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Don t panic 2 index

My View:

  • Some good points are made to balance the negativity of the ever-increasing DePuy fiasco but there is a danger of down-playing the fact that over 10,000 people world-wide are in pain, suffering and now consigned to a life of further revisions and less and less options as their hips fail as a result of the defective implants.
  • Balance – yes – but don’t forget the people – and the people that don’t yet know that their health is being affected by these hips – or will be in a few years.

However, I can’t get my head around his statement “In the case of chromium and cobalt, a significant number of patients have higher than expected levels in the bloodstream, but to date, no adverse effects have been confirmed — asymptomatic patients should not be concerned about potential harm.”

Maybe we just read different stuff…

  • Remember – a few people died from SARS – and that was a global catastrophe – the problem with metal on metal hips is not just a DePuy problem – me and many others have the same problems with Smith & Nephew’s Birmingham HR & THR implants… and there are other manufacturers too…
  • DePuy will love this “voice of reason”… great PR…

There’s No Need to Panic About Hip Implant Recall

By Dr. David Lipschitz

Source: click here

The recall of the DePuy metal-on-metal artificial hip replacement by Johnson & Johnson has led to concerns about the potential danger of these implants.

Depuy recall 7 images

Approximately 12 percent of patients who received the DePuy metal-on-metal implant required repeat surgery to replace the defective joint. This is more than twice the expected rate of failure. These artificial hips tend to loosen, and patients may experience pain and difficulty walking. Fractures have been reported and two parts of the artificial hip have become dislocated and are no longer able to move smoothly for normal walking.

FDA RECALL images

In addition, metal debris from the faulty implant has lodged in surrounding tissue, causing significant irritation and pain. A great deal of scar tissue forms as well as a series of benign growths called pseudotumors, which consist of scar and purulent tissue.

Any time there is a recall or a problem of any kind identified in health care, patients and the legal system immediately begin to seek compensation from the enormously wealthy companies that market these devices. As a result, TV, the Internet and newspapers are full of information and advertisements seeking symptomatic patients who may be eligible to participate in a class action suit with the prospect of receiving large sums for damages and needless pain and suffering.

The majority of patients should be reassured that they are quite unlikely to experience any problem from their metal-on-metal hip implants, which are designed to last 15 years. And while the risk of failure is higher than expected with the DePuy hip replacement, more than 87 percent of implants work well with excellent results. Provided local symptoms are not present, no patient should be alarmed and demand that their metal-on-metal hip be replaced. Nor should they be concerned by the recent report indicating that cobalt and chromium contained in any metal implant can enter the bloodstream and cause illness in other parts of the body.

Metalosis

Perhaps because of litigation and public outcry, the U.S. Food and Drug Administration (FDA) has asked for increased monitoring of all 22 commercially available metal-on-metal hip implant replacement systems. It hopes to determine the true likelihood of loosening of the joint, local inflammation caused by the implant, and the dangers of the release of metal ions into the bloodstream. In the case of chromium and cobalt, a significant number of patients have higher than expected levels in the bloodstream, but to date, no adverse effects have been confirmed — asymptomatic patients should not be concerned about potential harm.

Depuy Recall 5 images

The FDA encourages every patient with a metal-on-metal implant to contact their orthopedic surgeon, and whether symptomatic or not, the patient should agree to participate in the surveillance program. Then as much information as possible can be obtained and everything can be done to assure patient safety and the best possible quality of life.

The FDA surveillance program will include an analysis of every adverse effect from all types of metal implants, the reason why revision surgery is needed, and the incidence of pain and difficulty walking in those patients who do not have revision surgery. The FDA also suggests measuring patients’ chromium and cobalt levels before receiving a metal-on-metal implant and at frequent intervals for the first eight years after the surgery.

To date there is no definitive evidence to suggest that any patient has experienced illness elsewhere in the body, but very rare reports have attempted to show a link between the metal implant and cardiac, neurological and thyroid disease.

DePuy Recall 6 images

No one should have a cobalt level above 1 microgram per milliliter, and many patients with metal implants may have values as high as 5 micrograms. Effects of cobalt toxicity include vision and hearing loss, heart and nerve damage, memory loss and rashes.

Fortunately, only chromium 3 is found in metal implants, and the evidence that it causes toxicity is minimal. Chromium 3 is an essential metal in our diet that is required for the normal metabolism of glucose, fat and protein. While increased levels of chromium 3 have been found in the blood tissues of those with implants, no increase in chromium 6 (which causes fertility problems, lung disease and cancer) levels have been identified.

Based on this information, it is now more important than ever that those who have had an implant or those about to receive one discuss the issue in detail with their surgeon. There may now be greater reluctance to use a metal-on-metal implant, but the best advice for those who have one is to stay as informed as possible and not panic.

 

There’s No Need to Panic About Hip Implant Recall

By Dr. David Lipschitz

The recall of the DePuy metal-on-metal artificial hip replacement by Johnson & Johnson has led to concerns about the potential danger of these implants.

Approximately 12 percent of patients who received the DePuy metal-on-metal implant required repeat surgery to replace the defective joint. This is more than twice the expected rate of failure. These artificial hips tend to loosen, and patients may experience pain and difficulty walking. Fractures have been reported and two parts of the artificial hip have become dislocated and are no longer able to move smoothly for normal walking.

In addition, metal debris from the faulty implant has lodged in surrounding tissue, causing significant irritation and pain. A great deal of scar tissue forms as well as a series of benign growths called pseudotumors, which consist of scar and purulent tissue.

Any time there is a recall or a problem of any kind identified in health care, patients and the legal system immediately begin to seek compensation from the enormously wealthy companies that market these devices. As a result, TV, the Internet and newspapers are full of information and advertisements seeking symptomatic patients who may be eligible to participate in a class action suit with the prospect of receiving large sums for damages and needless pain and suffering.

The majority of patients should be reassured that they are quite unlikely to experience any problem from their metal-on-metal hip implants, which are designed to last 15 years. And while the risk of failure is higher than expected with the DePuy hip replacement, more than 87 percent of implants work well with excellent results. Provided local symptoms are not present, no patient should be alarmed and demand that their metal-on-metal hip be replaced. Nor should they be concerned by the recent report indicating that cobalt and chromium contained in any metal implant can enter the bloodstream and cause illness in other parts of the body.

Perhaps because of litigation and public outcry, the U.S. Food and Drug Administration (FDA) has asked for increased monitoring of all 22 commercially available metal-on-metal hip implant replacement systems. It hopes to determine the true likelihood of loosening of the joint, local inflammation caused by the implant, and the dangers of the release of metal ions into the bloodstream. In the case of chromium and cobalt, a significant number of patients have higher than expected levels in the bloodstream, but to date, no adverse effects have been confirmed — asymptomatic patients should not be concerned about potential harm.

The FDA encourages every patient with a metal-on-metal implant to contact their orthopedic surgeon, and whether symptomatic or not, the patient should agree to participate in the surveillance program. Then as much information as possible can be obtained and everything can be done to assure patient safety and the best possible quality of life.

The FDA surveillance program will include an analysis of every adverse effect from all types of metal implants, the reason why revision surgery is needed, and the incidence of pain and difficulty walking in those patients who do not have revision surgery. The FDA also suggests measuring patients’ chromium and cobalt levels before receiving a metal-on-metal implant and at frequent intervals for the first eight years after the surgery.

To date there is no definitive evidence to suggest that any patient has experienced illness elsewhere in the body, but very rare reports have attempted to show a link between the metal implant and cardiac, neurological and thyroid disease.

No one should have a cobalt level above 1 microgram per milliliter, and many patients with metal implants may have values as high as 5 micrograms. Effects of cobalt toxicity include vision and hearing loss, heart and nerve damage, memory loss and rashes.

Fortunately, only chromium 3 is found in metal implants, and the evidence that it causes toxicity is minimal. Chromium 3 is an essential metal in our diet that is required for the normal metabolism of glucose, fat and protein. While increased levels of chromium 3 have been found in the blood tissues of those with implants, no increase in chromium 6 (which causes fertility problems, lung disease and cancer) levels have been identified.

Based on this information, it is now more important than ever that those who have had an implant or those about to receive one discuss the issue in detail with their surgeon. There may now be greater reluctance to use a metal-on-metal implant, but the best advice for those who have one is to stay as informed as possible and not panic.

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