New Data From Britain About DePuy ASR Acetabular Hip Replacement Devices

By Independent Staff Writer 

Is Johnson & Johnson Telling the Truth About the Failure Rate?

Johnson & Johnson claimed the failure rate was 13% when it recalled the DePuy product in 2010, according to its press release. Johnson & Johnson started using the device in the United States in 2005 and based its failure rate on five years of research.  However, England has a hip registry dating back well before 2005.

This week a report by The British Orthopedic Association revealed the DePuy ASR XL hip replacement unit fails as often as 49% of the time. This is an astounding four times what Johnson & Johnson reported stated when it recalled the device last year.

Dr. David Beverland, an Irish orthopedic surgeon who does massive numbers of hip and knee replacements reported that he started implanting the ASR devices in his patients in September 2004 and stopped in May 2007. He declined to say why he stopped the implants, but reported that 32% of his ASR XL patients have been or will need a second hip replacement (revision) and 44% are symptomatic. Only about 22% of his ASR XL patients seem to have achieved a good result and three of his patients died after receiving the implant. This is a serious problem for the defense since Beverland has been a major consultant and product champion for DePuy.

Here are the real facts:

-        August 2010 – Johnson & Johnson recalled the ASR XL Acetabular System and DePuy ASR Hip Resurfacing System used in hip replacement surgery due to the number of patients who required a revision.

-        April 2011 – Johnson & Johnson agreed to pay $70 million in civil and criminal fines for bribing European doctors to induce them to prescribe their drugs or implant medical devices in patients unaware of their doctors’ financial incentives, according to The New York Times.

-        May 2011 – The British Orthopedic Association and British Hip Society released data that the DePuy ASR XL hip replacement unit fails as often as 49% of the time – four times more than reported by Johnson & Johnson in 2010.

Cobalt Poisoning: DePuy ASR Hip Implants Are a Serious Risk.

By Independent Staff Writer

January 6 2011 —A person with 1 microgram of cobalt in their bloodstream has nothing to worry about.

Someone whose blood contains more than 25 micrograms has cobalt poisoning.

And a patient whose blood contains more than 100 micrograms? Probably has a DePuy ASR hip implant.

As more and more patients who received DePuy ASR Acetabular hip replacement systems ask their doctors for blood tests, the numbers of people who have extraordinarily high levels of cobalt in their bloodstreams become staggering. Several of our own clients have received the worrying news that their cobalt levels are far above normal, and at least one doctor has published a case study of two DePuy hip implant recipients who have cobalt levels that are 100 to 500 times normal.

How Much Cobalt Is Normal?

If you go to a doctor and get a blood test, the amount of metal (including cobalt) in your bloodstream will be calculated in micrograms per deciliter. A healthy person has approximately 0.019 micrograms per deciliter – about one microgram for their entire body. The metal in your bloodstream only presents in very, very small amounts; someone with normal cobalt levels could gather all the cobalt in their system together and come up with an amount smaller than a grain of sand.

Even at highly toxic levels, the actual amount of cobalt looks very, very tiny. 0.5 micrograms per deciliter of cobalt is considered toxic. That’s about five grains of sand in a giant bucket of water. Seems small – but those tiny grains of metal can throw the entire chemistry of your body wildly out of order.

In Britain, there are regulations for keeping close observations on patients who have metal-on-metal bearings in any hip implants, including the ASR hip implants. At cobalt levels of 0.7 micrograms per deciliter, patients must be kept under observations. Symptoms at those levels include hip pain, dying tissue, and pseudotumors – masses under the skin. Generally doctors recommend revision if a patient with a hip implant has a cobalt concentration of 1.9 micrograms/deciliter or above.

Revision isn’t suggested until cobalt concentrations are one hundred times the mean average – even though levels are considered toxic at twenty-five times the average.

One patient with severe cobalt poisoning had levels of 6.6 micrograms/deciliter. That’s nearly three hundred and fifty times the mean average. The dangers of cobalt levels so high were quite apparent: in addition to hip pain, the patient showed declining cognitive function, was losing control of his senses like hearing and sight, suffered from seizures, heart failure, and multiple other problems.

The amount of cobalt that patient had in his blood was still small enough that it wouldn’t have filled a teaspoon. But the damage was great enough to threaten his life.

Patients With Defective DePuy ASR Hip Implants

By Andrew Sullo

SULLO & SULLO, LLP

 

HOUSTON — In the wake of DePuy Orthopedics, Inc.’s recall of defective ASR hip implant devices, patients and their physicians have been searching for ways to mediate the potential health risks involved. With complications ranging from dislocation of the implant components and bone fractures at the hip, to metal poisoning, or metallosis, finding an accessible, effective treatment is imperative.

Enter the Accelerated Recovery Performance Wave (ARPwave) System, a revolutionary method that has been used by professional athletes and weekend warriors alike to treat muscle-related injuries and speed post-surgical rehabilitation for years. The invention of Denis Thompson, an exercise physiologist based in Burnsville, Minnesota, the ARPwave uses a patented bio-electrical current, simultaneously with active range-of-motion and other exercise techniques, to significantly speed up the body’s natural recuperative ability.

The ARPwave is a Class 2 medical device that is FDA authorized for muscle re-education; relaxation of muscle spasms; increased local blood circulation; prevention and retardation of disuse atrophy; and maintaining and increasing range of motion. Protocols can also be specifically used with the ARPwave to accelerate post-surgical muscle rehabilitation of the shoulder, elbow, wrist, hip, knee, ankle, foot, and cervical and lumbar spine. For this reason, the device would be useful to patients experiencing complications related to a defective DePuy hip implant device. Treatment of the affected area could significantly lessen long-term damage to muscles and bone surrounding the faulty implant.

Bone deterioration is associated with disease; soon, it may also be linked to the DePuy ASR XL Acetabular System. And for good reason.

By Independent Staff Writer

As we try to describe the reasons the DePuy ASR XL Acetabular System present such a danger to your health, we occasionally use terms you may be only vaguely familiar with. This is an ongoing series of articles on the medical terms related to the DePuy hip recall and hip revision surgeries.
When undergoing hip surgery, there are generally two options for a hip implant: cemented and uncemented. Cemented implants, which involve attaching the implant directly to the surrounding bone by means of a specially constructed bone cement, have been used since the 1960s. Uncemented implants were introduced in the 1980s. The ASR XL Acetabular System is an uncemented implant.
The idea behind an uncemented implant is that healthy bone can grow into its surface, thus holding the implant in place by means of the body’s own materials instead of a foreign cement. Medical professionals hoped that this design would mean the patient could have a more active life since the concern of gradually wearing away the cement would be eliminated. Cementless total hip replacements are recommended for younger, more active patients and have shown, so far, better results in long-term studies.
Obviously, healthy bone is essential for an uncemented hip implant. Without healthy bone growth, the hip implant will not be secured into the rest of the skeleton and will not function as a replacement for the removed hip.
Evidence is showing that the DePuy ASR XL Acetabular System may cause serious bone deterioration in a number of ways. One of the most significant is osteolysis, which occurs when the body reabsorbs bone as part of an autoimmune response. Osteolysis has been noted as a side effect of many total hip replacement systems; the more debris that is released into the body, the more common osteolysis becomes. Metal-on-metal hip implants were thought to have less likelihood of debris because they are made of harder materials, but the ASR XL Acetabular System’s poor design caused significant friction and a great deal of metal debris, raising the risk of osteolysis.