It is difficult from a technical, cosmetic, and economic point of view to reconstructing large cranial defects. Large defects are patched with autologous bone, poly-methyl-methacrylate (PMMA), metal or mesh plates, ceramic hydroxyapatite or polymer reinforced with carbon fiber. There are specific advantages and problems with each material. PMMA-based implants are stable, biocompatible, non-conductive, chemically inert, radiolucent, and inexpensive and can be easily placed and modified.
What are cranial implants?
Cranioplasty is a neurosurgical procedure involving the repair of a cranial defect caused by trauma, tumor, neurosurgical procedures, and infection. The primary indications for cranioplasty are to protect cranial fluids and provide children with an untouched cranial vault for the normal development and growth of the brain. Consideration of esthetic and psychosocial implications is also required.
The ideal product for cranioplasty procedures should be malleable to accurately fit even complex cranial defects and depending on the cranial defect, it is expected to meet various requirements. With technological advancements, the accessibility of new materials and technological initiatives has increased. This presents the specificity for the patient population according to the treatment procedure and the surgeon.
In order to restore the skull contour and protect intracranial structures as well as normalize cerebral hemodynamics, cranial reconstruction is required. The different cranial implant helps to ensure correct alignment and preserve original aesthetics.
How has the industry grown in recent years?
• The high predominance of injury, wounds, road accidents
Traumatic brain injury (TBI) but also spinal cord injury (SCI) are progressively recognized as global health preferences because of the preventability for most injuries and the expensive and complex medical care they require. The TBI and SCI account for a significant portion of the global injury burden and are mainly caused by falls and road injuries.
The increase in TBI incidence over time may continue with an increase in population density, population getting older and increased use of motor vehicles, motorcycles, and bicycles. The number of people living with SCI is expected to increase due to population growth, which is significant due to the specialized care that people with SCI may require. Human brain injury causes vascular disruption and deposition in the neuropil of heme and iron compounds.
• Increasing incidence of neurological diseases
According to the World Health Organization, hundreds of millions of people worldwide are affected by neurological disorders: more than 50 million people have epilepsy; about 47 million people across the globe are affected by dementia. Common neurological disorders include epilepsy, headache, Parkinson's disease, and dementia, as well as neurological problems caused by other disorders, such as cerebrovascular disease and infections.
Also, the increase in life expectancy and the aging of the population at large in both developed and developing countries are likely to increase the pervasiveness of several chronic and progressive physical and mental illnesses, such as neurological disorders. As populations start aging around the world, neurological disorders in the coming years will put even greater pressure on healthcare services. However, existing intervention strategies to reduce non-communicable neurological disorders have low efficacy and are not implemented sufficiently, as is the case with many stroke prevention approaches.
• Cranioplasty procedures are becoming even more prevalent worldwide
Cranioplasty is a medical procedure performed after a previous decompressive craniectomy for ischemic or hemorrhagic disease, traumatic brain injury, or even after removal of cranial tumors. This surgical procedure helps to repair a defect on the cranial vault. Although it may seem to be an easy and routine operation, cranioplasty has a complication rate of up to 41 percent of cases. Infections, autologous bone flap resorption, and hematomas are the most commonly reported complications. Certain potential complications include wound dehiscence, seizures, hygroma, and poor cosmetic results.
One of the main factors that have increased the adoption of these implants across the globe is the increase in the target population that requires cranial implants. Cranioplasty is conducted mainly for traumatic injury following a craniectomy. Also, in all age groups, decompressive craniectomies or removals of tumors lead to cranioplasty. TBI leads to countless fatalities and continuous disabilities among individuals in the U.S. every year. TBI represents 282,000 hospitalizations and 2.5 million department visits to the emergency department. Over recent years, the frequency of TBI injuries has risen considerably. This has resulted in a nearly 47 percent rise in hospitalizations.
The cranial implants market is expanding exponentially with the growing prevalence of brain tumors and brain cancer. In addition, rising rates of injuries and head injuries contribute to the growth of the market for cranial implants. On the other hand, complicated manufacturing and high costs limit the growth of the market for cranial implants.
Typically, cranial defects were patched with metal plates or bone cement, and sometimes with stainless steel grids were implemented. The demerit of the conventional method is that in large reconstructions, particularly when the defect includes the craniofacial junction, a perfect fit and curvature can be difficult to achieve. Customized cranial implants include ease of implantation process, improved usability, reduced risk of complications and infections, and shortened operator time significantly.
In addition, advancements in the material used in cranial implant creation and high acceptance of advanced 3D printing are expected to create multiple opportunities in the future market. In particular, cranial implants are designed and built to the needs of the patient. Cranioplasty surgeries are designed to prevent untreated brain injuries and disease. Therefore, cranial implants are an important part of these operations. Such implants are made of plastic and other advanced materials with high temperature.