May 2, 2013

How Recipients of Stryker’s Rejuvenate and ABG II Hip Implant Devices Can Get the Help They Need—Part Two


As discussed in part one of this article, many recipients of the Stryker Rejuvenate and ABG II hip implant devices have found their lives turned upside down from adverse health symptoms relating directly to the recalled implants. Although makers of medical devices have a duty to ensure the safety of their products many patients who received all-metal or partial-metal hip implants have found that duty was not upheld. DePuy and Johnson & Johnson are currently embroiled in thousands of lawsuits over their own recalled hip implant and following the July, 2012 recall of the Rejuvenate and ABG II Stryker is beginning to see the lawsuits against their own company mount.

Less than five years elapsed between the time Stryker began marketing these two implants and the time of the recall. Many believe that greed is a factor related to the time which passes between the first adverse reports from patients about an implant and the eventual recall. Over 53,000 Stryker ABG II and Rejuvenates were sold, and it is thought that most of those were likely implanted although the United States does not maintain a hip implant database.

While all revision surgeries are considered riskier and more complex than the original hip implant surgery, there are particular risks associated with the Rejuvenate and ABG II. The stem of these devices is implanted deeply into the femur, therefore when it must be removed the process is fraught with potential problems. The surgical procedure itself takes from 4-5 hours which increases the likelihood of excess bleeding, damage to the nerves, infection and patient mortality. In fact, the mortality risk for a Rejuvenate or ABG II revision surgery is as high as 2.5% compared to less than 1% mortality risk for the original surgery.

In many cases the stem of the Rejuvenate and ABG II must literally be pried loose and dug out of the femur which can result in shattering of the femoral bone. Should this occur, the patient must be sent home in a wheelchair in the hopes that the bone will re-grow and a new implant can be placed in the hip. Some patients end up in a wheelchair for an extended period of time—or even for the rest of their life following a revision surgery for these recalled Stryker hip implant devices.

The recovery time following a Rejuvenate or ABG II revision surgery is significantly longer than the original recovery time—as long as six weeks. Dislocation is an issue which causes physical therapy to be much slower. Lost wages and medical expenses can be overwhelming for the patient and everyday tasks may become impossible. The FDA is in the process of looking at the current application process for artificial hips following the huge number of medical problems suffered by those with these devices. While the present system requires only that the device be substantially similar to another device on the market, new requirements would make clinical trials mandatory and patient safety would move to the forefront above financial gain for the hip manufacturers.

The FDA has also mandated that surgeons should carefully weigh the risks vs. benefits before recommending a metal hip implant to their patients. The patients should be given all information regarding the implant and should understand the risks involved. Patients who have a Stryker Rejuvenate or ABG II implant should make an appointment with their physician in order to undergo testing for metal levels as well as x-rays and an MRI. Even those patients who have suffered no ill effects from their hip implant should see a doctor to determine their risk for future issues. It can be wise to seek legal help as well; if you have already suffered from a recalled implant you are entitled to compensation for your medical expenses and lost wages. Because of the statute of limitations involved in product liability cases, if you have not yet experienced medical problems due to your implant it can still be a good idea to consult an attorney.