Wednesday, November 7, 2012

Stryker ABGII Hip Implant Revision Surgery: The Dangerous Potential Complications

Recipients of a Stryker Rejuvenate or ABGII Hip implant device may have been shocked to hear that both implants were recalled in July of 2012. Or, if you are one of the recipients who had already suffered adverse health effects from the Rejuvenate or ABGII then perhaps you were not so surprised to hear of the recall. It is possible that many of those who currently have one of these metal implants in their body are not yet aware of the recall. Stryker sent out an Urgent Safety Notice to physicians and hospitals in April of 2012 prior to the recall.

Potential Health Hazards of the Stryker ABGII and Rejuvenate Implants

Many recipients of the ABGII or the Rejuvenate began experiencing adverse health effects soon after they received the implant, while others did not have negative effects for a year, or two or three. According to the All Symptoms website while some recipients have yet to have any adverse effects, many liken having a metal-on-metal hip implant in the body to the proverbial ticking time bomb. The likelihood that the hip will fail, the patient will develop severe inflammation, pseudo tumors or pain as well as metal toxicity (which brings its own set of problems) is much higher than was believed when the metal hip implants were marketed.

The Perils of Revision Surgery

When a metal hip fails or the recipient experiences serious issues from the implant, it may be necessary to undergo revision surgery. According to Drug Watch, over 50,000 people in the U.S. must go through revision surgery to replace hip implants which have become “loose, painful, infected or dislocated.” When removing a Rejuvenate or ABGII the surgical procedure can be very complex and likely comes with many more dangers than the original hip implant surgery. Andrew Sullo, Managing Partner of Sullo & Sullo, a national products liability law firm based in Houston, Texas, states that in many cases the leg is going to receive considerably more damage because the revision requires a much bigger object and extends much deeper into the leg.

Drug Watch places the overall mortality rate of revision surgery at approximately 2.5 percent as compared to 1 percent for the first implant surgery. Additionally, the surgery is a lengthy one—from four to five hours from start to finish. Patients who undergo surgeries which last this long can develop infection, nerve damage or excessive bleeding. Following hip revision surgery patients may develop deep vein thrombosis. This can develop when a patient is required to be relatively inactive during recovery. The recovery time is considerably longer for a revision than for the original surgery, sometimes up to six weeks. Deep vein thrombosis can cause clots to form in the large veins of the leg, and if they should break away they can travel to the lungs or heart causing serious or even deadly embolisms.

Myositis ossification, a condition in which the bone grows around and encapsulates the hip joint, can also occur immediately following revision surgery. When revision surgery for an ABGII or a Rejuvenate implant – both manufactured by Stryker – is necessary the surgery can be even more challenging than those for other implants. These devices are typically implanted very deeply into the femoral bone so when they must be removed the surgeon literally has to dig them out of the bone. This can lead to broken femurs among revision patients as well as a higher rate of dislocation with the second implant simply because there is much less bone to attach to. Under the best of circumstances the complications of a revision surgery can be physically and emotionally taxing for patients, but for those who are undergoing revision due to a defective device, the anxiety, stress and potential complications increase.

Life Expectancy of Hip Implants

Although metal hip implants were marketed as lasting even longer than the “normal” 10-15 years, considering that the Rejuvenate gained FDA approval in 2008 and the ABGII in 2009, you can see that patients could not have had these implants in their bodies any longer than five years. Despite this short amount of time, many Rejuvenate and ABGII patients experienced fretting, corrosion and metal toxicity which contributed to their decision to undergo revision surgery. Yet even in light of the potentially harmful complications of revision surgery, many implant recipients have little choice. They need their hip to function normally again, or they may want the metal hip out of their body due to metal toxicity. Essentially, the only way for patients to have a chance of an active life once again is to undergo revision surgery even though most orthopedic surgeons see revision surgery as a last resort.

The Revision Surgery Process

During the actual surgery the hip will be dislocated then the orthopedic surgeon will remove the implant components which are causing issues. The original metal implant which is attached to the pelvic cavity is removed first and any cement left behind is cleared away. Next the socket is cleaned out and bone particles are added. A liner is added and if grafts of bone are needed to shore up a defective femur, they are put into place. A stem is placed into the femur, the implant components are put together and once it is determined that the implant moves as it should the cuts are closed with sutures. The consensus among orthopedic surgeons appears to be that even patients with no overt symptoms should be closely monitored with blood levels checked often. Any patient who develops pain, particularly in the groin, should see their physician immediately. Once the patient has seen their physician and discussed their options, it could be beneficial for them to visit with a knowledgeable legal professional.

Author: Sullo & Sullo Attorneys

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