Fw: Retrieved implants could be source of important data

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----- Original Message -----

From: " Kathi " <pureheart@...>

Sent: Sunday, October 13, 2002 9:43 AM

Subject: Retrieved implants could be source of important data

> MJ

>

> Retrieved implants could be source of important data

>

> A national system of removal and analysis of medical implants could

> reveal how well -- or poorly -- they function. But

> how would this system work?

>

> By Deborah L. Shelton, AMNews staff. Feb. 14, 2000. Additional

> information

>

>

> Although about 25 million Americans carry a medical implant of some type

> in their bodies, far more could be known about how the devices work --

> and fail -- if they were retrieved and

> analyzed after they have been replaced or when patients die.

>

> For example, more than 500,000 hips and 500,000 knees are replaced each

> year worldwide, about half in the United States. But only a dozen or so

> of those implanted in this country

> are retrieved and analyzed, said E. Baier, PhD, executive

> director of the University for Biosurfaces at State University of New

> York at Buffalo.

>

> A technology assessment panel gathered at a conference to discuss

> implants recently made a series of recommendations to the National

> Institutes of Health aimed at making it easier

> for medical implants to be retrieved and analyzed. It recommended that:

>

> Patients be provided with a card containing relevant information

> about their implant, such as the make and serial number and the name of

> the manufacturer.

> An aggressive education campaign be developed to teach patients,

> doctors and others about the importance of retrieving and analyzing

> implants.

> Training programs be established to increase the number of experts

> in the field.

> The medical device industry be more forthcoming in sharing

> information about adverse outcomes and possible defects with doctors,

> patients and other interested parties.

>

> Some conference participants suggested that a national implant registry

> be established.

>

> However, the panel concluded that such a system would be too expensive

> and complex to operate and that it would raise significant

> confidentiality issues.

>

> The number and types of medical implants have exploded since the 1960s,

> when hip replacements first became popular as a salvage operation for

> patients crippled by arthritis. Among

> the 350 implants available today are those that can prevent or delay

> death, restore function, reduce pain or serve a cosmetic or

> reconstructive purpose.

>

> " The generation with braces on its teeth will die with braces on its

> arteries, " said C. Lerner, PhD, vice president for strategic

> planning at ECRI, a nonprofit health services

> research organization. " The greater longevity of patients and their high

> activity levels, even in old age, mean that more people will require

> implants and even multiple implants. "

>

> Early on, hip replacement was expected to simply get the patient mobile

> again, said Dane A. , PhD, president and chief executive officer

> of Biomet Inc., a medical device

> manufacturer. " Today, almost any joint in the body can be replaced, and

> expectations have increased greatly, " he said. " Patients may seek a

> total joint replacement because they

> cannot play a good round of golf. "

>

> Although most people realize that a replacement joint will not last

> forever, the expectation is that the artificial joint will last decades,

> if not the rest of the patient's life, Dr. told the

> NIH conference on improving the performance of medical implants. Yet

> social-demographic changes might make such expectations unrealistic.

>

> " Current outcomes for musculoskeletal implant devices are strongly

> influenced by patient-specific risk factors, in that many individuals in

> the industrialized world are becoming heavier,

> remaining more active with aging and living longer, " said Jack E.

> Lemons, PhD, a professor in the Division of Orthopaedic Surgery and

> School of Dentistry at the University of Alabama

> at Birmingham.

>

> " Physicians would like to put in the best possible implants, " said

> Brandt Jr., MD, PhD, NIH panel and conference co-chair. " By

> retrieving those implants you can look at tissue

> reactions to the implant and the influence of tissue on the implant and,

> thereby, improve the design and effectiveness of implants for the

> future. "

>

> Retrieval analysis also can lead to improved surgical techniques, he

> said.

>

> An ideal system

>

> Retrieval databases also can provide valuable information. One of

> Biomet's implants, the AGC knee, was shown to be one of the best

> performing knees in the Swedish knee registry, a

> retrieval database. " This information, from a large national database,

> can reveal how a product will perform in a variety of patients and in

> the hands of surgeons with different

> experience, " Dr. said. " The databases can, therefore, help

> patients and surgeons understand what type of implant works best under

> all circumstances. "

>

> In the United Kingdom, five implant databases and several analysis

> centers for explants are funded by the Medical Devices Agency. The

> databases provide data on longevity, clinical

> performance and early warning of failure.

>

> In the United States, implant retrieval and analysis is currently

> conducted on an ad hoc basis by manufacturers and academic health care

> institutions.

>

> The Food and Drug Administration doesn't generally require postmarket

> studies on retrieved implants. " A decision for clinical or retrieval

> study would be made on a device-by-device

> basis, " said E. Marlowe, director of the office of science and

> technology in the FDA's Center for Devices and Radiological Health.

>

> In the 1980s, ECRI attempted to establish an implant registry to track

> patients in the event of device failure or product recalls. But after

> three years they were able to recruit fewer than

> 50 hospitals and establish a registry of fewer than 50,000 patients.

> After five years the operation was sold to Medic Alert, the maker of

> medical information bracelets, which

> discontinued the effort after about a year.

>

> The registry's failure was primarily due to fear of liability suits, Dr.

> Lerner said.

>

> High-profile cases, ranging from those against makers of heart valves to

> silicone breast implants, are signs of a harsh legal climate that shows

> no signs of abating, he said. Conference

> participants were unanimous in calling for tort reform to eliminate

> legal disincentives for implant retrieval and analysis.

>

> But there was no agreement on a fundamental and related issue: who

> actually owns an implant. Patients assume the devices belong to them,

> but company representatives said the

> devices remain the property of the manufacturer. " That issue has to be

> tackled as part of the whole discussion of liability and ownership of

> data, " Marlowe said.

>

> Dr. Baier has been advocating a national titlement system that would

> work much like that for automobiles. Under his proposal, each implant

> recipient would receive legal title to the

> implanted device. States would maintain a record of registered titles,

> and implant manufacturers would be required to disclose information

> about failures or product revisions.

>

> " If something goes wrong with your brakes, you get a notice, " Dr. Baier

> said. " It should work the same way with implants. "

>

> The panel recommended that patients receive implant registration cards

> that would include the implant make, model and serial number, as well as

> a place for them to note their wish to

> " donate " the device after their death. Presently, patients are not told

> which model they have received or who the manufacturer is.

>

> " An information card seems do-able and something the patient would have

> wherever they went, " said T. , PhD, acting deputy director of

> the National Heart, Lung and Blood

> Institute.

>

> Back to top.

>

>

> ADDITIONAL INFORMATION:

>

> 20 years ago, tracking implants was an idea far ahead of its time

>

> It was an ambitious plan to establish a national implant registry in the

> early 1980s. In retrospect, the idea was probably doomed to fail.

>

> " We were ahead of our times, " said Jeffery C. Lerner, PhD, vice

> president of strategic planning at ECRI, which ran the implant registry

> for five years before turning it over to Medic Alert,

> which discontinued it after a year.

>

> " ECRI first called for an implant registry in 1973 at Senate hearings,

> but nobody responded for a decade, so we answered our own call by

> establishing the National Implant Registry, "

> Dr. Lerner said.

>

> The concept was very appealing because it allowed tracking of patients

> and devices in the event of product failures, recalls or upgrades.

>

> The registry established " clinical juries, " composed of physicians,

> engineers, ethicists and risk managers, that helped administrators and

> doctors at a particular hospital determine

> whether to notify a patient about confirmed problems with an implant.

>

> The registry also alerted hospitals proactively about problems other

> hospitals had been experiencing.

>

> ECRI determined that lifetime tracking cost less than $20 per implant.

>

> A tracking service is critical when devices need to be replaced, Dr.

> Lerner said. In 1982, one hospital had to replace cardiac pacemakers in

> about 180 patients because they didn't

> know which ones had received pacemakers with defective leads, he said.

>

> Despite the registry's pluses, there were stumbling blocks. Fewer than

> 50 hospitals and 50,000 patients joined. And many patients were lost to

> follow-up. Within six months of leaving

> hospitals, almost 35% of patients with implants could not be tracked. By

> the end of two years, 50% of registered patients were lost to follow-up.

>

> The biggest challenge was fear of litigation by doctors and hospitals,

> which Dr. Lerner said tort reform could help resolve.

>

> Also, new capabilities for tracking implants now exist, such as coding

> and electronic systems, that could make it easier to locate patients

> today. " There wasn't an Internet or e-mail

> back then to track patients in the event of device failure or recalls, "

> he said.

>

>

>

>