#7-2. Regulatory limitations of the 3D printing technology and future goals

Dr. Jung-whan Baek (H Plastic Surgery)

The artificial joint that had been implanted may have been the best choice with the medical technology currently available in Korea. However, some countries are already using 3D printing to produce customized joint replacements for each patient. It is regrettable that the latest technology is prevented from being applied to patients due to regulatory barriers.

Image 2. Use of a 3D printed joint replacement in other countries.

It has been reported that many patients with oral cancer have already benefited from 3D printed implants. Precisely customized 3D printed implants and joint replacements are becoming common. Korea has the technology to produce customized implants and joint replacements, however, this technology cannot be applied due to legal and regulatory hurdles.

Image 3-1. 3D CT image showing the lost gonial angle, asymmetric mandible body, and chin enlargement.

The most ideal treatment for this patient would be bone replacement surgery with a customized implant. However, I had to perform a reconstruction using 3D Fit PMMA (bone cement) for correction of asymmetry and aesthetic improvement.

Image 3-2. This 3D CT image shows moderate correction of the asymmetry of the mandible.

Image 3-3. The view from the bottom also shows that the left side of the mandible has been volume-enhanced with an implant to restore symmetry.

The most effective correction would have used a customized joint replacement, however, I regret that it was not possible due to regulatory limitations. A doctor may find it a lot more difficult to accept legal or regulatory limitations than technological and surgical limitations.

I would like to introduce another case of such limitations. This patient has gone through pre-operative preparation for the past year but is unable to receive surgery due to lack of authorization.