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<DIV class=timestamp>March 16, 2007</DIV>
<DIV class=kicker></DIV>
<H1><NYT_HEADLINE type=" " version="1.0">History of Hernia Patch Raises
Questions on Implant Recalls </NYT_HEADLINE></H1><NYT_BYLINE type=" "
version="1.0"></NYT_BYLINE>
<DIV class=byline>By <A title="More Articles by Barry Meier"
href="http://topics.nytimes.com/top/reference/timestopics/people/m/barry_meier/index.html?inline=nyt-per">BARRY
MEIER</A></DIV><NYT_TEXT></NYT_TEXT>
<DIV id=articleBody>
<P>How do makers of implanted medical devices react when one of their products
starts breaking?</P>
<P>One answer can be found in the case of a hernia repair device made by a
subsidiary of <A title="C. R. Bard Inc."
href="http://www.nytimes.com/mem/MWredirect.html?MW=http://custom.marketwatch.com/custom/nyt-com/html-companyprofile.asp&symb=BCR">C.
R. Bard Inc.</A> In late 2005, the company sent out a recall, urging doctors to
stop using some versions of the product because a plastic component could break
and cut through a patient’s internal organs and tissue. </P>
<P>At the time, Bard executives said they knew about some serious injuries
potentially caused by the device, which is known as the Kugel patch. Since then,
the <A title="More articles about the U.S. Food And Drug Administration."
href="http://topics.nytimes.com/top/reference/timestopics/organizations/f/food_and_drug_administration/index.html?inline=nyt-org">Food
and Drug Administration</A> has received reports of more than 80 injuries and
other problems possibly related to it, including several fatalities.</P>
<P>Bard officials said recently in a statement that they had not recalled the
product sooner because complaints about failures were too few and unrelated to
raise any alarms. The company also said that both it and the subsidiary, Davol
Inc., had reacted responsibly.</P>
<P>But when F.D.A. officials inspected Davol in early 2006, they apparently
found other reasons that company officials and the agency might not have been
alerted earlier. For example, inspectors reported “discrepancies” and
“inconsistencies” in how Davol tracked and analyzed device-related complaints.
</P>
<P>And, in several instances, Davol also did not accurately report the possible
severity of complaints to the agency, a copy of an inspection report obtained by
The <A title="New York Times"
href="http://www.nytimes.com/mem/MWredirect.html?MW=http://custom.marketwatch.com/custom/nyt-com/html-companyprofile.asp&symb=">New
York Times</A> under the Freedom of Information Act shows.</P>
<P>Bard officials, who declined to be interviewed, said in a statement that they
have since addressed the agency’s concerns, and agency officials said they are
monitoring the company’s progress. </P>
<P>Still, at a time when the use of implanted medical devices is growing
sharply, the episode of the hernia patch is an example of what some experts say
is a far wider problem: that some major manufacturers, while contending that
they carefully monitor product safety, are not as rigorous as they should
be.</P>
<P>Harold Pellerite, a consultant to the medical device industry who worked for
two decades at the F.D.A., said he was surprised to discover how little
attention many companies pay to the issue. </P>
<P>“Firms take the opposite approach of what the F.D.A. expects,” said Mr.
Pellerite, who works for Quintiles Consulting in Rockville, Md.</P>
<P>Davol is not the only company where agency inspectors have found problems
with how a manufacturer tracks and reports possible device failures. </P>
<P>Another case in point: a liquid plastic material called Enteryx once sold by
<A title="Boston Scientific"
href="http://www.nytimes.com/mem/MWredirect.html?MW=http://custom.marketwatch.com/custom/nyt-com/html-companyprofile.asp&symb=BSX">Boston
Scientific</A> as a treatment for patients with severe acid reflux. The company
learned after a patient’s death in mid-2004 that some doctors, trying to inject
the product at a specific site in the base of the esophagus, could miss and
cause damage to other organs, including the heart.</P>
<P>But when agency inspectors went to Boston Scientific in mid-2005, they could
find no evidence that the device maker was adequately tracking reports from
doctors about that precise problem, a warning issued last year by the agency
shows. Soon after the inspection, the company recalled Enteryx, which may have
caused dozens of injuries, and perhaps some deaths. </P>
<P>In a statement, Boston Scientific, which was also warned by the agency in
that same letter about systematic failures in its product-safety review, said it
had since overhauled its procedures.</P>
<P>“We have greatly improved the methods we use to analyze complaints and
complaint trends,” the company said. </P>
<P>Under F.D.A. rules, producers are required to have systems in place to
collect and analyze any complaints they receive from doctors and hospitals about
their devices. They are also required to send to the agency any report
indicating that a device’s failure may have contributed to a patient’s death or
injury.</P>
<P>But the agency gives device makers significant leeway about how to set up
such systems, including what guidelines to use to help them determine when to
issue product alerts to doctors or to issue a recall. In addition, a company can
decide not to forward a complaint to the agency if it decides after an internal
review that its product was not at fault.</P>
<P>One result, said several experts like Mr. Pellerite, is that companies tend
to give themselves the benefit of any doubt.</P>
<P>Not long ago, one group of producers, makers of implanted heart devices,
agreed to adopt guidelines about how doctors should be alerted to potential
product hazards after a controversy involving the <A title="Guidant Corporation"
href="http://www.nytimes.com/mem/MWredirect.html?MW=http://custom.marketwatch.com/custom/nyt-com/html-companyprofile.asp&symb=GDT">Guidant
Corporation</A>. But the broader industry has not followed suit, even though
seemingly innocuous devices like the hernia patch can cause as much, if not
more, havoc in patients.</P>
<P>Kenneth W. Goodman, a co-director of the ethics program at the <A
title="More articles about University of Miami"
href="http://topics.nytimes.com/top/reference/timestopics/organizations/u/university_of_miami/index.html?inline=nyt-org">University
of Miami</A> who also served as an adviser to Guidant, said he believed that
companies needed to do so because the potential stakes involving implanted
medical devices are so high.</P>
<P>“If a doctor holds a device in their hand that might fail and you know about
it, then the doctor needs to know about it,” Mr. Goodman said.</P>
<P>Chris Lavanchy, a director at ECRI Inc., a firm that evaluates medical
devices, said that companies were concerned that sending up a flare too early
might jeopardize sales when there was no reason for concern.</P>
<P>“As a producer, you want to feel justified there is a real problem before
undertaking a recall,” Mr. Lavanchy said.</P>
<P>In the case of the Kugel patch, both Bard and the F.D.A. have urged doctors
not to remove the device unless a patient starts experiencing abdominal pain or
a fever, which may be a sign that a fractured device has cut tissue or is
causing a peritonitis-like infection. </P>
<P>The recalled large Kugel patches were used frequently to treat abdominal
hernias. The small and medium-size versions were not affected. (The Kugel patch
is just one of several types of devices used to repair hernias.)</P>
<P>Cynthia J. Wilson, who works for a health care system in Milwaukee, said that
she had to undergo emergency bowel surgery in 2004 to repair a hole caused by a
dislocated patch.</P>
<P>“I went to the hospital for two weeks and my friends were praying for me,”
said Ms. Wilson, who has filed a lawsuit against Bard. </P>
<P>The company declined to say how many lawsuits involving the device had been
filed or whether it had settled any of them.</P>
<P>The Kugel patch is made of two pieces of mesh that surround a flexible
plastic ring. To implant it, a doctor folds a patch, places it at the site of
the hernia, which is a spot where an organ pops through internal tissue that has
become weak or torn.</P>
<P>The released ring then springs back into its original shape, flattening the
patch. The meshlike material then serves as a substrate that allows internal
tissue to grow and resolve the hernia.</P>
<P>Davol, which is based in Cranston, R.I., makes the patch in various sizes and
shapes. And it was not long after it introduced the largest units in 2002,
F.D.A. records show, that company officials began to receive a small but
disproportionately high number of complaints about broken rings in those “extra
large” versions of the device.</P>
<P>Some of those complaints, agency records indicate, suggested that serious
injuries like the one experienced by Ms. Wilson might be occurring. </P>
<P>Bard officials said that the initial numbers were small given the number of
patches sold, and the problems cited were too random to form a troubling
pattern. </P>
<P>But in mid-2005, Bard said, Davol received 10 complaints about ring breaks
over a three-month period starting that June. Six of those reports, including
one involving a possible fatality, came from Germany, half of them from the same
doctor there. </P>
<P>Bard said that Davol officials initially had concluded, based on their
review, that the ring breaks were occurring because doctors were improperly
folding the patch while implanting it. </P>
<P>As a result, Davol halted production in August 2005 of the extra-large
patches, began to hold training sessions for doctors in Germany and started work
on revising its instructions to doctors elsewhere about how to implant the
device, Bard said.</P>
<P>But the company kept distributing the patch and doctors kept implanting it.
That allowed the problem to continue because Davol’s assessment proved
wrong.</P>
<P>In early December 2005, tests run by the company on a failed patch “suggested
for the first time that the source of the ring break was caused by a failure at
the ring weld,” according to Bard. </P>
<P>Davol soon recalled the extra-large versions of the patch and, several weeks
later, expanded that recall to include large versions of the device. It was
after that initial patch recall that F.D.A. officials went to Davol’s
headquarters in early 2006 to do an inspection. </P>
<P>What they found there, their report indicates, was a range of problems,
including flaws in the system used by Davol to track complaints. </P>
<P>For example, while Davol had purchased a new tracking system in 2004, that
program was incompatible with the earlier one it had been using, resulting in
significant “discrepancies” in how problems were recorded and reviewed, agency
inspectors reported.</P>
<P>Davol officials disagreed, that same report shows, saying they cross-checked
complaints by hand. But inspectors also reported that company officials had also
understated in several reports to the agency the potential severity of
device-related injuries, including three reports involving injuries and one
report involving a possible device-related death.</P>
<P>In a statement, Bard said that it had not submitted those reports to mislead
the agency but said that the company had incorrectly categorized the complaints
based on the information it had at the time. </P>
<P>Davol also retained an outside safety consultant around the time of last
year’s inspection to review its operations and recommend changes, the F.D.A.
report shows. The company has since redesigned all the versions of the Kugel
patch that it recalled, and those products are back on the market. </P>
<P>Tim Ulatowski, an F.D.A. enforcement official, said the agency was monitoring
Davol’s response to its concerns, adding that it was satisfied with what it had
done.</P>
<P>Mr. Lavanchy, the device expert at ECRI, said he believed that the pace of
Davol’s reactions to problems with the Kugel patch seemed understandable given
that it appeared from the company’s account that it was in the dark for a long
time about both the scope of the problem with the device and its cause.</P>
<P>But Professor Goodman of the University of Miami was less forgiving about how
long it took for the company to take action.</P>
<P>“It doesn’t take a surgeon to figure out that if you have a plastic object in
an abdomen that breaks, it is going to hurt someone pretty badly,” he
said.</P></DIV></DIV></BODY></HTML>