On Monday it became apparent that nearly half of surgeons who earned over one million dollars from manufacturers of orthopedic devices did not disclose the information when they published medical journal articles
“The findings raise troubling questions about undisclosed payments or royalties and other fees from medical device companies that could lead to biased scientific conclusions,” said David Rothman of the Institute on Medicine as a Profession.
The research team focused on five companies: Biomet; DePuy Orthopedics, a unit of Johnson & Johnson; Smith & Nephew; Stryker and Zimmer.
These companies paid $248 million in 2007 for consulting, honoraria or other payments for services, the team reported. The analysis also showed that payments to 41 orthopedic surgeons ranged from just over $1 million to $8.8 million.
Fewer than half disclosed a financial relationship between the researcher and company. Of those that disclosed a financial gain or funding none hinted at the size of the payments. In total 95 articles were published in medical journals.
This study raises serious questions around these hip implants. With the recent recall for the DePuy ASR hip implant and past recall and warnings for Stryker and Zimmer implants the consumer is to wonder who they can trust for safe orthopedic devices.
Styker Warning Letter 2007:
- Both of the recalled Trident Hip Implant cups where among the Stryker components mentioned in the FDA warning letter Stryker received on November 28, 2007.
- During that inspection, the FDA found a range of problems. Among the most serious where instances of bacterial contamination at the Stryker plant. The contamination included “clusters” of Staphylococcus bacteria, the pathogen that causes staph infections.
- Patients had been complaining about a range of problems, including pain, difficulty walking and “squeaky” joints, and some have had pieces of implant parts break off or wear down unevenly.
Zimmer Durom Cup Product Recall 2007:
- The Durom Cup hip replacement device fails to seat properly in some patients. U.S. surgeons have experienced elevated hip revision surgery rates since the Durom Hip Cup product was launched in the U.S. in 2006. Durom Cup patients often suffer for months or years prior to the replacement surgery because the x-rays of the Zimmer Durom Hip “look good” and do not reveal the failure of the Durom Cup to properly bond.
- The Durom Cup was first sold in the U.S. in 2006 and has been implanted in more than 12,000 patients in just two years. The complaint estimates that the device’s failure rate, to date, is between 20 and 30 percent; however, that figure is expected to increase as the device continues to fail over time.
- Since the beginning of 2008, the FDA has received about 300 complaints regarding the DePuy ASR cup involving patients in the US
- Johnson & Johnson announced the recall of the DePuy ASR Hip Implant system after data from the National Joint Registry of England and Wales showed that 1 out of every 8 patients (12%-13%) who had received one of the recalled devices had to undergo revision surgery within five years of receiving it