A large class-action lawsuit involving the use of a faulty medical device, Harley Davidson motorcycles and implants.
The “bone cement implantation syndrome” is a condition that occurs when the bone around an implanted medical device is compromised. The plaintiff in this lawsuit alleges that the manufacturer of the implant, HVC, was negligent and failed to warn consumers about potential complications from using the product.
Patients who were diagnosed with bone cement implantation syndrome or had joint implant revision surgery owing to bone cement failure may be eligible for a lawsuit.
Every year, about one million hip and knee replacement procedures are done. However, lawsuits claim that the bone cement used in these frequent operations might lead to uncommon but life-threatening problems.
Bone cement might break down, causing prosthesis to come loose. Complications such as bone cement implantation syndrome may occur when bone cement leaks bone marrow, fat, or cement into the circulation (BCIS). Oxygen shortage, low blood pressure, sudden loss of consciousness, blood clots, cardiac arrest, and even death may occur as a consequence of this illness.
Patients are suing goods makers for neglecting to warn the public about the dangers of their products. Fill out our free, no-obligation case evaluation to discover whether you or a loved one has been affected by BCIS or other bone cement-related issues.
What Are the Most Common Complications With Bone Cement?
Bone cement fragmenting, spilling into the circulation and surrounding tissue, and producing a variety of life-threatening illnesses have been documented by medical specialists.
When bone cement breaks, prostheses may become loose in patients’ bones, causing discomfort and a reduction in range of motion. The failure rate of high-viscosity cement (HVC) seems to be higher. Surgeons, on the other hand, prefer this sort of bone cement since it takes less time to produce.
DePuy ATTUNE knee replacement failures are linked to a high incidence of weak bone cement. Patients have stated that after two years of obtaining the ATTUNE knee replacement, the cement loosening from the implant caused the whole knee to collapse, necessitating revision surgery.
The circulation or surrounding tissue may be contaminated by bone marrow, fat, or cement.
Leaks may occur as a consequence of the use of bone cement. When bone cement is injected directly into the bone, it might seep from the needle into nearby tissue, veins, or along spinal nerves, causing nerve pain and other issues.
Bone marrow, fat, and cement may seep into the circulation when bone cement is used to bind prosthesis to the bone. Clogged arteries, pulmonary embolism, and cardiac arrest are all possible outcomes. These are all symptoms of bone cement implantation syndrome, an uncommon but frequently deadly illness (BCIS).
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Low Oxygen and Blood Pressure Linked to Bone Cement
Symptoms of BCIS might emerge as soon as the bone cement is administered. Hypoxia (insufficient oxygen to tissues), oxygen desaturation, low blood pressure, pulmonary embolism, cardiac arrest, and/or abrupt loss of consciousness are all common symptoms.
In one trial, 25% of patients who received bone cement had oxygen deficiency.
Recent study has shown a link between cemented hip replacements and oxygen deficiency (low blood oxygen).
In a study of 48 patients in France who had total hip arthroplasty, it was shown that eight of them (17%) suffered substantial oxygen desaturation.
Another research of 55 patients indicated that individuals who had a cemented long-stem hip replacement were more likely to have this problem. According to a 2002 research, oxygen desaturation occurred in 25% of patients.
The cemented long-stem hip replacement operation was also linked to low blood pressure, according to the researchers. Low blood pressure was a problem for 38% of the individuals.
The way the cement is manufactured might make a patient more prone to oxygen deprivation and high blood pressure. When the cement was mixed at atmospheric pressure, 53 percent of patients reported low blood oxygen and arterial pressure, according to a 2003 research published in Anaesthesia of 72 patients who underwent procedures to treat femoral fractures. Only 11% of patients had similar issues when the cement was mixed in a partial vacuum.
Synthes has agreed to pay $23.3 million in restitution for illegal bone cement tests.
One of the most well-known bone cement producers is Synthes. When marketing and distributing its Norian cement products, they reportedly disregarded not just safety advice, but also FDA instructions.
Synthes (now a Johnson & Johnson company) purchased Norian, a firm that created a calcium-phosphate cement named Norian XR, in the 1990s. When implanted, the cement might patch fractures and eventually turn into bone.
After taking Norian XR, at least five patients died on the operation table.
Despite the FDA’s requirement that Norian cement products be evaluated in clinical research before being authorized for spinal procedures, Synthes staff started marketing the product’s advantages to surgeons. Because Norian cement was not approved by the FDA for use in spinal procedures, selling it to surgeons for this reason was considered unlawful off-label marketing.
Some surgeons injected Norian cement into patients’ spines despite the absence of permission and comprehensive safety testing. On the operating table, at least five patients perished.
Synthes agreed to pay $23.3 million in penalties, confiscation, and a civil settlement after pleading guilty to performing fraudulent bone cement safety tests in 2010.
Four Synthes officials pled guilty a year later to allegations of conducting unlawful clinical research and off-label marketing. Each executive received a jail term and a $100,000 fine.
Lawsuits are being filed as a result of the failure of bone cement.
Some patients have sued bone cement makers, claiming that the cement failed to adequately hold implants in their joints.
According to a lawsuit filed against DePuy Orthopaedics in July 2018, the SmartSet GHB bone cement is substandard and harmful. Plaintiff Osa Green claimed that her knee implant loosened, causing extreme pain and trouble walking, necessitating revision surgery.
What is the Purpose of Lawsuits?
In product liability claims involving medical equipment such as bone cement, the makers are often accused of one or more of the following:
- Creating, selling, and/or distributing a faulty and unreasonably hazardous equipment.
- Inadequate testing of a medical device’s safety before marketing and distributing it.
- The public and medical community were not adequately warned about the device’s health concerns.
What Constitutes Eligibility for a Lawsuit?
You may be able to launch a claim against the manufacturers if you or a loved one had difficulties after having joint surgery using bone cement. These are some of them:
- Revision surgery is required due to implant loosening and debonding.
- Pneumonia, pulmonary embolism, and cardiac arrest are all symptoms of bone cement implantation syndrome.
Medical costs, lost pay, pain and suffering, and other damages may be recoverable via a lawsuit.
Problems with Bone Cement? We Can Assist
If you or a loved one had a pulmonary embolism, a cardiac event, or died as a result of a bone cement-related problem, you may be qualified to bring a lawsuit.
Our medical device lawyers have a lot of experience holding companies responsible for defective and harmful medical devices, such as hip and knee replacements. Please contact us right away to discover whether you are eligible for a lawsuit.
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The “class action lawsuits i may be eligible for” is a lawsuit that was filed against HVC Implantation Syndrome. The plaintiff alleges that the company has been negligent in providing proper instructions on how to use their product.
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