RFID-Embedded Breast Implants for Post-Implantation Identification

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Solution Overview

Problem

There is no accurate, economical, or practical way to identify breast implants already implanted in a patient's body, complicating recalls and control measures, especially for defective implants.

Innovation Solution

A breast implant with an embedded passive RFID transponder providing unique device identification, allowing post-implantation recognition and traceability, using a silicone elastomer shell with a patch covering an opening and a transponder positioned within the silicone gel filling.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Loss of information

If breast implants are made without integrated identification devices, then manufacturing is simpler and cost is lower, but there is no way to accurately identify or track implants after surgery

Engineering Contradiction:

Improveimplant identification informationVSAvoidimplant structure

Core Design Contradiction:

Loss of informationVSDevice complexity

Solution Approach 1:

The patent combines the identification function with the implant structure by integrating an RFID transponder directly into the implant. The transponder is embedded within the silicone gel filling, merging the identification device with the implant body into a single integrated unit that provides both structural and identification functions.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The implant structure serves multiple functions: it provides the breast augmentation function through the silicone shell and gel, while simultaneously serving as the identification carrier through the integrated RFID transponder. This multi-functionality eliminates the need for separate identification systems.

Inventive Principle:

Principle #6Universality (Multi-functionality)

2Loss of information

If patients undergo explantation procedures to identify defective implants, then implant identification is achieved, but patient trauma and medical costs increase

Engineering Contradiction:

Improveimplant identificationVSAvoidpatient trauma

Core Design Contradiction:

Loss of informationVSObject-affected harmful factors

Solution Approach 1:

The identification transponder is embedded into the implant during manufacturing before the implant is implanted into the patient. This preliminary action ensures that identification information is already in place and accessible through external scanning devices, eliminating the need for invasive explantation procedures to retrieve identification data.

Inventive Principle:

Principle #10Preliminary action

3Loss of information

If medical records are used to track implants, then some identification is possible, but records may be unavailable or inaccurate for recall and control

Engineering Contradiction:

Improveimplant tracking informationVSAvoididentification accuracy

Core Design Contradiction:

Loss of informationVSReliability

Solution Approach 1:

The implant provides its own identification through the integrated RFID transponder that can be scanned and read externally. This self-service capability means the implant carries its own identification data independently of external medical records, ensuring reliable and accurate tracking without dependence on record-keeping systems.

Inventive Principle:

Principle #25Self-service

4Loss of information

If a passive RFID transponder is embedded in the implant filling, then post-implantation identification is enabled, but the manufacturing process becomes more complex

Engineering Contradiction:

Improvepost-implantation device recognitionVSAvoidmanufacturing process

Core Design Contradiction:

Loss of informationVSEase of manufacture

Solution Approach 1:

The RFID transponder is nested within the silicone gel filling of the implant. This nesting approach allows the transponder to be incorporated during the filling process without requiring separate assembly steps, as the transponder becomes part of the filled implant structure through the existing filling hole and patch system.

Inventive Principle:

Principle #7Nested doll (Nesting)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

Enables convenient identification of breast implants within the body, ensuring accurate tracking and management of implants, including defective ones, without invasive procedures.

Implementation Method 1

the UDI is a passive RFID (radio frequency identification) transponder

Methodology Applied

Scientific EffectRFID (radio frequency identification): Electromagnetic Induction

Implementation Method 2

curing the silicone gel, wherein said gel curing further positions the transponder proximal to said patch and comprises heating the silicone-gel filled shell with transponder therein to a temperature of about 140° C. to 200° C. for up to about 8 hours

Methodology Applied

Scientific EffectGel curing: Heat Treatment

Implementation Method 3

applying a vacuum to the silicone gel-filled shell, removing air bubbles and positioning the transponder proximal to said patch

Methodology Applied

Scientific EffectVacuum: Vacuum

Data Source

PatentUS12396840B2Breast implants with integrated transponders

Publication Date: 2025.08.26 ESTABLISHMENT LABS SA

AI summary

The present disclosure provides, in various examples, an implant with a transponder embedded therein, and a method of identifying the implant while inside the human body. In certain examples, the method includes, for example, identifying an implant with an external reader and establishing a wireless communication between the external reader and the transponder. In an example, the implant is identified using information obtained during the wireless communication.