Showing posts with label patient outcome data. Show all posts
Showing posts with label patient outcome data. Show all posts
Monday, November 20, 2017
Thursday, November 9, 2017
All the Patient Outcome Information the Hip Surgeons Want You to Know . . . M/M failures mentioned???
Written by Laura Dyrda | Friday, 03 November 2017 17:06
The American Joint Replacement Registry released its 2017 Annual Report, outlining data on hip and knee replacements.
The report, released at the 2017 American Association of Hip and Knee Surgeons Annual Meeting in Dallas, Nov. 2 to Nov. 5, includes data from 654 institutions and 4,755 surgeons who performed 860,080 hip and knee replacements.
"The AJRR has seen significant growth since the previous report; this year's report has a 101 percent increase in procedures, a 57 percent increase in reporting institutions and a 50 percent increase in surgeons," said AJRR Board of Directors Chairman Daniel Berry, MD. The data includes primarily procedures performed in the hospital, although eight ASCs reported data for 1,020 procedures.
Key highlights from the report include:
1. Hip revision surgery burden: 8.6 percent (down from 14.6 percent in 2012)
2. Knee revision burden: 5.1 percent (down from 6.2 percent in 2012)
3. Primary knee implant design:
• Posterior stabilized: 48.5 percent
• Cruciate retaining: 35.3 percent
• Ultracongruent: 5.6 percent
• Other: 8 percent
4. Unicompartmental knee replacements: 3.2 percent of all primary knee replacements
5. Surgeons performing unicompartmental knee replacement: 24.3 percent
6. Surgeons performing patellofemoral arthroplasty: 4.7 percent
7. Average length of stay for primary hip replacements: 3.5 days
8. Average length of stay for primary knee replacements: 2.9 days
https://www.beckersspine.com/orthopedic-spine-practices-improving-profits/item/38792-8-key-trends-on-hip-and-knee-replacement-surgeries.html
Thursday, June 8, 2017
FDA Fails to Protect Patients from PREVENTABLE Bayer Essure Harm.
Updated: JUNE 6, 2017 — 7:38 PM EDT
The ranks of women harmed by Essure sterilization coils continue to grow, while the U.S. Food and Drug Administration’s efforts to inform them of the risks are not working, a 37,000-member advocacy group declared Tuesday.
Administrators of the six-year-old Facebook group Essure Problems said that in the first quarter of this year, the FDA received about 2,000 reports of women who underwent operations — usually hysterectomies — to remove coils that were causing complications such as pain and bleeding.
More than 9,000 removals have been reported since 2009, in addition to miscarriages, fetal deaths, and other problems, according to an analysis of the FDA’s “adverse events” reporting system. It was conducted by Madris Tomes, a former FDA manager who is the founding CEO of Device Events, based in York, Pa.
Angie Marie Firmalino, 44, a co-founder of the Essure Problem group on Facebook
“More than 15,500 adverse-event reports have been filed,” said Essure Problems cofounder Angie Marie Firmalino, 44, of Tannersville, N.Y., who needed a hysterectomy to get rid of fragments of broken coils. “We feel like the FDA needs to step in and take action. How much harm is acceptable for a non-lifesaving device?”
Asked for comment, the FDA said it “continues to review the available information about Essure, including reports of problems submitted to the FDA.”
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The manufacturer, Bayer Healthcare, emailed: “We take all adverse events seriously. … We have reached out to many women who have reported complications … and provided any guidance we can. There are risks with all medical procedures.”
Surgeries to Remove Essure
This analysis of data from the FDA’s voluntary adverse events reporting system shows how many women needed surgery — either hysterectomy or fallopian tube removal — to remove the Essure sterilization coils because of severe problems such as pain and bleeding. Reports have been steadily increasing with growing awareness of the dangers.
Essure Problems has been among those pushing the FDA since 2013 to take Essure off the market. The coils, approved 15 years ago, are implanted in the fallopian tubes to scar them shut. The device is marketed as a simple, nonsurgical alternative to conventional tubal surgery.
Last year, the FDA ordered Bayer to add label warnings that Essure can cause chronic pain, organ perforation, and allergic reactions, and to create a “patient decision checklist.”
But about 200 women have contacted Essure Problems over the last six months to say that doctors did not tell them about the label warnings or use the three-page checklist.
“Unfortunately for many women, they are being implanted without informed consent,” administrators of the Facebook group emailed the FDA on Monday, demanding tougher action.
The FDA’s response, shared by the group: “We understand your frustration. We assure you, Essure is a high-priority issue for the Agency and we continue to take feedback like yours into consideration.”
Bayer, which acquired Essure in 2013, has been hit by thousands of lawsuits over the coils. Last year, the German-based company’s annual report said it incurred losses of $413 million in connection with the devices.
Bayer has said it does not know how many women have implants, just that about a million Essure “kits” had been sold worldwide, most in the U.S. The company recently announced it would discontinue sales in two small markets, Finland and the Netherlands.
Thursday, March 31, 2016
PROPOSED Australia Settlement $250M: Defective J&J ASR hip
Sydney bus driver Joseph Pereira was a lead plaintiff in the case against Johnson & Johnson over faulty hip joints. Steven Siewert
by Marianna Papadakis
- Mar 31 2016 at 4:40 PM Updated Mar 31 2016 at 4:40 PM
Pharmaceutical and medical devices giant Johnson & Johnson will pay $250 million for faulty hip replacements in the second-biggest class action settlement in Australia over the past decade.
The conditional agreement between Johnson & Johnson and its British subsidiary DePuy International and lawyers for 1700 Australians was lodged at a short hearing at Sydney's Federal Court on Thursday and must be approved by a judge.
The companies were sued by Shine Lawyers and Maurice Blackburn five years ago. There was a 17-week trial last year. The biggest class action settlement was $800 million for the Victorian bushfires cases.
Lead plaintiff Sydney bus driver Joseph Pereira claimed the implants left him in constant pain and with elevated levels of heavy metals in his bloodstream.
The DePuy ASR resurfacing hip implant has led to a compensation package of $250 million from Johnson & Johnson. "
The DePuy ASR resurfacing hip implant has led to a compensation package of $250 million from Johnson & Johnson. Supplied
Johnson & Johnson withdrew the DePuy ASR hip implants from sale in Australia in December 2009 and issued a formal hazard alert for the products in August 2010.
Maurice Blackburn Lawyers senior associate Julian Schimmel said the settlement, following the court's approval, meant patients could be compensated if they had or still needed corrective surgery because of problems with hip implants.
PARTS 'DEFECTIVE'
The law firms alleged the ASR hip implants, which provided a total hip replacement, were defective, not fit for their purpose and not of merchantable quality.
Mr Schimmel said the case was settled on a "no admissions" basis.
Shine Lawyers partner Rebecca Jancauskas said a compensation scheme to distribute the money would be devised to ensure compensation paid to each group member reflected their individual circumstances and losses.
"We estimate there are still hundreds of Australians who are yet to have hip revision surgery and the settlement scheme will remain open for these people to access the compensation they are entitled to," Ms Jancauskas said.
A Johnson & Johnson spokeswoman said the company still used the ASR devices and they performed well in some patients.
"The respondents' priority is, and always has been, patient safety," the spokeswoman said. "Since the recall decision was made, the respondents have worked to provide patients and surgeons directly with the information and support they need.
"They have continued to focus on the care and wellbeing of all ASR patients, their family members and surgeons."
Johnson & Johnson is appealing a separate case in the United States concerning different Pinnacle metal-on-metal hip implants after the company was ordered by a Texas federal jury to pay about $US500 million ($650 million) to five plaintiffs who claimed they were injured by the devices.
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Wednesday, July 8, 2015
Bayer Essure 'birth control' device had a WARRANTY!
Conceptus(R) Introduces the Only Patient Reliance Warranty for Permanent Birth Control
Essurance Promise (TM) Program Confidently Demonstrates the Essure(R) Procedure's Unprecedented Performance
0 0 0 209
| Source: Conceptus, Inc.
MOUNTAIN VIEW, Calif., May 2, 2011 (GLOBE NEWSWIRE) -- Conceptus, Inc. (Nasdaq:CPTS), developer of the Essure® procedure, the most effective permanent birth control method available, today introduced the Essurance Promise™ Program, the industry's first-ever patient reliance warranty program, at the American College of Obstetricians and Gynecologists 59th Annual Clinical Meeting.
The Essurance Promise™ Program is an exclusive "out-of-pocket" payment assistance program for the Essure Confirmation Test. After a patient has had the Essure procedure and both inserts are successfully placed, she returns for her Essure Confirmation Test three months later. If she is told by her physician that the Essure procedure requires more time to be effective or she cannot rely on Essure for permanent birth for any reason at that time, the Company will pay her uncovered costs for the Essure Confirmation Test, up to a maximum of $150 per test, and in accordance with certain conditions.
Conceptus is uniquely able to offer such a warranty program because the Essure procedure's clinical and real-world commercial performance is unsurpassed among all other permanent birth control options, including tubal ligation, vasectomy and the only other competing hysteroscopic sterilization product. For nearly a decade of clinical trial follow-up, there have been zero reported pregnancies with the Essure inserts when properly placed. Results in the commercial setting over this same time period are equally compelling and continue to reflect the Essure procedure's superb clinical performance.
No other method of permanent birth control works better than the Essure procedure and no company other than Conceptus backs up their procedure with a reliance warranty, which gives women full confidence in this birth control choice.
"The Essurance Promise™ Program is an innovative solution demonstrating our conviction that patients can rely upon Essure for permanent birth control. The warranty supports both physicians and patients by giving them peace of mind when they choose the Essure procedure, while emphasizing the importance of the Essure Confirmation Test," said Mark Sieczkarek, president and chief executive officer of Conceptus. "This program further advances our leadership role in the hysteroscopic permanent birth control market that we pioneered more than a decade ago."
The Essure procedure is the market leader between two competing hysteroscopic sterilization procedures and has been trusted by more than half a million women since 2002. Following the introduction of the competitor's product last year, the market may have experienced confusion and lack of clarity regarding the differences between the two products. The Essurance Promise Program underscores Essure's unparalleled performance, including the fact that the competitor product's failure rate is 10 times higher than Essure's failure rate, based on three-year clinical data. In addition, Essure clinical trial patients have experienced zero reported pregnancies, while the competitor's product has resulted in 12 pregnancies in patients followed for five years. The Essure procedure has a proven clinical and commercial track record, but the competitor's product has yet to establish and report its long-term clinical and real-world, commercial safety and effectiveness.
A key competitive advantage of the Essure insert is its stainless steel/Nitinol inner/outer coil design, which is radiopaque and allows for visual confirmation of each insert's proper placement both during the procedure and during the Essure Confirmation Test. The competitor's insert is neither visible during the procedure nor during the confirmation test.
"The Essurance Promise Program is unprecedented for a permanent birth control procedure. Essure is backed by a growing body of scientific data validating the optimal design characteristics and clinical performance of Essure's Nitinol coil insert, both in the FDA trials and the clinical evidence reported in the literature over the past decade," said Barbara Levy, M.D., Medical Director for Conceptus. "I highly recommend that OBGYNs talk to their patients about the Essure procedure and the Essurance Promise Program."
Additional information on the Essurance Promise™ Program
Federal Law prohibits any company from offering this kind of program to Medicaid or Medicare patients and is also restricted where prohibited by law. Complete program details can be found on the Conceptus physician website www.essuremd.com.
About the Essure® Procedure
The Essure procedure, FDA approved since 2002, is the first permanent birth control method that can be performed in the comfort of a physician's office in less than 10 minutes (average hysteroscopic time) without hormones, cutting, burning or the risks associated with general anesthesia or tubal ligation. Soft, flexible inserts are placed in a woman's fallopian tubes through the cervix without incisions. Over the next three months, the body forms a natural barrier around and through the inserts to prevent sperm from reaching the egg. Three months after the Essure procedure, a doctor is able to perform an Essure Confirmation Test to confirm that the inserts are properly placed and the fallopian tubes are fully blocked, giving the patient reliance on Essure for permanent birth control.
The Essure procedure is 99.95% effective based on one year of follow up with zero pregnancies reported in clinical trials, making it the most effective form of permanent birth control on the market. The procedure is covered by most insurance plans, and when it is performed in a doctor's office the cost to the patient may be as low as a simple co-pay. Essure has been proven and trusted by physicians since 2002, with more than 500,000 women worldwide having undergone the Essure procedure.
About Conceptus, Inc.
Conceptus, Inc. is a leader in the design, development, and marketing of innovative solutions in women's healthcare. The Company manufactures and markets the Essure procedure. The Essure procedure is available in the United States, Europe, Australia, New Zealand, Canada, Mexico, Central and South America and the Middle East. The Company also promotes the GYNECARE THERMACHOICE® Uterine Balloon Therapy System by ETHICON™ Women's Health & Urology, a division of Ethicon, Inc., in U.S. OB/GYN physician offices.
The Conceptus, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=7961
Please visit www.essure.com for more information on the Essure procedure. Patients may call the Essure Information Center at 1-877-ESSURE-1 with questions or to find a physician in their area.
© 2011 Conceptus, Inc-- All rights reserved. Conceptus, Essure, Essurance Promise and Your Family is Complete. Your Choice is Clear are registered trademarks and service marks of Conceptus, Inc.
CC-2749 27APR11F
Investor Relations and Public Relations Contact: Cindy Klimstra (650) 962-4032
Wednesday, December 18, 2013
CMS Tracks/Publishes Joint Replacement Patient Outcomes!
December 18, 2013 1:52 am by Jordan Rau | MedCity News
FiDA
highlight
Medicare
has begun tracking the outcomes of hip and knee replacement
surgeries, identifying 95 hospitals where elderly patients were more likely to
suffer significant setbacks. The government also named 97 hospitals where
patients tended to have the smoothest recoveries.
The analysis, which was released last
week, is the latest part of the government’s push to improve quality at the nation’s hospitals
instead of simply paying Medicare patients’ bills. Medicare already assesses
hospital death rates, how consistently hospitals follow basic medical
guidelines and how patients rate their stays. The evaluation of hip and
knee surgery outcomes is significant because for the first time, Medicare is
rating hospitals’ performance on two common elective procedures.
Many patients needing joint replacements
want to know a hospital’s record when choosing where to have the procedure
done. This is not usually the case for treatment of conditions Medicare
has evaluated previously, such as heart attacks.
Of the 95 hospitals
where knee and hip surgery patients experienced difficulties after the
operation, nine were rated having both high readmissions and high complication
rates. Those hospitals were: Froedtert Hospital in Milwaukee; Grant Medical
Center in Columbus, Ohio; Mercy St. Anne Hospital in Toledo, Ohio; Northwestern
Memorial Hospital in Chicago; the Pennsylvania Hospital of the University of
Pennsylvania Health System in Philadelphia; Peterson Regional Medical Center in
Kerrville, Texas; Reston Hospital Center in Reston, Va.; Shannon Medical Center
in San Angelo, Texas, and Southside Regional Medical Center in Petersburg, Va.
Some of those hospitals complained
Monday that Medicare’s assessments were outdated since they covered operations
between July 2009 through
June 2012. A spokeswoman for Shannon Medical Center said the hospital
has improved since then, adding better technology and opening a clinic to
follow up with patients seven days after leaving. A spokeswoman for Southside
Regional Medical Center said that hospital adopted a new treatment model in
2012 for joint and spine patients and that their outcomes have “drastically
improved.”
Medicare
was cautious in how it marked hospitals, only categorizing them as outliers when
their records in hip and knee replacements were statistically different from
the national average.
The overwhelming majority of
hospitals—about 19 out of 20—were branded average, a Kaiser Health News
analysis found.
Table
Out of the 97 hospitals that did better
than average in avoiding either readmissions or complications, 25 were rated as
being better at both measures. Those included some big hospitals such as Sutter
General Hospital in Sacramento, Calif., and the Hospital for Special Surgery in
Manhattan. They also included some local hospitals such Holy Cross Hospital in
Fort Lauderdale, and several physician-owned hospitals that specialize in these
types of surgeries, such as Arkansas Surgical Hospital in Little Rock.
About
600,000 patients in the traditional Medicare program have their hips or knees
replaced each year. The growing popularity of these operations has made them a
more significant expense for Medicare and private insurers.
In 2010, there were 719,000 knee replacements costing nearly $12 billion and
332,000 hip replacements nearly $8 billion, according to the National Center for
Health Statistics.
Medicare
published the new outcomes data on its Hospital Compare
website. While few consumers use that
site, this information may reach a greater audience later on through groups and
publications, such as Consumer
Reports, that tap Medicare’s data in devising their own hospital
ratings.
“With elective procedures, consumers
like to do a lot of research to pick the right doctor and the right hospital,
so this is a good first step,” said Leah Binder, CEO of the Leapfrog Group, a nonprofit funded by
employers that judges hospital quality. However, she said the new ratings would
be of limited use for most patients because the Centers for Medicare &
Medicaid Services judged most hospitals’ performance as normal.
“We know there’s a significant variation
among hospitals, but CMS reports them all as average,” Binder said.
Financial Pressure
Hospitals may soon feel a financial
pinch from the evaluations. Medicare
plans to add hip and knee readmission rates to the criteria it uses when
deciding whether to penalize hospitals each year.
Since October, Medicare has been paying
less than it normally does to 2,225 hospitals
after determining their rates of rebounds for patients with pneumonia, heart
attacks and heart failure were too high, even by a small
amount. Starting in
the fall of 2014, when the joint replacements are to be factored into
the penalty program, hospitals are at risk of losing as much as 3 percent of
Medicare payments for each patient stay.
In its new
evaluation of hip and knee replacement patients, Medicare used two
measures. One was how
often the patients ended up being readmitted to the hospital within 30 days of
discharge. The other was how often they suffered one of eight
complications after the operation. Those included a
heart attack, pneumonia, sepsis or shock within seven days of admission. They
also included bleeding at the site of the surgery, a blood clot in the lung or
death within a month of admission. Medicare also counted mechanical complications with implants and
infections of the joint or wound within 90 days of admission.
The
quality of joint implants has been under scrutiny for several years. Some of the
surgical devices have been plagued by quality problems, especially
among artificial hips made of interlocking metal parts. The friction
created by these joints can create metal debris that damages the
surrounding flesh and bone. Two manufacturers have recalled their devices since
2010.
Problems Are Declining
Nationwide, the number of readmissions
following hip and knee replacement surgeries has been dropping, but not as
quickly as readmission rates for heart attack, heart failure or pneumonia
patients, according to a Medicare-commissioned study by the
Yale New Haven Health Services Corporation Center for Outcomes Research and
Evaluation.
Dr. Eric Coleman, an expert on
readmissions at the University of Colorado Anschutz Medical Campus, said some hospitals are trying to
prevent joint replacement patients from returning by educating them ahead of
the surgeries about how to take care of themselves and warning signs of
problems. This program provides “a chance to walk you through what to
expect, what your family would expect, how to arrange your home,” Coleman said.
“In most of the cases of readmission reductions, we’re still very reactive.”
Hospitals’ clientele appears to play
some role in how they fared after these surgeries. The outcomes for hip and knee replacements tend to be
slightly worse for hospitals that serve a high proportion of Medicaid patients,
according to the Yale study. The study also found that hospitals where more than one out of every five
patients were African-American tended to have slightly higher complication and
readmission rates than did hospitals with no black Medicare patients.
However, the report noted, some of these hospitals serving large numbers of
Medicaid or black patients also performed very well.
These kind of
racial and economic disparities in readmissions have long troubled
health policy experts. Some hospitals mostly cater to prosperous
patients who have the money, resources and education to get necessary
post-surgical care after discharge. But safety net hospitals often have a
harder time ensuring that low-income, less educated people follow the often
complex instructions about how to recover from a major surgery or
hospitalization.
In
Medicare’s new analysis, on average, hip and knee patients had a 5.4 percent
chance of having to return to the hospital. Nationally, the average
complication rate for patients after hip and knee replacement surgery was 3.4
percent. One hospital, Beaumont Health System
in Royal Oak, Mich., had a mixed record: Patients there were more likely to be
readmitted but less likely to suffer serious complications.
Hospital-Wide Readmissions Published
The government also last week released
its first ratings of how often Medicare patients of all diagnoses returned to
hospitals within 30 days. That “all cause”
measure is more encompassing than Medicare’s appraisals based on
heart attack, heart failure and pneumonia. A number of prominent experts,
including Congress’ Medicare Payment Advisory Commission, have been pushing for
this measure to be used in setting financial penalties for hospitals.
Medicare’s analysis found that 16
percent of Medicare patients ended up returning to a hospital within 30 days
between July 2011 through June 2012. Again rates varied significantly.
At 364
hospitals, or 8 percent, patients were more likely than average to return
within a month, the data show. These included the Cleveland Clinic, as well as
the clinic’s hospital in Weston, Fla.; both of Johns Hopkins’s hospitals in
Baltimore; and New York-Presbyterian Hospital in Manhattan.
Medicare did not count cases where the
patient was scheduled to return to the hospital, such as when a lung cancer
patient was admitted for pneumonia and later came back for a chemotherapy
treatment that had been planned. Medicare calculated that patients were less
likely than average to end up back for any reason at 315 hospitals, or 7
percent of the nation’s total.
Nancy Foster, an executive with the
American Hospital Association, said that tracking hospital-wide readmissions
was of limited value to hospitals that wanted to do better. “Most of the
interventions you would use are built and targeted around particular
conditions,” she said. “You have to know what’s driving patients back into the
hospital to address the problem. When you get this lump of all-cause
readmissions, you don’t know what to go after.”
KHN reporters Ankita Rao and Marissa
Evans contributed.
Public
reporting of CMS patient outcome data from joint replacement surgery has been a
'grown-up Christmas wish' for the last 5 years! Patient harm from lax
oversight of implants has cost us our humanity, needless suffering of patients
and their family members, trust in our government and care providers and a substantial
chunk of healthcare spending. Simply compiling the CMS data and making
that information available to researchers like Consumers Union Safe Patient
Project will clarify the true risks and benefits of implanted medical devices.
The legal system unfairly entitles Pharma and the medical device
industry, so preventing harm is essential to patient safety. My
blog/personal story: http://fida-advocate.blogspot.com
Friday, December 13, 2013
Gender targeting by (sometimes criminal) medical device industry? Breast implants, birth control, transvaginal surgical mesh?
BY JEAN-FRANCOIS ROSNOBLET AND ALEXANDRIA SAGE
MARSEILLE/PARIS Tue Dec 10, 2013 8:00am EST Reuters FiDA highlight
(Reuters) - The founder of a French breast
implant company was sentenced to four years in prison on Tuesday for hiding the true nature of
the sub-standard silicone used in implants sold to 300,000 women around the
world.
Jean-Claude Mas, 74, founder and long-time chief
executive of Poly Implant Prothese (PIP), was prosecuted after a worldwide
panic in 2011 when France
recommended that women with such implants should have them removed due to an abnormally high rupture rate.
Worries about the implants launched a flurry of
international lawsuits and prompted
calls for Europe to toughen controls on medical devices and fix its fractured
oversight system.
Once the third-largest global supplier of breast implants,
the company was shut in 2010 and its implants ordered off the market after
inspectors pursuing a tip-off discovered vats of industrial-grade silicone
outside the PIP factory in the southern town of La-Seyne-sur-Mer.
A Marseille criminal court also ordered Mas, who
had been pursued for aggravated fraud, to pay a 75,000-euro ($103,000) fine. His lawyer,
Yves Haddad, said he would appeal.
Four other
executives, including the chief financial officer, were sentenced to between
one-and-a-half and three years in prison, some of it suspended, and fined.
"It's a strong signal. This decision is what
victims were waiting for," said one of their lawyers, Philippe Courtois.
The president of a PIP victims group, Alexandra
Blachere, called it a "symbolic
sentence" that challenged any prejudice that there was "a
ditzy bimbo behind every pair of silicone breasts."
The two-month trial in April and May was held in
an exhibition center to accommodate the 7,400 civil plaintiffs and 300 lawyers. Jeers from the crowd
greeted Mas' appearance in the makeshift courtroom.
For less serious felonies in France,
the criminal court hands down a sentence without pronouncing a guilty or not
guilty verdict, which is implicit.
HIDDEN EVIDENCE
Mas
admitted using silicone created by trial and error that was never approved by
regulators and which cost a seventh of the price of silicone approved for use
in medical devices.
He has insisted the gel he had relied on since
the founding of the company in 1991 was non-toxic and has said women who
complain about their PIP implants are "fragile people, or people who are
doing it for the money."
A police investigation revealed a sophisticated fraud at PIP, which managed to
conceal the implants' ingredients from regulators, thereby allowing them to be
sold on international markets.
Before annual audits to the PIP factory by
private certification company TUV Rheinland, employees would clear away evidence of the cheaper gel
it used to fill implants.
For a special report on the PIP scandal, click
here:
TUV sued PIP for fraud, but a French court ruled
last month the German company had failed in its obligations of "vigilance
and caution" and ordered it to pay 3,000 euros to each of the 1,600
plaintiffs, women wearing PIP implants who had sued.
Health experts insist that no link has been
established between PIP implants and breast cancer.
Still, women around the world with PIP implants,
whether in Venezuela,
France
or Britain, have rushed to their surgeons to have them removed, fearing health
complications.
Since France recommended removal, some 14,729
women in France - nearly half of all French women with PIP implants - have
chosen this option, according to French regulators.
Regulators
say a quarter of PIP implants removed were found to be faulty, most having
ruptured.
Only one case of anaplastic large cell lymphoma,
a rare type of cancer originating in the lymphatic system, has been documented
in France from a women wearing PIP implants.
National health agencies have given differing
advice. While France and Venezuela
offered to reimburse women who have their PIP implants removed, other
countries, such as Britain, recommended that women merely have them checked.
Other legal cases related to PIP are still
pending in France, including one related to the 2010 death of a woman wearing
PIP implants. Another relates to tax fraud by Mas, his former girlfriend and
Chief Executive Claude Couty.
(Writing By Alexandria Sage; Editing by Mark John
and Ruth Pitchford)
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