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3D Printed Face Implant Receives FDA Approval

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on Aug 22 2014 , 06:00:17
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@ShaniePhillips1

3D printed organs, skulls and vertebrae are just a few of the ways 3D printing can literally be a part of us. On Tuesday, biomedical devices company Oxford Performance Materials (OPM) announced the latest addition to 3D printed body parts: a 3D printed face.

OPM has received official FDA approval for a 3D printed facial device that can be used on patients in need of facial reconstructive surgery. The 3D printed OsteoFab® Patient-Specific Facial Device (OPSFD), which is the first and only FDA cleared 3D printed polymeric facial implant, is entirely customizable. It is made of different 3D printed parts that are made to fit each individual patient’s anatomical features.

The implant on the left next to a model of how it could be used. Source: CNET

The implant on the left next to a model of how it could be used. Source: CNET

What is equally revolutionary about the 3D printed facial implant is the drastic reduction in price it brings to facial reconstructive surgery. As it is tailor-made to each patient, the OPSFD reduces overall cost of ownership of a facial implant by reducing operating time, hospital stay duration and the chance of procedure complications. It also minimizes time before surgery as the implant can be 3D printed quickly.

Scott DeFelice, the CEO of OPM, referred to the FDA’s approval of the OPSFD as a paradigm shift:

“There has been a substantial unmet need in personalized medicine for truly individualized – yet economical – solutions for facial reconstruction, and the FDA’s clearance of OPM’s latest orthopedic implant marks a new era in the standard of care for facial reconstruction. 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. 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.”

Skulls and faces that fit together

Oxford Performance Materials also developed the first and only 3D printed customizable skull implant, which was approved by the FDA in February 2013 and later used to replace 75% of a patient’s skull. According to the president of OPM’s biomedical division, the two implants can now be used together for more complex cases.

“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,” said President of OPM Biomedical, Severine Zygmont.

There is no doubt 3D printing is changing the face of surgery (pun intended). It lowers costs, decreases recovery time and improves results. Lets hope this latest breakthrough soon ushers in even further advances in the field of medicine.

Shanie Phillips is a senior contributor and editor at Inside3DP.com. Originally from the UK, Shanie has also spent many years based in Singapore, the US and now Israel. In addition to writing for Inside3DP she also has work published on several other news and innovation sites. Drop her a line at shanie@inside3dp.com.

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