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DePuy wants to shut down claims by patients. A year ago they were paying doctors to get patients to give up their rights in exchange for a "company" solution. Think of a chicken coop and a fox:

August 24, 2010 (Note: The DePuy ASR™ Hip Resurfacing System was only approved for use outside the U.S. and the ASR™ XL Acetabular System was available worldwide.) The official recall notice is attached.

ATTN: DePuy Customers

I am writing to share urgent and important information about DePuy’s decision to voluntarily recall the ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System.

Most ASR hip replacement surgeries have been successful. However, data recently received by DePuy shows that more people than expected who received the ASR hip require revision surgery.

For this reason, DePuy Orthopaedics is voluntarily recalling its ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System. This recall means additional testing and monitoring may be necessary to ensure your patients’ hips are functioning well. In some cases, patients may need revision surgery.

Our goal is to help you answer your patients’ questions and support their prompt follow up care and treatment. Please contact your patients and request that they schedule a follow up appointment for evaluation.

Lest you get confused, the "Customer" is the surgeon. The person whose DePuy hip implant is destroying their life is the "patient". So what is DePuy doing? Look a this:

We will provide you with a brief form to be completed for each patient, including date of surgery, components implanted, follow up status and the results of any metal ion testing. We appreciate your assistance with this process, and we will provide compensation at a rate of $50 per patient for each completed form that is submitted to DePuy.

DePuy put a bounty on patients. Doctors can get $50 for each patient they hook. And guess what else DePuy wants the doctor to do? They want to get the defective hardware back. They call the hardware "explants":

Reimbursement is subject to the completion and submission of required documentation to DePuy to confirm eligibility. Eligibility will be determined, in part, by validation that the patient has an ASR component implanted and has consented to provide DePuy with x-rays, explants and any other requested medical information after the revision surgery.

Tire manufacturers are notorious for sending goons to crash sites to stael the tires on cars that rolled over after a blowout. Tarentino will make a movie about this one day.

In an article in ORTHOPEDICS TODAY, August 2011, "High rate of adverse events found with metal-on-metal total hip arthroplasty" the doctors at one center in the UK concluded that changes are necessary:

The rate of adverse events, such as pseudotumor formation, high metal ion levels and metalloisis, caused by metal-on-metal total hip arthroplasties is higher than research previously indicated.

“Our study shows a substantially higher incidence of pseudotumor formation and subsequent revisions in patients with [metal-on-metal] MoM total hip arthroplasties than previously reported,” Bart H. Bosker, MD, a researcher in the department of orthopedic surgery at the Isala Clinics, The Netherlands, said during his presentation at the 12th EFORT Congress 2011.

For their study, Bosker and colleagues evaluated a prospective cohort of asymptomatic patients to determine the incidence of symptomatic pseudotumors after large-diameter femoral head MoM total hip arthroplasty (THA) and to identify potential risk factors for this condition.

They noted that they did not expect these results:

The investigators found that 42 patients were diagnosed with pseudotumors. Thirteen patients with a symptomatic pseudotumor underwent revision arthroplasty, which included a polyethylene acetabular component with a small-diameter metal head. The total revision rate was 12%.

“We did not anticipate the high incidence of pseudotumor formation. Most revision cases were identified only after applying an intensive screening protocol,” Bosker told Orthopedics Today. “We recommend close monitoring of patients with a MoM hip arthroplasty.”

In addition, the researchers found that patients with elevated metal ions displayed a four times higher risk of developing a pseudotumor. The investigators did not find a difference in clinical outcome scores among those with a tumor compared to those without a tumor, and did not identify any relation with head size or component orientation.

Although not involving a Depuy product, the medical literature shows that a patient must be very careful about implanting any medical device into their body. Furthermore, FDA approval or the local implant surgeon’s testimonial may is no assurance of safety.

Depuy wants to get patients to give up their rights, but future long term health problems makes that very unwise:

Many older recipients of the faulty hips, which have caused pain requiring another hip replacement and caused metal poisoning, will require home help and some of the younger patients may have to be compensated for loss of present and future capacity to earn a living for themselves and their families.

"Very little is currently known about the symptoms of cobalt and chromium poisoning, however from listening to the stories of the people who have spoken to me I know that headaches, thyroid problems, heart issues and even cancer are suspected to have resulted from high levels of these heavy metals being in the blood," Mrs Penfold said.

"Anyone with a metal on metal hip or knee should in my view have their cobalt and chromium levels tested, particularly if they do not feel well or have unexplained symptoms which are often being attributed to other things such as in one case post polio syndrome.

This article from Australia shows the worldwide scope of the problem.

One Comment

  1. Gravatar for Michael Monheit
    Michael Monheit

    Shocking that this took place. Well maybe not, considering that this is a medical device manufacturer that appears to put profits above patients.

    Thanks Wayne for raising our awareness about DePuy's actions, putting out bounty payments to doctors for each defective hardware (evidence of the defective device!!) that the doctors could get patients to agree that DePuy could recover back from the patients.

    And shame on any doctor that got a patient to sign something like this! I hope that this plan was foiled by a large number of responsible doctors refusing to take the bait.

    What nerve of DePuy to inject themselves into the doctor-patient relationship in such a way as to put the doctor at odds with the best interests of his or her patient.

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