Breast Implants

The Challenge

Breast augmentation and reconstruction are common operations for women who have suffered a mastectomy or for cosmetic purposes. Implants are manufactured with an outer shell, usually made of an elastomer like silicone, and filled with either silicone or saline. The shape and size of implant designs vary to accommodate patient preferences. The mechanical characteristics of these devices must be evaluated, following standards EN 12180 and ISO 14607, to ensure patient safety over time.

Our Solution

Breast implant testing is conducted to evaluate the performance of the design or material of a specific implant, and also for comparison with others on the market. A compression-fatigue test is used to evaluate the strength and life of the implant over time. With the implant mounted between compression platens, the test system must allow for cyclic compression of the implant for 2 million cycles at 200 cycles per minute. Instron^®'s 8800 fatigue testing system provides excellent accuracy and waveform fidelity when performing such fatigue tests in either load or position control. MAX™ software allows easy set-up of these straightforward cyclic tests, with variable data collection rates to optimize data storage and ensure that important data from events such as yield or failure is collected. Fatigue test systems can be run at higher frequencies to reduce test time without compromising the integrity of the test.

An impact resistance test is performed to ensure that the implant does not fail under sudden force. This test involves dropping a specified mass vertically onto the implant. In order to accurately control velocity and acceleration of the mass, as well as collect maximum impact load and deformation values, a Dynatup^® drop tower is highly recommended. The model 9250HV with Impulse™ machine control and data acquisition system accurately delivers a repeatable impact to the specimen while collecting load, time and energy data.

Tensile tests are commonly performed on the shell material to evaluate maximum strain and integrity of the joints. Gripping the material and accurate strain measurement are key factors in the test configuration. Instron's universal testing system together with pneumatic side action grips and a video extensometer accurately measures strain to ensure that the material does fail prematurely.