"A pestilence on him for a mad rogue! He poured a flagon of Rhenish on my head once. This same skull, sir, was Yorick's skull, the king's jester."
- Gravedigger, Hamlet
Instantly identifiable as a unique construct, the human face is a complex structure dependent on its underlying architecture to provide it with subtle and unique features. Once the lattice that supports the face has been damaged, reconstructing it becomes a daunting prospect. How does a surgeon return the features to a broken face with any accuracy and fidelity to the original?
"There's been a substantial unmet need in personalized medicine for truly individualized – yet economical – solutions for facial reconstruction," said Scott DeFelice, Chief Executive Officer and Chairman of Oxford Performance Materials. "The FDA's clearance of OPM's latest orthopedic implant marks a new era in the standard of care for facial reconstruction."
Oxford Performance Materials, Inc. is an advanced materials and additive manufacturing company and their OsteoFab Patient-Specific Facial Device is now the first and only FDA cleared 3D printed polymeric implant for facial indications. The material and process follows on the heels of a similar FDA clearance of the first 3D printed polymeric implant, the company's OsteoFab Patient-Specific Cranial Device. That clearance was granted in February 2013.
This latest technological breakthrough was first tested a year ago when a patient had nearly 75% of their skull replaced with a biomedical printed part made from PEKK. PEKK polymer has properties which are very like human bone, and that makes it an ideal choice for skull repair.
"Until now, a technology did not exist that could treat the highly complex anatomy of these demanding cases. With the clearance of our 3D printed facial device, we now have the ability to treat these extremely complex cases in a highly effective and economical way, printing patient-specific maxillofacial implants from individualized MRI or CT digital image files from the surgeon," says DeFelice. "This is a classic example of a paradigm shift in which technology advances to meet both the patient's needs and the cost realities of the overall healthcare system."
The OPSFD prosthetic will be 3D printed by OPM Biomedical, an original equipment manufacturer of medical devices utilizing the company's OsteoFab process. The process uses laser sintering additive manufacturing technology and a proprietary powder formulation to print orthopedic and neurological implants.
These implants, biocompatible, mechanically similar to bone, radiolucent and capable of supporting bone attachment, decrease patient time in operating rooms, the length of hospital stays and cut down on post-surgical complications.
"An exciting aspect of our technology is that additional complexity does not increase manufacturing cost, and having both cranial and facial devices cleared now enables us to answer ever more complex cases where upper facial structures can be incorporated with cranial implants as a single device," adds Severine Zygmont, President of OPM Biomedical. "As a result, additive manufacturing has the potential to not only improve patient outcomes, but fundamentally improve the economics of orthopedics on a global scale – for developed and developing countries. These are disruptive changes."