A major Australian newspaper is questioning why the country’s regulatory agency for drugs and medical devices allowed DePuy’s all-metal hip implants to be sold there for years after data showed they had a high early failure rate.
The report in the Sydney Morning Herald mentions documents the New York Times obtained through the Freedom of Information Act, which indicated that DePuy executives sold the devices in the United States and abroad despite knowing that they were potentially dangerous for patients who received them.
DePuy is a division of Johnson & Johnson.
The New York Times article mentions a model of hip implant that the U.S. Food and Drug Administration refused to approve in America because of its high early failure rate, but which DePuy marketed in other countries anyway. The report specifically mentions data from Australia showing that the device was failing at high rates just a few years after implantation, rather than lasting 15 years as expected.
The Sydney Morning Herald report states that Australia’s National Joint Replacement Registry identified a high failure rate with the DePuy implants as early as 2006, but the implants weren’t recalled in Australia until December 2009 – six months before Johnson & Johnson recalled them globally.
“About 5500 Australians have had the suspect DePuy hips fitted and hundreds have had to undergo risky operations to replace them,” the Morning Herald says.
Although the FDA did not approve the device mentioned in the Morning Herald report, it did approve a related all-metal hip implant that DePuy manufactured. Unfortunately, the DePuy implant that the FDA approved appears to have an even higher failure rate than the one the FDA rejected. Moreover, the version approved by the FDA was never tested in humans, due to a loophole in the approval process. Some are now calling for an overhaul of the medical device approval process.
Both models have resulted in thousands of lawsuits from patients suffering debilitating pain and injury from receiving them. In addition to the early failure rates, complaints include metal debris breaking off as the joints wear and getting into patients’ soft tissues.
If you’ve suffered injury as a result of getting a DePuy Orthopaedics hip implant, contact Lopez McHugh for a free consultation.
See the Morning Herald report here:
https://www.smh.com.au/national/health/question-over-timing-of-ban-on-implants-20120327-1vwlg.html
