Bone Cement Lawsuit
Patients may qualify for a lawsuit if they were diagnosed with bone cement implantation syndrome or required joint implant revision surgery due to bone cement failure.
Roughly one million hip and knee replacement surgeries are performed every year. But lawsuits allege that the bone cement used in these common procedures may cause rare, but potentially life-threatening, complications.
Bone cement may fragment, causing prosthetics to loosen from the bone. Bone cement may also leak bone marrow, fat, or cement into the bloodstream, resulting in complications like bone cement implantation syndrome (BCIS). This condition may result in oxygen deficiency, low blood pressure, unexpected loss of consciousness, blood clots, cardiac arrest, and even death.
Patients are filing lawsuits against product manufacturers for failing to notify the public of these health risks. If you or a loved one suffered from BCIS or other bone cement-related complications, fill out our free, no-obligation case review to see if you qualify for a lawsuit.
What Are Common Bone Cement Complications?
Medical professionals have reported cases of bone cement fragmenting, leaking into the bloodstream and surrounding tissue, and causing a number of life-threatening conditions.
When bone cement fragments, it can cause prosthetics to loosen from patients’ bones, causing pain and decreased range of motion. High-viscosity cement (HVC) appears to be more prone to failing. Surgeons prefer this type of bone cement though because it requires less time to prepare.
Weak bone cement is associated with the high rate of DePuy ATTUNE knee replacement failures. Patients have complained that they required revision surgery within two years of receiving the ATTUNE knee replacement due to the cement loosening from the implant, causing the entire knee to destabilize.
Bone marrow, fat, and cement may leak into the bloodstream or surrounding tissue.
Bone cement application may also result in leakages. When bone cement is inserted directly into the bone, it may leak from the needle into surrounding tissue, veins, or along spinal nerves, causing nerve pain and other complications.
When bone cement is used to secure prosthetics to the bone, the pressure may also cause bone marrow, fat, and cement to leak into the bloodstream. This can result in clogged arteries, pulmonary embolism, and cardiac arrest. These are all symptoms of a rare, but often fatal, condition, known as bone cement implantation syndrome (BCIS).
Bone Cement Linked to Low Oxygen and Blood Pressure
BCIS symptoms can appear immediately after bone cement is applied. Common symptoms include hypoxia (deficient oxygen to tissues), oxygen desaturation, low blood pressure, pulmonary embolism, cardiac arrest, and / or unexpected loss of consciousness.
In one study, 25% of patients who received bone cement suffered from oxygen desaturation.
Recent research has shown an association between cemented hip replacement procedures and oxygen desaturation (low blood oxygen).
A study following 48 patients in France who received total hip arthroplasty found that eight patients—17%—developed significant oxygen desaturation.
Another study of 55 patients found that this complication was even more likely to happen among patients who received a cemented long-stem hip replacement. The 2002 study claimed that oxygen desaturation occurred in 25% of patients.
Researchers also noted an association between the cemented long-stem hip replacement procedure and low blood pressure. Thirty-eight percent of patients suffered from low blood pressure.
How the cement is prepared may increase the likelihood that a patient suffers from oxygen desaturation and arterial pressure. A 2003 study published in Anaesthesia of 72 patients who underwent surgeries to repair femoral fractures, found that when the cement was mixed at atmospheric pressure, 53% of patients suffered low blood oxygen and arterial pressure. But when the cement was mixed in a partial vacuum, only 11% of patients suffered from these complications.
Synthes Pays $23.3 Million for Illegal Bone Cement Tests
Synthes is one of the most notorious bone cement manufacturers. They not only ignored safety recommendations, but also FDA orders when they marketed and distributed their Norian cement products.
In the 1990s, Synthes (now a Johnson & Johnson subsidiary) bought Norian, a startup who made a calcium-phosphate cement product called Norian XR. The cement when implanted could fill cracks and gradually transform into bone.
At least five patients died on the operating table after receiving Norian XR.
Even though the FDA said that Norian cement products would need to be tested in clinical studies before it could be approved for spinal surgeries, Synthes employees began promoting the benefits of the product to surgeons. Since Norian cement didn’t have FDA approval for use in spinal surgeries, marketing the product to surgeons for this purpose constituted illegal, off-label marketing.
Despite the lack of approval and thorough safety testing, some surgeons injected Norian cement into patients’ spines. At least five patients died on the operating table.
In 2010, Synthes pleaded guilty to conducting illegal bone cement safety tests, and agreed to pay $23.3 million in fines, forfeiture, and a civil settlement.
One year later, four Synthes executives pleaded guilty to charges that the company ran unauthorized clinical trials and engaged in off-label marketing. Each executive was sentenced to prison and fined $100,000.
Bone Cement Failure Prompts Lawsuits
Some patients have also filed lawsuits against bone cement manufacturers for the cement’s failure to properly secure implants to joints.
A complaint filed in July 2018 against DePuy Orthopaedics alleges that the SmartSet GHB bone cement is defective and unreasonably dangerous. Plaintiff Osa Green claimed she had to undergo revision surgery after her knee implant loosened, causing severe pain and difficulty walking.
What Do Lawsuits Allege?
Product liability lawsuits involving medical devices like bone cement often allege that the manufacturers are responsible of some combination of the following:
- Designing, selling, and / or distributing a device is defective and unreasonably dangerous.
- Insufficiently testing the safety of a medical device prior to selling and distributing it.
- Insufficiently warning the public and the medical community of the health risks associated with the device.
Who is Eligible to File a Lawsuit?
If you or a loved one suffered from complications after undergoing a joint surgery that used bone cement, you may be eligible to file a lawsuit against the manufacturers. These include:
- Implant loosening and debonding, requiring revision surgery
- Bone cement implantation syndrome, including pulmonary embolism and cardiac arrest
A lawsuit may be to help recover compensation for medical bills, loss of wages, pain and suffering, and more.
Bone Cement Problems? We Can Help
If you or a loved one suffered from a bone cement-related complication, like pulmonary embolism, cardiac events, or death, you may be eligible to file a lawsuit.
Our medical device attorneys have extensive experience holding manufacturers accountable for faulty and dangerous medical equipment, including hip and knee replacements. Contact us today to see if you may qualify for a lawsuit.
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