More than one million hip, knee and other joint replacement surgeries are performed each year in the U.S., most of which use bone cement to secure the artificial joint device in place. Most of the time, surgery will be successful, but some patients may experience serious complications.
In rare cases, bone cement may fragment and cause joint to loosen or may leak bone marrow, fat or cement into the bloodstream which can cause a serious complication known as Bone Cement Implantation Syndrome (BCIS). Notable bone cement manufacturers include Johnson & Johnson’s DePuy orthopedics unit, Biomet Zimmer ant others. All bone cement manufacturers have experienced some measure of concern with BCIS side effects.
BCIS may result in:
- Oxygen deficiency
- Low blood pressure
- Loss of consciousness
- Blood clots
- Cardiac arrest
Bone cement manufacturers may be facing a number of medical injury lawsuits due to complications of bone cement.
Bone Cement Side Effects
Bone Cement is a compound that is used to secure artificial joints and other bone stabilization devices in orthopedic procedures. It is composed of poly methyl methacrylate (PMMA) which is a type of synthetic glue used in a variety of technologies. Bone cement may be activated in a manner similar to epoxy or other resin-based glues and may also contain antibiotics, radiopaque crystals or other agents useful to the medical profession.
In some rare cases, the use of bone cement may result in complications including prosthetic loosening or fragmentation of cement due to premature breakdown. Fragmentation and loosening of the artificial joint device may result in severe pain and inflammation and may require revision surgery to correct and resolve the complications.
Revision surgery will remove a failed implant, clear debris remaining in joint space, and replace the failed artificial joint device with a new device. In some cases, more than one surgery will be required to repair and reconstruct tissue. Each additional surgery poses additional risk to the patient.
Bone Cement Implantation Syndrome (BCIS)
In more severe cases, patients may develop bone cement implantation syndrome (BCIS) which can result in a number of life-threatening complications including hypoxia, hypotension, cardiac failure and death.
BCIS is not well-understood, but typically occurs at the time of implantation, joint reduction or intraoperative manipulation of limb. Researchers have speculated that BCIS is caused, in part, by vasodilation which occurs in response to constituents of the glue. Other causes may include mechanical effects such as bone marrow leakage, fat leakage, bone particles, clots or other debris which may be transported to the heart and pulmonary system.
BCIS symptoms may appear immediately after bone cement is introduced and may be classified according to severity:
- Grade 1 – moderate hypoxia or decreased arterial pressure
- Grade 2 – severe hypoxia, hypotension or loss of consciousness
- Grade 3 – cardiovascular collapse
Grade 3 BCIS events may require cardiopulmonary resuscitation and may result in death. Certain risk factors may increase the chance for BCIS including:
- Pre-existing pulmonary hypertension
- Significant heart disease
- Bone growths or degradations
- Patients who are classified as ASA III or IV, indicating they have moderate to severe systemic disease
Bone Cement Preparation
HVC or high viscosity cement is reportedly preferred by surgeons as it is easier or quicker to prepare. It may, however, be more likely to cause complications.
Research studies have estimated that patients undergoing joint replacement or orthopedic surgery which uses HVC bone cement may experience hypoxia with oxygen levels low enough to deprive tissues, at a rate of up to 25%. Many of these patients may also suffer from low blood pressure during the procedure.
Studies have also indicated that the method of preparation of bone cement may also affect the chance of oxygen desaturation and blood pressure loss. When bone cement is mixed in a partial vacuum, fewer patients may experience complications however certain mixing conditions are not emphasized or promoted as necessary.
Illegal Bone Cement Testing
In the 1990s, a startup company, Norian which made a calcium phosphate bone cement product known as Norian XR, was acquired by Synthes, which was later acquired by Johnson & Johnson.
Bone cement product, Norian XR which was designed to expand and fill cracks in bone tissue once implanted, unfortunately resulted in the death of at least five patients. The U.S. FDA had not approved Norian XR use for spinal surgeries, indicating that testing would be required but the glue was illegally marketed to surgeons anyway, who used the cement and reported results to the company.
In 2010, Synthes pleaded guilty and agreed to pay $23.3 million in fines and settlements for conducting illegal testing and marketing. In 2011, four Synthes executives were fined $100,000 each and sentenced to prison terms for conducting unauthorized clinical trials and engaging in illegal marketing.
Synthes subsequently became part of the Johnson & Johnson orthopedics unit, DePuy Synthes.
Bone Cement Failure Lawsuits
Bone cement manufacturers including DePuy Orthopedics and parent company Johnson & Johnson, Biomet Zimmer, and other orthopedics companies are facing a number of HVC bone cement or BCIS lawsuits due to injuries caused by their products. One notable filing is allegations against the SmartSet GHB bone cement filed by a patient who received a knee implant which later loosened and caused severe pain and mobility problems.
Bone cement manufacturers have been accused of insufficiently testing their products, selling defective or dangerous products and failing to warn the public about the dangers of their products.
People who file medical products lawsuits like the bone cement lawsuits may be eligible for compensation for medical costs, lost wages, pain and suffering and other damages or wrongful death if a loved one has died. Each case is unique and should be evaluated by a legal expert.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.