Breasts firmness testing
To detect ruptured breasts implants
With Tim Brown - Plastic Surgeon
(Australia) : www.timbrown.com.au
Working on the results of a very complete
study involving more than 50 patients
concerning a device for measuring soft
tissue firmness and its application in
cosmetic breast surgery
Agrosta has proposed to Tim 3 generations of devices,
with big improvements between each of them :
- The first machine had a visual abutment, and
hemispheric tip
- The second machine had a big head with 3 touch
sensors on the abutment
- The third machine had a touch sensor with a small
head, and was giving very consistent results
First generation firmness tester for breasts, with
hemispheric tip, and no tactile sensor on abutment
In order to assess inter and intra observer reproducibility,
10 observers measured breast implant firmness at nine
different regions of a single silicone breast implant,
placed on a hard flat surface. Each observer measured
the same point, 10 times consecutively. Inter-observer
reproducibility was the consistency of pressure readings
between different observers on the same point. Intra-
observer reliability was the consistency of pressure
readings each observer made on the same point.
Measurements of firmness of the implant confirmed that
inter observer error was unacceptable with the first
prototype. The limitations lay in the operator dependant
speed at which the probe was applied to the implant and
visual assessment of when abutment of the base plate on
the breast had occurred. Despite this, measurements
made by the same operator using the first prototype had
good reproducibility and were therefore used in this study.
The last instrument we have designed and proposed
includes a specific spheric tip, with a smaler abutment,
and a touch sensor (Copper ring fixed on the sensor
head)
This prototype addressed the problem of inter observer
error by including a touch sensor on the abutment, so the
contact was detected by the instrument ensuring
consistent deformation of the implant or breast. The
problem of inter operator speed was resolved by
including a timer that commences once the pressure
reaches 3 kgms-2 and stops as soon as the touch
sensors are in contact with the breast.
Several publications are available concerning
“Mammacompliance”, measuring Capsular Fibrosis, or
Identation Tonometry of breasts. Breast tonometry is
difficult because the breast varies in thickness and
density, and it overlies a hard chest wall. The results
achieved with silicone implants are usually assessed on
the basis of the clinical and therefore subjective
technique of Baker’s classification.
The implantation of silicone protheses for breast
augmentation is one of the most frequent operations
performed by plastic surgeons. The most feared
complication that can develop is capsular fibrosis, which
may adversely affect the cosmetic success of the
operation. None of the techniques for objectively
measuring capsular fibrosis has so far been wholly
convincing because the measuring devices available to
date have been too inaccurate and unreliable.
The last progresses of Makers technologies, like 3D
printing or Arduino boards with standard touch modules
allow KLOTZ Scientific to propose a very accurate and up
to date device with high accuracy for a reasonable price
This instrument is proposed for a price of 4800 €
including freight worldwide