It is no surprise that hip replacement surgery has been increasing steadily in the last 20 years; a growing number of Americans are aging. In the next four decades, the number of Americans who are 65 years old and older will amount to 23 percent of the total population.
According to the Centers for Disease Control and Prevention (CDC), there were 326,100 hip replacement surgeries performed in 2010. This is double than the numbers performed in the prior ten years. Even more hip replacement surgeries are expected to be performed in the future.
Major hip implant manufacturers, such as DePuy, Wright Medical, and Stryker, have developed alternative designs over time. One design feature that was thought to create more durable joints replaced the metal-on-ceramic joints with metal-on-metal construction.
Over time, concerns about metal-on-metal hip replacement devices began to arise. The metal surfaces rub against each other and cause metal debris to be created. The debris seeps into surrounding tissues and the rest of the body. As a result, numerous patients with these devices experience problems associated with these implants. This design has been taken off the market; yet, thousands of patients still have these implants today.
Although rare, infections after hip replacement surgery can occur. Symptoms of an infection include redness at the surgical incision site, pain, and fever. If the infection cannot be treated by a course of antibiotics, it might be necessary for the surgeon to operate to clean out the infection and apply antibiotics directly to the infection site. This is only possible within the first few weeks of surgery. After that, a revision surgery might be necessary to address the infection. In this case, the original implant is removed and a new one is put in its place.
If the infection was caused by a defective medical device, then a person may be entitled to recover compensation for medical expenses. Further compensation might be available if a medical device used during the procedure was defective and caused the infection.
There have been alleged reports of increased incidents of infection following hip surgeries when Bair Hugger warming blankets are used on patients. This is a forced-air warming blanket that is used to regulate body temperature during the procedure.
Recent published findings found that using these blankets may result in up to 1,000 times the number of airborne contaminants compared to traditional warming blankets and techniques. There is an ongoing multi-district litigation involving thousands of patients who suffered from infections following hip replacement surgeries.
Long-term complications following hip replacement surgery are possible. These are most prevalent when the implant is a metal-on-metal design. Conditions that have been found after hip replacement using this design include metallosis, pseudotumors, and cobalt and chromium metal poisoning.
Metallosis is a medical condition that leads to a variety of negative health impacts, including tissue and bone death and organ damage. Metallosis can also result in metal entering the bloodstream, causing nervous system, kidney, thyroid, and heart problems.
Symptoms associated with metallosis include the following:
Hip implants are expected to last at least 10 years. Metallosis typically begins to show signs within nine months to four years after surgery.
The U.S. Food and Drug Administration (FDA) regulates approval of both drugs and medical devices. Drugs must be proven to be safe and effective before being approved for use except for some very limited emergency uses. The FDA has a tiered approval system for medical devices that involves three classifications.
The FDA requires all medical device manufacturers to comply with the following:
Further controls depend on the class of the device. Classification is risk-based with devices posing more significant risk to the patient or the user being subjected to a more stringent approval process. The classifications include the following:
Before a company can market a medical device, it must get the FDA’s permission. A company can file a premarket notification 510(k) or request a premarket approval (PMA) from the FDA.
A 510(k) is submitted by a manufacturer if it plans to market a device that is substantially equivalent to a legally marketed device that does not require premarket approval. If the FDA agrees with the assessment, then the manufacturer can market the device immediately.
Most of the time, the FDA does not require any clinical evidence before making its determination on these requests. In contrast, a PMA is submitted by a manufacturer to the FDA along with sufficient valid scientific evidence to provide a reasonable assurance that the device is safe and effective for its intended use.
Sometimes, flaws in a device are realized after it has been marketed and used. Many metal-on-metal hip replacement medical devices fall into this category. A number of these from various manufacturers have been recalled over the years.
While recalls are often publicized in press releases, it is unlikely one will find out about recalls this way. First, contact the doctor and find out the manufacturer and model number of the hip replacement device.
Next, check on the FDA’s website where medical device recalls are listed to see if the implant has been recalled. If a person develops symptoms in the future, then they will have the information that is needed.
Sometimes, doctors knowingly implant defective devices. It will be important to evaluate whether a doctor knew of the recall at the time it was implanted. It is also possible that the device was not correctly implanted during surgery. A person may be entitled to compensation if the doctor’s malpractice was the reason for problems with the hip replacement.
Seeking compensation for injuries related to a defective implant will vary, depending on the number of defective medical devices, whether the doctor properly implanted the device, and other important considerations.
Medical device liability cases are often complex, so it is important seek legal counsel right away.
If you have experienced an infection following a hip replacement surgery, it is important that you understand your legal options. You may be entitled to seek compensation for your medical bills and pain and suffering. Our respected Philadelphia defective medical device lawyers at Brookman, Rosenberg, Brown & Sandler help clients with complicated defective medical device claims. Contact us online or call us at 215-569-4000 for a free consultation. Located in Philadelphia, we serve clients throughout Pennsylvania and New Jersey, including Delaware County, Chester County, and Philadelphia County.