I first heard of 3D printers being used to replace human body parts in an episode of Grey’s Anatomy. Little did I know that 3D printers are already being utilized in the real world for patients with bone disease or head traumas.
Several months ago, 3D printing helped a 22-year-old woman from the Netherlands who has a rare bone disease resulting in impeded vision and motor coordination. For this procedure, a mold of the woman’s skull was 3D printed, and from that a biocompatible plastic skull was made by the Australian company Anatomics.
After a successful implant procedure, the woman, whose name hasn’t been released, is back at work with no visible signs of surgery. Her vision has been fully restored.
In a freak accident in Spain, 27-year-old U.K. resident Jon Fenton broke every bone in his face, as well as all four limbs, when he fell from a fifth floor balcony. A 3D printer created a model of his skull and surgeons used it as a guide as they re-broke the facial bones to reconstruct his face.
Medical-grade titanium implants helped 29-year-old Stephen Power, a motorcycle accident victim in Wales whose cheekbones, top jaw, nose, and skull were broken despite the use of a helmet. Surgeons refractured and rebuilt his face with custom 3D-printed metal implants in a surgery that Powers said was “life changing” for him.
But perhaps the most exciting news in the 3D-printed facial implants field comes from Oxford Performance Materials (OPM) in Stamford, CT. The company uses its OsteoFab technology to produce medical and implant parts from a thermoplastic polymorphous plastic called polyetherketoneketone (PEKK).
Layer by layer, OPM prints 3D implants using laser sintering technology adapted for PEKK. The manufacturing process takes just two weeks or less.
According to Scott DeFelice, the president and CEO of OPM, the plastic material his company uses is preferred by surgeons for a variety of reasons. “Titanium conducts heat, so implants can get hot or cold, and it’s a stiffer material,” DeFelice says. “Plus, in comparison to other plastics, our material is more bone-like and more precise.”
Besides being lighter than titanium and non-heat conducive, OPM’s plastic is biocompatible, mechanically similar to bone in density and stiffness, and radiolucent, which means it doesn’t interfere with X-Rays. The implants also appear to be osteoconductive, which means they can work as scaffolding for the growth of a patient’s own bones, and the manufacturing technique OPM uses creates tiny surface details that encourage the growth of cells and allow bones to attach more easily to native tissue.
The company received its FDA clearance in February 2014, and just days later, the first implant operation in the United States was conducted on a man who was missing part of his cranial bone. The OPM implant, which took five days to fabricate, replaced 75 percent of his skull.
According to DeFelice, the company now makes about 50 skull implants a month for distribution in North America, South America, Europe, and the Middle East, with clearance coming soon for Japan.
But OPM is not stopping there. “We have submitted a request to the FDA for mid-face implants, which is a much bigger market than skulls,” DeFelice says. “Implants for spines, another potentially large market, are next, and we expect that over the next 24 to 36 months our implant production will rise to hundreds, perhaps thousands, per month.” Each bone replacement type has the potential to become a standalone market worth up to $100 million.
No one could be more grateful for this new technology than Ayan Oma Muhumed, a 27-year-old Somali woman. Muhumed had lived with a bullet hole in her face since the age of two when she was injured in the Somali Civil War. The Foundation for Orthopedic Reconstruction (FOR) arranged for Muhumed’s reconstructive surgery, with a team of surgeons and 20 volunteers donating their time and OPM donating the implant.
During surgery, the area damaged by the bullet that hit her face 25 years ago was replaced. The shy young woman, who was afraid to emerge from her home previously, has transformed into a more confident person fully participating in life once again.
“We love technology and challenges, but there is a lot of pleasure in doing this work, “DeFelice concludes. “We solve problems that couldn’t be solved before.”
Photo courtesy of OMP