April 09, 2015 - If you were implanted with a DePuy Pinnacle hip device, and have been keeping up with the litigation concerning the Pinnacle, you may wonder whether you should undergo DePuy Pinnacle hip revision surgery. When a hip implant fails, or has caused serious issues such as DePuy Pinnacle hip metallosis, a doctor may advise the patient to have the implant removed and replaced with a safer model.
In this case, the decision to have DePuy Pinnacle hip revision surgery may be a fairly simple one. Unfortunately, not every Pinnacle recipient has been counseled to undergo revision surgery, making the decision much more difficult. On the surface, it may appear fairly straightforward. After all, if you have not suffered any ill effects from your DePuy Pinnacle hip device, why would you undergo a potentially risky hip revision surgery? The answer to that question is multi-faceted. Consider the following factors:
· The Failure Rate of the Pinnacle
While the smaller head size of the Pinnacle (as compared to the recalled ASR) is believed to be instrumental in the lower failure rate of the Pinnacle, that failure rate is still unacceptably high. A study done in the United Kingdom concluded the Pinnacle, when used with a metal liner, had a failure rate of 8% at five years and 16% at 6.5 years. Many believe this number is considerably higher. At the time DePuy recalled the ASR, they admitted to a failure rate of 12% at five years.
· The High Number of Adverse Event Reports
In 2010, 548 adverse event reports were sent to the FDA regarding the Pinnacle hip device. In 2011, over 1,200 additional adverse event reports were received. These adverse event reports may represent only a small portion of the total number of consumer issues related to the Pinnacle. It is generally held that only 1-10% of all adverse events are actually reported to the FDA.
· Increased Risk for Pinnacle Hip Devices with Metal Liners
Initially the Pinnacle hip device was used in conjunction with an Ultima metal liner which resulted in friction and corrosion between the cup and the ball-shaped head. This led to the generation of excess metal ion debris flooding the body. Despite known issues with the Pinnacle, it has never been recalled, however the metal liner was discontinued in mid-2013. Patients who received a Pinnacle with the Ultima metal liner are likely at a much higher risk for failure, metallosis and metal toxicity.
· Difficulties for Unrevised Patients as Evidenced by Recent Settlements
The recent settlements for the recalled Stryker Rejuvenate and ABGII hip implants as well as the DePuy ASR hip implant, have been structured in such a way that primarily, only those who have undergone hip revision surgery are eligible to reimbursement. One may speculate that those patients who still have their original Pinnacle implant may find it much harder to receive compensation for present or future injuries related to the Pinnacle under any possible future settlement agreement, should one occur. [DePuy has indicated it is strongly committed to defending its Pinnacle Hip Implant.]
More than 6,600 Pinnacle lawsuits have already been filed; despite a decision in favor of the defendant in late 2014, bellwether trials are currently being set. If you have experienced any symptoms of DePuy Pinnacle hip metallosis—or even if you have not—it could be beneficial to speak to a DePuy Pinnacle hip lawyer regarding potential DePuy Pinnacle hip litigation.