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Medtronic Withheld Reports of their Failed Implants

http://www.nj.com/specialprojects/index.ssf?/specialprojects/implants/implants2.html

Only companies knew when their devices failed


Sunday, August 11, 2002

BY ROBERT COHEN AND J. SCOTT ORR
Star-Ledger Staff


WASHINGTON -- Hailed as marvels of modern technology, two medical
devices went on the market in September 1999 to treat patients whose
weakened arteries could kill them at any time.

An artery is a thick-walled vessel that carries blood away from the
heart. The beauty of these new implants, according to the companies
that made them, was that they could shore up the body's largest artery
without major surgery.

The new treatments for an abdominal aortic aneurysm -- the weakening
and ballooning of the wall of the aorta -- were promoted by their
makers as effective systems that not only would save patient lives but
would do so with fewer surgical complications, shorter hospital stays
and reduced recovery time.

But it turns out that the makers, Medtronic Inc. of Minneapolis and
Guidant Corp. of Indianapolis, were not always forthcoming with the
public, physicians or the Food and Drug Administration. The FDA
accused both of withholding vital data about effects of their devices.

Under the FDA's de facto honor system, the reporting of problems with
medical implants is left to the companies, and often companies are
reluctant to admit mistakes and to recall products. The cases of
Medtronic and Guidant provide unsettling evidence that even respected
manufacturers sometimes operate outside the FDA's patient- safety
rules.

Even when devices are subjected to the FDA's most rigorous pre-market
approval screening, as was the case in the artery implants, problems
that threaten the health of patients are allowed to slip through the
system's many cracks.

Medtronic and Guidant conducted human clinical trials and tracked
patient success, failure and complication rates -- a process used for
only about 2 percent all medical device applications. Their data were
reviewed by an FDA advisory panel of doctors and by the FDA staff
before approval was granted.

But government do***ents show that Medtronic, the maker of the AneuRx
Stent Graft System, withheld what the FDA described as "significant"
data from the agency regarding patients in clinical trials who
experienced aneurysm ruptures -- the very type of event the device was
designed to prevent.

While Medtronic continued to market its product, Guidant Corp., the
maker of the Ancure Endograft System, voluntarily recalled its
aneurysm device. The FDA announced Guidant "failed to report many
device malfunctions and adverse events, including severe vessel damage
associated with deployment of the device." In fact, the FDA said, the
company was marketing a different device than the one the FDA
approved.

Although the FDA could have imposed monetary penalties for hiding
important patient safety information, it sanctioned neither
manufacturer.


SURPRISE DATA


If an abdominal aortic aneurysm bursts, it is almost instantly fatal.
On average, 15,000 Americans die that way each year.

Using the conventional approach, surgeons open up the abdomen, move
delicate organs aside and replace the weakened artery with synthetic
tubing.

The procedure requires a hospital stay of a week or longer and can
mean months of recuperation. The mortality rate for such surgery is
around 5 percent; many of the patients who die are elderly.

Medtronic's AneuRx is a stent that, in contrast, is inserted into the
aorta through a small incision in the patient's legs. It is then
positioned within the aneurysm and offers an alternative route for the
blood flow.

In a May 2000 letter to Medtronic, a Minneapolis-based world leader in
the manufacture of heart implants, the FDA complained that it had
heard of only two ruptures during clinical trials; a month after it
approved the device, it was informed by the company that five more had
taken place.

The FDA said that by hiding these problems, Medtronic impeded "a full
review of the product's safety and effectiveness." The company later
confirmed in a letter to doctors that three more unreported ruptures
had occurred during the clinical trials, bringing the total to 10.

Almost a year later, the FDA sent its own letter to doctors citing
evidence by then of 25 aneurysm ruptures and other medical
complications. After its initial scolding by the FDA, and the
subsequent letter to physicians, Medtronic added some new warnings for
doctors but kept its device on the market.

Tom Wilder, vice president and general manager of Medtronic's
endovascular stent graft unit, said there were differences with the
FDA over whether the clinical-trial rupture data for AneuRx needed to
be reported.

In hindsight, he said, the company "regrets" the situation and has
worked to improve its reporting and monitoring systems. Wilder added
that the "underlying fact is the ruptures didn't change the clinical
results of the trial."

Chris Zarins, chief of vascular surgery at Stanford University Medical
Center in California and the lead clinical investigator, said AneuRx
has been successful in preventing aneurysm rupture in more than 98
percent of patients. Zarins also said patients always can have medical
complications and problems after surgery, but maintained the AneuRx
rates are lower than for traditional surgery.

Some 22,000 of the devices, costing about $12,000 each, have been
implanted in patients worldwide. Government data show 591 "adverse
events" involving AneuRx reported to the FDA through June, including
361 injuries to patients and 58 deaths.

The company says the rate of complications as reflected in the data is
low when compared with the number of devices that have been implanted.

David Feigal, director of the FDA's Center for Devices and
Radiological Health, said the agency has begun to see some independent
studies suggesting that "broader use of the product may not be better
than the surgery."

"If that is the case, that is something we will have to deal with,"
said Feigal.


DOWN THE BLOODSTREAM


The company's reported success rates are not very comforting to Ed
Gilleon, a 65-year old retired truck driver whose life was forever
altered by his May 26, 2000, aneurysm operation in which the Medtronic
device was implanted.

The Flagler, Colo., resident said he was assured by doctors that they
"had this thing that would fix me up and get me going and in good
shape and out of the hospital in a few days."

Within three months of his operation, Gilleon was experiencing intense
pain and soon learned that the device had moved down the bloodstream,
blocking 70 percent of the function of one kidney and 30 percent of
the other. Unable to remove the device, the doctors implanted another
stent to keep Gilleon alive.

"I know any jarring motion or any bend could kill me. That is what I
live with every day," said Gilleon. "I have no feeling in my right leg
and buttocks because of the nerve damage. I take morphine to dull the
pain.

"It's unimaginable what this has done to me. I used to enjoy life. But
I am very limited in what I can do now."

Gilleon's operation came within days of the FDA's warning letter to
Medtronic and the company's own safety notice to doctors announcing
the clinical trial ruptures and emphasizing other drawbacks --
including, as in Gilleon's case, the migration of the stent.

The company's letter warned doctors that not everyone is an ideal
candidate for the device and that patients should commit to lifetime
monitoring, including imaging tests every three to six months.

Gilleon is among 28 people who have sued Medtronic. Two of the
Medtronic cases have been dismissed; the others are pending. The
lawsuits claim the company withheld important safety data, never told
the patients about the need for lifetime monitoring and never gave
adequate warnings regarding many of the known adverse consequences.

At least seven other lawsuits have been filed against Guidant, whose
Ancure implant is a patch with metal hooks that grab onto a healthy
section of the aorta.

The companies are contesting the lawsuits, arguing their products are
safe, the warnings were sufficient, and the patients who used the
devices were in a high-risk class. Medtronic is also seeking to have
the lawsuits dismissed by arguing that FDA regulation of medical
devices pre-empts courts from applying a different standard through
state product liability laws.


'TURNED THEMSELVES IN'


Guidant Corp., the maker of the Ancure Endograft System, recalled its
aneurysm device March 16, 2001.

Guidant's Ancure is inserted through an incision in the groin. The
device forms a kind of sleeve that provides a new path for the blood
to flow.

The company now admits about 520 blood vessel injuries went unreported
once the product was approved and on the market -- a strikingly large
number. The FDA also criticized the company for making manufacturing
changes without approval.

The FDA's Feigal said, "The Guidant Corp. came to us and said: We made
modifications to the device and should have submitted an application
because the current device being marketed isn't the one you approved."

Guidant, a worldwide industry leader based in Indianapolis, suffered
the economic consequences of withdrawing its product from use for five
months. The move cost the company an estimated $15 million and a share
of the $260 million a year spent on implants to treat aneurysms.

"Guidant sort of turned themselves in" and came up with a corrective
plan, Feigal said. He said the agency believes the product had
significant value for some patients and should be available.

Beverly Huss, president of Guidant Endovascular Solutions, a unit of
the parent company, said an internal audit in 2000 turned up the large
number of unreported "adverse events" and also led to the conclusion
the manufacturing changes should have been disclosed.

"We took it very seriously and made lots of changes in our system,"
said Huss. "It's a credit to our organization that we went to the FDA
very openly and told them about the issues and brought forward a
corrective action plan."

She said the company has sold about 15,000 of its implanted devices
worldwide. The cost of each implant is $10,450. She said data show a
low rupture rate, with four years of clinical experience demonstrating
that 97 percent of the patients have experienced either controlled or
shrinking aneurysms.

Government data show 1,092 adverse events regarding Ancure were
reported to the FDA through June, including reports of 734 patient
injuries and 48 deaths. The number of reports has dwindled since the
device was changed and reintroduced last August.

Neither Medtronic nor Guidant faced fines or other sanctions from the
FDA, a common situation at an agency reluctant to take strong
enforcement actions against medical device makers.

Some experts attribute the lack of sanctions to the FDA's close
working relationship with the industry and a regulatory approach that
has long been geared more toward obtaining compliance than punishing
wrongdoers. Others say the FDA has too little staff to investigate and
develop cases, particularly in light of a federal law that imposes a
high legal threshold on the agency for tough enforcement sanctions.

"The FDA's system does not have any teeth," said Mark Burton, a San
Francisco attorney whose law firm of Hersh & Hersh has filed lawsuits
claiming Medtronic and Guidant failed to protect patients and marketed
defective products.

"People are making money and withholding information on devices, and
people are being injured and dying. The companies barely get a slap on
the wrist," said Burton.

"It is true of all the medical products that there are very weak
penalties," acknowledged the FDA's Feigal.

Tomorrow: Hip replacements.
» A glitch can kill, but pacemaker users will take that chance
» Back to beginning


(For years, this newsgroup has been harassed by Medtronic Shill, Mark
Probert under many of his alases)

http://www.humanticsfoundation.com/PropagandistProbert.html