Monday, January 30, 2012

Things You Should Know About Johnson & Johnson’s and DePuy Orthopedics’ Attempts to Help Hip Implant Recipients

Introduction
DePuy hip implants were used widely throughout the world, beginning in 2003, and in the United States from 2005. Although concerns were raised regarding the safety of these hip implant devices, a recall by DePuy was not issued until August of 2010 when DePuy received data from the National Joint Registry showing the five year revision rate for the ASR hip replacement system was approximately 12-13%. This study appeared to show that the risks for revision surgery were highest among female patients who received the smaller ASR heads which were less than 50mm in diameter. The recall in 2010 was voluntary on the part of DePuy and Johnson and Johnson and the pharmaceutical giant has subsequently issued several field safety notices to physicians to enable them to help their patients whose health has been affected by the DePuy hip implant failure.

Potential Problems with the DePuy Hip Implant
The metal-on-metal construction of DePuy’s metal hip implant may allow grinding, resulting in metal particles entering the surrounding tissue. These metal shavings cause contamination and once the surrounding tissue is contaminated it will allow even more metal particles to enter the blood stream, becoming toxic to surrounding tissue. The person who may be having an issue with the DePuy implant may suffer serious or chronic pain, inflammation, possible detachment of the implant, bone fracturing surrounding the hip implant, and dislocation of the implant.

Initial Safety Notice Issued
One of the first safety notices issued to physicians stated that all patients who were recipients of the ASR system should immediately be informed of the recall, and asked to return for a follow-up visit. The notice goes on to tell physicians the procedure for addressing those patients who appear to have radiographic changes which could possibly indicate product failure. As per DePuy’s April 22, 2010 device alert, some patients may have developed a progressive reaction in the soft tissue surrounding the implant to the metal particles released from the device. The earlier the revision surgery is performed, the better, according to the DePuy safety notice.

DePuy advises physicians that any patient who is symptomatic or any whose cup was implanted at an angle greater than 45 degrees—particularly in the smaller devices—have blood measurements of cobalt and chromium ion levels performed. If the levels of the metal ions are elevated above y parts per billion for either metal, a subsequent test should be performed in three months, and a possible cross-sectional image taken as cobalt and chromium toxicity is possible. The DePuy advice for those patients whose MRI or ultrasound scan reveals reactions of the soft tissue, collections of fluids or masses of tissue is that patients should discuss revision surgery with their physician.

DePuy Financial Support for Patient Follow-up
This same initial field safety notice issued by DePuy to physicians, details the potential financial support they intend to offer to any patients who need medical services associated with the recall of the hip implant device. DePuy will cover any cost which is considered reasonable and customary and is associated with monitoring and treatment. DePuy will provide reimbursement for any necessary diagnostic testing the patient undergoes as a result of the surgeon’s concern about the safety of the hip implant device. If the surgeon recommends a revision procedure for his or her patient, DePuy agrees to provide reimbursement, however this reimbursement is subject to completion and submission of all required documentation. DePuy states they may not cover surgeries which involve size mismatches, traumatic injuries where there is no evidence of soft tissue reaction at the time of the surgery or in cases where infection caused the revision surgery. There may be other exclusions claimed by DePuy in a case-by-case basis.

Your Risk for Medical Problems Following a DePuy Hip Implant
As stated, your estimated risk for problems following your hip implant can range from 12% to possibly as high as 49%. If you had hip replacement surgery after July of 2003, you may be at risk, however since DePuy did not maintain a list of patients who received the hip implant device, they are unable to warn patients directly, meaning the burden is placed on the individual recipient. DePuy has asked patients who think they may have had a DePuy hip device implanted to call their help line and share their medical information.

It is advisable to contact an experienced product liability attorney before you provide sensitive medical information to DePuy--or anyone for that matter. Should you sign an authorization form which gives DePuy access to your medical records, they may decline to cover all the damages related to the defective artificial hip implant. Unfortunately, DePuy has failed to address the questions of tissue contamination by the metallic cobalt and chrome ions released into the body, and there is no clear medical determination as to the potential long-term effects of this metal contamination. Chromium poisoning symptoms include inflammation and necrosis of the surrounding tissue, impaired liver function, asthma and shortness of breath and hearing and vision impairments. Cobalt poisoning can lead to many of the same symptoms. It’s important that you receive experienced counsel from a DePuy hip recall attorney to ensure you do not lose any of your valuable rights of recovery.

Author: Sullo & Sullo Attorneys

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