprise Institute; Rita Redberg, cardiology professor at UC San Francisco; and Bradley Merrill Thompson, device attorney in Washington, D.C. with Epstein, Becker & Green. Edited excerpts follow.
Does the system work?
WSJ: Does the FDA’s approach stymie innovation, or do patients need more protection?
DR. GOTTLIEB: FDA’s approach to regulating devices, in contrast to its requirements governing drugs, was designed by Congress to recognize that not all devices pose the same degree of risk. Therefore, the volume of data that the FDA requires should be closely matched to the risk of the product in question.
The problem today is the FDA has deviated from the original spirit of that idea. It’s trying to apply a much more uniform and druglike approach to its regulation of medical devices, increasing the hurdles that new products must clear. At the same time, the FDA is treating more low-risk devices like they were high risk.
One example where the FDA is trying to apply a more druglike approach to devices is in the growing use of “sham” surgeries. The FDA literally asks device makers to randomly assign patients to either get a new medical product, or undergo a fake surgery [as a placebo] to simulate the same procedure. In a recent trial, involving a device for the treatment of high blood pressure, patients were asked to undergo an angiogram—a procedure with risks—without knowing if they’d get the real treatment.
The FDA began asking some medical-device makers to use dummy surgical procedures a few years ago, to make its review of medical devices more like its review of drugs. Only in the case of devices, having a placebo group often can mean obligating a patient to a fake surgery. In that setting, consumers are being asked to take a risk without any prospect of a benefit. That seems unethical, and unnecessary.
The FDA also is showing a desire to classify more things that merely inform consumers as medical devices. One example is seen in the FDA’s approach to consumer apps, like those found on an iPhone. A lot of these apps are really low risk.
MR. THOMPSON: While there are certainly some incidents of the FDA regulating devices too stringently, they are by and large the exception. You mention placebo-controlled device trials. In the example you cite, however, the FDA did not order the company to use a placebo control. That was the company’s idea. The fact that the FDA permits the use of placebo controls is hardly evidence that the FDA is overregulating.
You suggest the FDA overregulates mobile apps. In the last couple of years, it has sought to reduce, not enlarge, its regulatory oversight. For example, it has deregulated the hardware and software that takes data from medical devices like a blood glucose meter and transmits it for storage and display. That was a big step forward.
Instead of sweeping, fundamental reform to either clamp down or loosen up FDA oversight, I favor continuous improvement guided by continuous review of agency performance data as well as marketplace and scientific trends.
DR. REDBERG: As a cardiologist taking care of patients every week, I see too many whose lives have been harmed and who have suffered greatly from untested or inappropriate devices. And that doesn’t begin to address the billions of dollars these devices add to health-care bills.
Only a few percent of all devices on the U.S. market go though the only pathway that requires any clinical data. And even that most-stringent pathway doesn’t require two randomized clinical trials. In fact it doesn’t even require one; this most rigorous evidence standard can and frequently is met by non-randomized trials without controls, or by case-series or even expert opinion.
These devices cannot be removed without significant risk of serious morbidity or death, as has been learned by the many women who received pelvic mesh, or had their uteri removed with the aid of morcellators, for just two of many possible examples. Yet another example of a high-risk implanted device entering the market without clinical studies is the inferior vena cava filter, which for some models, studies have shown that 1 in 4 fracture after implantation in the major blood vessel entering the heart and are risky to remove. And after metal-on-metal hips, touted as a great innovation, entered the U.S. market without clinical studies, many Americans learned the hard way that they have a fourfold increased revision rate compared with other artificial hips and leak metal ions into the bloodstream.
WSJ: Brad and Scott, isn’t it clear that too often, devices get on the market with minimal evidence of safety?
DR. GOTTLIEB: My concern is that a lot of the fundamental questions about device safety turn on issues of biomechanical performance. For example, some common questions are how resilient an implanted valve will be to the shearing effects of blood flow, a joint to constant stresses, or the durability of a pacemaker’s circuits.
The FDA is trying, in too many cases, to answer these questions by requiring longer and larger trials in people and large animals like pigs and sheep.
The issue at the heart of the tragedy with [uterine] morcellators [in hysterectomies] is a different one. Here there was a much more fundamental misunderstanding about the biology of a disease state. The FDA didn’t fully appreciate the risk of certain kinds of cancer, and how frequently they occurred.
MR. THOMPSON: The truth, I think, lies somewhere in between the extremes that [Dr. Gottlieb] and [Dr. Redberg] have staked out. I agree with [Dr. Redberg] that sometimes unsafe or ineffective products reach the market. Morcellators are indeed a recent example. That’s regrettable. However, that fact, by itself, doesn’t mean we should fundamentally change the system.
Out of all of the thousands of medical devices that the FDA clears each year, how many turn out to be unsafe or ineffective? Not many. But further, and equally importantly, how effective are alternative regulatory systems in approving important new medical devices in a timely way? Changing the system in a way that delays or even forecloses the sale of safe and effective breakthrough medical devices hurts patients, too.
Preventing failures
WSJ: In one of the worst failures, a Medtronic defibrillator wire, the company relied on stress testing, not a clinical trial; 268,000 patients were exposed to a wire that led to multiple deaths.
MR. THOMPSON: That problem was found eight years ago. The fact you need to go back that far speaks to the overall robustness of the FDA process.
DR. GOTTLIEB: The failure of any defibrillator lead is tragic, but to portray the malfunction of Medtronic’s lead as an example of a device failure that could have been avoided through a bigger clinical trial gives short shrift to the basic science and engineering challenges that permeate this type of problem, and how one tries to prevent it from occurring.
Keep in mind that 99.8% of all medical devices have no serious adverse events associated with them. The U.S. is the gold standard when it comes to device safety. There are always opportunities to enhance the process. For example, the FDA is implementing a unique device identifier [UDI] system to better track device performance [after approval].
DR. REDBERG: Only a few percent of all medical devices enter the market via a pathway that requires at least some clinical data.
Simply put, for the vast majority of medical devices, there is NO requirement to demonstrate safety and effectiveness.
We must have national, publicly available registries of devices and procedures, so that we can track in real-time the outcomes, and then truly know the benefits and the risks.
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The Natural Product Transforming the Lives of Cancer Patients After Surgery
Mar 23, 2015 | The Telegraph
By Cherrill Hicks
It would be hard to think of a worse moment in Caroline Brown’s stellar musical career than when she realised, around this time two years ago, she could no longer play her beloved cello. As artistic director of the Hanover Band, one of the UK’s finest period instrument orchestras, she was determined to take part in a concert of Bach’s St John Passion at Chichester Cathedral, despite having recently undergone gruelling surgery for a rare cancer on her appendix.
“It was a huge mistake” she says. “You have to exert incredible effort playing a cello.” Particularly a cello made in the baroque style, which unlike modern instruments has no endpin to support its weight, meaning this beautiful but considerably bulky instrument has to be gripped between the knees.
“I could barely stand after that performance and for the next two weeks I was in agony,” she recalls. “I realised that was it. I thought I would never play again.”
The 61-year-old musician, who lives with her husband Stephen in Brighton, sounds surprisingly matter-of-fact about the ordeal she has undergone over the past three years, after surgery for a “silent” tumour on her appendix led to complications that almost killed her.
Damage to her abdominal wall resulted in peritonitis (a potentially fatal infection of the abdominal lining) and septicaemia (blood poisoning). For two years she has had to live with a stoma bag – “most unpleasant” she says stoically; and not long after the Easter concert two years ago, as her abdominal wall collapsed, she developed a hernia the size of a football.
It is only thanks to the expertise of surgeons at London’s Royal Marsden Hospital, Caroline believes, that she has survived. Crucially, her abdominal wall has been repaired by an innovative “natural” product derived from calf skin, which vastly reduces the risks of lethal infection. “It is called acellular dermal matrix and it is transforming the outcomes for cancer patients needing breast reconstruction or bowel and abdominal repairs,” says her reconstructive surgeon, Paul Harris.
Caroline’s life has revolved around music: her talent on the cello, learnt from the age of 10, has seen her regularly perform with Sadlers Wells Royal Ballet and other national orchestras. Her particular passion is for the early music movement, which aims to create an authentic sound using period instruments, and 35 years ago she founded the Hanover band (Hanover being the period 1714-1830, while “band” is the 18th century term for orchestra). It quickly became a huge success, playing Beethoven, Mozart and Haydn internationally. Although, she adds: “Our repertoire is very large – from Bach to Gilbert & Sullivan”.
But nearly three years ago, in April 2012, she developed persistent vaginal bleeding that left her exhausted. A scan showed a mass on her right ovary, which was removed by surgeons at the Royal Sussex County Hospital that July. Initially, doctors assumed she had ovarian cancer; it only became clear three months later that the mass was a Krukenberg tumour – a rare form of metastatic cancer that develops on the ovary, from a “silent” primary cancer, usually located in the gastrointestinal tract.
“Krukenberg tumours are rare, accounting for only about one to two per cent of all ovarian tumours,” says Mr Harris. “The term describes the phenomenon of a 'silent’ primary tumour producing metastases [tumours formed by cells that have spread] in the ovary and the patient presents with signs of ovarian cancer: pain, abdominal swelling, loss of appetite and weight loss.” A scan in August 2012 showed Caroline’s “silent” tumour was on the appendix – also an extremely rare occurrence, accounting for about 0.5% of all intestinal cancers. “A doctor said it was pure luck they discovered it,” she says.
Further surgery to remove the appendix and part of the colon resulted in disastrous leakage from the bowel and life-threatening bouts of peritonitis and septicaemia. Several emergency operations later, faced with the breakdown of the right side of the abdominal wall and the contents of the bowel flooding the abdomen, surgeons were forced to create a stoma - bringing the end of the small intestine through an opening on the skin surface so that waste can be passed out into an artificial pouch. By which time Caroline was critically ill with blood poisoning. “They actually thought I only had a few days to live,” she says. “I recovered though – my surgeon nearly fell over when he saw me still standing.”
But having a stoma, she says, is profoundly demoralising. And things got even worse when damage to her abdominal wall led to a massive hernia forming just below the stoma. Her musical career seemed to be over. “It is difficult to explain how awful you feel not playing,” she says. “Music has been my life and without it I can’t express myself.”
She started to help organise the band along with Stephen, the band’s manager. “But I went from discussing musical points with colleagues, being part of a common effort, to being an observer,” she says. “I found it very hard to come to terms with. I still do. It’s been a sadness.”
In January 2013, Caroline was referred to the Marsden. The band has royal connections (the Duke of Kent is a patron), and influential friends and supporters came to her aid. Within days she was admitted.
Chemotherapy started in February, but by this time, recalls Mr Harris, Caroline was in bad shape. “She could hardly walk and was in a great deal of pain,” he says. “She had a stoma, a hernia the size of a football and an open wound. But we felt it was too early to go back in and reverse the stoma or repair the hernia.”
Not only that, but when she was tested for MRSA the musician was found to be carrying the dangerous superbug on her skin and mucous membranes. “Quite a lot of the population are walking round with the bug on their skin,” says Mr Harris. “It is harmless unless there is a wound or you are going to undergo surgery, when an infection could be life-threatening.” Efforts to clear it with a regimen of chemicals for washing and antibiotic cream for vulnerable areas such as armpits and creases in the groin had little effect. Mr Harris was particularly worried about the risk of using the standard synthetic mesh to repair her hernia. “If it became infected after surgery, it would be impossible to treat,” he says.
Instead he favoured a special mesh made of a natural substance – in this case, calf skin. Called acellular dermal matrix (ADM), it can be derived from from pig, calf or even human skin (this last is preferred in the US but is not licensed in the UK).
“ADM has all the cells removed so just the collagen is left. It is a biological product, increasingly used in soft tissue reconstruction surgery, in particular breast reconstruction. The joy of using this natural substance is it develops its own blood supply and becomes part of the patient,” he explains. “So if it was to become infected, the patient’s own white blood cells would eradicate infection, with the aid of antibiotics.”
The drawback of ADM is its cost: for Caroline’s hernia it was around £14,000. “It is very expensive and the NHS has to be careful with money,” says Mr Harris. “We wrote a submission to the local commissioners and at the 11th hour funding was sorted out.”
Last November Caroline underwent an eight-hour operation. Consultant surgeon Satvindar Mudan reversed the stoma, reconnecting the two sections of bowel; Mr Harris reconstructed the abdominal wall with a large sheet of ADM. He also removed a further mass found within the abdominal wall.
Three months later, Caroline is still recovering but relieved that “everything feels in the right place”. Doctors are monitoring the cancer cells, which scans have shown are still present in her peritoneum. “I do feel positive and try to look ahead but it does leave you anxious,” she says.
Without the Marsden’s expertise – particularly in reconstructive surgery - she may not have survived. “This was about restoring her dignity and her quality of life,” says Mr Harris.
Now she is busy organising a Hanover Band concert at St Andrew Church in Holborn for the end of this month, in aid of the Marsden. The orchestra will perform the St John Passion. She hopes to be playing again herself in six months, but using an endpin to support her cello. Although, she adds with a wry smile, “it is against my principles.”
“A lot of people are pessimistic about the benefits of the NHS,” she says, “but I had all this marvellous treatment on the health service. I wouldn’t have been able to do it otherwise.”
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