FAILED Hip Implants prompt FDA study.

 New FDA Study to Look atCauses of Failure in Hip Implants

Posted: 25 July 2013

By Alexander Gaffney, RF News Editor  FiDA Highlight

One of the largest medical device scandals in the last decade has involved

metal-on-metal hip implants, so-named because of the metal (usually chromium)

attachment that attaches a leg to a metal socket.

In the wake of their failures, the US Food and Drug Administration (FDA) moved to examine its regulatory processes, eventually deciding to require premarket approval (PMA) applications for all such implants. But now evidence has emerged that the agency still has further questions about what more it could have done to prevent the devices from ever having reached the market.

Background

Medical devices are a relatively recent addition to FDA's regulatory authority, with FDA only receiving the authority to vigorously regulate them in 1976 under the Medical Device Amendments. Because some medical devices were already marketed at that time, FDA classified them all as class III, high-risk medical devices until it could review and classify them properly.

Some of those devices went on to serve as predicates for 510(k) premarket notification applications, which claimed that they were substantially equivalent to already-approved devices and were thus able to avoid conducting clinical trials to re-prove their safety and efficacy.

The problem with that, some researchers claim, is that many of the original devices which metal-on-metal hips claimed to be ancestors of have since been recalled from the market under dubious circumstances, meaning the devices might never have been safe to begin with. Further, the metal-on-metal hips were not so similar to the original device as to be clearly substantially equivalent. Devices of this sort are routinely approved and are referred to as "split predicates."

In light of those concerns—and a lack of action on the part of Congress during the 2012 passage of the Food and Drug Administration Safety and Innovation Act to explicitly close the so-called loophole—FDA announced on 17 January 2013 that it would move to require all metal-on-metal implant devices to be submitted in the form of a PMA or PDP, which typically require clinical trials in support of the application and thus an investigational device exemption (IDE) application as well.

A New Study

But even with these new requirements, FDA said it is still concerned about hip implants in general, and most especially with respect to how they are worn down. In the case of metal-on-metal hips, the chromium coatings of the device wore each other down, in some cases dislodging metal chromium shavings that caused tissue damage and raised fears about metal ions entering the bloodstream and causing cancer.

In a solicitation notice posted on the Federal Business Opportunities (FBO) website, FDA noted that "there is renewed concern of wear and corrosion of conical head/stem taper junctions in modern modular total hip replacements." While not a "new phenomenon," FDA said new design changes like metal-on-metal bearings, larger femoral heads and modular designs have reintroduced the issue even as the new features more closely approximate patient features.

As a result, FDA said it's embarking on a new project to "investigate the potential link between volumetric wear and corrosion of conical head/stem taper junctions in explanted total hip replacements and clinical outcomes."

As with nearly all solicitation notices, it's looking to the private sector to help it design and run the study, the results of which will be used to "aid development of standard test methodologies for preclinical evaluation of total hip implants."

The study will reportedly look at 250 explanted metal-on-metal hip replacements of various sizes and genders and use the American Society for Testing and Materials (ASTM) protocol for corrosion testing to analyze them. "De-identified patient data and radiographs must be available or obtainable for all devices," the notice explains.

The end goal of the project, which should take about two years total to conduct, is to generate a peer-reviewed journal article explaining correlations between wear and corrosion and relevant parameters (e.g. implantation time, lateral offset, head size, materials, and modularity).

Solicitations are due to FDA by 1 August 2013.

REGULATORY FOCUS Departments: Under RAPS Quality & Compliance Science & Technology Perspective It's the Law

   

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Consumer App for Reporting Adverse Events to FDA!

Reporting Adverse Events? There's an App for That, But Not for Industry--Yet

Latest News | Posted: 24 April 2013

Need to report an adverse event related to a medical device? Now patients are about to find there's an app for that, US regulators revealed yesterday.   https://medwatcher.org

Background

The US Food and Drug Administration (FDA) takes in an enormous number of adverse event reports each year through various systems, including MedWatch.

One issue, however, is that manufacturers, healthcare providers and patients are held to different standards. Medical device manufacturers, for example, are held to medical device reporting regulations that require them to report to MedWatch any adverse events they are made aware of, including for off-label uses.

Patients and healthcare providers, meanwhile, are able to report adverse events, but are not required to do so.

That difference has led to significant under-reporting of adverse events according to some estimates, posing a challenge for regulators in their attempts to transition more of the regulatory assessment process to postmarket settings. If, for example, a particularly dangerous adverse event is only seen in one out of every 10,000 patients, it might not be picked up by clinical testing. Once on the market, lax adverse event reporting practices by healthcare providers could delay the time at which the company and regulators become aware of that safety issue, potentially putting more consumers at risk for a dangerous event.

A New App

That's where FDA's new MedWatcher adverse event reporting application (iOS version) (Android version) comes in, said Bill Maisel, deputy director for science and the chief scientist at FDA's Center for Devices and Radiological Health (CDRH), in a statement.

"This app allows medical device users to easily report suspected or known problems with a device from their smartphone or tablet," he said. Users in this context include patients, caregivers, and healthcare professionals, FDA explained.

Maisel later said in an interview with the Wall Street Journal that the crux of the issue for FDA was: "How can we all find out earlier than we have been finding out?"

"We'll get access to better data more quickly now," he hypothesized.

The audience the application is not to be used by is worth noting in this context: Medical device manufacturers and healthcare providers. Maisel said that these two groups, "will continue to be required to report problems through the Medical Devices Reporting System and the Medical Product Safety Network."

Indicative of Future Changes?

But as Jeffery Shuren, director of CDRH, said at the Medical Device Manufacturers Association's (MDMA) annual meeting in April 2012, the system could be a harbinger of changes to come for industry.

According to MD+DI's Arundhati Parmar, Shuren said that the MedWatcher app "will push through adverse events into the database that will replace the Manufacturer and User Facility Device Experience (MAUDE) database. “It would make it easier for aggregating adverse event reporting.”

That functionality could eventually lead to device manufacturers being given the same reporting capabilities as consumers—an outcome that seems all the more likely given that the MedWatcher app is basically just a more user-friendly version of FDA's Form 3500, according to FDA.

"We're transforming this network into a modern system that uses electronic health information," William Maisel confirmed in an interview with the Wall Street Journal.

But the idea of an app hasn't received unanimous support. Paul Ivsin, a consulting director for clinical trials, argued last week that FDA would be better served by avoiding the use of apps entirely, and instead focus on "developing a robust set of Application Programming Interfaces (APIs) that can be used by the teams who are developing medical data apps." That would result in a wider array of more customizable options to meet the needs of hospitals, manufacturers and patients, he argued. In addition, they could link up with other databases, such as the Sentinel Initiative, giving users access to more information. That would also be in line with a 2012 White House directive ordering agencies to make more data open to the public via APIs.

For now, though, FDA can only wait and see whether consumers actually use the applications. As of the time of this article's publication, the app has been downloaded more than 10,000 times.

Failed Implanted Medical Device 'phased out'

J.&J. Unit Phasing Out All-Metal Hip Devices

By BARRY MEIER   The New York Times

Published: May 16, 2013  FiDA highlight

The orthopedic unit of Johnson & Johnson said Thursday that it was phasing out production of all-metal replacement hips, a move reflecting an industrywide trend to abandon the once widely used implants because of high early failure rates.

In 2010, the company, DePuy Orthopaedics, recalled an all-metal model known as the Articular Surface Replacement, or A.S.R., because it was failing just a few years after implant. Typically, artificial hips made from materials like plastic and metal last 15 years or more before they wear out and need to be replaced.

But after that recall, the company continued to sell an all-metal version of a popular hip model called the Pinnacle. In doing so, DePuy insisted that the all-metal Pinnacle was safe and performing on par with other hip replacements, a position it reiterated on Thursday.

It is estimated that all-metal replacement hips — in which both the cup and ball of a device are made from metal — once accounted for about one in three hip implants used in the United States. However, the metal components rubbed against each other as a patient moved, creating tiny particles that could damage tissue, muscle and bone.

Johnson & Johnson is facing a wave of lawsuits from patients who say they were injured when all-metal implants sold by the company failed. It faces over 10,000 cases related to the A.S.R. and 3,300 cases related to the all-metal Pinnacle, according to a company filing with the Securities and Exchange Commission

In a statement Thursday, DePuy pointed to two factors behind its decision to drop the all-metal Pinnacle: sharply declining surgeon demand for all-metal devices and a recent ruling by the Food and Drug Administration affecting such products.

In January, the agency told producers of all-metal hips that any models that were cleared for sale through a regulatory route that did not require premarket clinical testing in patients would have to run such studies to continue selling them.

“DePuy has communicated to the F.D.A. its decision not to pursue” such studies for the device, the company said in its statement.

The company said it was also discontinuing sales of a metal component that can be used with a ceramic hip implant called the Complete. Sales of the metal component used in both the Pinnacle and the Complete will end in August, the company said
.

Patient/public access to implant data still missing!

Losing preferential treatment

Physicians face limited choice in medical device selection as hospitals push to slash supply-chain costs

 Modern Healthcare

By Jaimy Lee   FiDA highlight  

Posted: February 15, 2013 - 12:01 am ET

 Gagged by their supply contracts, some hospitals have devised a simple way to educate physicians about the cost of pricey implants: using color-coded stickers to indicate the level of a device's price.

Many of these hospitals are barred by confidentiality clauses with device manufacturers that limit, in some instances, whether hospitals in the same health system can share pricing data about the devices they purchase. Instead, they mark the devices with colored tags specifying high-, medium- or low-cost options.

The widespread use of confidentiality clauses—which limit price transparency and hospitals' ability to shop for devices based on price—and longstanding relationships between physicians and device companies are the two major factors driving costs higher on implantable devices such as artificial knees and hips or cardiovascular stents, which are among the most expensive items hospitals buy.

 They are frequently called physician preference items because orthopedic and cardiovascular surgeons traditionally make the final decisions as to which devices a hospital will use. Only over the past five years or so have some hospital administrators started to implement strategies to reduce the costs of these items.

However, mounting pressure on hospital margins, the increasing number of physicians employed by hospitals and the shift to new payment models that align the financial priorities of hospitals, physicians and a patient's cost of care indicate that the concept of a physician's preference may soon be a thing of the past.

“This will be an area where there is a lot of opportunity for cost containment because it's an area that has really run rampant in the past and has not been well controlled by many hospitals,” says Dr. Kevin Bozic, vice chairman of orthopedic surgery at the University of California at San Francisco. “There's not as much flexibility and fat in the system. They're going to have to be much more efficient and function with the same discipline as other businesses.”

At the same time, the costs of many implantable device procedures continue to rise. Orthopedic procedures accounted for most of the growth in Medicare implantable device procedures from 2004 to 2009, with spending on those procedures increasing 8.1% annually for five years, according to a Government Accountability Office report from January 2012.

There is little publicly available data showing the individual prices of implantable devices and whether those prices are rising. But the same report found examples of “substantial price variation,” with one hospital paying $4,500 for a specific primary total hip construct and another paying $8,000 for the same product.

“The cost of joint implant constructs used for knee and hip replacement vary widely and are major contributors to the variation in the cost of care for patients undergoing total joint replacement,” according to a separate study published last year in the Journal of Bone & Joint Surgery.

With hospital margins under pressure, many large health systems and integrated delivery networks have become increasingly aggressive about implementing cost-cutting initiatives that target medical devices. They usually focus on reducing prices and the number of manufacturers—which can lead to better volume discounts—as well as seeking better utilization practices.

Hospitals have introduced gain-sharing programs that allow physicians to share in cost savings. They're also creating device registries that track performance to help inform purchasing decisions and instituting bundled-payment models that may also reduce costs and improve quality.

However, there are no specific efforts under way to ban the use of confidentiality clauses.

Jeffrey Lerner, president and CEO of the ECRI Institute, an independent health technology assessment organization, says that increased awareness of the clauses, as well as the ongoing cost pressures and market changes, could lead to increased pricing transparency.

But there's more to reducing a health system's supply costs than just addressing price, says Brent Johnson, vice president of supply chain and imaging services and chief purchasing officer for Intermountain Healthcare, Salt Lake City. There is greater financial benefit when Intermountain better manages utilization and standardizes practices rather than solely focusing on price, he says.

“In this industry, we tend to tiptoe around physicians. That they are allowed preference is a huge conflict of interest most of the time,” Johnson says. “When the physician has a choice between keeping his loyalty and whatever benefit he gets from the vendor and keeping his salary whole, he'll abandon the preference in a minute.”

Many physicians develop preference for specific devices or manufacturers early in their careers. In a fee-for-service model, physicians have little incentive to choose less-expensive devices and more often than not their interests are closely aligned with those of the manufacturer rather than the hospital. This is changing.

“There have been more attempts to align the interests, financial or otherwise, of hospitals and physicians,” UCSF's Bozic says. “More physicians are employed by hospitals; more physicians are entering into joint ventures or co-management agreements with hospitals; and newer payment methodologies such as bundled payments are effectively putting both the hospital and the physicians at risk for the cost of care, (which) aligns their incentives around improving quality and reducing costs.”

The Affordable Care Act is at the center of many of these changes. Along with the introduction of new payment models, such as accountable care organizations and patient-centered medical homes, the inclusion of the Physician Payments Sunshine Act is expected to make the financial relationships between physicians and manufacturers more transparent.

Related content

Video: NYU Langone Medical Center Executive Gerard DeSilva discusses supply-chain issues

Under the Sunshine Act, device companies are required to collect data about the payments, gifts and other “transfers of value” they give to physicians. That data will be posted online beginning in September 2014, which might give hospitals and physicians an incentive to reduce the appearance or prevalence of certain relationships.

“That level of disclosure may be operating to weaken the bond between the implanting surgeon and the company,” ECRI's Lerner says.

In fact, physicians are increasingly getting involved with supply chain-led initiatives to reduce costs. Dr. Richard Parker, chairman of orthopedic surgery at the Cleveland Clinic, has been working closely with the 11-hospital system's supply-chain staff since 2008. Parker, a sports medicine surgeon, was named chair of orthopedic surgery in 2009. “When I moved into that leadership role, I became much more acutely aware of costs,” he says.

With the move toward what Parker calls “value-based medicine,” physicians are becoming more engaged in supply decisions, especially in the cases where a change in device can affect patient care or when the price of a device makes up a large percentage of certain DRGs. He says there is little pushback from other physicians who may question some standardization efforts.

“We attract individuals who, quite frankly, value the brand of the organization more than their individual brand,” Parker says. “They realize that in order for this to continue we have to get our arms around these things.”

At Intermountain, the doctors who are members of physician preference committees for orthopedics, cardiovascular, neurology, trauma and surgical services items are “already more engaged, accepting of change and know this is where we're headed,” Johnson says.

The first time the supply-chain team tackled the costs of orthopedic devices was in 2007, when the 21-hospital system was spending about $32 million annually on that device category alone.

That same year, Johnson received approval from the system's administrators to share up to 30% of documented first-year savings on the costs of orthopedic devices with the system's orthopedic surgeons. By supporting Intermountain's strategy to implement standard pricing policies—physician support pressured suppliers to comply—the physicians could use the savings to purchase other equipment, supplies or training.

The approach worked, and Intermountain now re-evaluates the cost of physician preference device categories every two years. The average savings for every category assessment is about 20% each time, Johnson says.

However, he views many of the pending payment reforms as the potential forces in driving the concept of “preference” out of the industry. If a physician has to take a 20% deduction on the cost of a procedure or agree to use a limited number of suppliers, the physician will be more likely to support standardization, Johnson says.

“Healthcare reform isn't just about cost. We've got to manage utilization,” he says. “We need physicians and surgeons to not just be loyal to one supplier, we need them on board to help us manage utilization and standardization and value beyond just price.”

So while market and regulatory change may be coming, it may not be occurring as quickly as some hospitals would like. Physician preference items are usually among a hospital's most expensive supply costs. With few organizations willing to make further cuts to labor costs—an organization's highest expense—they are instead focusing on reducing their second-largest expense—supplies—with physician preference items being a key target.

“Nonlabor (cost) is now getting a lot of attention because we squeezed everything we can out of the labor side,” says Ed Hardin, vice president of supply chain management for Christus Health in Texas. “We can't afford to make those kinds of cuts, so we've got to get more efficient and more effective about how we run our supply chain.”

Physician preference items account for about 57% of total supply costs for Christus Health, Hardin says, a percentage that has increased 10% since 2008. “It's rising as a percentage of total supply expense, whereas commodity spend has gone down,” he says.

As the cost of physician preference items continues to make up a larger percentage of total supply costs, some hospital systems have looked outside of their networks in an effort to better address the costs of these devices.

Cleveland Clinic and Dignity Health, both large health systems, have formed separate joint ventures that specifically aim to address the costs of physician preference items.

San Francisco-based Dignity Health developed a for-profit company called SharedClarity with UnitedHealthcare and up to 10 additional and unnamed health systems.

“These organizations are combining data to help inform healthcare organizations about the best-performing medical devices through comparative effectiveness studies,” according to SharedClarity's website. “For the first time, these exclusive studies will enable doctors and administrators to make informed decisions based on clinical proof rather than manufacturer influence.”

When the Cleveland Clinic announced its joint venture with VHA this month, it stressed that it will focus on how it can reduce the costs of physician preference items for its hospitals. However, there are also plans to bring in VHA members, Cleveland Clinic affiliates and other organizations.

The Greater New York Hospital Association recently received approval from the U.S. Justice Department to establish a voluntary gain-sharing program for its member hospitals. UCSF's Bozic says the university is looking into the possibility of developing a similar program.

ECRI's Lerner says more hospital systems will form partnerships or other ventures to help them rein in the costs of these devices. “Change brings a lot of experimentation,” he says. “We have to see how it actually plays out.”

One of the largest concerns for executives who manage supply-chain purchasing at hospitals is how to obtain and use clinical data that allow them to choose between competing devices. The goal: improving patient outcomes and avoiding repeat operations known as revisions. As payers turn toward bundled payments, avoiding revisions can also lower costs. Kaiser Permanente and the Cleveland Clinic have each maintained system device registries that can better track how a device performs after implantation.

Government registries in Australia and the United Kingdom were the first to discover that metal-on-metal hip implants were failing at a faster rate than other hip devices. More than 93,000 metal-on-metal hip implants sold by Johnson & Johnson's DePuy Orthopaedics unit were later recalled, which led not only to revisions but also to thousands of lawsuits.

In addition, the number of recalls in recent years may have caused a splinter in the relationships between physicians and manufacturers.

“There have been disappointments for physicians,” Lerner says. “We've had high-profile recalls. You have this gigantic problem with metal-on-metal implants, which makes a huge impact. That's massive, and I think it undermines that complete trust bond between the surgeons and the companies.”

TAKEAWAY: Reducing the number of vendors and developing new ventures are among the ways hospitals are targeting supply-chain costs.

U.S. lags in medical device implant safety.

Europe Ups the Post-Market Ante for New MedicalDevices

January 14, 2013 12:57 pm by Amy Siegel | 0 Comments

It should come as no surprise that the movement toward more rigorous post-market surveillance of medical devices has gone global. While US med-tech titans like Medtronic and J&J have made headlines for selling bad defibrillator leads and faulty hip joints, America certainly doesn’t have the monopoly on device recalls; it was a French company that marketed substandard breast implants used in some half million women worldwide, landing the CEO in jail after a media-stirring manhunt.

Fueled by this highly visible run of device recalls, post-market data demands are increasing for the more risky (Class III and some Class II) new medical technologies in the U.S. as well as in Europe. While Europe may still provide a faster route to regulatory approval for such devices, post-market requirements are creeping in like an expensive final cheese course served by European regulators and health systems just when companies are feeling most broke and tired. So regulatory approvals may come, but actual, meaningful revenues? Not so fast.

To dig deeper on the changing med-tech launch conditions in Europe, S2N talked to Terry McCarthy, Co-Founder and Managing Director of FirstClinTech, a Holland-based company providing a range of services (business development, clinical support, logistics and technical service) aimed at ’easing’ medical device companies into the EU markets. FirstClinTech came to life filling a service void left by a failed ventricular assist device company, so Terry knows a thing or two about the market challenges for novel medical technologies in Europe.

On paper, European-wide efforts to strengthen and harmonize regulation of innovative medical devices are progressing at a leisurely pace, with a target adoption of yet-to-be-clarified regulations by 2019. ’Don’t let that timeline lull you into complacency, though,’ warns Terry, who is already seeing some Notified Bodies stepping up their post-market data requirements ahead of any new regulations being in force. This escalation in post-market requirements has real, quantifiable implications for emerging med-tech companies.

Delayed Commercial Revenues

Terry cites recent examples where Notified Bodies have made CE approval of implantable devices conditional upon satisfactory surveillance data captured for a defined period of time or number of implants. ’We often confront the unrealistic assumption that as soon as you have CE mark you can start selling and generate revenue,’ says Terry. While companies generally understand that significant revenue will be gated by reimbursement, which is in turn gated by efficacy data, heightened post-market regulatory requirements could translate into longer dwell times in ’limited launch’ (a.k.a. paltry revenue) mode than expected. For some product types, companies are often end up giving away lots of devices during this phase, further reducing early market revenues.

Increased Post-Market Expenses

The most obvious cost associated with post-market surveillance is study management; this expense can vary widely depending on the surveillance study size and device complexity. ’You want to do enough science to back up what you said in your dossier,’ advises Terry, ’and also see that the patients enrolled in the post-market study resemble those in the pre-market study.’ For example, a physician might be tempted to try a newly approved device in a ’train wreck’ patient for whom there are no other options, even if this is an off-label application with much lower efficacy prospects. ’Ensuring that appropriate patients are included in the post-market surveillance studies means that companies need to have people on the ground interacting with centers,’ says Terry.

Tougher Sales Channel Decisions

This need for tighter control in the early commercialization phase can also impact the decision of whether and when to go with direct sales representatives or sell through a distributor in Europe. ’A distributor will naturally want to sell as many devices as possible, whereas company management and the Notified Body all want the first tranche of patients to be done in a fairly controlled way,’ cautions Terry. Other post-market obligations, such as device traceability (another recall-inspired global initiative), must also be carefully considered in distributor relationships and contractual arrangements.

Despite heavier post-market burdens, regulatory consistency across Europe will likely benefit emerging med tech companies in the end. ’The current situation is confused,’ says Terry. ’Harmonization should improve transparency and establish a more level playing field for medical device companies.’ A major bridging of regulatory frameworks across the Atlantic, however, is likely a long way off. Terry and others agree that Europe will continue to take a more risk-based, safety-focused approach to device approvals for the foreseeable future. Getting insurance payment for new devices in Europe, or the US, is another matter entirely.

For more predictions and insights about the changing landscape for med tech in Europe, read this excellent article from FirstClinTech.

Read more: http://medcitynews.com/2013/01/europe-ups-the-post-market-ante-for-new-medical-devices/#ixzz2Kh76XYlR

President Obama: Faulty Medical Devices

This is a joyous day!

President Obama has been re-elected.  

In his 2012 State of the Union Address President Obama indicated that he was aware of faulty implanted medical devices and that targeted regulation is necessary to strengthen the U.S. free market.  

“We've all paid the price for lenders who sold mortgages to people who couldn't afford them, and buyers who knew they couldn't afford them. That’s why we need smart regulations to prevent irresponsible behavior. Rules to prevent financial fraud, or toxic dumping, or faulty medical devices don't destroy the free market. They make the free market work better,” Obama said.

Removal of  conflicted regulators from decision-making and rescinding industry entitlements  heightens assurance to patients that implanted devices are safe and effective.  Patients with access to accurate post-market data from CMS and hospitals make informed decisions and patient harm is reduced.  Businesses that produce valued implants will thrive.  

Let's get to work!

Harmed Patient asks PCORI to Fund Research on Implants

This letter was emailed to Susan E. Sheridan, Director of Patient Engagement, PCORI Patient Centered Outcomes Research Institute, www.pcori.org ssheridan@pcori.org 10/29/12

Dear Susan,

Joleen Chambers has asked me to send information to help enlighten your knowledge as to failed implants. On June 27-28^th, 2012 I traveled to Washington, DC to speak to the FDA re: metal hips.

I was proud to participate in this function, hoping some good may come from the meeting. However, the FDA heard testimonies from other victims of metal hip nightmares and they heard from renown scientist, surgeons and doctors from our country that they saw no need to use metal on metal hip devices as they have recently proven to cause more harm than good. The FDA has been gathering information on this matter for years

Yet market share and rate of returns seem to dictate what actions are or are not taken regarding these devices. The apparent ongoing corruption is sickening.

If the Church, the auto and oil industries, Penn State, now the Boy Scouts are all held accountable for their miss deeds or malfunctions how does a medical device get a free pass when it causes harm to more people than the acceptable failure rate.

I had a Smith & Nephew Birmingham hip resurfacing device implanted in 2007, after my 3^rd dislocation the device was removed in 2010 leaving me in the  hospital fighting for my life for 11 months, 12+ surgeries etc.

I was an active 61 old, played sports, great work, great grandchildren and family, friends etc all of these great things have been altered for the rest of my life. Today I am in a wheelchair, I can no longer do the things I enjoyed the most in life, playing with the kids, hunting, fishing my personal life with my wife has been destroyed. The list goes on and on.

 I have become an advocate in as much I am searching for answers as to why this happened, how it happened and what can I do to see it never happens again based on present day circumstances.

I have helped folks through the internet, letting them know they aren’t alone in this nightmare, I have actually got a few victims into see a specialist in orthopaedic hip problems when other surgeons refused to help.

If you are so inclined please read the FDA notes on the meeting held in DC on September 8, 2005 regarding the approval of the Smith & Nephew hip (BHR) The sole patient test group was controlled by one of the inventors of the bhr, these patients were cherry picked all from the abroad, no test done in the USA, this individual received 66 million pounds for his company ( the highest gross income reported by this company Midland Medical Tech was 23 million pounds—so how is it worth 66 million—then the individual received an additional 33 million pounds once the bhr was pma (pre-marketing approved) by the FDA—Conflict of interest???

The minutes of this meeting clearly state enough unkown answers and it expressed enough concerns on the bhr that it never should have been approved, yet it passed by a 3/2 vote.

Wright medical submitted a letter asking for this device’s approval to be denied as it had conflicting materials of the rules and regulations stated by the FDA, so how did it get approved –CORRUPTION.

To make matters worse because the bhr was pma approved it is now protected by the pre-emption laws. Basically they get to hurt me (others) and there is little I can do about it.

I have accumulated enough information and material on this matter to write a book, however what I want is accountability from the manufacturer for me and the 1000’s of others the device has hurt.

I think this is enough to get you started, I am available and willing to do whatever I can to see justice is served and those that need help will receive it.

You can reach me hbs924@verizon.net  or my cell is 941-928-29

Found this in the mouse maze! Patient last to know.

 Being a patient advocate is like running in a maze designed to disorient and exclude.

Regina Holliday (patient advocate, artist) painted this while attending the PCORI patient-engagement workshop in DC today.  It is unreasonable of PCORI/FDA to expect any patient or advocate to demonstrate more tenacity or willingness to work productively.  This system is rigged.  I await my invitation to the December 4 PCORI meeting.

FDA PushesDevice Surveillance Plan That Could Involve PCORI; Off-Label, Data Access Debated

Posted: September 11, 2012  (FiDA highlight)

FDA device officials are pushing for a national postmarket surveillance monitoring system that emphasizes Unique Device Identifiers and their incorporation into electronic health records, device registries, modernized adverse event reporting and new methods to analyze postmarket information, laying out the plan in a paper released late last week and discussed at a public meeting Monday (Sept. 10). The head of the health law's comparative effectiveness institute expressed interest in participating in the initiative, which FDA hopes will extend beyond the agency.

Stakeholders also debated potential governance structures, eventually floating a public-private partnership. When pressed on the role the health law's Patient-Centered Outcomes Research Institute could play, PCORI Executive Director Joe Selby said he is particularly interested in involving patients and contributing analytic methods. “We’d be glad to be party to discussions like that,” he told and FDA official during the meeting. He said, however, there should be a business case made to each party, and it is more challenging to make the case for patients and health systems.

While industry, consumer and academic stakeholders lauded FDA’s effort, concerns emerged about off-label uses and access to the data, given issues with patient protections and company proprietary concerns. “The key is going to be implementation,” said Paul Brown, government relations manager with the National Research Center for Women and Families. He cited examples in the report that spurred concerns about the potential to incentivize off-label use as the data collected through postmarket surveillance could support new indications.

“Analysis of de-identified EHR data containing a unique device identifier demonstrates that within the practice of medicine, physicians have been treating patients with incontinence due to other causes -- and the data demonstrates the device is as effective as it is in patients with incontinence due to prostate surgery,” according to an example comparing potential future uses of the system to the current state where manufacturers must conduct clinical trials to expand labeled indications. “The company submits the analysis and (the Center for Devices and Radiological Health) approves an expansion of the labeled indication solely on the basis of the collected postmarket data.”

Brown warned that, depending on implementation, the system could provide an incentive for companies not to conduct clinical trials and potentially exacerbate problems with off-label promotion. Another device safety advocate, however, said using the postmarket data would allow for a real-world analysis of devices as many risks are unknown until products are available to a broader patient population.

Brown also took issue with FDA suggestions that postmarket data could be used in support of device down classifications, saying such information should also be used to support up classification if appropriate. Further, he said FDA should have access to information in registries to detect safety signals, an issue that also emerged as academic and industry stakeholders debated who would have access to the device data as it could affect hospitals and individual practitioners. Industry stakeholders also expressed concern that the system should not try to be “all things to all people.”

FDA device center director Jeffrey Shuren emphasized that the agency would leverage national and international registries, as opposed to creating a registry repository.

“Let me be clear, we don’t need registries for every type of medical device nor is it feasible or sustainable to do so,” he said. “And we don’t want to develop a central repository.” Individual repositories should remain such as it helps protect patient privacy, he said.

Thomas Gross, director of the device center’s office of surveillance and biometrics, said the agency has already facilitated the development of dozens of registries. With regard to modernizing adverse event reporting, Gross touted the use of triggers in electronic health records to automate the reporting and a medical app that is being piloted.

FDA device officials said they hope to release a finalized version of the plan by the end of the year. -- Alaina Busch (abusch@iwpnews.com)