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One of the often unrecognized realities of having breast implants is that one day they will fail. Almost all women will eventually experience breast implant failure and have to have them replaced. The definition of breast implant failure is that the containment bag or shell develops a hole or a tear which can allow its contents to be released. For saline implants this results in deflation and obvious loss of breast size. For silicone implants, failure can be more occult since silicone gel is not absorbable and breast size does not immediately change, if ever.

 

Many patients understandably ask why do breast implants fail? Why does the shell fail and is it caused by anything that a patient does? And can it be prevented or the risk reduced?

 

The containment shell of a breast implant is composed of a flexible silicone elastomer material. In essence it is a very thin rubber-like material that can be stretched to varying degrees. This is essential because, like breast tissue, an implant must be capable of undergoing regular deformation of its shape. Breast implant shell failure occurs from three main causes. These can be categorized as physical deformities of the implant shell known as edge creases and valve failures and cyclical loading phenomenon of low stress repetitive loading and high stress one time loading.

 

Edge creases are where folds occur in the implant shell. Look carefully at any breast implant sitting on a table, saline-filled or silicone gel, and you will see varying degrees of folds present. These folds are the most common location where implant failure develops. These folds act as areas of increased material stress as motion occurs across and around them. This is why, for example, underfilling of saline breast implants is known to lead to earlier deflation because it creates more folds. It is also why stiffer more form-stable types of silicone gel implants (so called gummy bears) may lead to improved longevity of breast implants. Every implant has a valve or patch area where it is filled. This creates a seam between this valve area and the rest of the implant shell. This can be an additional area of failure if separation occurs.

 

Low stress repetitive loading are those events that occur all the time such as sleeping on one’s stomach, the up and down movement from running or the pressure of a tight uplifting bra. They do not put very much stress on the implant shell but, over a long period of time with enough repetitions, will cause an implant tear to develop. This is similar to the stretching of a rubber band. When done enough times, it will eventually break. This is known as cyclical loading and is what causes most things in life to fail, even the human body. These are events that I wouldn’t stop doing as they are part of everyday normal life. This includes mammograms but the risk of missing the detection of breast cancer is not worth protection of the shell in avoiding them.

 

High stress single time loading relates to injuries or traumatic events. High force loads, like being hit in the chest by an object (e.g., fall or motor vehicle accident) places stresses on the shell that they are not ideally designed to resist. As well designed as they are, according to the American Society of Testing Materials document F703 and the FDA guidance document for inflatable breast prostheses, breast implants can not be manufactured to the standards of resisting such forces any more than a window pane of glass can be cost-effectively made to resist the impact of a hammer.

 

Manufacturing breast implants is a balance of having a lifelike breast feel but being able to withstand low stress cyclical loading over a reasonable length of time. Breast implant failure is inevitable with average intact implant times of between 10 to 20 years. No one thinks of breast implants like the tires on their car…but they should.  With enough wear and mileage, both eventually need to be replaced.

 

Dr. Barry Eppley

Indianapolis, Indiana  

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