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Rapid and Low-cost Prototyping of Medical Devices Using 3D Printed Molds for Liquid Injection Molding
Published on: June 27, 2014
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Current status of liquid injectable silicone.
1Department of Surgery (Plastic), New York Hospital-Cornell University Medical Center, 525 E. 68 St., 10021, New York, New York.
Aesthetic Plastic Surgery
|November 1, 2013
Summary
Liquid injectable silicone has potential in specific corrective surgeries but requires controlled use. Further research is needed to establish safety and efficacy before general availability.
Area of Science:
- Plastic and Reconstructive Surgery
- Biomaterials Science
Background:
- Liquid injectable silicone has a controversial history in corrective surgery.
- Previous studies yielded mixed results and raised safety concerns.
Purpose of the Study:
- To re-evaluate the safety and efficacy of liquid injectable silicone.
- To define the appropriate clinical applications and usage guidelines for liquid silicone.
Main Methods:
- A new, rigorous, and restrictive study protocol was developed in cooperation with the American Society of Plastic and Reconstructive Surgeons (ASPRS).
- The study, approved by the FDA, focuses on major tissue defects of the head and neck.
- A larger, geographically distributed group of investigators was selected, supervised by a medical monitor.
Main Results:
- The initial study was terminated due to protocol limitations.
- A new, more detailed protocol was designed to address safety and efficacy concerns.
- The new study aims for a 7-year duration with a limited patient cohort.
Conclusions:
- Liquid injectable silicone has potential benefits in limited, specific situations when used correctly.
- General availability is not recommended until safety, efficacy, and controlled usage are established.
- Further controlled studies are essential to determine the long-term status and acceptance of liquid silicone.
