3D Printed Facial Implant Approved by the FDA


Three-dimensional printing uses modified ink-jet printers to spray cells and biomaterials into shapes that mimic human organs, tissues and structures. These three-dimensional printers have been used to make a variety of implantable structures.

Last year, Oxford Performance Materials announced that they had successfully created a 3D-printed implant that could replace 75 percent of a patient’s skull. This OsteoFab Patient Specific Cranial Device was made of PEKK (Polyetherketoneketone) biomedical polymer and was printed by using CAD files that had been developed to personally fit each patient’s specific dimensions. PEKK is an ultra high performance polymer used in biomedical implants and other highly demanding applications. The PEKK polymer has the advantage of being biomechanically similar to bone. The Osteofab skull implant was approved by the FDA in February of 2013.

Osteofab

The success of OsteoFab laid the groundwork for the recent FDA approval of Oxford’s OsteoFab Patient-Specific Facial Device, a customizable implant for facial reconstruction.

ORM 3D printed facial implant

Implants like this are known as “biocompatible implants,” which behave mechanically, in this case, like real bone.  The techniques developed by Oxford Performance Materials allow engineers to fabricate pieces that match an individual patient’s specific facial dimensions and structure in a manner that reduces the overall cost of the procedures required to surgically reconstruct a face after devastating injury. Due to these technical advances pioneered by Oxford Performance Materials, facial implants can be fabricated very quickly, which allows the plastic surgeons to get the patient into surgery sooner rather than later.

“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,” said Scott DeFelice, CEO of Oxford Performance Materials, in a statement. “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.”

Oxford’s 3D-printed Osteofab cranial implants also have FDA approval and could potentially be combined with these facial implants into a single device for treating severe cases.  Although these facial implants have not yet been used in the United States, Oxford said the implants are now available to doctors and hospitals.

From artificial fingertips to airway splints that help babies breathe, 3D printing has provided the means to address complex surgical repairs.  The good news is that skull caps and facial bones are just the beginning of what 3D printing technologies can achieve.  We may soon see FDA approval for other bones, like knee caps, hips, and even small bones in the fingers and hands.

It’s all a part of a growing wave that could make 3D printers just as common as MRI machines in the tool kits used by physicians to repair and heal injured people.

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mburatov

Professor of Biochemistry at Spring Arbor University (SAU) in Spring Arbor, MI. Have been at SAU since 1999. Author of The Stem Cell Epistles. Before that I was a postdoctoral research fellow at the University of Pennsylvania in Philadelphia, PA (1997-1999), and Sussex University, Falmer, UK (1994-1997). I studied Cell and Developmental Biology at UC Irvine (PhD 1994), and Microbiology at UC Davis (MA 1986, BS 1984).