80 000
haláleset. 2 millió sérülés. Eljött az ideje, hogy egy orvosi eszközre kerüljön.
A betegek
szenvednek az F.D.A. nem képes megfelelően megjeleníteni vagy monitorozni a
termékeket.
A Szerkesztői Testület
A szerkesztőbizottság képviseli az igazgatóság, a szerkesztő
és a kiadó véleményét. Elkülönítve a hírteremtől és az Op-Ed szekciótól.
2019. május 4.
Amikor az
Élelmiszer- és Gyógyszerügyi Hivatal a múlt hónapban bejelentette, hogy nem
tudja garantálni a hüvelyi hálós termékek hosszú távú biztonságát és
hatékonyságát - az évtizedek óta forgalmazott orvostechnikai eszközöket - a
több tízezer nő által károsított kollektív válasz. a termékek valami hasonlónak
hangzott: Duh.
A háló, amely a medencék elhelyezésére szolgál, amikor az
izmok túlságosan gyengék ahhoz, hogy a munkát elvégezzék, már régóta kötődnek
az életváltó sérülésekhez, köztük
2018-tól közel 80 haláleset. Az elmúlt évtizedben hét vállalat töltött egy
kollektív 8 milliárd dollár több mint 100 000 betegkövetelés megoldására - a
vaginális hálóval (vagy a medencei hálóval szembeni peres ügyek),
mint az Egyesült Államok történelmének egyik legnagyobb tömeges
kártérítési ügye. Ahogyan ezek a peres eljárások egyértelművé váltak,
ezeknek az orvostechnikai eszközöknek a többsége piacra került, szinte semmilyen klinikai adatokkal.
Hihetetlennek
tűnik, hogy az emberi szervezetben tartózkodó termékeket a betegek számára a
biztonság vagy a hatékonyság bizonyítása nélkül használják fel. De
a szabályozási kiskapuknak és a laza felügyeletnek köszönhetően a legtöbb
orvostechnikai eszközt rosszul ellenőrzik a piacra való kibocsátásuk előtt, és
a tényeket gyengén figyelik.
A problémák több évig is eltűnhetnek, és lehetetlennek
bizonyulnak, részben azért, mert az állandó
implantátumok nem könnyen kivonhatók a testből. (A hálószem
eltávolítása a medencéből hasonlított a rágógumi eltávolításához hosszú, vastag
hajból). Ha baj keletkezik, a készülékgyártók gyakran megoszlanak, a
szabályozók és a jogorvoslatokat kereső betegek hosszú és drága bírósági
csatákra kényszerülnek. Végül a hibás termékek évekig maradhatnak a piacon.
A F.D.A. a
múlt hónapban végül kihúzta a piacon a fennmaradó hüvelyi hálótermékeket (bár
a legtöbb vállalat már abbahagyta az eladást, mivel mindezek a peres
eljárások). Csütörtökön az ügynökség azt mondta, hogy nem tiltja meg a rákos
formához kapcsolódó mellimplantátumot, és oly sok más mellékhatást, amit az
orvosok új kifejezést alkottak - „mellimplantátum-betegség”. évek óta, gyenge
biztonsági bizonyítékok alapján. A szabályozók most azt mondják, hogy nincs
elegendő bizonyíték a kárra annak igazolására, hogy a döntést megfordítsák.
A várakozási fenyegetések kockázatai nagyok: Az elmúlt évtizedben közel
kétmillió sérülés és több mint 80 000 haláleset kapcsolódott a hibás
orvostechnikai eszközökhöz, sokan kevéssé klinikai teszteléssel,
a vizsgálati újságírók nemzetközi konzorciumának globális vizsgálata szerint. .
80,000 Deaths. 2 Million
Injuries. It’s Time for a Reckoning on Medical Devices.
Patients suffer as the F.D.A. fails to adequately
screen or monitor products.
The editorial board represents the opinions of the
board, its editor and the publisher. It is separate from the newsroom and the
Op-Ed section.
·
May 4, 2019
·
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CreditSofia Pashaei
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CreditCreditSofia
Pashaei
When the Food and Drug Administration announced last month that
it couldn’t guarantee the long-term safety and efficacy of vaginal mesh
products — medical devices that have been on the market for decades — the
collective response from tens of thousands of women harmed by the products
sounded something like this: Duh.
The mesh, which is used to hold pelvic organs in place
when muscles become too weak to do the job, has long been tied to life-altering
injuries, including nearly 80 deaths as of 2018. In the past decade, seven
companies have spent a collective $8 billion to
resolve more than 100,000 patient claims — making litigation over vaginal mesh
(or pelvic mesh, as it is sometimes called) one of the largest
mass tort cases in United States history. As those lawsuits have made
clear, most of these medical devices were approved for market with nearly no
clinical data.
It seems incredible that products meant to reside
inside the human body would be used on patients without any proof of safety
or efficacy. But thanks to regulatory loopholes and lax oversight, most medical
devices are poorly vetted before their release into the marketplace and poorly
monitored after the fact.
Problems
can take years to emerge and can be impossible to correct, in part because
permanent implants are not easily extracted from the body. (Removing mesh from
pelvic tissue has been likened to removing chewing gum from long, thick hair).
When trouble does arise, device makers often equivocate, regulators dither and patients
seeking redress are forced into lengthy and expensive court battles. In the
end, faulty products can remain on the market for years.
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The F.D.A. finally pulled the remaining vaginal mesh
products off the market last month (although most companies had already stopped
selling them because of all those lawsuits). But on Thursday, the agency said it would not ban a breast implant linked to a rare form of cancer and so many
other side effects that doctors have coined a new term — “breast-implant
illness.” Like mesh, the breast implant was approved years back, based on
meager safety evidence. Regulators now say there is not enough proof of harm to
justify reversing that decision.
The risks of waiting loom large: In the past
decade, nearly two million injuries and more than 80,000 deaths have been
linked to faulty medical devices, many approved with little to no clinical
testing, according to a global investigation by
the International Consortium of Investigative Journalists.
Women are particularly well acquainted with this
cycle. Essure,
a permanent birth control device consisting of two metal coils injected into
the fallopian tubes, has been linked to autoimmune disorders and more than
800 pregnancy losses. The product was pulled from the market last year — by the device maker, which cited declining sales,
not by the F.D.A. And the power morcellator — a spinning blade that shreds
uterine tissue so it can be more easily extracted from the body — has proved
deadly for some women, whose cancer was spread by the device. As The Times has reported, the morcellator was widely used for 20 years before
regulators realized there was a problem.
But that’s not to suggest that only women are
affected: There have been metal hips that released poisonous debris into the
body, implantable defibrillators that shock people at random (causing
indescribable terror) and artificial heart valves with questionable shelf
lives. In operating rooms, there have been staplers that
misfire; temperature control machines that spray bacteria into open chest cavities; and robotic surgeons that slap, burn and, in some cases, maim
patients.
In
every one of these cases, a combination of dubious regulatory approvals, skimpy
post-market surveillance, and faltering responses from regulators caused
irrevocable harm that might have been avoided.
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After searing investigations by journalists and patient advocates, the F.D.A. has promised
to make “transformative” changes to medical device regulation. But so far, the
agency’s suggestions have been meager at best. And in the meantime, regulators
have accelerated the device approval process, not slowed it down.
Dr. Jeffrey Shuren, head of the
agency office in charge of device regulation, has suggested that the
benefits of bringing innovative products to market quickly are worth the
increased risks.
It’s true that devices have restored hearing, vision
and the ability to walk and have provided many other benefits to millions of
people. But the drive to innovate does not justify the growing catalog of
medical device disasters. Patients should not have to wonder whether devices
will save their lives or destroy them. Reasonable changes could greatly improve
the current system.
CreditSofia Pashaei
Image
CreditSofia Pashaei
Tighten approval standards. Regulatory loopholes — some of which date to the dawn
of device regulation and were not meant to be permanent — enable companies to
bring new or “updated” medical devices to market without testing them in human
trials first. Companies need only to convince regulators that their products
are similar to ones that are already approved, even if the other products are
decades old or were subsequently pulled from the market. Eight years ago the
Institute of Medicine advised the F.D.A. to
abolish at least one of these loopholes, what’s known as the 510(k) pathway. It’s past time for the agency to heed that advice,
and to ensure that no medical device intended for permanent residence inside a
human body is used on patients without first being rigorously tested.
Fix post-market surveillance: Industry proponents say that medical devices can be
brought to market quickly and safely by having companies conduct rigorous
testing after products go to market instead of beforehand. But companies often
fail to complete such studies, even when they’re ordered by regulators. What’s
more, device makers frequently skirt rules requiring them to report publicly
all incidents of malfunction, injury or illness — often through mechanisms that
the F.D.A. itself created. And after years of wrangling, the industry and its
regulators have still not fully put a system in place to better notify patients
of product recalls and other safety issues.
The
F.D.A. has vowed to fix some of these lapses. They’ve promised to abolish
reporting exemptions that keep safety issues hidden from the public and to
promote breast implant registries that monitor patient outcomes.
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That’s a good start, but more can be done. An industry
that prides itself on innovation, and earns some $400 billion in
annual revenue, should be well equipped to build a global medical device
registry where patient outcomes for all medical devices are openly monitored,
and where doctors and patients can log concerns and obtain information.
Loosen industry’s grip. Dr. Shuren reportedly referred to device makers, not
consumers, as his office’s main customers at a recent industry gathering. As
misguided as that statement may sound, he’s not wrong: The medical device industry
funds 35 percent of the office’s work, and by law, that funding is contingent
upon the agency’s approving devices quickly, and through the least restrictive
pathway possible.
It’s not solely those laws that give medical device
makers influence over regulators. The industry maintains a well-oiled revolving
door with the F.D.A. — as The Associated Press has
noted, the last four people to hold Dr. Shuren’s position have gone on to
lucrative industry gigs. Device makers also spent more than $300 million lobbying Congress in the decade ending in 2017,
according to the Center for Responsive Politics. What’s more, they pay doctors
and hospitals hundreds of millions in consulting fees every
year, according to the National Center for Health Research. None of
this violates any rule, but all of it contributes to the current crisis.
Medical institutions and professional societies should
establish, or amplify, guidelines discouraging
such payments. Stronger laws that provide more funding for the work of device
regulation — so that the F.D.A. is not as reliant on industry dollars — would
also help the agency to fulfill its mission.
That
mission is to protect patients.
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