Frequently Asked Questions

Included, below, are some frequently asked questions about the topic. However, these are not all-inclusive. Consulting a physician to learn more about treatment options and to answer any questions you may have is important. Only a physician can tell you if PRO-DENSE Injectable Regenerative Graft and the associated procedures discussed on this website are right for you or your child and any unique circumstances. Not everyone is a good candidate for PRO-DENSE Injectable Regenerative Graft. Evaluating whether PRO-DENSE Injectable Regenerative Graft is appropriate involves substantial discussion with a physician to adequately evaluate risks and benefit information including general risks and unique patient circumstances.

Q. What is a benign bone cyst or tumor?

A. This is a condition in which bone is replaced with fluid or abnormal tissue resulting in a bone void. There are many different types of cysts or tumors that present in different places in the skeleton and are common to different age groups including children and adolescents. These voids can lead to weakened bone and result in pain and/or fracture. It is important to understand that most of these tumors are actually benign (i.e. not cancerous) and do not spread to other parts of the body. They can often be treated non-surgically, and surgical treatment can be minimally invasive depending on the type of cyst involved.

Q. How do bone cysts and tumors form?

A. Unfortunately, this is not entirely well understood for some cysts and tumors. There are different causes for the different lesions which can make it difficult to determine how and where they come from. A surgeon will discuss you or your child’s condition with you for better understanding.

Q. Is the cyst/tumor cancer?

A. Benign bone tumors/cysts are not cancers and never metastasize or spread to other parts of the body. These tumors are typically localized and can be healed with the right treatment, although some can be persistent or recur.

Q. Which cysts/tumors are treated conservatively and which are treated with surgery?

A. The answer to this question is likely dependent on several factors, such as the type of cyst/tumor, the size and location, and aggressive nature among others. However, in general, if the lesion is relatively small and not in danger of fracture, and appears to have a more latent appearance (i.e. isn’t growing fast), a conservative treatment option may be available. Please consult your physician.

Q. How is a cyst/tumor treated surgically?

A. Again, depending on several factors, the cyst/tumor may be accessed with a small incision and injected, or may require more exposure of the bone with removal and bone grafting. A surgeon will assess these various factors and will choose the best approach based on his or her experience.

Q. What is PRO-DENSE and how does it work?

A. PRO-DENSE is a synthetic composite of calcium sulfate and calcium phosphate, two biocompatible materials that have been used in bone grafting for over 100 years.The composite is unique in how it resorbs in the body, and how the body responds by laying down dense, new bone. Pre-clinical work and clinical experience demonstrate that the rate at which the body resorbs the PRO-DENSE graft and replaces with newly regenerated bone seems to be timed just right.

Q. What are the risks of PRO-DENSE?

A. There are always risks inherit in any surgical procedure. A surgeon must evaluate the appropriateness of the procedure based on personal medical training and experience. Certain individuals should not undergo surgery. And, for certain individuals, this product may not be the best treatment option. For example, patients with pre-existing conditions, severe vascular or neurological disease, or patients who are pregnant may not be the best candidate for PRO-DENSE.

Possible adverse effects include but are not limited to:

  • Wound complications including hematoma, site drainage, bone fracture, infection, and other complications that are possible with any surgery
  • Fracture or extrusion of the bone void filler, with or without particulate debris generation
  • Deformity of the bone at the site
  • Incomplete, or lack of, osseous ingrowth into bone void, as is possible with any bone void filler
  • Transient hypercalcemia
  • Potential to pressurize material in a closed void, which could result in fat embolization and/or embolization of the device material into the blood stream


For more information on risks, specific to this product, please consult the
Indications/Contraindications portion of this website, by clicking here.

Clinical Data Support

There are several peer-reviewed published reports on the use of PRO-DENSE™ Click Here

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