On December 14, 2011 the New York Times published an article saying that three U.S. senators have proposed a bill reinforcing medical device regulations. The authors of the bill were Richard Blumenthal (D-CT), Herb Kohl (D-WI), and Charles E. Grassley (R-IA). These senators are providing bipartisan support for a “wave of medical device industry-friendly” bills that would restructure regulations of the Food and Drug Administration (FDA), requiring more stern clearances of medical products.
Besides authoring the bill, they also sent inquiries to five major manufcaturing companies of medical devices, consulting them how they track product safety and recall devices. The manufacturers were  Johnson & Johnson, an artificial joint maker; Zimmer Holdings, another producer of artificial joints; Medtronic, a heart and spinal implant producer; Boston Scientific, a heart device maker, and C. R. Bard, a surgical implant maker.

As for Johnson & Johnson’s case in particular, after informationwas out saying that the devices have defects in one out of eight clients, the ASR XL Acetabular System and the ASR Hip Resurfacing System were withdrawn. There are about 93,000 recipients of these products worldwide. Factory production and sale of the two prosthetic items started in 2003. In August 2010, DePuy carried out a worldwide recall.

Problem with Metal-on-Metal Hip Replacements

Design problems with metal-on-metal hip implants, particularly the DePuy ASR hip devices, may cause the metal components to rub against each other and shed microscopic metal particles into the body. Body reactions to these metal particles may cause soft tissue damage, cause inflammatory reactions and lead to bone loss. This may possibly result in a need for a hip revision operation, a more risky and agonizing surgery.

The presence of the metal parts may boost the amount of chromium and cobalt in the blood. This may cause metallosis (blood poisoning) and genotoxicity (genetic damage).
In a statement, a spokeswoman for DePuy, Mindy Tinsley, said, “We believe we made the appropriate decision to recall at the appropriate time given the available information.”
 
Johnson & Johnson Faces Legal Complaints
Johnson & Johnson have been charged with compensatory claims by their patrons, legal specialists say. They were the suffering victims of DePuy product failures and defects, among them displacements, fractures and loosening. According to legal obsevers, the DePuy hip replacement recall should stand as a lesson to other device manufacturers to strengthen and certify the safety of their products.
 
References:
•         nytimes.com/2011/12/15/business/bill-would-require-more-monitoring-of-implants.html?_r=1
•         arthritistoday.org/news/asr-depuy-hip-replacement-recall078.php
•         health.ezinemark.com/patients-implanted-with-defective-mom-hip-devices-at-high-risk-of-metallosis-7d32146a00c7.html
•         usrecallnews.com/2011/01/a-brief-background-of-metallosis-cobaltism-and-metal-on-metal-hip-implants.html
 

Osteoarthritis (OA) is the most prevalent type of joint disorder. It is caused by the breakdown and eventual loss of the cartilage of one or more joints. For cases of OA that do not respond to conservative treatment, surgery, like hip replacement surgery for hip joints, is recommended.  However, an editorial written by a doctor says that many hip replacement surgeries are avoidable. 
 
OA, otherwise known as the “wear-and-tear” arthritis is idiopathic in nature. Several risk factors may cause the condition, doctors say.  However, no single risk factor is enough to cause OA.  Some of the identified risk factors include age, obesity, injury or overuse, genetics, muscle weakness, gender and other underlying diseases.  Having these risk factors does not necessarily mean that one will surely acquire osteoarthritis. 
 
Dr. Louis Pack, author of the book The Arthritis Revolution, clarified the difference between correlation and cause. Though age is believed to be the leading cause of OA, he pointed out in his editorial in CNN, that age only has a correlation to the condition. He added that age was not the reason behind the condition. Dr. Pack said that in almost all cases of osteoarthritis, only one hip or knee joint is affected. 
 
The risk-factor weight also has the same argument. Dr. Pack cited examples showing that some significantly overweight people have no joint problems. Others, who weigh far less, have arthritic joints.   He further stated that only one knee or hip is affected of the many overweight patients. Certainly, not only a single side bears the weight. 
 
What precedes the process of osteoarthritis is misalignment. A study published in the Journal of the American Medical Association in 2001 says that a five-degree misalignment from the ankle to the hip increased the progression of OA three to four times.  The researchers from renowned Mayo Clinic supported this result in 2008. The study showed that a single degree of bad alignment from the ankle to the hip will result to a 55 percent increase on the risk of OA. "Age was only weakly associated with an increase risk," according to the study. 
 
Abnormal alignment is the root cause of osteoarthritis.  Researchers say that if medicine focused more on this than trying to produce other invasive methods of treatment, number of replacement surgeries will be cut to half. There will be reduction in the number of patients needing hip replacement surgery and possibly affected by DePuy hip replacement recall. 


Reference:
ncbi.nlm.nih.gov/pubmedhealth/PMH0001460/
medicinenet.com/osteoarthritis/article.htm
mayoclinic.com/health/osteoarthritis/DS00019
arthritis.org/disease-center.php?disease_id=32http://edition.cnn.com/2011/10/28/health/alignment-hip-replacements-pack/index.html