Subcutaneous Implant Tests

In preclinical research, a subcutaneous implant is an implant that is introduced into subcutaneous tissue by surgery or injection and is used to deliver a drug over an extended period of time. Examples of drugs administered in this manner include proprietary test substances, insulin, hormones, and other long-acting drugs.

In general, a subcutaneous implant is a body modification that is placed under the skin, allowing the body to heal over the implant and creating an elevated design. These types of implants fall into the broad category of body modification. Many subcutaneous implants are manufactured from silicone, either carved or molded. Many people who use subcutaneous implants use them in conjunction with other body modifications to create the desired dramatic effect. This procedure is also known as three-dimensional implant.

The chip or test implant is placed in a pocket the surgeon creates in the skin. Once this medical device is placed, the wound is closed with wound clips, surgical adhesive, or interrupted stitches.

Today, the subcutaneous implant is approved in over 60 countries and is used by millions of people worldwide. These devices are widely used for long-acting birth control in the United States and Europe. Although relatively safe in nature, their implantation and removal may be associated with potential complications, some of which require surgical intervention.

There are essentially two main types of subcutaneous implants: subcutaneous implants and transdermal implants. There are also magnetic subcutaneous implants. Subcutaneous implants are completely embedded in the dermis (dermis is the layer of the skin between the epidermis and subcutaneous tissue, consisting of connective tissue and protecting the body against impacts). Transdermal implants are placed partially under the skin, leaving the rest exposed. The implant is first placed between the skin layers. The part of the implant to be placed under the skin must have a smooth shape.

The main standard taken into consideration in subcutaneous implant tests is the "ASTM F1408-20a Standard practice for subcutaneous screening test for implant materials" standard developed by the American Society for Testing and Materials (ASTM).

This standard describes a short-term test method for screening subcutaneous tissue reaction to implant candidate materials in small laboratory animals. The material can be dense or porous. This method may not work for absorbable materials depending on absorption kinetics. Tissue reactions are evaluated by comparing them with the responses evoked by control materials, which are considered clinical implant materials.

This test method, in conjunction with appropriate biological tests, including other ASTM test methods, is used to evaluate the biocompatibility of materials used in the manufacture of devices for clinical application. It is also suitable for evaluating the effect of special surface textures and known materials.

This test method does not provide a comprehensive assessment of the systemic toxicity, carcinogenicity, teratogenicity or mutagenicity of the material. Additional information regarding the final finished state of the material may be needed, such as evaluation of implantation at a clinically relevant location.

The ASTM F1408-20a standard is a guide for a short-term screening test to evaluate tissue response to materials that may be selected for implantation into the human body. This testing is performed before long-term testing to eliminate unsuitable candidate materials early and avoid unnecessary animal testing.

This application is generally used to detect the toxic effects of materials. However, it is particularly suitable for testing materials intended to come into contact with subcutaneous tissues or soft tissues in general. Especially for materials intended to be placed in muscle tissues, the "ASTM F763-04(2016) Standard practice for short-term screening of implant materials" standard is preferred.

given to businesses by our organization Among numerous testing, measurement, analysis and evaluation studies, there are also subcutaneous implant testing services.