http://theladyisachamp.blogspot.com
WEDNESDAY,
NOVEMBER 28, 2012
Breaking News
Major Victory for Women!
And for Women’s Health
Care!
Dateline: Miami, November
28, 2012
By Lana C. Keeton
(copyright protected)
The Center for Devices and
Radiological Health (CDRH) will be up-classifying all Synthetic Surgical Mesh
for Pelvic Organ Prolapse repair from Class II to Class III within one year.
Even better, in the very
near future, all but one of the most popular prolapse kits, will no longer be
sold.
The CDRH will be announcing
important new regulations in December. Companies will have to pay an upfront
fee of $250,000.00 to be part of a registry along with conducting 3 year
clinical trials to prove safety and effectiveness of these “kits” which is not
possible and will cost them millions.
And there will be major new
requirements for surgeons implanting surgical mesh in the pelvis. No longer
will surgeons be able to take a weekend course taught by an industry paid
“medical advisor/consultant” to start implanting a filthy petroleum waste by
product into women.
Medical mercenaries will
now think twice before they mutilate women internally with a foreign body
polymer that shrinks, hardens and moves at will within their pelvis mercilessly
destroying their lives.
Doctors on the prolapse kit
bandwagon who have ignored what they earned in med school about foreign bodies,
checked their medical training at the door when they walked into the operating
theatre and spouted the ridiculous mantra that foreign body polymers are
biocompatible and inert will now be held accountable for their actions. Praise
the Lord!!
Just as I was quoted in Bloomberg News in
January when the FDA mandated 522 studies of 99 synthetic surgical mesh
products used for prolapse and incontinence, industry knows it will not be able
to prove these “medical devices” safe or effective and it will cost them
millions they are unwilling to spend.
And there it is. It was
never about health. It was always about the money, no matter how many millions
of people were harmed or put at risk for serious harm or even death.
Now we are seeing the death
of insanity in women’s health. Another “Dalkon Shield” bites the dust.
Patients and patient
advocates have won a very long and significant battle for the safety of
patients who will not be harmed in the future!!
http://www.bloomberg.com/news/2012-01-05/fda-orders-safety-studies-for-vaginal-implants-made-by-j-j-and-c-r-bard.html
By Alex Nussbaum & David Voreacos
- Jan 5, 2012 3:19 PM CT
Johnson & Johnson
(JNJ) and C.R. Bard Inc.
(BCR) must study rates of organ damage and complications linked to
vaginal mesh implants, U.S. regulators said, responding to patient advocates
who say the devices have harmed women.
The Food and Drug
Administration wrote J&J, C.R. Bard and 31 other
manufacturers, telling them to conduct three years of trials on safety and
effectiveness, the agency’s William Maisel (see FiDA blog dated 11/2/12 High Standards for FDA Leaders? FDA Official
Pleads Guilty to Prostitution Charge, Gets One Day of Probation)
said
yesterday in a telephone interview. An FDA report in July found a fivefold jump in deaths,
injuries or malfunctions tied to the products.
Almost 300,000 synthetic meshes were implanted in
U.S. women in 2010 to treat incontinence or shore up pelvic muscles, the agency
estimates. The devices’ alleged failures have spurred more than 650 lawsuits
against manufacturers and heightened scrutiny of the FDA program that cleared
the products for sale without human testing.
“Now these
companies are going to have to tell the truth,” said Lana Keeton, a mesh recipient and patient advocate from Austin,
Texas. While companies say implants are safe, “up until now, there’s been no
data,” she said. “It’s all been marketing.”
J&J, the biggest maker of vaginal mesh, fell (JNJ) less than 1
percent to $65.40 at the close in New York. C.R. Bard also declined (BCR) less than 1
percent to $85.94. J&J is based in New Brunswick, New Jersey, and C.R. Bard
in Murray Hill, New Jersey.
The letters
ask each manufacturer to collect data on the results and potential
complications of transvaginal procedures, in which the hammock-like meshes are
threaded in place through an incision in the vagina. The FDA said in July that
it wasn’t clear from available studies whether the devices provided a benefit
over older methods in certain cases.
Guiding Doctors
“We believe there are certain uses of mesh where we
need additional data to help guide the clinical community,” said Maisel, deputy director of
science for the agency’s device- approval center. “Our goal is to make
sure the right women use it at the right time.”
The meshes were approved through the FDA’s 510(k)
system, which allows products to reach the market without human testing if the
agency decides they’re similar to devices already for sale. In October,
Bloomberg News reported many implants can trace their approvals back to a Boston Scientific (BSX)
Corp. mesh recalled for safety concerns in 1999.
Yesterday’s letters covered only devices already on
the market. Consumer groups say they want the action to be just a first step
toward requiring studies before the products can reach the market, said Amy
Allina, a policy director at the National Women’s
Health Network in Washington.
‘The Right Thing’
“It would
have been better if the products that had hurt women had never gone out in the
first place,” she said in a telephone interview. “But now that they’re out
there, we’re encouraged to see the FDA doing the right thing and requiring the
companies to provide more information.”
Even before
the studies are done, they will serve to warn off patients, said Keeton, the Texas woman and founder of
the group Truth in Medicine.
“What
woman’s going to sign up for a study when they know” the potential
complications, she said by telephone.
Keeton sued
J&J over injuries she blamed on a 2001 implant. The case was dismissed by a
federal judge in 2007. She has also worked as a paid consultant to lawyers
suing mesh makers.
Matthew Johnson, a
spokesman for J&J’s Ethicon unit that makes the devices, said the company
was reviewing the correspondence from the FDA.
‘Most Studied’
“Ethicon’s transvaginal mesh devices are already
among the most studied devices on the market, and we will continue to support
their use in surgical repair with clinical evidence, through
investigator-initiated and company-sponsored trials,” he said in an e-mail.
The FDA letters also went to companies including Endo Pharmaceuticals Holding Inc.
(ENDP) of Chadds Ford,
Pennsylvania, and Boston
Scientific, based in Natick, Massachusetts. The
companies have 30 days to respond.
Kevin Wiggins from Endo Pharmaceuticals and Eric
Olson from Boston Scientific didn’t return phone calls seeking comment. Scott
Lowry, a C.R. Bard spokesman, also didn’t return a message.
The edges of mesh fibers can constrict or cut into
internal organs after they’ve been implanted, studies have found. The procedure
is also prone to infection because the vagina through which the devices are
inserted isn’t a sterile environment, said Clifford Wheeless, an emeritus
associate gynecology professor at Johns Hopkins University (43935MF)
School of Medicine, in a telephone interview last year.
High-Risk
In
September, an advisory panel recommended the FDA reclassify mesh used for pelvic organ prolapse,
a condition in which weakened muscles fail to support internal organs, as
“high-risk” devices that require human testing. The FDA hasn’t made a
decision yet, Maisel said. The agency isn’t likely to heed the call of some
patient advocates for a complete recall, he said.
“There’s strong support in the clinical community
that mesh serves a role for certain patients,” Maisel said. “Our goal is not to
completely remove these products from the market.”
Manufacturers sell about $175 million worth of
prolapse mesh worldwide and another $295 million for incontinence treatments,
C.R. Bard executives estimated on a conference call in 2010. Even for the top
sellers, the products make up only about 1 percent to 2 percent of sales, said
Michael Matson, a Mizuho Securities USA analyst in New York.
“Patients are already well aware of these issues
and the markets have been declining already,” he said.
To contact the reporter on this story: Alex
Nussbaum in New York at anussbaum1@bloomberg.net;
David Voreacos in Newark, New Jersey at dvoreacos@bloomberg.net;
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net; Michael Hytha at mhytha@bloomberg.net
Lana Keeton testifies 10/2/2010 at Second Annual Truth In Medicine conference, DC 12 minute YouTube video footage.
Wendell Potter