Indications, Safety, and Warnings Sacroplasty

DESCRIPTION

KYPHON™ Xpede™ Bone Cement is a polymethylmethacrylate (PMMA) that contains approximately 30% barium sulfate. It is designed for delivery in a highly viscous state.

INDICATIONS FOR USE

KYPHON™ Xpede™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathological fracture may include a symptomatic microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.

RISKS

The complication rate with Kyphon™ Balloon Kyphoplasty has been demonstrated to be low. There are risks associated with the procedure (e.g., cement extravasation), including serious complications, and though rare, some of which may be fatal. For complete information regarding indications for use, contraindications, warnings, precautions, adverse events, and methods of use, please reference the devices’ Instructions for Use included with the product.

Please see the package insert for the complete list of indications, warnings, precautions, and other important medical information.

CONTRAINDICATIONS

PMMA bone cement is contraindicated in the presence of active or incompletely treated infection at the site where the bone cement is to be applied, for treatment of non-pathological, acute traumatic fractures of the vertebra or sacrum, and in cases involving either displaced sacral fractures or compromise of the sacral foramina.

WARNINGS

• The sterile KYPHON™ Xpede™ Bone Cement is designed and intended for one time use only. Do not re-sterilize and/or re-use. Sterility is assured only if the unit container is not damaged.
• Maintain aseptic surgical technique to prevent possible infection including treatment site infection.
• Monitor patients carefully for any change in blood pressure during and immediately following the application of bone cement. Adverse patient reactions affecting the cardiovascular system, including Bone Cement Implantation Syndrome (BCIS), have been associated with the use of bone cements. Hypotensive reactions have occurred between 10 and 165 seconds following application of bone cement; they have lasted from 30 seconds to 5 or more minutes. Some have progressed to cardiac arrest. Patients should be monitored carefully for any change in blood pressure during and immediately following the application of bone cement, especially those potentially at increased risk for peri-operative death, including elderly patients, patients with underlying cardiac or pulmonary compromise, and patients being treated for multiple vertebral body fractures in one procedure.
• Cement leakage may cause tissue damage, nerve or circulatory problems, and other serious adverse events.
• Caution should be exercised during the mixing of the two components to prevent excessive exposure to the concentrated vapors of the monomer, which may produce irritation of the respiratory tract, eyes, and possibly the liver.
• Polymerization of the bone cement is an exothermic reaction, which occurs while the cement is hardening in situ. According to the ISO 5833 standard, the temperature can be as high as 90°C ± 5°C. The released heat may damage bone or other tissues surrounding the implant.
• The liquid component is a powerful lipid solvent. It should not be allowed to come into contact with rubber or surgical gloves. Should contact occur, the gloves may dissolve and tissue damage may occur. Wearing a second pair of gloves and adherence to the mixing instructions may diminish the possibility of hypersensitivity reactions. The mixed bone cement should not make contact with the gloved hand until the bone cement is being tested for the consistency of dough.
• Personnel wearing permeable contact lenses should not be near or involved in mixing the bone cement; soft contact lenses are permeable.
• The handling characteristics of bone cements are affected by operating room conditions, including the room temperature, temperature of the cement components prior to mixing, humidity, the geometry of the mixing apparatus, time spent mixing, and the geometry of the delivery device. Any change in one or more of these conditions can alter the handling characteristics of the bone cement, including the following:
  • Handling period – the time it takes for the bone cement to reach the doughy state (the cement has reached the doughy state when it no longer sticks to surgical gloves).
  • Working period – the time the bone cement remains in the doughy state, and can be delivered.
  • Hardening period – the time it takes for the bone cement to harden or until it can no longer be delivered.

The user must be aware of these factors and adjust technique to account for variability in operating room conditions.

• Avoid over-pressurization of the bone cement and do not insert the bone cement into the vertebral body until the bone cement has reached the doughy state. The cement has reached the doughy state when it no longer sticks to surgical gloves. Maintain patient positioning until the end of the polymerization process. Failure to do so may lead to extravasation of the bone cement beyond the site of its intended application and may or could damage the surrounding tissues.
• The safety of the bone cement in pregnant women or in children has not been established. Bone cement may adversely affect bone growth and fetal health.
  
• Difficulty in swallowing and blistering of the throat, alleged to be an allergic reaction to the use of bone cement, have also been reported.
• Do not mix more than one vial of liquid and one packet of powder together at any one time. Never modify the ratios between the liquid and solid components. Doing so can affect bone cement properties, including handling characteristics.
• Long-term follow-up is advised for all patients on a regularly scheduled basis. Inadequate filling or unanticipated postoperative events may affect the stability of the bone cement and/or the bone cement-bone interface. A fibrous tissue layer may develop between the cement and the bone, and loosening of the bone cement may occur leading to failure.
• KYPHON™ Xpede™ Bone Cement is provided in finished form with all the necessary components for use. The addition of radio pacifier, e.g. barium; antibiotics; or other drugs or materials to KYPHON™ Xpede™ Bone Cement is not recommended. Never add other substances or foreign bodies to the acrylic resin. The safety and effectiveness of adding such drugs or materials has not been evaluated and may cause patient harm.
• Modifying the polymerization time by either warming or cooling the bone cement and/or associated delivery devices has not been tested and could affect bone cement properties, including handling characteristics.

PRECAUTIONS

• Store product below 25°C. Keep the product at a temperature of 23 ± 1°C for a period of 24 hours prior to use.
• Never deliver bone cement into the vertebral body without the use of high quality fluoroscopic guidance capable of visualizing movement of bone cement.
• Only physicians thoroughly trained in the surgical use of bone cement and kyphoplasty or vertebroplasty should use KYPHON™ Xpede™ Bone Cement. The operator should have specific training and be familiar with the properties, handling characteristics, and application of the bone cement and adhere to the instructions for use.
• Do not use after the expiration date printed on the package. The device may not be safe or effective beyond its expiration date.
• Do not use damaged products. Prior to use, inspect the packaging and product to verify no damage has occurred.
• Follow the mixing and handling instructions to avoid contact dermatitis. Strict adherence to the instructions for mixing the powder and liquid components may reduce the incidence of this complication.
• Adequately ventilate the operating room to eliminate as much monomer vapor as possible. The liquid monomer is highly volatile and flammable. Ignition of monomer fumes caused by use of electrocautery devices in surgical sites near freshly implanted bone cements has been reported.
• Dispose of the polymer component in an authorized waste facility. The liquid component can be evaporated under a well ventilated hood or absorbed by an inert material and transferred in a suitable container for disposal.
• Use imaging techniques during needle placement and during injection. Extravasation can occur during cement injection if the needle is in an artery or vein, or if unseen microfractures are prevalent. Embolization can also occur if the needle is placed in an artery or vein. Cement extravasation may cause tissue damage, nerve or circulatory problems, and increase risk for future fractures.
• If bone cement is seen outside of the vertebral body/sacrum or in the circulatory system during the procedure, immediately stop the injection.
• Ensure immediate surgical support is available for urgent surgery, if required.

ADVERSE EVENTS

Serious adverse events, some with fatal outcome, associated with the use of acrylic bone cements intended for vertebroplasty or kyphoplasty include:

• Cardiac arrest
• Cerebrovascular accident
• Myocardial infarction
• Pulmonary embolism
• Cardiac embolism

Although the majority of these adverse events present early within the post-operative period, there have been some reports of diagnoses beyond a year or more after the procedure.

Other reported adverse events relevant to the anatomy being treated with acrylic bone cements include:

• Deep or superficial wound infection
• Fistula
• Hematoma
• Hemorrhage
• Heterotopic new bone formation
• Extravasation of bone cement beyond the site of its intended application potentially resulting in, but not limited to:
  • Compression or irritation of nerve structures, such as the spinal cord or nerve roots, causing radiculopathy, parasthesia, paraplegia or paralysis.
  • Introduction into the vascular system resulting in embolism of the lung and/or heart or other clinical sequelae.
• Pyrexia due to allergy to bone cement.
• Short-term conduction irregularities.
• Thrombophlebitis.
• Transitory fall in blood pressure.
• Migration of hardened bone cement bolus.
• Extravasation of bone cement into sacral foramen or sacroiliac joint potentially resulting in but not limited to:
  • Compression or irritation of sacral nerve structures causing radicular pain.
  • Sacroiliac joint dysfunction