Plastic Mesh Surgically Implanted in Mothers: What Could Go Wrong?

“I was rotting from the inside”: The vaginal surgery secretly destroying mothers’ lives.

MICHELLE ANDREWS

April 28, 2017  FiDA highlight

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Kim Blieschke had no idea her life would change irreparably when she was advised to undergo a “straightforward” surgery to correct pelvic organ prolapse – a complication from childbirth that results in surrounding organs to bulge or sag down into the vagina.

But moments after waking up from her transvaginal mesh implant procedure in 2006, where a web of polypropylene plastic was embedded into her vaginal wall, the mum-of-four knew “something wasn’t quite right”.

“I was in intense pain that they couldn’t control,” Kim told me over the phone from her Port Pirie home, in the South Australian countryside.

“I woke up with quite substantial bruising all over my buttocks and perineum and upper thighs. The bruises were the size of my hand.”

"I had necrotic flesh in there." (Image supplied)

"It was a pain like you wouldn't believe," she said. "Doctors said I'd be in the hospital for two or three days, but I was there for seven. On the three-hour car ride home, sitting was almost unbearable."

From there, Kim's condition spiralled.

"My doctor kept saying it will be better, it will be better, but I ended up taking three months off work," she told me. "I couldn't drive, I couldn't lift, I couldn't even sweep the floor."

Doctors made Kim feel like she was imagining the pain, but as a seasoned paramedic, she knew something was awry when her vagina developed a "foul smell".

"I told my GP something wasn't quite right, and it turned out I had necrotic flesh in there."

The polypropylene - a material used to create everything from plastic chairs to water bottles - had ignited Kim's natural foreign body reaction. Her body wasn't just trying to fight the mesh, it was trying to kill it.

The Therapeutic Goods Administration says transvaginal meshes were approved by "conformity assessment certification either from a EU certification body or the TGA".

By 2014 the TGA admitted its assessment process for the mesh was not “mature” and lacked “rigour”, and subsequently announced there was “little evidence to support the overall effectiveness of these surgical meshes as a class of products”.

By 2015 - a decade after mesh was first approved for embedding within the vaginas of thousands of Australian women - 72 of the 100 mesh products on the Australian market were delisted.

Despite this, where the TGA acknowledged shortcomings of the devices, it mostly blamed "the skill and training of the surgeon and the patient selection".

While the TGA said in a statement to Channel 10 it has only received 205 adverse event reports, and "the reported rate of complications was low", Kim argues this is because the channels of reporting post-surgical problems is convoluted and lacks transparency.

The implant that Kim was told to not worry about, the one she was told was simple and straight forward, was eroding away, and destroying her body with it.

"I felt like I was rotting from the inside," she describes.

By the time 2013 rolled around - some seven years after Kim's surgery - her surgeon had retired. The South Australian mum had developed chronic nerve damage which consumed her right hip, knee and two of her toes.

The fetid mesh was deeply affecting her sex life with longterm partner Jared, too.

"When I had intimate relations with my partner, he could feel the hard and brittle arms of my implant against him. It was unbearable.

"A lot of women's partners and husbands have just walked away and left them because of the impact it has on their sex lives, but thankfully my partner has been wonderfully supportive."

The "disastrous" effect the mesh has had has seen Kim spend "hundreds of thousands of dollars", take months at a time off work, and use up all of her long service leave just to find some relief from the constant pain.

Because the real clincher is this: While Australian surgeons are more than happy to insert mesh into women's pelvic floors, they're not so willing to remove it. In fact, there are only two doctors in the world who offer to take out transvaginal mesh, and both live in the United States.

To have the toxic mesh removed requires a six-month stint off work to visit the US, and an upfront payment of $50,000, something Kim pursued and succeeded with.

There are only two doctors in the world who offer to take out transvaginal mesh. (Image supplied)

While the mesh might be out of her body, the havoc it wreaked is irreversible and will stay with Kim forever.

"My mesh was embedded in my bowel, my rectum, and my urethra," Kim told me. "Now, my whole pelvic floor is just a massive scar tissue. I am now incontinent, my nerve damage and muscle damage is permanent, and I live on medications."

Kim also lives with a level of anxiety she likens to post traumatic stress disorder.

"I'm certainly not the woman and I am not the mother I once was," she said. "I feel like I've lost a big part of myself. I can't be with my kids as much as I'd like, I can't play or do all the things I wanted to do with them. There are some days when I can't get out of bed."

If there is any solace in this tragedy, it's that Kim Blieschke can find comfort in the other Australian women who have also lived this hell. In fact, hundreds have reported serious health complications as a result of transvaginal mesh implants to the TGA, and a medical review predicts there are 4000 more silently suffering in the shadows behind them.

When Kim found someone who had experienced what she had online, she was overwhelmed.

"I just burst into tears because I honestly thought that I was on my own," she said. "I was told that it was all in my head, and to find that there was someone else, and for all these women to come forward was incredible.

"It's something that nobody really wants to talk about because people feel embarrassed, but as far as I'm concerned I want everyone to know about it."

"I want everyone to know about it." (Image supplied)

Kim is now one of the handful of women who are leading the charge to have transvaginal mesh implants banned. Her meeting with Victorian Senator Derryn Hinch last year proved pivotal in pushing discussion forward about what Hinch describes as "one of the greatest medical scandals and abuses of mothers in Australia's history".

It falls in line with the opinion of The Royal Australian and New Zealand College of Obstetricians and Gynaecologists, who state that "very little robust information is available on the efficacy and long term safety" of polypropylene mesh to treat pelvic organ prolapse, warning women of "adverse" effects.

Thanks to women like Kim, and Senator Hinch, there is now a Senate inquiry into the mesh, which has a reporting date of November 30.

But the aim is to do more than just have the mesh banned - it's to get justice.

"We would like someone to be answerable to this," Kim explained. "Because none of the surgeons are mandated to report the complications, they don't. We want women to have informed consent, because a lot of women are just told this is a straight forward operation when it's not, it can ruin lives."

And on behalf of Mamamia, we dearly hope Kim, and the many women beside her, succeed.

If you are a victim of transvaginal implants, Mamamia encourages you to lodge a complaint by clicking on your state: 

Victoria; New South Wales/ACT; Queensland; South Australia; Western Australia; Tasmania; Northern Territory.

 http://www.mamamia.com.au/transvaginal-mesh-implants/

No Harmed Patient/Stakeholder at the WSJ Roundtable Discussion on Medical Device Regulation

Do the FDA’s Regulations Governing Medical Devices Need to Be Overhauled?

Most products get to market via a fast-track process; three experts debate whether the current system makes sense

By THOMAS M. BURTON  FiDA highlight added

March 22, 2015 11:00 p.m. ET

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.

Mr. Burton is a reporter in the Washington bureau of The Wall Street Journal. He can be reached at tom.burton@wsj.com.

My comment:

"The Wall Street Journal and Thomas M. Burton have my gratitude for tackling this issue, but my dismay for having a ‘roundtable’ discussion that does not include the patient perspective.  

You do not need to go back eight years to find implanted medical devices failing.  Nearly 70,000 women are in federal court in an MDL lawsuit for failed pelvic mesh sold by more than a half dozen U.S. medical device makers.  14,000 women have met on Facebook Essure Problems to provide mutual support and begin the legal and legislative process of removing this dangerous Bayer ‘permanent’ birth control product from the market.  The company is profiting while they suppress information and harm more young women and their families.

As a trained FDA Patient Representative (9/2010) I learned what little regard the clearance process had for PREVENTABLE harm to patients.  In the ‘Informed Consent’ there is no access to non-proprietary patient outcome research on the device and no discussion of the impact of “Riegel v Medtronic” and pre-emption on the civil rights of the patient should he/she be harmed.  There is no product warranty and hospitals and doctors have a back-door way of dealing with the complex medical issues of a FAILED device:  the patient is referred for psychiatric help, a pain clinic or the doctor/patient relationship is severed by the doctor.   Harmed patients are buried alive by the perpetrators-in plain sight.”  This is legal, thanks to aggressive lobbyists for the medical device (petroleum, chemical, metals) industry.  

http://www.wsj.com/articles/do-the-fdas-regulations-of-medical-devices-need-to-be-overhauled-1427079649?KEYWORDS=FDA

"PROVE IT !!!" M-o-M hips, pelvic surgical mesh, Essure birth control . . .

Health officials tell medical technology group to'prove it'

By Sabriya Rice

Posted: October 8, 2014 - 3:15 pm ET

Tags: Costs, Medical Devices, Medical Technology, Quality

“Prove it.” That was the resounding message to medical-device manufacturers during the annual Advanced Medical Technology Association conference in Chicago this week. Innovation is needed to advance medicine and better patients' quality of life, but gone are the days of sticking higher price tags on products that only provide incremental improvements, the leaders of health insurance companies, health systems, quality improvement and consumer organizations told the industry.

“We don't want to squelch innovation,” said Dr. Scott Josephs, national medical officer for the health insurance provider Cigna Corp. “But tell me what I'm getting for my healthcare costs. Show me that these new technologies are superior,” he told the audience during a session Wednesday morning.

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Payment reform puts medical-device industry on the defensive

Josephs was joined on the panel by Susan DeVore, president and CEO of the health improvement organization and group purchasing organization Premier; and Mark Neaman, CEO of the Chicago area's NorthShore University HealthSystem. An essential element in the aim for higher efficiency will be the need to more critically assess the value of new innovations, the panelists said.

“If it's clinically appropriate but equally efficacious to existing technology, then frankly it's just adding costs to the system,” Josephs said. “That's not something we would prefer.”

Fee for service is dead and the current landscape “is a bit chaotic,” noted DeVore, who said health providers are in the process of integrating what has been a fragmented industry. In light of that, the old ways of doing things are not going to suffice, Neaman said. “The stakes are very high for us as providers,” he told the audience.

New payment models aimed at improving efficiency and getting a handle on costs have proliferated quickly in recent years, nurtured by provisions of the Patient Protection and Affordable Care Act. Many providers are joining accountable care organizations, which are risk-sharing mechanisms available through government payers like Medicare as well as private payers, in which members agree to strive for cost and quality targets and share savings or losses.

Monday, AdvaMed promoted an industry-funded white paper based on the responses of officials from nine unnamed health insurance companies who were interviewed about their movement toward pay-for-performance and risk-based contracts. Officials from five insurers said they had become more selective about approving coverage for new technologies in the past three years. Four said they plan to demand more evidence before covering products. All said costs were driving their organizations to explore new reimbursement models.

The trade group representing medical-device manufacturers worried these rapidly burgeoning pay-for-performance and risk-based reimbursement models will result in what AdvaMed CEO Stephen Ubl called “unintended consequences.”

Too many of the arrangements emphasize cost targets over quality benchmarks, said Joe Almeida, the trade group's chairman as well as CEO of the medical-device manufacturer Covidien. “They run the risk of really tipping too far, so physicians have incentive not to adopt things that really benefit patients,” said David Nexon, an AdvaMed senior vice president.

Health economists countered that the white paper may have overstated those concerns and that it's hard to make the extrapolation. Insurers agreed, saying truly superior innovations would not be overlooked, even if they come at higher costs. And most health officials interviewed by Modern Healthcare said the key factor is the proof.

“The thing that's been missing from the model until now is the evidence,” said Diana Zuckerman, a researcher who has been critical of the Food and Drug Administration's procedures for approving and monitoring medical devices.

The federal agency's recent plans for an accelerated approval pathway for some medical devices has been met with criticism by consumer advocates who say such efforts put patients in danger.

During a conference session on Tuesday afternoon, FDA Commissioner Dr. Margaret Hamburg said that as science and technology advance at extraordinary rates, the agency wants to stay up to speed as a partner with the medical technology community. A more efficient system overall will allow for the delivery of new science and technology for patients in more reliable and cost-effective ways, but the emphasis on speed doesn't mean a step away from scientific rigor, she said.

As new products make their way to the forefront, no matter how rapidly, the onus is increasing for manufacturers to ensure that providers are convinced the innovations are worth the financial investment.

It's not about the lowest price point, that's just one part of the overall value equation, Cigna's Josephs said. It's about having more data and conceiving of partnership arrangements to help get there, according to Premier's DeVore. “Bring your evidence and data, and bring a willingness to collaborate and take risks,” she said.

Follow Sabriya Rice on Twitter: @MHsrice

Medical device industry is "unlike" just about any other consumer industry!

About 80 percent of hip doctors haveno idea how much a hip replacement costs

            BY JENNY GOLD   Washington Post  Wonkblog

            January 7 at 10:20 am

What will a gallon of milk set you back? How about a new car? You probably have a rough idea.

But what about a medical device, the kind that gets implanted during a knee or hip replacement? Chances are you have no clue. And you are not alone: The surgeons who implant those devices probably don’t know their cost, either, a new survey shows.

Medicare spends about $20 billion each year on implantable medical devices, nearly half of it for orthopedic procedures. And as the population ages and more Americans get joint replacements, that number is only going up, which will have a bigger and bigger impact on the nation’s health care spending.

But orthopedic surgeons don’t know much about how much their work contributes to that spending. They were able to correctly estimate the cost of a device only 21 percent of the time, according to a survey of 503 physicians at seven major academic medical centers published this week in the journal Health Affairs. Their guesses ranged from 1.8 percent of the actual price to 24.6 times the actual price. (Researchers could not release the actual costs because they signed nondisclosure agreements with the hospitals.)

Medical residents were worse at guessing — they were correct only 17 percent of the time. Estimates within 20 percent of the actual cost were considered correct. The study did not look at what patients know about cost.

“In orthopedic surgery, we’re never told how much things cost. We never see the cost displayed anywhere, and even if you were interested, there’s no great way to find it,” says Kanu Okike, lead author of the  study and an orthopedic surgeon at Kaiser Permanente Moanalua Medical Center in Honolulu (Kaiser Health News is not affiliated with Kaiser Permanente).

Unlike pretty much every other consumer industry, health care costs are not transparent, even for the surgeons. Each hospital system and purchasing group negotiates deals with device manufacturers and signs a nondisclosure form, promising not to share the details of those prices with anyone else.  That’s because “medical device manufacturers strive to keep their prices confidential so that they can sell the same implant at a different price to different health care institutions,” the study authors write.

But costs matter: For a total knee replacement, the actual piece of machinery that gets implanted can cost from $1,797 to $12,093, depending on the negotiated price. And there’s little evidence that one particular device is any better than another for the patient, says Okike.

The hospital actually has a financial incentive to use cheaper devices — it’s paid a lump sum for the procedure by Medicare (the government’s health insurance program for seniors and disabled people). That means that if a hospital uses a cheaper device, it ends up with a bigger profit.

But hospitals don’t tend to pressure surgeons to use the cheaper device, says Kevin J. Bozic, an orthopedic surgeon at the University of California San Francisco who studies the cost of medical devices. That’s because orthopedic surgeons are big moneymakers. “They don’t want to offend the doctors. They cater to them however they can, which includes not telling them which devices to use,” he explains.

And many orthopedic surgeons are aligned with a particular manufacturer, says Bozic, and receive a consulting fee or royalty for using that particular device. That makes them even less likely to take cost into consideration.

Some hospitals are seeking to make the devices' pricetags more transparent, in the hopes that just knowing what things cost will encourage surgeons to make different choices and lower spending. There are some glimmers of hope, including a national pilot project that makes a surgeon’s payment for each surgery dependent on the cost of the devices they use.

“But at the root of it, the biggest problem is the lack of price transparency across the industry,” says Okike. And device manufacturers aren’t in a hurry to change that without some sort of pressure.

Kaiser Health News is an editorially independent program of the Henry J. Kaiser Family Foundation, a nonprofit, nonpartisan health policy research and communication organization not affiliated with Kaiser Permanente.

Failed implant Device Alliance (JjrkCh) comment: 

Consumers must ask the orthopedic surgeon "What is the brand/model you are implanting?" and get a UDI- unique device identifier code.  "What is the warranty for this implanted product?"  "What are the validated clinical (live human) studies of patient outcomes from this specific implanted device?"  So far, the medical device industry has avoided accountability while gaining federal legal entitlements because of the ease of clearance by the FDA.  (The public believes there is a "regulator" for safety and effectiveness.)  If "informed consent" included this information, clarifying the loss of basic civil rights of the harmed patient, there would be no reason to discuss cost.  Who would purchase a car or a toaster this way?  My blog is Failed Implanted Device Alliance.  It compiles information about the safety and effectiveness issue. 

Proprietary Silo for Medical Devices: PCORI Irrelevant?

Where Is the Patient Stakeholder?  FiDA highlight.

By Jaimy Lee  Modern Healthcare

Posted: April 9, 2013 - 8:00 am ET

Health insurer UnitedHealthcare and about 50 hospitals say they will conduct research comparing some of the costliest medical devices on the market and then use that data to inform their purchasing decisions as part of a joint venture.

UnitedHealthcare and Dignity Health, a 37-hospital system based in San Francisco, formed  SharedClarity last year.

Since then, the Phoenix-based venture has added Baylor Health Care System, which operates 11 hospitals in Texas, and Advocate Healthcare, a 10-hosptial system based in Oak Brook, Ill., as its newest members. There are plans to include up to seven other health systems over the next few months.

“Our members have a tremendous thirst for getting independent information about how medical devices perform,” said Mark West, SharedClarity's president and a former vice president of supply chain management for UnitedHealthcare.

Implantable medical devices are among a hospital's most expensive supply costs. The prices of these devices are also rising, making them a concern for hospitals and insurers seeking to better manage the costs of pricey procedures such as hip and knee implants. 

Many hospitals have implemented cost-cutting strategies for devices and other physician-preference items, and some have formed new ventures that aim to address the costs of these products. Earlier this year, the Cleveland Clinic and VHA announced a joint venture that aims to target the costs of physician preference items.

However, SharedClarity is unique in that the venture was formed between an insurer and a health system. SharedClarity said it will identify the best-performing devices in 30 categories by using clinical data gathered from member hospitals and claims information from UnitedHealthcare, West said. The device categories range from stents and defibrillators to pacemakers and knee and hip implants. 

The hospital systems then plan to pool their purchasing volume to negotiate better prices on what they find to be the best-performing devices. In addition, hospitals that are part of UnitedHealthcare's provider networks will have access to those devices at prices negotiated by SharedClarity, although the prices will be less favorable than what the member hospitals receive.

The studies are expected to begin this spring. Richard Roth, Dignity's vice president of strategic innovation, said he expects the first purchasing decisions to be made next fall.

“As Dignity is entering in accountable care organizations and we're doing bundled payments and we're continually demonstrating the tenets of reform, this is going to be a valuable intelligence tool as we're caring for patients,” Roth said.

Both providers and insurers have lamented a lack of independent data about how implants perform, as well as lack of transparency about how they are priced. As more hospitals and insurers are taking on risk-based reimbursement strategies, they say there is a need for better data.

The higher failure rates of metal-on-metal hip implants, which led to revision surgeries and thousands of lawsuits against Johnson & Johnson, would have been caught sooner if data about the performance of those devices had been captured, according to West. 

SharedClarity will not only compare types of device and how they perform, it will also research how some devices fare when compared to different types of treatments or therapies.

“Our goal is to shed a light on this and create transparency,” Roth said.

Biomet Knee Warranty: Patient Advocates Not Buying It!

Go to the link  Biomet direct-to-consumer ad now running on TV in the U.S.   The Biomet knee warranty is here.

What the warranty should say:

1. This device is designed to last for _______ years.  

2. Normal use is defined as ____________.

3. Patients will encounter no legal/paperwork barriers to accessing the warranty.        

4. Hospital and testing costs are fully covered.The product cost is incidental to patient harm costs such as lost income, pain and suffering. 

5.  Revision is failure and prompts payment under the warranty.  Increased function and pain reduction are expected. Introduction of new patient harm such as exposure to toxic materials or need for increased medical intervention is a failure.  

6. Patients should bear no expense for testing costs for devices with sub-optimal results.

7. Immediate patient compensation in contested cases is assured. Financial responsibility is pre-defined in a default agreement between producer/hospital/surgeon.    

8. Like MSDS sheets, every source and material in the device is listed and the long term health issues related to exposure are disclosed.  Such documentation must be provided to the patient in pre-op informed consent along with history of FDA product approval(510k or PMA) and number implanted to date. 9. A comprehensive federal implanted medical device registry is fully public and free. Exercised warranties will be immediately visible.  The medical device industry functions in a transparent and ethical manner to the benefit of the nation and citizens of the United States.  Profit reflects the value of its' contributions to the health of patients.

Concerns that Prompted this Blogpost:

Direct-to-consumer ads are intended to drive sales.   "The industry's only Lifetime Knee Implant Replacement Warranty^† in the U.S." is limited to the cost of the component only--not covered are hospital and surgeon fees, related surgery living costs (travel, hotel, transportation, etc.), and loss of economic benefit while surgery is repeated.

Prior to Biomet and the implanted medical device industry reaching the conclusion that "less is more" and advertising an (anemic but much-needed) warranty thousands of patients remain harmed and uncompensated. 

Reuters: Nearly $5B failed metal hip implants

http://reut.rs/NneL9r

Insight: As lawsuits climb, J&J may have new hip trauma

Thu, Jul 12 2012

By Debra Sherman  Reuters  (FiDA blog bold, highlight color)

CHICAGO (Reuters) - Johnson & Johnson faces a potentially more damaging and costly sequel to the $3 billion recall of its ASR all-metal artificial hips two years ago, one of the most expensive medical device failures in U.S. history.

A successor to ASR, the Pinnacle metal-on-metal hip system has nearly 1,600 lawsuits pending in U.S. courts. Doctors who are tracking large groups of patients with both products estimate that more than 10 percent of the Pinnacle all-metal hips will have failed in the next two to three years.

Metal-on-metal hip implants were sold on being more durable than those made of other materials, such as polyethylene or ceramic. They are meant to last up to 15 years, but as controversy over all metal-on-metal implants heats up, fewer surgeons are using them.

A survey taken by the American Academy of Orthopaedic Surgeons in 2010 showed 16 percent of surgeons were using metal-on-metal implants before the U.S. Food and Drug Administration warned of potential problems. That number dropped to 10 percent since the FDA warning, and doctors say the number probably has dwindled further.

Many patients with the Pinnacle metal-on-metal device are experiencing the same problems as those who got the ASR product, including pain and swelling, limited mobility, and dislocation. Perhaps most concerning, some doctors say, is the high levels of cobalt and chromium in the bloodstream resulting from wear of the all-metal implants. Metallosis, as it is known, can lead to cardiovascular, neurological, renal and thyroid problems, in addition to destroying soft tissue, muscle and bone.

"We're simply seeing the tip of the iceberg with metal-on-metal failures," Dr Mary O'Connor, an orthopedic surgeon at the Mayo Clinic in Jacksonville, Florida, said of the entire class of metal-on-metal devices. O'Connor said she does not use metal-on-metal hip implants because she has been concerned about metal poisoning for years.

The new round of complaints represents a significant threat for J&J's DePuy Orthopedics unit, whose Pinnacle line includes non-metal models and covers a much wider range of products than ASR. The diversified healthcare giant, under new Chief Executive Alex Gorsky, has also just raised its bet on orthopedic products with the $20 billion purchase of device maker Synthes.

"Litigation is what it is, but the ASR is a very different system and has a very different design and has very different clinical performance" than the Pinnacle, said Mindy Tinsley, a spokeswoman for DePuy. "We recalled it because it was not performing as it should."

She said DePuy is closely monitoring the performance of the Pinnacle metal-on-metal system, but is "very confident" in the product and will vigorously defend itself against lawsuits. DePuy did not make other executives available for comment.

DePuy and FDA officials said there is not sufficient evidence linking metal ions in the blood to health risks.

A total of 500,000 patients in the United States have received metal-on-metal hips, according to government data. Of those patients, an estimated 150,000 received the Pinnacle device, and 37,000 got the ASR implant. But while J&J has set aside $3 billion to settle the 3,000 ASR lawsuits, it is fighting complaints related to the Pinnacle device -- meaning that patients with virtually identical problems are facing different financial burdens.

Frances Grisham, 50, from Jackson, Tennessee, recently had surgery to repair a fracture to her left hip caused by the ASR implant. She was reimbursed for most of her out-of-pocket expenses and could be eligible for some of the settlement funds.

Harriett Bowen, 64, from Salisbury, Maryland, received the Pinnacle all-metal hip in 2008. She soon developed the same symptoms as Grisham: pain, limited mobility and elevated levels of cobalt and chromium in her blood. In July 2011, Bowen's left hip fractured at the implant site, requiring more surgery.

Bowen's doctor determined she had a cobalt and chromium count of 7 micrograms per liter (mcg/L), a level flagged by UK health authorities as worrying. "He said, 'Look, we've got to get this thing out of you.' It nearly scared me to death."

Unlike Grisham, she has received no compensation for the repair from J&J. Bowen is suing J&J.

"I have never done anything like this before, but considering what I went through for three years, I feel like I should be compensated," said Bowen.

PROBLEMS WITH ALL-METAL CITED ACROSS INDUSTRY

While other makers of total hip replacement systems -- including Smith & Nephew, Zimmer Holdings, Wright Medical and Biomet Inc -- face similar complaints, the numbers of devices involved is much smaller. The next most widely used product belongs to Biomet, which is defending itself against lawsuits over its metal-on-metal M2a Magnum Hip System.

Legal experts say J&J is taking a harder line defending itself against Pinnacle metal-on-metal claims, hiring a top product liability defense firm and refusing to recognize patient complaints or pay for replacing the hip devices - known as revision surgery. It maintains the device performs better than other all-metal hip implants.

Paul Voorhorst, director of biostatistics and data management at DePuy, told an FDA advisory panel last month that the Pinnacle metal-on-metal device "is performing consistent with or better than other metal-on-metal products."

Should the Pinnacle lawsuits be found to have merit, J&J could end up paying nearly $5 billion to cover revision surgeries alone, according to plaintiff attorneys. DePuy revenue last year was $5.81 billion, or 9 percent of J&J's total.

Legal experts not involved in the cases say J&J probably is just taking its chances to see how the first few lawsuits play out - a common strategy for Big Pharma in major drug litigation cases. They say J&J may be aided in its defense by the lack of any U.S. program to track the performance of medical devices once they are implanted in people's bodies.

"The last thing plaintiff lawyers want is to go one by one (for each case). With so much unknown, proving cause and effect may be difficult," said Carl Tobias, Williams professor of law at the University of Richmond School of Law.

Cindy Schipani, professor of business law at the University of Michigan, said J&J could be playing with fire if the Pinnacle metal-on-metal devices are shown to be defective.

"They lose credibility if they keep saying they're not responsible and then it turns out the product is the problem," she said. "I question this strategy."

NO HARD DATA

While doctors can report problems about the Pinnacle to an FDA database, products with that name also include artificial hips that are not exclusively made of metal. One product is metal-on-polyethylene, the most popular of the Pinnacle devices, and another is metal-on-ceramic. A Reuters search of the database could not isolate adverse events reported for the all-metal Pinnacle, which is the least used of the Pinnacle products.

There is also no hard data yet on the Pinnacle's failure rate, partly because DePuy does not publicly disclose how many were implanted. DePuy's Voorhorst told the FDA advisory panel that 4 percent to 4.5 percent of these Pinnacle implants require a second surgery to fix the devices within five years after implantation, which is in line with other hip devices.

Felecia Stern, an attorney with Bernstein Liebhard LLP, represents Bowen, Grisham and many other patients who received the ASR and Pinnacle all-metal devices. She noted that the recall of 93,000 ASR implants in 2010 led doctors to notify patients and monitor for high metal levels. But problems with the Pinnacle are being reported less systematically since the devices weren't pulled from the market.

"At the end of the day we will see a similar occurrence of high metal levels in Pinnacle metal-on-metal recipients as more and more of them get their blood tested. That is certainly what we are seeing in our client population," she said.

Her firm also serves on the Plaintiffs Steering Committee for the federal Pinnacle lawsuits, which have been consolidated into a multi-district litigation in Texas.

The FDA has been monitoring problems with all-metal hip implants and convened the panel of outside advisers last month to discuss their safety. The panel concluded there was little reason for surgeons to use these devices given the risks.

In May 2011, the agency ordered device makers to conduct follow-up studies in cases in which an implant's failure could have serious consequences. Companies would be expected to take blood samples from patients to measure metal ion levels. But more than a year later, the FDA and device manufacturers agreed on study protocols for less than one quarter of the devices. Most of the study plans, including DePuy's, have not been finalized.

"We need more data to better understand how these devices perform," FDA spokeswoman Michelle Bolek said. "We are open to a more collaborative effort, if it helps us get the data we need."

MINIMIZING RISK

The final failure rate for the ASR device has not yet been established, but a study released last March by the British Orthopaedic Association and the British Hip Society indicated a failure rate of up to 49 percent after six years - nearly four times the rate cited by DePuy when it recalled the device.

Dr David Langton is an orthopedist who has studied all-metal implants for years and supplied the two British organizations with data. He said he expects the ASR failure rate to rise to 80 percent at eight years. Based on a cohort of about 1,000 patients he is tracking at North Tees Hospital in the UK, the Pinnacle metal-on-metal hip has a failure rate of 8 percent at five years. He said that rate climbs to 16 percent after 6-1/2 years.

About 150,000 Pinnacle metal-on-metal devices are estimated to be implanted in patients outside the United States.

Several differences between the ASR and Pinnacle metal-on-metal could explain a lower failure rate.

One main reason is that the Pinnacle has a smaller head; larger heads are associated with higher failure rates because there is more friction.

Langton believes it is just be a matter of time before Pinnacle all-metal device failure rates climb, as more metal debris from the implant are released into the bloodstream and tissue. And while the failure rate might be lower than ASR, the absolute number of patients is higher.

"We believe the (Pinnacle) failure rate will be far above 10 percent," said attorney Brian Devine of Seeger Salvas LLP, which is handling both ASR and Pinnacle cases.

That would translate into second replacement surgery for 15,000 patients, he said. In 2002, Sulzer Medica AG paid an average of $250,000 per revision on its 2001 recall of its InterOp hip. Adjusting for inflation, an average J&J settlement could be $319,000 per revision, or $4.785 billion in total, he said.

Mayo Clinic's O'Connor is worried that the entry of metal ions into the bloodstream will damage internal organs, not just the surrounding tissues in the hip socket. There are also concerns high ion levels cause cancer, though that has not been proven.

"Autopsy studies of patients with metal-on-metal implants showed metal ions were everywhere the body - in the liver, the spleen, all over the place," O'Connor said.

(Reporting by Debra Sherman; Editing by Michele Gershberg, Edward Tobin, Leslie Adler)

(Reporting by Debra Sherman; Editing by Michele Gershberg, Edward Tobin, Leslie Adler)