As discussed in part one of this article, removing a recalled Stryker ABG II or Rejuvenate during revision surgery is not an easy decision for the patient to make. Because the femoral stem of these two Stryker models is implanted deeply within the femur bone, removing that stem brings significant risks of fracturing the femur. In fact, the procedure has been likened to removing a one-inch piece of rebar from a slab of concrete. In short, the stem piece must be forced out of its position which results in a much longer surgical procedure—as much as 4-5 hours—thereby increasing the risks of infection, blood loss, nerve damage and patient mortality. The overall mortality rate of revision surgery is approximately 2.5 percent as compared to one percent for the original hip implant surgery.
Because of the complexity of the surgery the recovery time is significantly longer than that of the original hip implant surgery. Dislocation is a problem following revision of a Rejuvenate or ABG II therefore physical therapy goes much more slowly. Patients who undergo revision of a Rejuvenate or ABG II can be hit not only with extreme medical expenses but lost wages due to the longer recovery time. In some cases, the patient may even be left unable to walk, confined to a wheelchair for life.
In June of 2012, an Orthopedic and Rehabilitation Devices Panel was convened by the FDA in order to obtain the most up-to-date scientific and clinical opinions regarding the risks of all-metal hip implants. Information from this panel was put into an FDA Safety Communication regarding metal hip implants. Many believe the FDA approval process for hip implant devices may be somewhat to blame for the problems associated with these all-metal and partial-metal implants. Under the present system, the manufacturer must only show that their implant is substantially equivalent to an implant already on the market. There are no requirements for clinical trials, meaning many of these hip implants have been marketed with little or no regard for consumer safety.
Recently the FDA has proposed changes to the approval process which would require manufacturers to bear the burden of proving effectiveness and safety of hip implants prior to placing them on the market. After a review of over 100 studies, the FDA concluded that patients who received larger implants than necessary as well as small women were particularly at risk of experiencing serious problems from metal hip implants. Further, surgeons should carefully screen their implant patients and weigh the additional risks associated with patients who are obese, have a sensitivity to metals, are extremely active, have been diagnosed with renal insufficiency or those with a suppressed immune system.
In other words, risk vs. benefit should be weighed carefully and patients should be provided with updated information regarding the very real health risks of metal hip implants. Those who have a Stryker Rejuvenate or ABG II should see their physician immediately. A full exam plus blood tests, x-rays and MRIs should be given, not only to those experiencing difficulties from their implant but even for those who have not yet experienced adverse health symptoms. Following a full medical workup it can be advisable to consult an experienced product liability attorney to ensure you do not miss the narrow window of opportunity for filing a lawsuit against the manufacturer of your defective hip implant.