Preview Newsletter
Ethicon 3/23
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Patients in Disbelief as Mesh Company Sales Reps Were Allowed in Theatre While Surgeons Carried Out Intimate Operations
Mar 22, 2015 | Daily Record and Sunday Mail
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... -
*New* Open Letter to Judge Goodwin
Mar 20, 2015 | Mesh Medical Device News Desk
By Jane Akre
...I feel as though no one is listening. American Medical Systems, my mesh manufacturer, is taking its sweet time to issue a decent settlement to thousands of us... -
Do the FDA’s Regulations Governing Medical Devices Need to Be Overhauled?
Mar 22, 2015 | The 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...
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Mar 22, 2015 | Daily Record and Sunday Mail
By Marion Scott
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.”
Would you be happy consenting to an operation involving a mesh implant?YESNO
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.”
Sunday Mail dossier of failed tape and mesh implants delivered to Parliament
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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*New* Open Letter to Judge Goodwin
Mar 20, 2015 | Mesh Medical Device News Desk
By Jane Akre
Editors Note* Judge Jospeh Goodwin is overseeing more than 70,000 transvaginal mesh cases consolidated in his federal court in West Virginia. That occurred three years ago and mesh settlements either are slow in coming or nonexistent. This MND readers writes an open letter to Judge Goodwin to help her. Please chime in if you you feel the same way. We will bring this article to Judge Goodwin’s attention. Thank you.
Dear Judge Goodwin-
I’m writing this a day before I have to put my dog down. She’s been my constant companion for 14 years and that, along with my mesh pain and the lag in any settlement talks has me looking for strength to continue.
I feel as though no one is listening. American Medical Systems, my mesh manufacturer, is taking its sweet time to issue a decent settlement to thousands of us. Many of us are out of time. I simply cannot wait another two years for AMS to decide to give us whatever amount they choose. My brain is gone, I’m not healing, I am depressed, angry and frustrated. My husband and I live paycheck to paycheck.
At the very least AMS should be offering us lost wages for our suffering. I had to stop working because the OxyContin no longer allowed me to function. Even my doctor said stop working. An auto accident victim receives lost wages, which for me, I calculated to be about $500,000. I’m not being greedy, I just want my wages back.
I need physical therapy and another removal surgery. Without any settlement monies, I cannot afford it.
Judge Goodwin, if AMS and the others will not offer settlements approximating what they have taken away, send these claims back to the states to be tried. Let’s move things along. We know they are not serious because they are not even talking to individual attorneys about us, their clients. How can the companies know what we have lost if they don’t ask? Are they just giving a ballpark number? That is not acceptable!
My little dog was like my child. She gave me the strength to carry on. Now I have to say goodbye to her too along with so much of my life I have lost.
Judge Goodwin, Can you help us? Please. To wait just adds insult to injury and many of us cannot endure this travesty any longer. I cry every day and I so sick of all of this. Please keep me in your prayers along with all the other women. I just wonder how many have to die or think about it before someone listens.
I have no hope and strength left. I’m just waiting to die without a decent settlement soon.
God Bless,
Anonymous woman
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Do the FDA’s Regulations Governing Medical Devices Need to Be Overhauled?
Mar 22, 2015 | The 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; andBradley 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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