Thursday, February 28, 2013
Thursday, February 14, 2013
Make Aware of 40% Failure in Hip Implant By BARRY MEIER
I found a great article from The New York Times. Please read!
Document: Projection of Hip Implant Failure Rate
-Dr. John G Florendo
Aware of 40% Failure in Hip Implant
By BARRY MEIER
Published: January 22, 2013
Document: Projection of Hip Implant Failure Rate
An internal analysis conducted by Johnson & Johnson in 2011 not long after it recalled a troubled hip implant estimated that the all-metal device would fail within five years in nearly 40 percent of patients who received it, newly disclosed court records show.
Johnson & Johnson never released those projections for the device, the Articular Surface Replacement, or A.S.R., which the company recalled in mid-2010. But at the same time that the medical products giant was performing that analysis, it was publicly playing down similar findings from a British implant registry about the device’s early failure rate.
The company’s analysis also suggests that the implant is likely to fail prematurely over the next few years in thousands more patients in addition to those who have already had painful and costly procedures to replace it.
The internal Johnson & Johnson analysis is among hundreds of internal company documents expected to become public as the first of over 10,000 lawsuits by patients who got an A.S.R. prepares to go to trial this week. The episode represents one of the biggest medical device failures in recent decades and the forthcoming trial is expected to shed light on what officials of Johnson & Johnson’s DePuy Orthopaedics division knew about the device’s problem before its recall and the actions they took or did not take.
The trial, which is expected to begin Friday in California Superior Court in Los Angeles, may also provide a guide to the consequences of the A.S.R. episode to Johnson & Johnson, both for the company’s finances and its reputation. Last year, the company took a $3 billion special charge, much of it related to medical and legal costs associated with the device. DePuy has offered to pay patient costs for replacement procedures.
The A.S.R. belonged to a once-popular class of hip implants in which a device’s cup and ball component were both made of metal. While the A.S.R. was the most failure-prone of those implants, surgeons have largely abandoned using such devices in standard hip replacement because their components can grind together, releasing metallic debris that damages a patient’s tissue and bone.
On Friday, Judge J. Stephen Czuleger, who is presiding over the Los Angeles case, unsealed a number of motions that contained portions of pretrial depositions of DePuy officials as well as related company records. Those disclosures, like the company’s estimate of the A.S.R.’s failure rate, represent only a tiny fraction of the information that will become public if the trial proceeds. Over the last two years, plaintiffs’ lawyers working on A.S.R.-related lawsuits have reviewed tens of thousands of internal DePuy documents and taken depositions from dozens of company executives.
Executives of DePuy have long insisted that their handling of the A.S.R. was forthright and appropriate. In mid-2010, when DePuy recalled the implant, officials said they were doing so because data that year from the National Joint Registry of England and Wales showed for the first time that it was failing prematurely at a higher rate than competing implants. In 2011, the British implant registry updated its projected failure rates for A.S.R. patients who had had it the longest, saying it was failing in one-third of them. It was that estimate that was challenged by DePuy.
About 7,000 of the A.S.R. lawsuits have been consolidated in a federal court in Ohio. An additional 2,000 cases have been consolidated in a California state court. The California case chosen to go to trial this week was selected because the plaintiff, a man named Loren Kransky, has cancer and may not live much longer, lawyers involved in the case said. DePuy has already settled a few A.S.R. cases before trial and it may choose to do so in Mr. Kransky’s case as well.
About 93,000 patients worldwide received an A.S.R., about one-third of them in the United States.
There are two versions of the A.S.R., one used in standard hip implants and the other used in an alternative replacement procedure known as resurfacing. Only the standard implant was sold in the United States. Both versions of the A.S.R., however, used the same metal hip cup as part of their design.
Asked for comment about the company’s internal analysis, a spokeswoman for DePuy, Mindy Tinsley, said in a statement that it “was based on a small, limited set of data that could not be used to generalize” the overall failure rate for the A.S.R.
In 2011, when DePuy challenged the British joint registry’s findings, the company made similar comments. Other medical organizations, however, have also projected very high failure rates for the A.S.R.
Hip implants, which are generally made from metal and plastic, often last for 15 years before they wear out and need to be replaced. Such devices can fail prematurely for a variety of reasons, but the early replacement rate is typically 1 percent after a year, or 5 percent at five years.
In pretrial testimony, Paul Voorhorst, DePuy’s director of biostatistics and data management, said that the company performed several reviews of A.S.R. failures in patients in fall 2011, a year after it recalled the model.
Based on the number of patients who had already undergone device replacement at the time, DePuy estimated that about 37 percent of patients who got an A.S.R. might need to have it replaced within five years of receiving it.
Last year, The New York Times reported that DePuy executives decided in 2009 to phase out the A.S.R. and sell off its inventories weeks after the Food and Drug Administration asked the company in a letter for additional safety data about the implant.
The F.D.A. also told the company at that time that it was rejecting its efforts to sell the resurfacing version of the device in the United States because of concerns about “high concentration of metal ions” in the blood of patients who received it.
In other pretrial testimony released Friday, a DePuy engineer stated that company officials were aware in 2008 of reports by an English surgeon that the resurfacing version of the A.S.R. was releasing high levels of metallic ions, particularly in women. As a result of the reports, company officials felt they had to move quickly to redesign the implant.
Wednesday, February 13, 2013
Friday, February 8, 2013
3 Reasons Japanese Women don't get old or fat
3 Reasons Japanese Women Don’t Get Fat Or Old
Let’s be clear… This is an outrageous statement. However, did you know that Japan has one of the longest life expectancies of any population? On top of that… they have the longest health expectancy!
WHO
Many know that Japan boasts a very healthy population. One of the worlds healthiest. The Japanese healthcare system according to the World Health Organization consistenly ranks around the 10th spot in the world. While the USA & Canada are down around 37 & 30 respectively. But don’t let the WHO global report bring you down as there are those that are skeptical as to just how accurate and relevant it’s rankings really are.
Many know that Japan boasts a very healthy population. One of the worlds healthiest. The Japanese healthcare system according to the World Health Organization consistenly ranks around the 10th spot in the world. While the USA & Canada are down around 37 & 30 respectively. But don’t let the WHO global report bring you down as there are those that are skeptical as to just how accurate and relevant it’s rankings really are.
Okinawa Centenarian StudyDid you know that in Okinawa, Japan, there were so many centenarian’s (people who live to be at least 100 years of age or more) that, in 1975, an ongoing study began and is still ongoing?
Not only are these people living to 100 (or beyond) they also have a history of aging slowly and delaying or sometimes escaping, the chronic diseases of aging that have be ravaging, in ever increasing numbers, the populations here in North America including dementia, cardiovascular disease (such as coronary heart disease and stroke) and cancer.
The goal of the Okinawa Centenarian Study is to uncover the genetic and lifestyle factors responsible for this remarkably successful aging phenomenon so that they can better the health and quality of life for the rest of us.
How to Stay Healthy & Live to 100Of course living to 100 if you’re struck with serious disease and lack of vitality is a miserable thought. What if you could live to 100, be healthy, clear minded and full of vigor and vitality?
Well, it looks as if both science and anecdotal evidence are saying that there is a lot we can learn from the Japanese people and their way of life… especially their diet.
We cover diet a lot here on FOHN. It turns out, as the old expression goes, we really are what we eat. Many of our featured expert interviews cover diet and just how important it is when acheiving our health and wellness goals.
Our title for this blog post was inspired by this blog post. It mentions some pretty interesting points about the Japanese diet and lifestyle.
Here are 3 reasons that describe exactly why Japanese women do not get as fat on average as the populations here in North America. Many of these below factors also could possibly promote the long life & health span mentioned in the Okinawa study.
1. The ingredients simmering in a Japanese kitchen are a simple variety of foods eaten on a consistent and daily basis:
- Fish
- Sea Vegetables
- Land Vegetables
- Soy (I’ll add that there are also many fermented soy products consumed in Japan which we don’t see much of here in North America)
- Rice
- Fruit
- Green Tea
2. The Japanese enjoy home cooked meals on a daily basis. A traditional meal consists of grilled fish, a bowl of rice, simmered vegetables, miso soup, sliced fruit for dessert and green tea. The Japanese consume almost 10 percent of the world’s fish, although they make up about 2 percent of the world’s population. That’s 150 pounds per year, per person compared to the world average of 35 pounds. And this daily dose of omega-3 fatty acids may well explain why they live long and healthy lives. That, and the fact they consume 5 times the amount of cruciferous vegetables (broccoli, cabbage, kale, cauliflower and brussel sprouts) than Americans do.
3. The emphasis of Japanese cooking is to use what is fresh and in season. According to author Moriyama, “Japanese supermarkets are cathedrals of freshness. Food is not only dated, it’s timed—Japanese women buy fish, meat, vegetables, or prepared meals that are timed by the half hour they were packed that day.”
Although anecdotal, it seems to reason we could all benefit from eating more fresh local organic foods and produce.
Fermented Foods – Gross but Good?
Finally lets touch on one food that is supposed to be provide numerous health benefits from heart health to potentially helping suppress tumors in breast cancer studies. Natto is apparently the same consistency of mucous and tastes just about the same. However somehow the Japanese apparently consume this super food regularly and it may very well be a major contributor to their health as well.
There are many other soy products that the Japanese consume regularly as well, many of them fermented; Nama Shoyu is one of them. It’s important to note that many of the soy products consumed here in North America are processed/refined/cooked and therefore do not contain the many health properties listed in the above raw/live/fermented (cultured with good bacteria and enzymes) products.
What Do You Think?
Do the Japanese really have it all figured out? Is it really reasonable to assume that just eating a simple diet of fresh and local produce (getting away from processed and refined foods) can be the answer to staying thin and healthy for a really long time?
Please let us know your opinion in the “comments” section below and share, link, tweet and plus this post for your friends!
Be Well!
- Erai Beckmann
Article from The Future of Health Now
http://www.thefutureofhealthnow.com/3-reasons-japanese-women-dont-get-fat-or-old/
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