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Home > Archive > Politics and Medicine > October 2006 > Device-Maker Medtronic Weighed Down With Lawsuits
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Device-Maker Medtronic Weighed Down With Lawsuits
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| Ilena Rose 2006-10-16, 4:28 pm |
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LOL ... I have no idea how seeing a picture of me would indicate
whether or not I have had implants in the past ... but dream on!
The extraordinarily high rate of rupture with implants does INDEED
cause enormous problems ... necrosis, infections, silicone throughout
the body, systemic immune problems.
For years, the same Junk Science Propaganda claimed "only" a 5%
rupture rate ... pure and utter lies. Now they claim that if an
implant ruptures ... so what?
For more ... please visit:
www.BreastImplantAwareness.org
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| Ilena Rose 2006-10-17, 4:28 pm |
| Note from Ilena Rosenthal: So much for disbarred Probert's claims
about the low failure rate of this company he financially profit$$$
from.
Medtronic device recalls updated to Class I
http://www.farrin.com/legal-news/pr...-to-class-i.php
FDA updates Medtronic medical device recalls to Class I; warning
letter sent to company for quality system failures - 9/13/06
The U.S. Food and Drug Administration (FDA) has sent a warning letter
to Medtronic, Inc. stating its production practices to produce two
medical devices do not meet federal quality standards. Dated August
29, 2006, the letter gives Medtronic 15 business days to file a
correction plan with the FDA for its Fridley, MN, manufacturing
facility outside Minneapolis.
The Fridley plant produces an implantable drug pump catheter that was
pulled from the U.S. market in July, 2006 after the company received
22 reports of catheter tips dislodging in the spines of patients
implanted with the devices. On Friday, September 8, the FDA upgraded
the recall to a Class I, its most serious recall classification for
medical devices.
A Class I recall is issued when a product is considered to have a high
probability of causing personal injury or death to a consumer. The
catheter tip is made of platinum-iridium and may be dislodged by the
guide wire during implantation. Dislodgement could raise the risk of
infection or other serious health problems in patients implanted with
the devices.
The Medtronic recall involves the following medical devices that have
not yet been implanted:
Medtronic Model 8731 intrathecal tip catheters, made on or before
August 2004
Medtronic Model 8598 intrathecal catheter distal revision kit, made on
or before August 2004
Implanted devices have not been recalled at this time. According to
the “Dear Doctor” letter issued by Medtronic, Inc. in July, most
patients with dislodged catheter tips had them remaining in the
intrathecal space. Patients who reported adverse incidents with
Medtronic catheters complained of post-operative leg pain and chronic
back pain.
Concerned consumers who may be experiencing pain should report
problems with implanted devices to the FDA Medwatch program:
Phone: 1-800-FDA-1088
Fax: 1-800-0178
Mail:
MedWatch
HF-2, FDA
5600 Fishers Lane
Rockville, MD 20852-9787
Make a MedWatch report now
Sources: “FDA Sends warning letter to Medtronic,” Memphis Business
Journal, September 12, 2006; Jim McCartney, “Medtronic says it will
fix drug-pump catheter flaws,” St. Paul Pioneer Press, September 13,
2006; “Dear Healthcare Provider Letter,” Medtronic, July 2006.
Product Liability
Defective or deficient consumer products that cause injuries to
consumers can be the subjects of product liability lawsuits brought to
trial by a personal injury lawyer. Frequently recalled products
include cars, pharmaceutical and over-the-counter drugs, children's
toys, defective articles of clothing, and other common household
products.
Back to Top Medical Device Injuries
According to the Institute of Medicine, over a million Americans are
severely injured each year by events involving medical devices; in
2002 alone, the US. Food and Drug Administration received more than
111,000 reports of adverse events involving medical devices (U.S. FDA
Consumer Magazine, July-August 2003). If you have been injured while a
medical device was deployed during your medical treatment, you should
consider consulting with a NC medical device liability attorney who
can advise you about the possible merits of your
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