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